Patient and Healthcare Provider Resource

Patient and Healthcare Providers Resource

OralChemoEdSheets.com, Patient + Healthcare Providers Resource

OralChemoEdSheets.com, the Patient and Healthcare Providers Resource

Zelboraf®

(ZEL boh raf)

Zelboraf® (Vemurafenib) is used to treat patients with melanoma who have a BRAF V600E mutation.

Zelboraf® (Vemurafenib) is used to treat patients with melanoma who have a BRAF V600E mutation.

Page 1 VEMURAFENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — vemurafenib (VEH myoo RA feh nib) Brand name — Zelboraf® (ZEL boh raf) Approved uses Vemurafenib is used to treat patients with melanoma who have a BRAF V600E mutation. Dose and schedule Taking vemurafenib 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 vemurafenib is 960 milligrams (960 mg) to be taken by mouth at a scheduled time twice a day. Vemurafenib can be taken with or without food but at the same time each day. Vemurafenib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow vemurafenib, talk to your care provider or pharmacist for possible options. If you miss a dose of vemurafenib: Take the missed dose only if it has been less than four 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 four 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 vemurafenib 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 vemurafenib at room temperature (68°F–77°F) in a dry location away from light. Keep vemurafenib out of reach of children and pets. Leave vemurafenib in the provided packaging until it is ready to be taken. Whenever possible, give vemurafenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give vemurafenib 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 vemurafenib 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. VEMURAFENIB ORAL CHEMOTHERAPY EDUCATION Page 2 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 vemurafenib. Do not mix other medications into the box with vemurafenib. 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, whether or not gloves are worn. If you have any unused vemurafenib, 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 vemurafenib. If you are traveling, put your vemurafenib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Vemurafenib remains in your body for several days after it is taken, so some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take vemurafenib, 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 vemurafenib 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 Vemurafenib 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. VEMURAFENIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Vemurafenib The common side effects that have been known to happen in more than 30% of patients taking vemurafenib 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 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 or a spasm interferes with your activity. If the pain or weakness bothers you, ask your provider how you may ease 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. 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. 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. Continued on the next page VEMURAFENIB 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 that can help. Sun sensitivity, sunburn easily 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. Skin tags (papillomas) Check your skin regularly for any new growths, moles, or warts. Tell your care provider about any changes in your skin. 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 vemurafenib. 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 vemurafenib. Do not breastfeed while taking vemurafenib and for two weeks after the last dose of vemurafenib. 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. VEMURAFENIB ORAL CHEMOTHERAPY EDUCATION Page 5 Obtaining medication Talk with your care provider about how to obtain your vemurafenib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.gene.com/patients/medicines/zelboraf Product prescribing information: https://www.gene.com/download/pdf/zelboraf prescribing.pdf Updated — September 3, 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.

Zolinza®

(zoh-LIN-zah)

Zolinza® (Vorinostat) is used to treat adult patients with cutaneous T-cell lymphoma (CTCL).

Zolinza® (Vorinostat) is used to treat adult patients with cutaneous T-cell lymphoma (CTCL).

Page 1 TER VORINOSTAT ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — vorinostat vor IN oh stat Brand name — Zolinza® zoh LIN zah Approved uses Vorinostat is used to treat adult patients with cutaneous T cell lymphoma CTCL . Dose and schedule Taking vorinostat 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 vorinostat is 400 milligrams 400 mg to be taken by mouth at a scheduled time once a day. Vorinostat should be taken with food, at the same time each day. Vorinostat should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow vorinostat, talk to your care provider or pharmacist for possible options. If you miss a dose of vorinostat, 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 vorinostat 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 vorinostat at room temperature 68°F–77°F in a dry location away from light. Keep vorinostat out of reach of children and pets. Leave vorinostat in the provided packaging until it is ready to be taken. Whenever possible, give vorinostat to yourself and follow the steps below. If a family member, friend, or caregiver needs to give vorinostat 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 venetoclax 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. If a daily pill box or pill reminder is used, a separate one should be used for vorinostat. Do not mix other medications into the box with vorinostat. 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.

Zydelig®

(zy-DEH-lig)

Zydelig® (Idelalisib) is used to treat adults with certain types of leukemias and lymphomas, specifically the following:
• Chronic lymphocytic leukemia (CLL)
•Follicular B-cell non-Hodgkin lymphoma (FL)
•Small lymphocytic lymphoma (SLL)

Zydelig® (Idelalisib) is used to treat adults with certain types of leukemias and lymphomas, specifically the following:
• Chronic lymphocytic leukemia (CLL)
•Follicular B-cell n...

Page 1 IDELALISIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — idelalisib i deh luh LIH sib Brand name — Zydelig® zy DEH lig Approved uses Idelalisib is used to treat adults with certain types of leukemias and lymphomas, specifically the following: Chronic lymphocytic leukemia CLL Follicular B cell non Hodgkin lymphoma FL Small lymphocytic lymphoma SLL Dose and schedule Taking idelalisib 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 idelalisib is 150 milligrams 150 mg to be taken by mouth at a scheduled time twice a day. Idelalisib can be taken with or without food, but at the same time each day. Idelalisib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow idelalisib, talk to your care provider or pharmacist for possible options. If you miss a dose of idelalisib, follow these guidelines: Only take the missed dose if it has been less than six 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 six 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 idelalisib 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 idelalisib at room temperature 68°F–77°F in a dry location away from light. Keep idelalisib out of reach of children and pets. Leave idelalisib in the provided packaging until it is ready to be taken. Whenever possible, you should give idelalisib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the idelalisib 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. IDELALISIB ORAL CHEMOTHERAPY EDUCATION Page 2 3. Gently transfer the idelalisib 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. If a daily pill box or pill reminder is used, a separate one should be used for idelalisib. Do not mix other medications into the box with idelalisib. 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 idelalisib, 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 idelalisib. If you are traveling, put your idelalisib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since idelalisib 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 idelalisib, 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 that 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 idelalisib 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 Idelalisib has many drug interactions. 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. Avoid live vaccines during treatment with idelalisib. IDELALISIB ORAL CHEMOTHERAPY EDUCATION Page 3 Serious side effects Idelalisib can cause serious liver damage. Idelalisib can cause severe diarrhea, inflammation of the colon commonly called colitis , or perforation hole of the intestine. Idelalisib can cause inflammation of the lungs commonly called pneumonitis . Idelalisib can increase your risk for infections that are very serious and may lead to death. Side Effects of Idelalisib The common side effects that have been known to happen in more than 30% of patients taking idelalisib 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: 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. 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 Abdominal pain Continued on the next page IDELALISIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Problems with your lungs Contact your provider if you have any new or worsening lung problems, including cough, shortness of breath, wheezing, or difficult breathing. This may be a sign of pneumonia an infection in the lungs or pneumonitis inflammation of the lungs . 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 four or more. You feel dizzy or lightheaded. You have diarrhea along with severe abdominal pain, nausea or vomiting, chills, or fever. 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. 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 idelalisib. 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 idelalisib. Do not breastfeed while taking idelalisib and for one month after the last dose of idelalisib. 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. IDELALISIB ORAL CHEMOTHERAPY EDUCATION Page 5 Obtaining medication Talk with your care provider about the process for obtaining your idelalisib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.zydelig.com Product prescribing information: www.gilead.com/~/media/Files/pdfs/medicines/oncology/zydelig/zydelig pi.pdf Product resources: www.zydeligaccessconnect.com/hcp Updated – January 15, 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.

Zykadia®

(zy-KAY-dee-uh)

Zykadia® (Ceritinib) is used to treat metastatic non-small cell lung cancer (NSCLC) that has a genetic mutation of the anaplastic lymphoma kinase (ALK) gene.

Zykadia® (Ceritinib) is used to treat metastatic non-small cell lung cancer (NSCLC) that has a genetic mutation of the anaplastic lymphoma kinase (ALK) gene.

Page 1 CERITINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name ceritinib (seh RIH tih nib) Brand name Zykadia® (zy KAY dee uh) Approved uses Ceritinib is used to treat metastatic non small cell lung cancer (NSCLC) that has a genetic mutation of the anaplastic lymphoma kinase (ALK) gene. Dose and schedule Taking ceritinib 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 ceritinib is 450 milligrams (450 mg) to be taken by mouth at a scheduled time once a day. Ceritinib should be taken with food at the same time each day. Ceritinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow ceritinib, talk to your care provider or pharmacist for possible options. If you miss a dose of ceritinib: 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 ceritinib 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 ceritinib at room temperature (68°F–77°F) in a dry location away from light. Keep ceritinib out of reach of children and pets. Leave ceritinib in the provided packaging until it is ready to be taken. Whenever possible, give ceritinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give ceritinib 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 ceritinib 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. CERITINIB ORAL CHEMOTHERAPY EDUCATION Page 2 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 ceritinib. Do not mix other medications into the box with ceritinib. 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 ceritinib, 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 ceritinib. If you are traveling, put your ceritinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since ceritinib 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 ceritinib, 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 ceritinib 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 Ceritinib 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 ceritinib; avoid eating or drinking these during treatment with ceritinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. CERITINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Ceritinib The common side effects that have been known to happen in more than 30% of patients taking ceritinib 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 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 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 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. Changes in kidney function Your kidney (renal) function will 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 CERITINIB ORAL CHEMOTHERAPY EDUCATION Page 4 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. 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 electrolytes and other laboratory values High glucose levels High amylase levels Low phosphorous 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 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. Continued on the next page CERITINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Abdominal pain Abdominal pain or discomfort may occur. Report any serious pain or symptoms to your care provider immediately. If these side effects occur with nausea and vomiting, you might have inflammation of your pancreas (pancreatitis). 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. Drink 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 ceritinib. Women of reproductive potential should use effective contraception during therapy and for a minimum of six months after the last dose of ceritinib. Men with female partners of reproductive potential should use effective contraception during therapy and for a minimum of three months after the last dose of ceritinib. Do not breastfeed while taking ceritinib and for two weeks after the last dose of ceritinib. 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 ceritinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) CERITINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Additional resources Product website: www.us.zykadia.com Product prescribing information: www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/ zykadia.pdf Product resources: www.us.zykadia.com/patient support/financial resources Updated – June 19, 2019 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 © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.

Zytiga®

(Zye-tee-ga)

Zytiga® (Abiraterone Acetate) is used in combination with prednisone to treat men with prostate cancer.

Zytiga® (Abiraterone Acetate) is used in combination with prednisone to treat men with prostate cancer.

ShowAll Page1ABIRATERONE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — abiraterone acetate (A-bih-RA-the-rone A-seh-tayt) Brand name — Zytiga® (zye-Tee-ga) Approved uses Abiraterone acetate is used in combination with prednisone to treat men with prostate cancer. Dose and schedule Taking abiraterone acetate 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 abiraterone acetate is 1,000 milligrams (1,000 mg) to be taken by mouth at a scheduled time once a day. o Abiraterone acetate must be taken without food (at least one hour before or two hours after a meal or snack) at the same time each day. o Abiraterone acetate should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow abiraterone acetate, talk to your care provider or pharmacist for possible options. o Prednisone is recommended to be dosed at 5 mg by mouth twice daily, with food. For example, if you take prednisone with your breakfast at 8 am, you may want to take abiraterone at 7 am or one hour before breakfast on an empty stomach. o If you miss a dose of abiraterone acetate or prednisone, 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 abiraterone acetate 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 abiraterone acetate at room temperature (68°F–77°F) in a dry location away from light. o Keep abiraterone acetate out of reach of children and pets. o Leave abiraterone acetate in the provided packaging until it is ready to be taken. o Whenever possible, give abiraterone acetate to yourself and follow the steps below. If a family member, friend, or caregiver needs to give abiraterone acetate 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 abiraterone acetate 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. ABIRATERONE ORAL CHEMOTHERAPY EDUCATION Page 2 o If a daily pill box or pill reminder is used, a separate one should be used for abiraterone acetate. Do not mix other medications into the box with abiraterone acetate. 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 abiraterone acetate, 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 abiraterone acetate. o If you are traveling, put your abiraterone acetate in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Abiraterone acetate remains in your body for several days after it is taken, so some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take abiraterone acetate, 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. 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 abiraterone acetate 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 Abiraterone acetate has many drug interactions. Inform your care providers of all prescription medications, over-thecounter medications, vitamins, and herbal products that you are taking. o Abiraterone acetate should be taken without food. o Grapefruit or grapefruit juice may interact with abiraterone acetate; avoid eating or drinking these during treatment with abiraterone acetate. o Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. ABIRATERONE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Abiraterone Acetate The common side effects that have been known to happen in more than 30% of patients taking abiraterone acetate 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 electrolytes and other laboratory values High trigylceride levels Low glucose levels Low sodium levels Changes in some lab 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 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 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, 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. Continued on the next page ABIRATERONE ORAL CHEMOTHERAPY EDUCATION Page 4 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Pregnancy, sexual activity, and contraception o Women should not become pregnant and men should not get a partner pregnant while taking abiraterone acetate. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of one week after the last dose of abiraterone acetate. 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 abiraterone acetate, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about how to obtain your abiraterone acetate (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.zytiga.com Product prescribing information: www.zytiga.com/shared/product/zytiga/zytiga-prescribing-information.pdf Product resources: www.zytiga.com/patient-and-caregiver-resources/zytiga-stories Updated – August 20, 2017 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. ABIRATERONE ORAL CHEMOTHERAPY EDUCATION Page 5 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