Patient and Healthcare Provider Resource

Patient and Healthcare Providers Resource

OralChemoEdSheets.com, Patient + Healthcare Providers Resource

OralChemoEdSheets.com, the Patient and Healthcare Providers Resource

Revlimid®

(REV-lih-mid)

Revlimid® (Lenalidomide) is used to treat adult patients with certain types of blood cancers, including mantle cell lymphoma, multiple myeloma, and myelodysplastic syndrome. It may be used in combination with another medication, dexamethasone.

Revlimid® (Lenalidomide) is used to treat adult patients with certain types of blood cancers, including mantle cell lymphoma, multiple myeloma, and myelodysplastic syndrome. It may be used in combination with ano...

Page 1 LENALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — lenalidomide leh nuh LIH doh mide Brand name — Revlimid® REV lih mid Approved uses Lenalidomide is used to treat adult patients with certain types of blood cancers, including mantle cell lymphoma, multiple myeloma, and myelodysplastic syndrome. It may be used in combination with another medication, dexamethasone. Dose and schedule Taking lenalidomide as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose of lenalidomide will be determined by your overall health, diagnosis, and individual treatment needs. Lenalidomide is to be taken by mouth one time per day. Lenalidomide can be taken with or without food but at the same time each day. Lenalidomide should be taken whole and not opened, crushed, cut, or dissolved. If you are unable to swallow lenalidomide, talk to your care provider or pharmacist for possible options. If you miss a dose of lenalidomide: Only take the missed dose if it has been less than 12 hours since you were supposed to take it. Then, take the next dose at the regularly scheduled time. Do not take the missed dose if it has been more than 12 hours since you should have taken it. Simply take the next dose at the regularly scheduled time. Do not take two doses at one time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle lenalidomide with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store lenalidomide at room temperature 68°F–77°F in a dry location away from light. Keep lenalidomide out of reach of children and pets. Leave lenalidomide in the provided packaging until it is ready to be taken. Whenever possible, give lenalidomide to yourself and follow the steps below. If a family member, friend, or caregiver needs to give lenalidomide to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the lenalidomide from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. LENALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Page 2 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder is used, a separate one should be used for lenalidomide. Do not mix other medications into the box with lenalidomide. The person filling the box or reminder should wear gloves. Gloves are not necessary if you are filling the box or reminder. When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused lenalidomide, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of lenalidomide. If you are traveling, put your lenalidomide in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since lenalidomide remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take lenalidomide, it is important to follow the instructions below every day for as long as your treatment lasts. This will keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or lenalidomide with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Lenalidomide has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. LENALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Lenalidomide The common side effects that have been known to happen in more than 30% of patients taking lenalidomide are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased white blood cells WBCs and increased risk of infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk for having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection such as: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for fever or chills. Continued on the next page Serious side effects Lenalidomide can cause serious birth defects. Do not take lenalidomide if you are pregnant or think you might be pregnant. Lenalidomide can lower your white blood cells and your platelets, increasing your risk of infection and bleeding. Lenalidomide can increase your risk for a blood clot. LENALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water/fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Continued on the next page LENALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Constipation Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Stay active and exercise, if possible. Eat foods high in fiber like raw fruits and vegetables. Contact your care provider if you have not had a bowel movement in three or more days. Your care provider may recommend over the counter medications to help with your constipation. A daily stool softener such as docusate Colace® and/or laxative such as senna Senakot® may be helpful. If these do not help within 48 hours, tell your provider. Continued on the next page LENALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Page 6 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Possible Side Effect Management Rash or itchy skin Keep your skin moisturized with creams and moisturizing lotions to decrease the risk of rash or itchiness, and wear loose fitting clothing. Avoid using perfumes and cologne because these products may increase rash symptoms. Avoid being in the heat for long periods of time. Your provider may recommend an over the counter antihistamine or a topical cream. Sunlight can make symptoms worse. Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to ultraviolet UV radiation occurs from 10 am–4 pm. Wear long sleeved clothing, with UV protection if possible. Wear broad brimmed hats. Apply broad spectrum sunscreen UVA/UVB with at least SPF 30 as often as directed on the bottle. Use lip balm with at least SPF 30. If your rash or itching continues to worsen, contact your care provider. Back pain and muscle pain or spasms Keep a diary of your pain or spasms, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. Stay as active as possible, but know that it is okay to rest as needed, too. Tell your care provider if pain or spasms interfere with your activity. If the pain or spasms bother you, ask your provider what you may use to help with this discomfort. Take pain medication only that has been prescribed or recommended by your care provider. Nausea or vomiting Eat and drink slowly. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication that can help. LENALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Page 7 Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking lenalidomide, during any treatment breaks, and for at least four weeks after stopping this medication. Do not take lenalidomide if you are pregnant or think you might be pregnant. Lenalidomide can cause serious birth defects. If you think you might be pregnant, notify your care provider right away. Women of childbearing age and potential must have two negative pregnancy tests prior to starting lenalidomide and will need to repeat this test with each cycle or sooner. Women of childbearing age and potential should use two forms of birth control or go without having sex during treatment with lenalidomide and for at least four weeks after stopping treatment. Men who are taking lenalidomide must always wear a latex or synthetic condom during sex, during treatment breaks, and for at least four weeks after stopping lenalidomide because the drug can be found in sperm. Notify your care provider if you have unprotected sex with a woman. Do not donate sperm while taking lenalidomide, during treatment breaks, and for four weeks after stopping this medication. Do not breastfeed while taking lenalidomide and for four weeks after the last dose of lenalidomide. It is safe to hug and kiss, but the special precautions described above are required before sexual activity. Blood product donation It is recommended that you do not donate blood or blood products such as platelets while receiving lenalidomide and for at least four weeks after your last dose of lenalidomide. Obtaining medication Talk with your care provider about how to obtain your lenalidomide. Lenalidomide is available only through a Risk Evaluation and Mitigation Strategy REMS program, and prescribers, patients, and pharmacies must be certified with this REMS program. Only a 28 day supply of medication can be obtained from the pharmacy at one time, and this medication is not eligible for automatic refills. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.revlimid.com Product prescribing information: www.celgene.com/content/uploads/revlimid pi.pdf Product resources: www.celgenepatientsupport.com Updated — September 8, 2017 LENALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Page 8 Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2017 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional instructions

Ribociclib

(RY-boh-SY-klib)

Ribociclib (Kisqali®) is used to treat hormone receptor–positive (HR+) or human epidermal growth factor receptor 2–negative (HER2-) advanced or metastatic breast cancer. It is used in combination with an aromatase inhibitor.

Ribociclib (Kisqali®) is used to treat hormone receptor–positive (HR+) or human epidermal growth factor receptor 2–negative (HER2-) advanced or metastatic breast cancer. It is used in combination with an aroma...

Page 1 RIBOCICLIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — ribociclib RY boh SY klib Brand name — Kisqali® kis Kah lee Approved uses Ribociclib is used to treat hormone receptor–positive HR+ or human epidermal growth factor receptor 2–negative HER2 advanced or metastatic breast cancer. It is used in combination with an aromatase inhibitor. Dose and schedule Taking ribociclib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of ribociclib is 600 milligrams 600 mg to be taken by mouth once daily for 21 consecutive days followed by 7 days off treatment. Ribociclib can be taken with or without food, at the same time each day, preferably in the morning. Ribociclib should be taken whole and not crushed, cut, opened, or dissolved. If you are unable to swallow ribociclib, talk to your care provider or pharmacist for possible options. If you miss a dose of ribociclib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose, and let your care provider know about any missed doses. Storage and handling Handle ribociclib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store ribociclib at room temperature 68°F–77°F in a dry location away from light. Keep ribociclib out of reach of children and pets. Leave ribociclib in the provided packaging until it is ready to be taken. Whenever possible, you should give ribociclib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give ribociclib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the ribociclib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. A daily pill box or pill reminder is not recommended to be used with ribociclib. If you have any unused ribociclib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of ribociclib. RIBOCICLIB ORAL CHEMOTHERAPY EDUCATION Page 2 If you are traveling, put your ribociclib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since ribociclib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take ribociclib, it is important to know the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or ribociclib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Ribociclib has many drug interactions, please inform your care provider of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Grapefruit, pomegranate, grapefruit juice, or pomegranate juice may interact with ribociclib; avoid eating or drinking these during treatment with ribociclib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. RIBOCICLIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Ribociclib The common side effects that have been known to happen in more than 30% of patients taking ribociclib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection such as: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience: Shortness of breath Dizziness Palpitations Continued on the next page RIBOCICLIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Nausea or vomiting Eat and drink slowly. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Changes in liver function Your liver function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Unusual bleeding or bruising Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by 4 or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Continued on the next page RIBOCICLIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Hair loss alopecia Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with stress of hair loss. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking ribociclib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of three weeks after the last dose of ribociclib. Do not breastfeed while taking ribociclib and for three weeks after the last dose of ribociclib. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your ribociclib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.us.kisqali.com/metastatic breast cancer Product prescribing information: www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/ kisqali.pdf Product resources: www.us.kisqali.com/metastatic breast cancer/patient support/financial resources Updated — March 14, 2018 RIBOCICLIB ORAL CHEMOTHERAPY EDUCATION Page 6 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.

Rubraca®

(roo-BRAH-kuh)

Rubraca® (Rucaparib) is used to treat ovarian cancer in women who have a genetic mutation called BRCA.

Rubraca® (Rucaparib) is used to treat ovarian cancer in women who have a genetic mutation called BRCA.

Page 1 RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — rucaparib roo-KA-puh-rib Brand name — Rubraca® roo-BRAH-kuh Approved uses Rucaparib is used to treat ovarian cancer in women who have a genetic mutation called BRCA. Dose and schedule Taking rucaparib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of rucaparib is 600 milligrams 600 mg to be taken by mouth at a scheduled time twice a day. Rucaparib may be taken with or without food, but at the same time each day. Rucaparib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow rucaparib, talk to your care provider or pharmacist for possible options. If you miss a dose of rucaparib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle rucaparib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store rucaparib at room temperature 68°F–77°F in a dry location away from light. Keep rucaparib out of reach of children and pets. Leave rucaparib in the provided packaging until it is ready to be taken. Whenever possible, you should give rucaparib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the rucaparib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the rucaparib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for rucaparib. Do not mix other medications into the box with rucaparib. The person filling the box or reminder should wear gloves. Gloves are not necessary if you are filling the box or reminder. When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused rucaparib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of rucaparib. If you are traveling, put your rucaparib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since rucaparib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take rucaparib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low-flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or rucaparib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Rucaparib has many drug interactions. Please inform your care providers of all prescription medications, over-the-counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Rucaparib The common side effects that have been known to happen in more than 30% of patients taking rucaparib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in kidney function Your kidney renal function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Decreased amount of urination Swelling in your legs and feet Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed, too. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Nausea or vomiting Eat and drink slowly. Drink 8-10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Changes in liver function Your liver function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Continued on the next page RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low-fiber foods e.g., bananas, applesauce, potatoes, chicken, rice, toast . Avoid high-fiber foods e.g., raw vegetables, raw fruits, whole grains . Avoid foods that cause gas e.g., broccoli, beans . Avoid lactose-containing foods e.g., yogurt, milk . Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over-the-counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your health care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Continued on the next page RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Constipation Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day, unless your care provider has instructed you to limit your fluid intake because of some other health problem. Stay active and exercise, if possible. Eat foods high in fiber, like raw fruits and vegetables. Contact your care provider if you have not had a bowel movement in three or more days. Your care provider may recommend over-the-counter medications to help with your constipation. A daily stool softener, such as docusate Colace® , and/or a laxative, such as senna Senokot® , may be helpful. If these do not help within 48 hours, tell your provider. Changes in laboratory values high calcium levels Changes in some laboratory values may occur and will be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your healthcare provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red- or brown-colored urine Continued on the next page RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Decreased appetite or weight loss Talk to your care provider if you notice a sudden decrease in weight while taking this medication. When you do not feel like eating, try the following: Eat small frequent meals instead of three large meals each day. Keep snacks nearby so you can eat when you feel hungry. Take liquid nutritional supplements. Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Taste changes Some people experience a metallic or bitter taste in their mouth. To help with taste changes, try the following: Choose and prepare foods that look and smell good to you. Use plastic utensils if food tastes like metal. Flavor foods with spices to change taste. Suck on mints or chew gum to mask taste. Brush teeth before and after eating with a soft bristle toothbrush. Avoid smoking. Notify your doctor if you are having trouble eating or are losing weight. Abdominal pain Abdominal pain or discomfort may occur. Report any serious pain or symptoms to your care provider immediately. RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 7 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking rucaparib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of six months after the last dose of rucaparib. Do not breastfeed while taking rucaparib and for two weeks after the last dose of rucaparib. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on rucaparib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your rucaparib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 8 Additional resources Product website: www.rubraca.com Product prescribing information: clovisoncology.com/files/rubraca-prescribing-info.pdf Product resources: www.rubraca.com/support-resources Updated – August 14, 2017 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy-to-understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2017 by Hematology/Oncology Pharmacy Association. All rights reserved.

Rucaparib

(roo-KA-puh-rib)

Rucaparib (Rubraca®) is used to treat ovarian cancer in women who have a genetic mutation called BRCA.

Rucaparib (Rubraca®) is used to treat ovarian cancer in women who have a genetic mutation called BRCA.

Page 1 RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — rucaparib roo-KA-puh-rib Brand name — Rubraca® roo-BRAH-kuh Approved uses Rucaparib is used to treat ovarian cancer in women who have a genetic mutation called BRCA. Dose and schedule Taking rucaparib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of rucaparib is 600 milligrams 600 mg to be taken by mouth at a scheduled time twice a day. Rucaparib may be taken with or without food, but at the same time each day. Rucaparib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow rucaparib, talk to your care provider or pharmacist for possible options. If you miss a dose of rucaparib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle rucaparib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store rucaparib at room temperature 68°F–77°F in a dry location away from light. Keep rucaparib out of reach of children and pets. Leave rucaparib in the provided packaging until it is ready to be taken. Whenever possible, you should give rucaparib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the rucaparib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the rucaparib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for rucaparib. Do not mix other medications into the box with rucaparib. The person filling the box or reminder should wear gloves. Gloves are not necessary if you are filling the box or reminder. When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused rucaparib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of rucaparib. If you are traveling, put your rucaparib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since rucaparib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take rucaparib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low-flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or rucaparib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Rucaparib has many drug interactions. Please inform your care providers of all prescription medications, over-the-counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Rucaparib The common side effects that have been known to happen in more than 30% of patients taking rucaparib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in kidney function Your kidney renal function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Decreased amount of urination Swelling in your legs and feet Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed, too. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Nausea or vomiting Eat and drink slowly. Drink 8-10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Changes in liver function Your liver function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Continued on the next page RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low-fiber foods e.g., bananas, applesauce, potatoes, chicken, rice, toast . Avoid high-fiber foods e.g., raw vegetables, raw fruits, whole grains . Avoid foods that cause gas e.g., broccoli, beans . Avoid lactose-containing foods e.g., yogurt, milk . Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over-the-counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your health care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Continued on the next page RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Constipation Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day, unless your care provider has instructed you to limit your fluid intake because of some other health problem. Stay active and exercise, if possible. Eat foods high in fiber, like raw fruits and vegetables. Contact your care provider if you have not had a bowel movement in three or more days. Your care provider may recommend over-the-counter medications to help with your constipation. A daily stool softener, such as docusate Colace® , and/or a laxative, such as senna Senokot® , may be helpful. If these do not help within 48 hours, tell your provider. Changes in laboratory values high calcium levels Changes in some laboratory values may occur and will be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your healthcare provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red- or brown-colored urine Continued on the next page RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Decreased appetite or weight loss Talk to your care provider if you notice a sudden decrease in weight while taking this medication. When you do not feel like eating, try the following: Eat small frequent meals instead of three large meals each day. Keep snacks nearby so you can eat when you feel hungry. Take liquid nutritional supplements. Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Taste changes Some people experience a metallic or bitter taste in their mouth. To help with taste changes, try the following: Choose and prepare foods that look and smell good to you. Use plastic utensils if food tastes like metal. Flavor foods with spices to change taste. Suck on mints or chew gum to mask taste. Brush teeth before and after eating with a soft bristle toothbrush. Avoid smoking. Notify your doctor if you are having trouble eating or are losing weight. Abdominal pain Abdominal pain or discomfort may occur. Report any serious pain or symptoms to your care provider immediately. RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 7 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking rucaparib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of six months after the last dose of rucaparib. Do not breastfeed while taking rucaparib and for two weeks after the last dose of rucaparib. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on rucaparib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your rucaparib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 8 Additional resources Product website: www.rubraca.com Product prescribing information: clovisoncology.com/files/rubraca-prescribing-info.pdf Product resources: www.rubraca.com/support-resources Updated – August 14, 2017 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy-to-understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2017 by Hematology/Oncology Pharmacy Association. All rights reserved.

Ruxolitinib

(RUK-soh-LI-ti-nib)

Ruxolitinib (Jakafi®) is used to treat patients with myelofibrosis and polycythemia vera.

Ruxolitinib (Jakafi®) is used to treat patients with myelofibrosis and polycythemia vera.

Page 1 RUXOLITINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — Ruxolitinib RUK soh LI ti nib Brand name — Jakafi® JA kah fy Approved uses Ruxolitinib is used to treat patients with myelofibrosis and polycythemia vera. Dose and schedule Taking ruxolitinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of ruxolitinib is 5 milligrams 5 mg to 25 milligrams 25 mg to be taken by mouth at a scheduled time twice a day. Ruxolitinib can be taken with or without food but at the same time each day. Ruxolitinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow ruxolitinib, talk to your care provider or pharmacist for possible options. If you miss a dose of ruxolitinib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose, and let your care provider know about any missed doses. Storage and handling Handle ruxolitinib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store ruxolitinib at room temperature 68°F–77°F in a dry location away from light. Keep ruxolitinib out of reach of children and pets. Leaving ruxolitinib in the original packaging is preferred. Whenever possible, give ruxolitinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give ruxolitinib to you, they may also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the ruxolitinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. RUXOLITINIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for ruxolitinib. Do not mix other medications into the box with ruxolitinib. The person filling the box or reminder should wear gloves. Gloves are not necessary if you are filling the box or reminder. When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused ruxolitinib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of ruxolitinib. If you are traveling, put your ruxolitinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Because ruxolitinib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take ruxolitinib, it is important to follow the instructions below every day for as long as your treatment lasts. This will keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or ruxolitinib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Ruxolitinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Grapefruit or grapefruit juice may interact with ruxolitinib; avoid eating or drinking these during your treatment with ruxolitinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. RUXOLITINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Ruxolitinib The common side effects that have been known to happen in more than 30% of patients taking ruxolitinib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: A bloody nose that bleeds for more than 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or hold your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Continued on the next page RUXOLITINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in electrolytes and other laboratory values High cholesterol levels Changes in some laboratory values may occur and should be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling in your legs or feet Red or brown colored urine If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking ruxolitinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 30 days after the last dose of ruxolitinib. Do not breastfeed while taking ruxolitinib and for two weeks after the last dose of ruxolitinib. Inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on ruxolitinib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your ruxolitinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO RUXOLITINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Additional resources Product website: www.jakafi.com Product prescribing information: www..jakafi.com/pdf/prescribing information.pdf Product resources: www.jakafi.com/support and resources.aspx Updated — July 11, 2018 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.

Rydapt®

(RY-dapt)

Rydapt® (Midostaurin) is used to treat adult patients with a type of acute myeloid leukemia, and other blood cell disorders.

Rydapt® (Midostaurin) is used to treat adult patients with a type of acute myeloid leukemia, and other blood cell disorders.

Page 1 MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — midostaurin MY doh STAW rin Brand name — Rydapt® RY dapt Approved uses Midostaurin is used to treat adult patients with a type of acute myeloid leukemia, and other blood cell disorders. Dose and schedule Taking midostaurin as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of midostaurin is 50 milligrams 50 mg or 100 mg to be taken by mouth at a scheduled time twice a day. Midostaurin should be taken with food at the same time each day. Midostaurin should be taken whole and not opened, crushed, cut, or dissolved. If you are unable to swallow midostaurin, talk to your care provider or pharmacist for possible options. If you miss a dose of midostaurin, do not take an extra dose or two doses at one time. Simply take the next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle midostaurin with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store midostaurin at room temperature 68°F–77°F in a dry location away from light. Keep midostaurin out of reach of children and pets. Leave midostaurin in the provided packaging until it is ready to be taken. Whenever possible, give midostaurin to yourself and follow the steps below. If a family member, friend, or caregiver needs to give midostaurin to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the midostaurin from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. A daily pill box or pill reminder is not recommended to be used with midostaurin. MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 2 If you have any unused midostaurin, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of midostaurin. If you are traveling, put your midostaurin in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since midostaurin remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take midostaurin, it is important to follow the instructions below every day for as long as your treatment lasts. This will keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or midostaurin with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Midostaurin has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Grapefruit or grapefruit juice may interact with midostaurin; avoid eating or drinking these during treatment with midostaurin. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Midostaurin The common side effects that have been known to happen in more than 30% of patients taking midostaurin are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk for having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection such as: Fever temperature more than 100.4°F or 38°C Chills Sore or scratchy throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for fever or chills. Nausea or vomiting Eat and drink slowly. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication that can help. Continued on the next page MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in electrolytes and other laboratory values High glucose levels Low calcium levels High lipase levels High uric acid levels Low sodium levels Changes in some laboratory values may occur and should be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red or brown colored urine Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Mouth irritation or sores Practice good mouth care. Rinse your mouth frequently. Brush your teeth with a soft toothbrush or cotton swab after meals. Use a mild nonalcohol mouth rinse at least four times a day after eating and at bedtime . One example is a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm not hot water. If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care provider if you experience pain or sores in your mouth or throat. Continued on the next page MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water/fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Continued on the next page MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Headache Ask your provider what you may use to help with this discomfort. Contact your care provider right away if your headache: Follows a head injury Is severe, especially if it starts suddenly Does not go away after three days Is associated with vomiting, visual disturbance, neck stiffness, drowsiness, confusion, made worse by coughing or lowering the head, rash, weakness in an arm or leg, or numbness Fluid retention or swelling Do not stand for long periods of time. Keep your legs elevated when sitting or lying down. Avoid eating salty foods, which can increase swelling. Avoid wearing tight fitting clothing and shoes. Weigh yourself daily. Contact your care provider if you notice: Swelling in the hands, feet, or legs Shortness of breath Weight gain of five pounds or more in a week Continued on the next page MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 7 Possible Side Effect Management Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Abdominal pain Abdominal pain or discomfort may occur. Report any serious pain or symptoms to your care provider immediately. Muscle or joint pain Keep a diary of your pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. Stay as active as possible, but know that it is okay to rest as needed, too. Tell your care provider if pain or a spasm interferes with your activity. If the pain bothers you, ask your provider what you may use to help with this discomfort. Take pain medication only that has been prescribed or recommended by your care provider. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking midostaurin. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of four months after the last dose of midostaurin. Do not breastfeed while taking midostaurin and for four months after the last dose of midostaurin. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on midostaurin, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about how to obtain your midostaurin. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 8 Additional resources Product website: https://www.us.rydapt.com Product prescribing information: https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/ files/rydapt.pdf Product resources: https://www.us.rydapt.com/interested in/patient support Updated — September 8, 2017 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2017 by Hematology/Oncology Pharmacy Association. All rights reserved.

Soltamox®

(SOL-ta-mox)

Soltamox® (Tamoxifen Citrate) is used to treat certain types of hormone-dependent breast cancer and to prevent breast cancer in some high-risk individuals.

Soltamox® (Tamoxifen Citrate) is used to treat certain types of hormone-dependent breast cancer and to prevent breast cancer in some high-risk individuals.

Page 1 TAMOXIFEN ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — tamoxifen citrate tuh MOK sih FEN SIH trayt Brand name — Soltamox® SOL ta mox Approved uses Tamoxifen is used to treat certain types of hormone dependent breast cancer and to prevent breast cancer in some high risk individuals Dose and schedule Taking tamoxifen as instructed is important to allow your treatment to be as effective as possible so here are some key points to remember o Your dose may vary but the usual dose of tamoxifen is 20 milligrams 20 mg to be taken by mouth at a scheduled time once a day o Tamoxifen can be taken with or without food but at the same time each day o Tamoxifen should be taken whole and not crushed cut or dissolved If you are unable to swallow tamoxifen talk to your care provider or pharmacist for possible options o If you miss a dose of tamoxifen do not take an extra dose or two doses at one time Simply take your next dose at the regularly scheduled time Be sure to write down if you miss a dose and let your care provider know about any missed doses Storage and handling Handle tamoxifen with care Just like when chemotherapy is given into the vein this drug can be toxic and exposure of the drug to others should be limited o Store tamoxifen at room temperature 68°F–77°F in a dry location away from light o Keep tamoxifen out of reach of children and pets o Leave tamoxifen in the provided packaging until it is ready to be taken o Whenever possible give tamoxifen to yourself and follow the steps below If a family member friend or caregiver needs to give tamoxifen to you they also need to follow these steps 1 Wash hands with soap and water 2 Put on gloves to avoid touching the medication Gloves are not necessary if you give the drug to yourself 3 Gently transfer the tamoxifen from its package to a small medicine or other disposable cup 4 Administer the medicine immediately by mouth with water 5 Remove gloves and do not use them for anything else 6 Throw gloves and medicine cup in household trash 7 Wash hands with soap and water TAMOXIFEN ORAL CHEMOTHERAPY EDUCATION Page 2 o If a daily pill box or pill reminder is used a separate one should be used for tamoxifen Do not mix other medications into the box with tamoxifen The person filling the box or reminder should wear gloves gloves are not necessary if you are filling the box or reminder When empty the box or reminder should be washed with soap and water before refilling Be sure to wash hands with soap and water after the task is complete whether or not gloves are worn o If you have any unused tamoxifen do not throw it in the trash and do not flush it down the sink or toilet Talk to your care provider or pharmacist about proper disposal of tamoxifen o If you are traveling put your tamoxifen in a sealed plastic bag Ask your pharmacist if any additional travel precautions are needed Handling body fluids and waste Because tamoxifen remains in your body for several days after it is taken some of the drug may be present in urine stool sweat or vomit Once you have started to take tamoxifen it is important to follow the instructions below every day for as long as your treatment lasts This is to keep yourself loved ones and the environment as safe as possible o Pregnant women should avoid touching anything that may be soiled with body fluids from the patient o Toilet and septic systems You may use the same toilet septic tank and/or sewer that you usually use If you have a low flow toilet close the lid and flush twice to ensure all waste has been discarded If the toilet or toilet seat becomes soiled with urine stool or vomit clean the surfaces before other people use the toilet Wash hands with soap and water after using the toilet o If you need a bedpan be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day o If you do not have good control of bladder or bowels use a disposable pad with a plastic back a diaper or a sheet to absorb body waste o Wash any skin that has been exposed to body waste or tamoxifen with soap and water o Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing If you do not have a washer place the soiled linens in a plastic bag until they can be washed o Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids Drug and food interactions o Tamoxifen has many drug interactions Inform your care providers of all prescription medications over the counter medications vitamins and herbal products o Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines Serious side effects of tamoxifen o Tamoxifen can increase your risk of having a blood clot including stroke o Tamoxifen can increase your risk of endometrial cancer TAMOXIFEN ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Tamoxifen The common side effects that have been known to happen in more than 30% of patients taking tamoxifen are listed in the left side of this table You MAY NOT experience these side effects Options to help manage any side effects that do occur are included on the right side of this table These should be discussed with your care provider If you experience any side effect you cannot manage or that is not listed here contact your care provider Possible Side Effect Management Hot flashes sudden sweating and feelings of warmth If hot flashes are bothersome Mild regular exercise program may help Consult first with your care provider Try staying in a cool environment Wear layers so that you can remove outer layers when experiencing a hot flash Avoid or limit caffeine spicy food alcohol and stress which may worsen hot flashes Inform your care provider if your hot flashes are bothersome as there may be medications that can help Increased vaginal discharge If vaginal discharge is bothersome wear a mini pad throughout the day Notify your care provider if the discharge becomes bloody or has an unusual smell Fluid retention or swelling Do not stand for long periods of time Keep your legs elevated when sitting or lying down Avoid eating salty foods which can increase swelling Avoid wearing tight fitting clothing and shoes Weigh yourself daily Contact your care provider if you notice any of the following Swelling in the hands feet or legs Shortness of breath Weight gain of five pounds or more in a week If you experience ANY uncontrolled side effect call your physician or healthcare center immediately INSTITUTIONAL CONTACT INFO TAMOXIFEN ORAL CHEMOTHERAPY EDUCATION Page 4 Pregnancy sexual activity and contraception o Women should not become pregnant and men should not get a partner pregnant while taking tamoxifen Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of two months after the last dose of tamoxifen o Do not breastfeed while taking tamoxifen and for two months after the last dose of tamoxifen o Inform your care provider if you become pregnant o It is safe to hug and kiss Special precautions may be needed for sexual activity while on oral chemotherapy and you are encouraged to ask your care provider Obtaining medication o Talk with your care provider about the process for obtaining your tamoxifen PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website http //soltamox com Product prescribing information http //soltamox com/wp content/uploads/2016/07/Soltamox FDA Approved Package Insert pdf www accessdata fda gov/drugsatfda docs/label/2005/17970s053lbl pdf Product resources http //soltamox com/resources network Updated – August 30 2017 TAMOXIFEN ORAL CHEMOTHERAPY EDUCATION Page 5 Additional instructions Important notice The Association of Community Cancer Centers ACCC Hematology/Oncology Pharmacy Association HOPA National Community Oncology Dispensing Association Inc NCODA and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources This guide does not cover all existing information related to the possible uses directions doses precautions warnings interactions adverse effects or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional Provision of this guide is for informational purposes only and does not constitute or imply endorsement recommendation or favoring of this medication by ACCC HOPA NCODA or ONS who assume no liability for and cannot ensure the accuracy of the information presented The collaborators are not making any representations with respect to the medications whatsoever and any and all decisions with respect to such medications are at the sole risk of the individual consuming the medication All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional Permission Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise easy to understand information about oral cancer drugs Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information However commercial reproduction or reuse as well as rebranding or reposting of any type are strictly prohibited without permission of the copyright holder Please email permission requests and licensing inquiries to Contact@NCODA org Copyright © 2017 by Hematology/Oncology Pharmacy Association All rights reserved

Sonidegib

(soh-NIH-deh-gib)

Sonidegib (Odomzo®) is used to treat patients with basal cell carcinoma.

Sonidegib (Odomzo®) is used to treat patients with basal cell carcinoma.

Page 1 SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — sonidegib soh NIH deh gib Brand name — Odomzo® oh DOM zoh Approved uses Sonidegib is used to treat patients with basal cell carcinoma. Dose and schedule Taking sonidegib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of sonidegib is 200 milligrams 200 mg to be taken by mouth at a scheduled time once a day. Sonidegib should be taken on an empty stomach 1 hour before or 2 hours after a meal or snack and at the same time each day. Sonidegib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow sonidegib, talk to your care provider or pharmacist for possible options. If you miss a dose of sonidegib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle sonidegib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store sonidegib at room temperature 68°F–77°F in a dry location away from light. Keep sonidegib out of reach of children and pets. Leave sonidegib in the provided packaging until it is ready to be taken. Whenever possible, give sonidegib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give sonidegib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the sonidegib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for sonidegib. Do not mix other medications into the box with sonidegib. The person filling the box or reminder should wear gloves gloves are not necessary if you are filling the box or reminder . When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused sonidegib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of sonidegib. If you are traveling, put sonidegib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Because sonidegib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take sonidegib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or sonidegib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Sonidegib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Sonidegib should be taken on an empty stomach 1 hour before or 2 hours after a meal or snack . Grapefruit or grapefruit juice may interact with sonidegib; avoid eating or drinking these during treatment with sonidegib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Serious side effects of sonidegib Sonidegib can cause serious birth defects. Do not take sonidegib if you are pregnant or think you might be pregnant. Women should use effective contraception. Men should always use a condom even if you have had a vasectomy during sex with female partners who are pregnant or are able to become pregnant. See pregnancy, sexual activity, and contraception section on page 5 for more details. SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Sonidegib The common side effects that have been known to happen in more than 30% of patients taking sonidegib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in kidney function Your kidney renal function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Decreased amount of urination Swelling in your legs and feet Changes in electrolytes and other laboratory values High creatine phosphokinase levels High glucose levels High lipase levels Changes in some laboratory values may occur and will be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your healthcare provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red or brown colored urine Muscle or joint pain or weakness Keep a diary of your pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. Stay as active as possible, but know that it is okay to rest as needed, too. Tell your care provider if pain interferes with your activity. If the pain or weakness bothers you, ask your provider what you may use to help with this discomfort. Hair loss alopecia Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with stress of hair loss. Continued on the next page SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Taste changes Some people experience a metallic or bitter taste in their mouth. To help with taste changes, try the following: Choose and prepare foods that look and smell good to you. Use plastic utensils if food tastes like metal. Flavor foods with spices to change taste. Suck on mints or chew gum to mask taste. Brush teeth with a soft bristle toothbrush before and after eating. Avoid smoking. Notify your doctor if you are having trouble eating or are losing weight. Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Nausea or vomiting Eat and drink slowly. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication that can help. Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods e.g., bananas, applesauce, potatoes, chicken, rice, toast . Avoid high fiber foods e.g., raw vegetables, raw fruits, whole grains . Avoid foods that cause gas e.g., broccoli, beans . Avoid lactose containing foods e.g., yogurt, milk . Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Continued on the next page SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Weight loss Talk to your care provider if you notice a sudden decrease in weight while taking this medication. When you do not feel like eating, try the following: Eat small frequent meals instead of 3 large meals each day. Keep snacks nearby so you can eat when you feel hungry. Take liquid nutritional supplements. Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking sonidegib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 8 months for men and 20 months for women after the last dose of sonidegib. Do not breastfeed while taking sonidegib and for 20 months after the last dose of sonidegib. Inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your sonidegib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 6 Additional resources Product website: www.odomzo.com Product prescribing information: www.odomzo.com/themes/custom/odomzo/global/pdfs/pi.pdf Product resources: www.odomzo.com/support you need Updated – September 9, 2017 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2017 by Hematology/Oncology Pharmacy Association. All rights reserved.

Sorafenib

(sor-A-feh-nib)

Sorafenib (Nexavar®) is used to treat patients with unresectable hepatocellular carcinoma, advanced kidney cancer (renal cell carcinoma), or differentiated thyroid carcinoma.

Sorafenib (Nexavar®) is used to treat patients with unresectable hepatocellular carcinoma, advanced kidney cancer (renal cell carcinoma), or differentiated thyroid carcinoma.

Page 1 SORAFENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — sorafenib sor A feh nib Brand name — Nexavar® NEK suh var Approved uses Sorafenib is used to treat patients with unresectable hepatocellular carcinoma, advanced kidney cancer renal cell carcinoma , or differentiated thyroid carcinoma. Dose and schedule Taking sorafenib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of sorafenib is 400 milligrams 400 mg to be taken by mouth at a scheduled time twice daily continuously without a scheduled off treatment period. Sorafenib should be taken on an empty stomach one hour before or two hours after a meal or snack at the same time each day. Sorafenib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow sorafenib, talk to your care provider or pharmacist for possible options. If you miss a dose of sorafenib: Do not take an extra dose or two doses at one time. Simply take the next dose at the regularly scheduled time. Be sure to write down if you miss a dose, and let your care provider know about any missed doses. If you need to have surgery, tell your care provider you are taking sorafenib. Sorafenib may need to be stopped until your wound heals after some surgeries. Storage and handling Handle sorafenib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store sorafenib at room temperature 68°F–77°F in a dry location away from light. Keep sorafenib out of reach of children and pets. Leave sorafenib in the provided packaging until it is ready to be taken. Whenever possible, give sorafenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give sorafenib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the sorafenib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for sorafenib. Do not mix other medications into the box with sorafenib. The person filling the box or reminder should wear gloves gloves are not necessary if you are filling the box or reminder . When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused sorafenib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of sorafenib. If you are traveling, put your sorafenib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Because sorafenib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take sorafenib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or sorafenib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Sorafenib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Sorafenib should be taken on an empty stomach one hour before or two hours after a meal or snack . Grapefruit or grapefruit juice may interact with sorafenib. Avoid eating or drinking these during treatment with sorafenib. Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines. SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Sorafenib The common side effects that have been known to happen in more than 30% of patients taking sorafenib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods e.g., bananas, applesauce, potatoes, chicken, rice, toast . Avoid high fiber foods e.g., raw vegetables, raw fruits, whole grains . Avoid foods that cause gas e.g., broccoli, beans . Avoid lactose containing foods e.g., yogurt, milk . Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Pain or discomfort in hands and/or feet Hand foot skin reaction HFSR appears on the palms of the hands and soles of the feet. It can appear as a rash, callus, or peeling skin, and the area has increased sensitivity to heat or a “pins and needles” sensation. Let your care provider know right away if you experience this side effect. To prevent HFSR, you can do the following: Soak your feet in a water bath with Epsom salt and gently pumice any callused skin. Exfoliate and keep hands and feet moisturized. Avoid tight fitting shoes or socks. Use cushioning i.e., gloves when performing activities that increase pressure on the palms of your hands. Hair loss alopecia Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with the stress of hair loss. Continued on the next page SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Changes in electrolytes and other laboratory values Low albumin levels Low phosphate levels High lipase levels High thyroid levels Low calcium levels High international normalized ratio levels High amylase levels Changes in some laboratory values may occur and should be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red or brown colored urine Decreased appetite or weight loss Talk to your care provider if you notice a decrease in weight while taking this medication. When you do not feel like eating, try the following: Eat small, frequent meals instead of three large meals each day. Keep snacks nearby so you can eat when you feel hungry. Take liquid nutritional supplements. Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Continued on the next page SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal/diary and report these to your physician. Contact your healthcare provider for high blood pressure or if the following symptoms occur: Headache Dizziness Chest pain Shortness of breath Fluid retention, weight gain, or swelling Rash or itchy skin Keep your skin moisturized with creams and moisturizing lotions to decrease the risk of rash or itchiness, and wear loose fitting clothing. Avoid using perfumes and cologne as these products may increase rash symptoms. Avoid being in the heat for long periods of time. Your provider may recommend an over the counter antihistamine or a topical cream. Sunlight can make symptoms worse. Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to ultraviolet UV radiation occurs from 10 am–4 pm. Wear long sleeved clothing, with UV protection if possible. Wear broad brimmed hats. Apply broad spectrum sunscreen UVA/UVB with at least SPF 30 as often as directed on bottle. Use lip balm with at least SPF 30. If your rash or itching continues to worsen, contact your care provider. Abdominal pain Abdominal pain/discomfort may occur. Report any serious pain or symptoms to your care provider immediately. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 7 Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking sorafenib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of two weeks after the last dose of sorafenib. Men taking sorafenib should use condoms even after a vasectomy during therapy and for a minimum of two weeks after the last dose. Do not breastfeed while taking sorafenib and for one month after the last dose of sorafenib. Inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your sorafenib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.nexavar us.com/?WHGRedir=1 Product prescribing information: http://labeling.bayerhealthcare.com/html/products/pi/Nexavar PI.pdf Product resources: www.nexavar us.com/resources/?p=liver Updated – December 12, 2017 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2017 by Hematology/Oncology Pharmacy Association. All rights reserved.

Sprycel®

(SPRY-sel)

Sprycel® (Dasatinib) is used to treat adults and children with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+). Dasatinib is also used to treat adults with acute lymphoblastic leukemia (ALL) that is Ph+.

Sprycel® (Dasatinib) is used to treat adults and children with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+). Dasatinib is also used to treat adults with acute lymphoblastic l...

Page 1 DASATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — dasatinib da SA tih nib Brand name — Sprycel® SPRY sel Approved uses Dasatinib is used to treat adults and children with chronic myeloid leukemia CML that is Philadelphia chromosome–positive Ph+ . Dasatinib is also used to treat adults with acute lymphoblastic leukemia ALL that is Ph+. Dose and schedule Taking dasatinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of dasatinib is 100 milligram 100 mg to 140 milligrams 140 mg to be taken by mouth at a scheduled time once a day. Dasatinib can be taken with or without food, but at the same time each day. Dasatinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow dasatinib, talk to your care provider or pharmacist for possible options. If you miss a dose of dasatinib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose, and let your care provider know about any missed doses. Storage and handling Handle dasatinib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store dasatinib at room temperature 68°F–77°F in a dry location away from light. Keep dasatinib out of reach of children and pets. Leave dasatinib in the provided packaging until it is ready to be taken. Whenever possible, you should give dasatinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the dasatinib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the dasatinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. DASATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for dasatinib. Do not mix other medications into the box with dasatinib. The person filling the box or reminder should wear gloves. Gloves are not necessary if you are filling the box or reminder. When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused dasatinib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of dasatinib. If you are traveling, put your dasatinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since dasatinib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take dasatinib, it is important to follow the instructions below every day for as long as your treatment lasts. This will keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or dasatinib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Dasatinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Grapefruit or grapefruit juice may interact with dasatinib; avoid eating or drinking these during your treatment with dasatinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. DASATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Dasatinib The common side effects that have been known to happen in more than 30% of patients taking dasatinib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: A bloody nose that bleeds for more than 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or hold your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page DASATINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection such as: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience: Shortness of breath Dizziness Palpitations Fluid retention or swelling Do not stand for long periods of time. Keep your legs elevated when sitting or lying down. Avoid eating salty foods, which can increase swelling. Avoid wearing tight fitting clothing and shoes. Weigh yourself daily. Contact your care provider if you notice any of the following: Swelling in the hands, feet, or legs Shortness of breath Weight gain of five pounds or more in a week Continued on the next page DASATINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Headache Ask your provider what you may use to help with this discomfort. Contact your care provider right away if your headache: Follows a head injury Is severe or starts suddenly Does not go away after 3 days Is associated with vomiting, visual disturbance, neck stiffness, drowsiness, confusion, rash, weakness in an arm or leg, or numbness; or is made worse by coughing or lowering the head. Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by 4 or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking dasatinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 30 days after the last dose of dasatinib. Do not breastfeed while taking dasatinb and for two weeks after the last dose of dasatinib. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on dasatinib, and you are encouraged to ask your care provider. DASATINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Obtaining medication Talk with your care provider about the process for obtaining your dasatinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: https://www.sprycel.com Product prescribing information: https://packageinserts.bms.com/pi/pi sprycel.pdf Product resources: https://www.sprycel.com/resources Updated — March 6, 2018 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.

Stivarga®

(stih-VAR-guh)

Stivarga® (Regorafenib) is used to treat colorectal cancer, gastrointestinal stromal tumor, and hepatocellular carcinoma.

Stivarga® (Regorafenib) is used to treat colorectal cancer, gastrointestinal stromal tumor, and hepatocellular carcinoma.

Page 1 REGORAFENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — regorafenib REH goh RA feh nib Brand name — Stivarga® stih VAR guh Approved uses Regorafenib is used to treat colorectal cancer, gastrointestinal stromal tumor, and hepatocellular carcinoma. Dose and schedule Taking regorafenib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of regorafenib is 160 milligrams 160 mg to be taken by mouth at a scheduled time once a day for the first 21 days of each 28 day cycle. Regorafenib should be taken with water after a low fat meal that contains less than 600 calories and less than 30% fat and at the same time each day. Two examples are a 1% low fat cottage cheese 4 ounces , 1 English muffin with 1 tablespoon of fat free butter, 1 tablespoon of jam, and 8 ounces of apple juice and b 1 cup of cooked pasta, 1/2 cup of meatless marinara sauce, 1.5 cups of vegetable salad, and 1 tablespoon of oil/vinegar salad dressing. Regorafenib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow regorafenib, talk to your care provider or pharmacist for possible options. If you miss a dose of regorafenib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. If you need to have surgery, tell your care provider you are taking regorafenib. Regorafenib may need to be stopped until your wound heals after some surgeries. Storage and handling Handle regorafenib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store regorafenib at room temperature 68°F–77°F in a dry location away from light. Keep regorafenib out of reach of children and pets. Leave regorafenib in the provided packaging until it is ready to be taken. Whenever possible, give regorafenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the regorafenib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the regorafenib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. REGORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 2 A daily pill box or pill reminder is not recommended for use with regorafenib. If you have any unused regorafenib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of regorafenib. If you are traveling, put your regorafenib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Because regorafenib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take regorafenib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or regorafenib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Regorafenib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with regorafenib; avoid eating or drinking these during treatment with regorafenib. Talk with your care provider or pharmacist before receiving any vaccines. Serious side effects of regorafenib Regorafenib can cause liver damage. Laboratory tests will be needed to monitor your liver function. REGORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Regorafenib The common side effects that have been known to happen in more than 30% of patients taking regorafenib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Kidney damage Your care provider will monitor your kidney function by checking the amount of protein in your urine. Changes in electrolytes and other laboratory values Low calcium levels Low phosphate levels Low sodium levels High lipase levels Changes in some laboratory values may occur and will be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red or brown colored urine Continued on the next page REGORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed, too. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Decreased appetite or weight loss Talk to your care provider if you notice a decrease in weight while taking this medication. When you do not feel like eating, try the following: Eat small frequent meals instead of three large meals each day. Keep snacks nearby so you can eat when you feel hungry. Take liquid nutritional supplements. Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Pain or discomfort in hands and/or feet Hand foot skin reaction HFSR appears on the palms of the hands and soles of the feet. It can appear as a rash, callus, or peeling skin, and the area has increased sensitivity to heat or a “pins and needles” sensation. Let your care provider know right away if you experience this side effect. To prevent HFSR, you can: Soak your feet in a water bath with Epsom salt and gently pumice any callused skin. Exfoliate and keep hands and feet moisturized. Avoid tight fitting shoes or socks. Use cushioning i.e., gloves when performing activities that increase pressure on the palms of your hands. Continued on the next page REGORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods e.g., bananas, applesauce, potatoes, chicken, rice, toast . Avoid high fiber foods e.g., raw vegetables, raw fruits, whole grains . Avoid foods that cause gas e.g., broccoli, beans . Avoid lactose containing foods e.g., yogurt, milk . Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page REGORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Mouth irritation or sores Practice good mouth care. Rinse your mouth frequently. Brush your teeth with a soft toothbrush or cotton swab after meals. Use a mild nonalcohol mouth rinse at least 4 times a day after eating and at bedtime . One example is a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm not hot water. If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care provider if you experience pain or sores in your mouth or throat. Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal/diary and report these to your physician. Contact your healthcare provider for high blood pressure or if the following symptoms occur: Headache Dizziness Chest pain Shortness of breath Fluid retention, weight gain, or swelling Voice changes or hoarseness These changes are not permanent and should go away when you are not taking the medication. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking regorafenib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of two months after the last dose of regorafenib. Do not breastfeed while taking regorafenib and for two weeks after the last dose of regorafenib. Inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. REGORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 7 Obtaining medication Talk with your care provider about the process for obtaining your regorafenib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.stivarga us.com Product prescribing information: http://labeling.bayerhealthcare.com/html/products/pi/Stivarga PI.pdf Product resources: www.stivarga us.com/useful resources Updated – September 26, 2017 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.

Sunitinib

(soo-NIH-tih-nib MA layt)

Sunitinib (Sutent®) is used to treat patients with gastrointestinal stromal tumor (GIST), advanced renal cell carcinoma (RCC), and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET).

Sunitinib (Sutent®) is used to treat patients with gastrointestinal stromal tumor (GIST), advanced renal cell carcinoma (RCC), and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET).

Page 1 SUNITINIB MALATE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — sunitinib malate soo NIH tih nib MA layt Brand name — Sutent® SOO tent Approved uses Sunitinib is used to treat patients with gastrointestinal stromal tumor GIST , advanced renal cell carcinoma RCC , and progressive, well differentiated pancreatic neuroendocrine tumors pNET . Dose and schedule Taking sunitinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of sunitinib is: 50 milligrams 50 mg to be taken by mouth at a scheduled time once a day for 4 weeks on treatment followed by 2 weeks off for GIST and RCC. 37.5 milligrams 37.5 mg to be taken by mouth at a scheduled time once a day continuously without a scheduled off treatment period for pNET. Sunitinib can be taken with or without food, but at the same time each day. Sunitinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow sunitinib, talk to your care provider or pharmacist for possible options. If you miss a dose of sunitinib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. If you need to have surgery, tell your care provider you are taking sunitinib. Sunitinib may need to be stopped until your wound heals after some surgeries. Storage and handling Handle sunitinib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store sunitinib at room temperature 68°F–77°F in a dry location away from light. Keep sunitinib out of reach of children and pets. Leave sunitinib in the provided packaging until it is ready to be taken. Whenever possible, give sunitinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give sunitinib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the sunitinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. SUNITINIB MALATE ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for sunitinib. Do not mix other medications into the box with sunitinib. The person filling the box or reminder should wear gloves gloves are not necessary if you are filling the box or reminder . When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused sunitinib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of sunitinib. If you are traveling, put your sunitinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Because sunitinib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take sunitinib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or sunitinib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Sunitinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with sunitinib; avoid eating or drinking these during treatment with sunitinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Serious side effects of sunitinib Sunitinib can cause serious liver problems. Laboratory tests will be needed to monitor your liver function. SUNITINIB MALATE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Sunitinib The common side effects that have been known to happen in more than 30% of patients taking sunitinib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Continued on the next page SUNITINIB MALATE ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Changes in kidney function Your kidney renal function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Decreased amount of urination Unusual swelling in your legs and feet Continued on the next page SUNITINIB MALATE ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Changes in electrolytes and other laboratory values High or low glucose levels High amylase or lipase levels High creatinine kinase levels High uric acid levels High or low calcium levels High or low phosphate levels Changes in some laboratory values may occur and should be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red or brown colored urine Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods e.g., bananas, applesauce, potatoes, chicken, rice, toast . Avoid high fiber foods e.g., raw vegetables, raw fruits, whole grains . Avoid foods that cause gas e.g., broccoli, beans . Avoid lactose containing foods e.g., yogurt, milk . Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Continued on the next page SUNITINIB MALATE ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Nausea or vomiting Eat and drink slowly. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication that can help. Mouth irritation or sores Practice good mouth care. Rinse your mouth frequently. Brush your teeth with a soft toothbrush or cotton swab after meals. Use a mild nonalcohol mouth rinse at least 4 times a day after eating and at bedtime . One example is a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm not hot water. If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care provider if you experience pain or sores in your mouth or throat. Decreased appetite or weight loss Talk to your care provider if you notice a sudden decrease in weight while taking this medication. When you do not feel like eating, try the following: Eat small frequent meals instead of 3 large meals each day. Keep snacks nearby so you can eat when you feel hungry. Take liquid nutritional supplements. Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Continued on the next page SUNITINIB MALATE ORAL CHEMOTHERAPY EDUCATION Page 7 Possible Side Effect Management Taste changes Some people experience a metallic or bitter taste in their mouth. To help with taste changes, try the following: Choose and prepare foods that look and smell good to you. Use plastic utensils if food tastes like metal. Flavor foods with spices to change taste. Suck on mints or chew gum to mask taste. Brush teeth with a soft bristle toothbrush before and after eating. Avoid smoking. Notify your doctor if you are having trouble eating or are losing weight. Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal/diary and report these to your physician. Contact your healthcare provider for high blood pressure or if the following symptoms occur: Headache Dizziness Chest pain Shortness of breath Fluid retention, weight gain, or swelling Heartburn Some people experience a burning discomfort in their stomach. To help with heartburn: Avoid smoking Limit your caffeine intake Elevate the head of your bed while sleeping or lying down Do not eat within 1 hour before going to bed Avoid foods that are fatty, caffeinated, alcoholic, or citrus. If the heartburn bothers you, ask your provider what you may use to help with the discomfort. Skin and hair color changes Changes to your skin and hair color may occur during treatment. They may both look yellow or get lighter in color. Usually they return to normal after treatment. Abdominal pain Abdominal pain/discomfort may occur. Report any serious pain or symptoms to your care provider immediately. SUNITINIB MALATE ORAL CHEMOTHERAPY EDUCATION Page 8 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking sunitinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of sunitinib. Do not breastfeed while taking sunitinib and for one month after the last dose of sunitinib. Inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your sunitinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.sutent.com Product prescribing information: http://labeling.pfizer.com/showlabeling.aspx?id=607 Product resources: www.sutent.com/help paying for sutent Updated – October 15, 2017 SUNITINIB MALATE ORAL CHEMOTHERAPY EDUCATION Page 9 Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional instructions

Our Foundation Sponsors

Our Sustaining Sponsors