Patient and Healthcare Provider Resource

Patient and Healthcare Providers Resource

OralChemoEdSheets.com, Patient + Healthcare Providers Resource

OralChemoEdSheets.com, the Patient and Healthcare Providers Resource

Scemblix®

Asciminib (Scemblix®) is used to treat chronic myeloid leukemia (CML).

WAsciminib (Scemblix®) is used to treat chronic myeloid leukemia (CML).

Page 1 Name of your medication Generic name — asciminib (as-KIM-uh-nib) Brand name — SCEMBLIX® Approved uses Asciminib is used to treat chronic myeloid leukemia (CML). Dose and schedule Taking asciminib 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 asciminib is: • 80 milligrams (80 mg) to be taken by mouth at a scheduled time once a day OR • 40 milligrams (40 mg) to be taken by mouth at a scheduled time twice a day approximately 12 hours apart • 200 milligrams (200 mg) to be taken by mouth at a scheduled time twice a day approximately 12 hours apart o Asciminib should be taken without food, at the same time each day. Do not eat for at least 2 hours before and 1 hour after taking asciminib. o Asciminib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow asciminib, talk to your care provider or pharmacist for possible options. o If you miss a dose of asciminib: • For once daily dosing: 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. • For twice daily dosing: only take the missed dose if it has been less than 6 hours since you were supposed to take it. • 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. ASCIMINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Drug and food interactions o Asciminib has many drug interactions; please inform your care providers of all prescription medications, over-the-counter medications, vitamins, and herbal products. o Grapefruit or grapefruit juice may interact with asciminib; avoid eating or drinking these during treatment with asciminib. o Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle asciminib 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 asciminib at room temperature (68 to 77 F) in a dry location away from light. o Keep asciminib out of reach of children and pets. o Leave asciminib in the provided packaging until it is ready to be taken. o Whenever possible, you should give asciminib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the asciminib 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 asciminib 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. o A daily pill box or pill reminder is NOT recommended to be used with asciminib. o If you have any unused asciminib, 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 asciminib. o If you are traveling, put your asciminib in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed.

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

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.

Sutent®

(SOO-tent)

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

Sutent® (Sunitinib) 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

Tabloid®

(TAB-loyd)

Tabloid® (Thioguanine) is used to treat adult and pediatric patients with acute myeloid leukemia (AML).

Tabloid® (Thioguanine) is used to treat adult and pediatric patients with acute myeloid leukemia (AML).

Page 1 THIOGUANINE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — thioguanine THY oh GWAH neen Brand name — Tabloid® TAB loyd Approved uses Thioguanine is used to treat adult and pediatric patients with acute myeloid leukemia AML . Dose and schedule Taking thioguanine as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose is based on many factors, including your height and weight, overall health, and diagnosis. Thioguanine can be taken with or without food, but at the same time each day. Thioguanine should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow thioguanine, talk to your care provider or pharmacist for possible options. If you miss a dose of thioguanine, 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 thioguanine 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 thioguanine at room temperature 68°F–77°F in a dry location away from light. Keep thioguanine out of reach of children and pets. Leave thioguanine in the provided packaging until it is ready to be taken. Whenever possible, you should give thioguanine to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the thioguanine 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 thioguanine 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 thioguanine. Do not mix other medications into the box with thioguanine. 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. THIOGUANINE ORAL CHEMOTHERAPY EDUCATION Page 2 If you have any unused thioguanine, 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 thioguanine. If you are traveling, put your thioguanine in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since thioguanine 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 thioguanine, 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 thioguanine 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 Thioguanine 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. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. THIOGUANINE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Thioguanine The common side effects that have been known to happen in more than 30% of patients taking thioguanine 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 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 THIOGUANINE ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management 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 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 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 thioguanine. 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 thioguanine. Do not breastfeed while taking thioguanine and for one month after the last dose of thioguanine. 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 thioguanine. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO THIOGUANINE ORAL CHEMOTHERAPY EDUCATION Page 5 Additional resources Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2004/12429s022lbl.pdf Updated — February 5, 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.

Tabrectra™

(ta-BREK-tah)

Tabrectra™ (Capmatinib) is used to treat metastatic non-small cell lung cancer (NSCLC) that has a genetic mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

Tabrectra™ (Capmatinib) is used to treat metastatic non-small cell lung cancer (NSCLC) that has a genetic mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-app...

Page 1 CAPMATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — capmatinib (kap MA ti nib) Brand name — Tabrectra™ (ta BREK tah) Approved uses Capmatinib is used to treat metastatic non small cell lung cancer (NSCLC) that has a genetic mutation that leads to mesenchymal epithelial transition (MET) exon 14 skipping as detected by an FDA approved test. Dose and schedule Taking capmatinib 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 capmatinib is 400 milligrams (400 mg) to be taken by mouth at a scheduled time twice a day. Capmatinib can be taken (with or without) food, but at the same time each day. Capmatinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow capmatinib, talk to your care provider or pharmacist for possible options. If you miss a dose of capmatinib, 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. Drug and food interactions Capmatinib has many drug interactions. Please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice, Seville oranges (commonly found in marmalades), and star fruit may interact with capmatinib; avoid eating or drinking these during treatment with capmatinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Monitor caffeine intake. Capmatinib can increase the effects and duration of caffeine. Storage and handling Handle capmatinib 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 capmatinib at room temperature (68°F–77°F) in a dry location away from light. Keep capmatinib out of reach of children and pets. Whenever possible, you should give capmatinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the capmatinib 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 capmatinib from its package to a small medicine or other disposable cup. CAPMATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 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 will be used, contact your care team before using. • 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 capmatinib, 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 capmatinib. If you are traveling, put your capmatinib’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Capmatinib Below are common side effects that have been known to happen in about one third or more of patients taking capmatinib; these are listed on 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 • Decreased albumin • Increased amylase 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 • Abdominal pain Continued on the next page CAPMATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management 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 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 the following: • Swelling in the hands, feet, or legs • Shortness of breath • Weight gain of 5 pounds or more in a week 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. 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 CAPMATINIB 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 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. Serious side effects Capmatinib may cause your lung tissue to scar, which is called interstitial lung disease. Call your care team if you are feeling short of breath, have a fever, or have a lasting dry cough. While taking capmatinib, your skin may be more sensitive to the sun. Use sunscreen or protective clothing when out in the sun, even on cloudy days, and avoid tanning booths. Talk to your care team about other ways to prevent or manage this side effect. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since capmatinib 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 capmatinib, it is important to adhere to 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. CAPMATINIB ORAL CHEMOTHERAPY EDUCATION Page 5 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 capmatinib 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. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking capmatinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 7 days after the last dose of capmatinib. Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking capmatinib and for 7 days after the last dose of capmatinib. 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 capmatinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.hcp.novartis.com/products/tabrecta/met exon 14 skipping mutation nsclc Product prescribing information: www.novartis.us/sites/www.novartis.us/files/tabrecta.pdf Product resources: www.us.tabrecta.com/met exon 14 skipping mutation nsclc Updated – May 2020 Additional instructions CAPMATINIB ORAL CHEMOTHERAPY EDUCATION Page 6 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 © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved.

Tafinlar and Mekinist

(TA-fin-lar and MEH-kih-nist)

The combination of Tafinlar and Mekinistis used to treat a variety of cancers including melanoma, lung cancer, thyroid cancer or other cancers that have a certain mutation in a gene called BRAF. Tafinlar and Mekinist may also be used for other treatments.

The combination of Tafinlar and Mekinist is used to treat a variety of cancers including melanoma, lung cancer, thyroid cancer or other cancers that have a certain mutation in a gene called BRAF. Tafinlar and Mekinist may also be used for other treatments.

Page 1 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic Names – dabrafenib (duh-BRA-feh-nib) and trametinib (truh-MEH-tih-nib) Brand Name – Tafinlar (TA-fin-lar) and Mekinist (MEH-kih-nist) Common uses The combination of dabrafenib and trametinib is used to treat a variety of cancers including melanoma, lung cancer, thyroid cancer or other cancers that have a certain mutation in a gene called BRAF. Dabrafenib and trametinib may also be used for other treatments. Dose and schedule Taking dabrafenib and trametinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. o For both dabrafenib and trametinib, do not take two doses at one time, and be sure to write down if you miss a dose and to let your care provider know about any missed doses. o Do not take an additional dose of either medication if vomiting occurs after administration. Continue with the next scheduled dose. o Both dabrafenib and trametinib should be taken on an empty stomach. Take dabrafenib and trametinib 1 hour before or at least 2 hours after a meal. o Dabrafenib and trametinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow dabrafenib and trametinib, talk to your care provider or pharmacist for possible options. Drug and food interactions o Dabrafenib and trametinib have many drug interactions. Inform your care providers of all prescription medications, overthe counter medications, vitamins, and herbal products that you are taking. o Grapefruit or grapefruit juice may interact with dabrafenib; avoid eating or drinking these during treatment with dabrafenib. o Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Dabrafenib Trametinib Usual dose: 150 mg twice a day If you miss a dose: Only take if it has been less than 6 hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. Usual dose: 2 mg once daily If you miss a dose: Only take 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. Page 2 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION Storage and handling Handle dabrafenib and trametinib 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 dabrafenib at room temperature (68 to 77 F) in a dry location away from light. o Store trametinib in the refrigerator (36 to 46 F) in a sealed plastic bag or closed container to prevent exposure to food and spills. Do not freeze. o Keep dabrafenib and trametinib out of reach of children and pets. o Leave dabrafenib and trametinib in the provided packaging until it is ready to be taken. o Whenever possible, you should give dabrafenib and trametinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the dabrafenib and trametinib 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 dabrafenib and trametinib 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. o A daily pill box or pill reminder is not recommended to be used with dabrafenib or trametinib. o If you have any unused dabrafenib and trametinib, 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 dabrafenib and trametinib. o If you are traveling, put your dabrafenib and trametinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Page 3 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION Side Effects of Dabrafenib and Trametinib The common side effects that have been known to happen in about one third or more of patients taking dabrafenib and trametinib 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 glucose levels • Low sodium levels • Low phosphate levels • Low albumin levels • Low calcium levels • Low magnesium 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 Fever You may feel hot, cold and shivery, achy, or dizzy. This usually starts during the first month of therapy but could happen at any time. • Call your doctor immediately if you have a fever (temperature more than 100.4°F or 38°C). • Ask your doctor if you can take medicine to help with the fever. 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 Continued on the next page Page 4 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION 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 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 known that it is okay to rest as needed, too. • You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience: • Shortness of breath • Dizziness • Palpitations Nausea or vomiting • Eat and drink slowly. • 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 foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t lay 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. Continued on the next page Page 5 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION Serious side effects of abiraterone acetate o Secondary malignancy is the growth of a cancer months or years after treatment. This is a rare but possible side effect of dabrafenib. o Dabrafenib and trametinib may be harmful to your eyes. Be sure to inform your care provider of any issue you have with your vision, or pain in your eyes. Your provider may stop treatment with dabrafenib if your eyes are affected. o Serious fevers can occur when dabrafenib is used with trametinib. 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/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. Rash or thickening of the skin (hyperkeratosis) • 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 UV (ultraviolet) radiation occurs between the hours of 10 am and 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. Page 6 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION o If you have a G6PD deficiency, dabrafenib can increase risk for hemolytic anemia. Call your care team if you experience weakness, dizziness, yellowing of the skin or whites of your eyes, or dark or brown urine. o Trametinib may rarely cause irritation of your bowel or tear or hole in your intestine, called bowel perforation. Speak to your care team right away if you have diarrhea, high fever, nausea, vomiting, or severe stomach pain. o Trametinib may cause your lung tissue to scar, which is called interstitial lung disease, or swelling of lung tissue which is called pneumonitis. Call your care team if you are feeling short of breath, chest pain, have a fever, or have a lasting dry cough. o Dabrafenib and trametinib can cause serious birth defects. Do not take dabrafenib and trametinib if you are pregnant or think you might be pregnant. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: Handling body fluids and waste Since dabrafenib and trametinib 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 dabrafenib and trametinib, 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. 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 dabrafenib and trametinib 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. Pregnancy, sexual activity, and contraception o Women should not become pregnant and men should not get a partner pregnant while taking dabrafenib and trametinib. o Females of childbearing age and potential should use effective non-hormonal contraception during therapy and for a minimum of 2 weeks after the last dose of dabrafenib and effective contraception (may be hormonal) during therapy and for a minimum of 4 months after the last dose of trametinib. Page 7 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION 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 © 2022 by Hematology/Oncology Pharmacy Association. All rights reserved. o Males with female partners of reproductive potential should use effective contraception during therapy and for a minimum of 1 week after the last dose of dabrafenib and 4 months after trametinib. o Do not breastfeed while taking dabrafenib and trametinib and for 2 week after the last dose of dabrafenib and 4 months after the last dose of trametinib. o Please 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 team for assistance. Obtaining medication Talk with your care provider about the process for obtaining your dabrafenib and trametinib. Additional resources Product website: www.us.tafinlarmekinist.com Product prescribing information: www.novartis.com/us-en/sites/novartis_us/files/tafinlar.pdf, www.novartis.com/us-en/sites/novartis_us/files/mekinist.pdf Product website: www.us.tafinlarmekinist.com/advanced-melanoma, www.us.tafinlarmekinist.com/metastatic-nsclc Updated – December 19, 2022 Additional instructions

Tafinlar®

(TA-fin-lar)

Tafinlar® (Dabrafenib) is used to treat patients with: • Melanoma that has a genetic mutation called BRAF V600E or V600K and may be used in combination with trametinib. • Non-small cell lung cancer that has a genetic mutation called BRAF V600E and is used in combination with trametinib. •Anaplast...

Tafinlar® (Dabrafenib) is used to treat patients with: • Melanoma that has a genetic mutation called BRAF V600E or V600K and may be used in combination with trametinib. • Non-small cell lung cancer that has a...

Page 1 DABRAFENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — dabrafenib (duh BRA feh nib) Brand name — Tafinlar® (TA fin lar) Approved uses Dabrafenib is used to treat patients with the following: Melanoma that has a genetic mutation called BRAF V600E or V600K and may be used in combination with trametinib Non small cell lung cancer that has a genetic mutation called BRAF V600E and may be used in combination with trametinib Anaplastic thyroid cancer that has a genetic mutation called BRAF V600E and may be used in combination with trametinib Dose and schedule Taking dabrafenib 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 dabrafenib is 150 milligrams (mg) to be taken by mouth at a scheduled time twice a day. Dabrafenib should be taken twice daily and trametinib should be taken once daily at the same time every day. Both dabrafenib and trametinib should be taken on an empty stomach (one hour before or two hours after a meal or snack) and at the same time each day. Dabrafenib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow dabrafenib, talk to your care provider or pharmacist for possible options. If you miss a dose of dabrafenib: • Take the missed dose only 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 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. Drug and food interactions Dabrafenib 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 dabrafenib. Avoid eating or drinking these during treatment with dabrafenib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. DABRAFENIB ORAL CHEMOTHERAPY EDUCATION Page 2 Storage and handling Handle dabrafenib 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 dabrafenib at room temperature (68°F–77°F) in a dry location away from light. Keep dabrafenib out of reach of children and pets. Leave dabrafenib in the provided packaging until it is ready to be taken. Whenever possible, give dabrafenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give dabrafenib 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 dabrafenib 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 will be used, contact your care team before using: • 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 dabrafenib, 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 dabrafenib. If you are traveling, put your dabrafenib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed.DABRAFENIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Dabrafenib Below are common side effects that have been known to happen in about one third or more of patients taking dabrafenib are listed on 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. Thickening of the skin (hyperkeratosis) Ask your care provider for management strategies if this bothers you. 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 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 pageDABRAFENIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in electrolyte and other laboratory values • High glucose levels • Low phosphate 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 Headache Ask your provider what you may use to ease headaches. Contact your care provider immediately if your headache: • Follows a head injury • Is severe, or 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 Fever You may feel hot, cold and shivery, achy, or dizzy. This usually starts during the first month of therapy but could happen at any time. • Call your doctor immediately if you have a fever (temperature more than 100.4°F or 38°C). • Ask your doctor if you can take medicine to help with the fever. Continued on the next pageDABRAFENIB ORAL CHEMOTHERAPY EDUCATION Page 5 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 interferes with your activity. If the pain or weakness bothers you, ask your provider how you may ease this discomfort. Take pain medication only that has been prescribed or recommended by your care provider. 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. Serious side effects of dabrafenib Secondary malignancy is the growth of a cancer months or years after treatment. This is a rare but possible side effect of treatment with dabrafenib. You may be at a higher risk of bleeding while taking dabrafenib. Be sure to seek medical attention right away if you have any majore bleeding. Also be sure to check for any signs of bleeding in your stool. Dabrafenib can make your heart work harder to pump blood to the rest of your body. Notify your healthcare provider if you experience shortness of breath or chest pain. Dabrafenib may be harmful to your eyes. Be sure to inform your care provider of any issue you have with your vision, or pain in your eyes. Your provider may stop treatment with dabrafenib if your eyes are affected. Serious fevers can occur when dabrafenib is used with trametinib. If you have a G6PD deficiency, dabrafenib can increase risk for hemolytic anemia. Call your care team if you experience weakness, dizziness, yellowing of the skin or whites of your eyes, or dark or brown urine. Rarely, dabrafenib can cause severe skin reactions, including Stevens Johnson syndrome, which can be life threatening. Seek emergency care if you have a severe rash or a rash on your mouth, eyes, or genitals. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO)DABRAFENIB ORAL CHEMOTHERAPY EDUCATION Page 6 Handling body fluids and waste Dabrafenib 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 dabrafenib, 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 dabrafenib 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. Pregnancy, sexual activity, and contraception Men and women of childbearing age and potential should use effective nonhormonal contraception during therapy and for a minimum of two weeks after the last dose of dabrafenib. Dabrafenib can cause hormonal contraceptive to be ineffective. o Do not breastfeed while taking dabrafenib and for two weeks after the last dose of dabrafenib. 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 dabrafenib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about how to obtain your dabrafenib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO)DABRAFENIB ORAL CHEMOTHERAPY EDUCATION Page 7 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 © 2021 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional resources Product website: https://www.us.tafinlarmekinist.com Product prescribing information: https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/ files/tafinlar.pdf Product resources: Melanoma: https://www.us.tafinlarmekinist.com/advanced melanoma/patient support/patient resources Lung cancer: https://www.us.tafinlarmekinist.com/globalassets/products37.com/tafinlarmekinist/lung/tafinlarmekinist patient medication guide.pdf Updated — May 28, 2021 Additional instructions

Tagrisso®

(tuh-GRIH-soh)

Tagrisso® (Osimertinib) is used to treat non-small cell lung cancer (NSCLC) that has a genetic mutation called epidermal growth factor (EGFR).

Tagrisso® (Osimertinib) is used to treat non-small cell lung cancer (NSCLC) that has a genetic mutation called epidermal growth factor (EGFR).

Page 1 OSIMERTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — osimertinib oh si MER ti nib Brand name — Tagrisso® tuh GRIH soh Approved uses Osimertinib is used to treat non small cell lung cancer NSCLC that has a genetic mutation called epidermal growth factor EGFR . Dose and schedule Taking osimertinib 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 osimertinib is 80 milligrams 80 mg to be taken by mouth at a scheduled time each day. Osimertinib should be taken with or without food at the same time each day. Osimertinib should be taken whole and not crushed or cut. If you are unable to swallow osimertinib, talk to your care provider or pharmacist for possible options. If you miss a dose of osimertinib, 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 osimertinib 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 osimertinib at room temperature 68°F–77°F in a dry location away from light. Keep osimertinib out of reach of children and pets. Leave osimertinib in the provided packaging until it is ready to be taken. Whenever possible, you should give osimertinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the osimertinib 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 osimertinib 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. OSIMERTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for osimertinib. Do not mix other medications into the box with osimertinib. 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 osimertinib, 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 osimertinib. If you are traveling, put your osimertinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Osimertinib 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 osimertinib, 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 osimertinib 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 Osimertinib 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. OSIMERTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Osimertinib The common side effects that have been known to happen in more than 30% of patients taking osimertinib 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 greater risk for 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 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, blood in your urine or stool, coughing up blood, or 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 OSIMERTINIB 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 related to some other health problem. 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, 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. 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, too. 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 Rash or dry/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 UV ultraviolet radiation occurs from the hours of 10 am through 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. OSIMERTINIB ORAL CHEMOTHERAPY EDUCATION Page 5 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 osimertinib. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of six weeks after the last dose of osimertinib. Men with female partners of childbearing age and potential should use effective contraception during therapy and for a minimum of four months after the last dose of osimertinib. Do not breastfeed while taking osimertinib and for two weeks after the last dose of osimertinib. Inform your care provider if you become pregnant. It is safe to hug and kiss, but special precautions may be needed for sexual activity while on oral chemotherapy. You are encouraged to talk to your care provider. Obtaining medication Talk with your care provider about how to obtain your osimertinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.tagrisso.com Product prescribing information: www.azpicentral.com/tagrisso/tagrisso.pdf#page=1 Product resources: www.tagrisso.com/lung cancer resources.html Updated – February 4, 2018 Additional instructions OSIMERTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 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.

Talzenna®

(Tal-ZEN-ah)

Talzenna® (Talazoparib) is used to treat HER2-negative breast cancer that has a genetic mutation in the BRCA gene.

Talzenna® (Talazoparib) is used to treat HER2-negative breast cancer that has a genetic mutation in the BRCA gene.

Page 1 TALAZOPARIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name talazoparib (TA luh ZOH puh rib) Brand name Talzenna® (Tal ZEN ah) Approved uses Talazoparib is used to treat HER2 negative breast cancer that has a genetic mutation in the BRCA gene. Dose and schedule Taking talazoparib 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 talazoparib is 1 milligram (1 mg) to be taken by mouth at a scheduled time once a day. Talazoparib can be taken with or without food, but at the same time each day. Talazoparib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow talazoparib, talk to your care provider or pharmacist for possible options. If you miss a dose of talazoparib, 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 talazoparib 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 talazoparib at room temperature (68°F–77°F) in a dry location away from light. Keep talazoparib out of reach of children and pets. Leave talazoparib in the provided packaging until it is ready to be taken. Whenever possible, you should give talazoparib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the talazoparib 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 talazoparib 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 talazoparib. Do not mix other medications into the box with talazoparib .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. TALAZOPARIB ORAL CHEMOTHERAPY EDUCATION Page 2 If you have any unused talazoparib, 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 talazoparib. If you are traveling, put your talazoparib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since talazoparib 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 talazoparib, 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 talazoparib 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 Talazoparib has many drug interactions. Please inform your care providers of all prescription medications, over thecounter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. TALAZOPARIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Talazoparib The common side effects that have been known to happen in more than 30% of patients taking talazoparib 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 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. 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 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, notice blood in your urine or stool, cough up blood, or have 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 seven to eight 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 TALAZOPARIB 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. 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 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. Headache Ask your provider what you may use to help with this discomfort. Contact your care provider right away if your headache has any of the following characteristics: Follows a head injury Is severe or starts suddenly Does not go away after three 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 Continued on the next page TALAZOPARIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Changes in electrolytes and other laboratory values High glucose 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 Weakness or fatigue Excessive hunger or thirst Excessive urination Serious side effects Talazoparib may rarely cause myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Low blood cell counts are common during treatment but can be a sign of MDS or AML. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Pregnancy, sexual activity, and contraception A pregnancy test is recommended prior to starting talazoparib. Women should not become pregnant and men should not get a partner pregnant while taking talazoparib. 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 talazoparib. Do not breastfeed while taking talazoparib and for one month after the last dose of talazoparib. 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 talazoparib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) TALAZOPARIB ORAL CHEMOTHERAPY EDUCATION Page 6 Additional resources Product website: https://www.talzenna.com/ Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2018/211651s000lbl.pdf Product resources: https://www.pfizeroncologytogether.com/patient Updated – October 22, 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 © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.

Tarceva®

(tar-SEE-vuh)

Tarceva® (Erlotinib) is used to treat people with metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) genetic mutation, and pancreatic cancer in combination with another medication, gemcitabine (Gemzar®).

Tarceva® (Erlotinib) is used to treat people with metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) genetic mutation, and pancreatic cancer in combination...

Page 1 ERLOTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — erlotinib (er LOH tih nib) Brand name — Tarceva® (tar SEE vuh) Approved uses Erlotinib is used to treat people with metastatic non small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) genetic mutation, and pancreatic cancer in combination with another medication, gemcitabine (Gemzar®). Dose and schedule Taking erlotinib 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 erlotinib is 150 milligrams (150 mg) for NSCLC and 100 mg for pancreatic cancer to be taken by mouth once daily. The dose may be adjusted by your care provider based on your individual needs. Erlotinib must be taken without food (at least one hour before or two hours after a meal or snack) at the same time each day. Erlotinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow erlotinib, talk to your care provider or pharmacist for possible options. If you miss a dose of erlotinib, 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. Drug and food interactions Erlotinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Medications that decrease stomach acid decrease erlotinib concentrations. Avoid use with proton pump inhibitors (e.g., omeprazole [Prilosec®], esomeprazole [Nexium®]), if possible. If taken with a histamine blocker (e.g., ranitidine [Zantac®], famotidine [Pepcid®]), take erlotinib 10 hours after the histamine blocker and at least 2 hours prior to the next histamine blocker dose. If taken with an antacid (e.g., calcium carbonate [Tums®], magnesium hydroxide, [Rolaids®]), separate erlotinib from the antacid by several hours. Grapefruit or grapefruit juice may interact with erlotinib; avoid eating or drinking these during treatment with erlotinib. Talk with your care team or pharmacist before taking new medications or supplements, or receiving any vaccines. ERLOTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Storage and handling Handle erlotinib 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 erlotinib at room temperature (68°F–77°F) in a dry location away from light. Keep erlotinib out of reach of children and pets. Leave erlotinib in the provided packaging until it is ready to be taken. Whenever possible, give erlotinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give erlotinib 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 erlotinib 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 will be used, contact your care team before using: • 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 erlotinib, 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 erlotinib. If you are traveling, put your erlotinib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. ERLOTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Erlotinib Below are common side effects that have been known to happen in about one third or more of patients taking erlotinib are listed on 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 Acne like rash A rash that looks like acne may appear on your face, chest, and upper back while taking this medication. • Your doctor may prescribe medication to help prevent or manage the rash. • If you get a rash, keep the area around it clean and dry. • Check with your care provider before using anything to treat it. • Do not use over the counter acne treatments, such as benzoyl peroxide or salicylic acid, and soaps containing alcohol. • Oatmeal baths and unscented moisturizers may help with itching. 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. 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 related to some other health problem. • 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, 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 ERLOTINIB 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. 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 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 the bottle. If your rash or itching continues to worsen, contact your care provider. 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 Continued on the next page ERLOTINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Cough or shortness of breath A cough that does not produce any mucous or congestion relief (dry cough) may occur while taking this medication. If you experience any breathing problems or shortness of breath, notify your care provider immediately. This may be a serious side effect of the medication. Decreased appetite or weight loss Talk to your provider if you notice a decrease in your weight while taking this medication. When you don’t 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. Increased risk for infection or fever Contact your care provider if you experience any signs or symptoms of an infection such as: • Fever (temperature higher 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. Serious side effects of erlotinib Erlotinib may be harmful to your kidneys. Speak to your care provider ito know when you need to have laboratory tests done to monitor your kidneys. If you get this side effect, your doctor may change your dose or stop treatment for some time. Tell your doctor right away if you get high fever, nausea, vomiting, severe abdominal pain. Erlotinib can increase your risk of having a stroke. Be aware of the signs of a stroke and seek medical attention immediately at the first sign of a stroke. Erlotinib can be harmful to the red blood cells in your body. Alert your care provider if you are feeling unusually tired, weak, or short of breath. Erlotinib may be harmful to your eyes. Be sure to inform your care provider of any issue you have with your vision, or pain in your eyes. Your provider may stop treatment with erlotinib if your eyes are affected. If you are taking warfarin while taking erlotinib you are at a much higher risk of bleeding. Be sure to regularly have your INR checked and seek medical attention at any signs of bleeding. ERLOTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Erlotinib 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 erlotinib, 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 erlotinib 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. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking erlotinib. 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 erlotinib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking erlotinib and for two weeks after the last dose of erlotinib. 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 erlotinib, and you are encouraged to ask your care provider. ABIRATERONE ORAL CHEMOTHERAPY EDUCATION Page 7 ERLOTINIB 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 © 2021 by Hematology/Oncology Pharmacy Association. All rights reserved. Obtaining medication Talk with your care provider about how to obtain your erlotinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: http://www.tarceva.com/patient Product prescribing information: https://www.gene.com/download/pdf/tarceva prescribing.pdf Product resources: http://www.tarceva.com/hcp/patient support/other programs Updated – July 15, 2021 Additional instructions

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