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Patient and Healthcare Providers Resource

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Ruxolitinib

(RUK-soh-LI-ti-nib)

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

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

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

Selinexor

Selinexor (Xpovio®) is used to treat multiple myeloma (MM) and is used in combination with another medication, dexamethasone.

Selinexor (Xpovio®) is used to treat multiple myeloma (MM) and is used in combination with another medication, dexamethasone.

Page 1 SELINEXOR ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name Selinexor Brand name Xpovio® (x PO Vee O) Approved uses Selinexor is used to treat multiple myeloma (MM) and is used in combination with another medication, dexamethasone. Dose and schedule Taking selinexor 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 selinexor is 80 milligrams (80 mg) to be taken by mouth on days 1 and 3 of each week. Selinexor can be taken with or without food, but at the same time each day. Selinexor should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow selinexor, talk to your care provider or pharmacist for possible options. If you miss or vomit a dose of selinexor, follow these guidelines: Do not take an extra dose or 2 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 Selinexor 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 may interact with selinexor; avoid eating or drinking this during treatment with selinexor. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle selinexor 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 selinexor at room temperature (68°F–77°F) in a dry location away from light. Keep selinexor out of reach of children and pets. Leave selinexor in the provided packaging until it is ready to be taken. Whenever possible, you should give selinexor to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the selinexor 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 selinexor from its package to a small medicine or other disposable cup. SELINEXOR 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. A daily pill box is not recommended to be used with selinexor. If you have any unused selinexor, 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 selinexor. If you are traveling, put your selinexor’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Selinexor Below are common side effects that have been known to happen in about one third or more of patients taking selinexor; 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 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, 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. Continued on the next page SELINEXOR ORAL CHEMOTHERAPY EDUCATION Page 3 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. 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 hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations 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 rather than 3 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. Continued on the next page SELINEXOR ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, 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 either of the following occurs: 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. Changes in electrolytes and other laboratory values Low sodium 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 and feet Red or brown colored urine Continued on the next page SELINEXOR ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever (temperature more than 100.4°F or 38°C) Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Serious side effects Selinexor can cause serious birth defects. Do not take selinexor if you are pregnant or think you might be pregnant. Selinexor can cause neurologic side effects, like dizziness, fainting, decreased alertness, and changes in your mental status, including confusion and decreased awareness of things around you (delirium). These problems can sometimes be severe. Tell your care team right away if you notice any of these signs or symptoms. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since selinexor 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 selinexor, 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. SELINEXOR ORAL CHEMOTHERAPY EDUCATION Page 6 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 selinexor 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 selinexor. Males and females of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 week after the last dose of selinexor. Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking selinexor and for 1 week after the last dose of selinexor. 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 team for assistance. Obtaining medication Talk with your care provider about the process for obtaining your selinexor. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2019/212306s000lbl.pdf Updated – July 29, 2019 Additional instructions SELINEXOR 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 © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.

Selpercatinib

(SEL-per-KA-tih-nib)

Selpercatinib (Retevmo™) is used to treat non-small cell lung cancer (NSCLC) that has a genetic mutation called RET fusion. Selpercatinib is used to treat thyroid cancer that has a genetic mutation or fusion in the RET protein.

Selpercatinib (Retevmo™) is used to treat non-small cell lung cancer (NSCLC) that has a genetic mutation called RET fusion. Selpercatinib is used to treat thyroid cancer that has a genetic mutation or fusion in ...

Page 1 SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — selpercatinib (SEL per KA tih nib) Brand name — Retevmo™ (reh TEV moh) Approved uses Selpercatinib is used to treat non small cell lung cancer (NSCLC) that has a genetic mutation called RET fusion. Selpercatinib is used to treat thyroid cancer that has a genetic mutation or fusion in the RET protein. Dose and schedule Taking selpercatinib 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 selpercatinib is between 120 milligrams (120 mg) and 160 mg to be taken by mouth at a scheduled time twice a day. Your dose is based on many factors, including your height and weight, overall health, and diagnosis. Selpercatinib can be taken with or without food, but at the same time each day. Selpercatinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow selpercatinib, talk to your care provider or pharmacist for possible options. If you vomit a dose of selpercatinib, do not take another dose. Wait until your next scheduled dose. If you miss a dose of selpercatinib, follow these guidelines: • Do not take the missed dose unless it is more than 6 hours until your next scheduled dose. Simply take the next dose at the regularly scheduled time. • Do not take two doses at one time. • Be sure to write down if you miss a dose, and let your care provider know about any missed doses. Drug and food interactions Selpercatinib 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 may interact with selpercatinib; avoid eating or drinking these during treatment with selpercatinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle selpercatinib 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 selpercatinib at room temperature (68°F–77°F) in a dry location away from light. Keep selpercatinib out of reach of children and pets. Leave selpercatinib in the provided packaging until it is ready to be taken. SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Whenever possible, you should give selpercatinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the selpercatinib 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 selpercatinib 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 selpercatinib, 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 selpercatinib. If you are traveling, put your selpercatinib’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Selpercatinib Below are common side effects that have been known to happen in about one third or more of patients taking selpercatinib; 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 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 Continued on the next page SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Changes in electrolytes and other laboratory values including • Low calcium levels • High glucose levels • Low albumin 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 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. Mouth irritation or sores or dry mouth Practice good mouth care. • Rinse your mouth frequently. • Brush your teeth with a soft toothbrush or cotton swab after meals. • Use a mild non alcohol 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. Continued on the next page SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low fiber foods, 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 either of the following occurs: • 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. 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 Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal/diary, and report your findings to your physician. Contact your healthcare provider for high blood pressure or if symptoms such as the following occur: • Headache • Dizziness • Chest pain • Shortness of breath • Fluid retention, weight gain, or swelling 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 SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management 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 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. Increased cholesterol levels Changes in cholesterol may occur and will be monitored by a simple blood test. You may not feel any symptoms if changes occur. Your care team will monitor for this. Serious side effects Selpercatinib may be harmful to your liver. Seek medical attention if you notice yellowing of the skin or whites of your eyes, dark or brown urine, bleeding, or bruising. You may have high blood pressure while taking selpercatinib. Take your blood pressure on a regular basis, and let your care team know of any large increases in blood pressure. SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Selpercatinib may cause a condition called QT or QTc prolongation, which is a heart rhythm that can cause fast, irregular heartbeats. These fast heartbeats may cause you to faint or have a seizure. In rare cases, this could be life threatening. Tell your care team right away if you feel faint, lightheaded, or dizzy, or if you feel your heart beating irregularly or fast, while taking selpercatinib. You may be at a higher risk of bleeding while taking selpercatinib. Contact your care team if you notice frequent nose bleeds, blood in your stool, bleeding that occurs by itself without injury, or bleeding that will not stop after 5 minutes of pressure. Severe allergic reactions are a rare but serious side effect of selpercatinib. Immediately seek medical attention if you notice difficulty breathing, swelling of the mouth or tongue, or a serious rash. Selpercatinib can cause cuts or wounds to heal more slowly. Tell your care team if you have a wound that doesn’t heal properly. Also tell your care team if you have a planned surgery or dental procedure, as selpercatinib should be stopped prior to your surgery. Your doctor may restart selpercatinib after your surgical wound has healed. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since selpercatinib 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 selpercatinib, 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. 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 selpercatinib 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 selpercatinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 week after the last dose of selpercatinib. Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Page 7 Do not breastfeed while taking selpercatinib and for 1 week after the last dose of selpercatinib. 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 selpercatinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.retevmo.com Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2020/213246s000lbl.pdf Product resources: https://www.retevmo.com/?section=savings support Updated – May 27, 2020 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 © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved.

Selumetinib

(SEL-yoo-MEH-tih-nib)

Selumetinib (Koselugo™) is used for pediatric patients (2 years of age or older) to treat neurofibromatosis type (NF1) with plexiform neurofibromas that cannot be removed by surgery.

Selumetinib (Koselugo™) is used for pediatric patients (2 years of age or older) to treat neurofibromatosis type (NF1) with plexiform neurofibromas that cannot be removed by surgery.

Page 1 SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — selumetinib (SEL yoo MEH tih nib) Brand name — Koselugo™ (koh SEL yoo goh) Approved uses Selumetinib is used for pediatric patients (2 years of age or older) to treat neurofibromatosis type (NF1) with plexiform neurofibromas that cannot be removed by surgery. Dose and schedule Taking selumetinib as instructed is important to allow your child’s treatment to be as effective as possible, so here are some key points to remember. Your child’s dose is based on many factors, including their height and weight, overall health, and diagnosis. Selumetinib should be taken on an empty stomach (at least 1 hour before or 2 hours after a meal or snack). Selumetinib should be taken whole and not crushed, cut, or dissolved. If your child is unable to swallow selumetinib, talk to your child’s care provider or pharmacist for possible options. If your child misses a dose of selumetinib, follow these guidelines: • Do not have your child take the missed dose if it is less than 6 hours until their next scheduled dose. Simply have your child take the next dose at the regularly scheduled time. • Do not have your child take two doses at one time. • Be sure to write down if your child misses a dose, and let your care provider know about any missed doses. Drug and food interactions Selumetinib has many drug interactions. Please inform your child’s care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with selumetinib; have your child avoid eating or drinking these during treatment with selumetinib. Selumetinib should be taken on an empty stomach (at least 1 hour before or 2 hours after a meal or snack). Talk with your child’s care provider or pharmacist before your child takes new medications or supplements or receives any vaccines. Selumetinib capsules contain vitamin E. Excessive intake of vitamin E may increase your child’s risk of bleeding. Talk with your child’s healthcare provider before giving your child any supplements with vitamin E. Storage and handling Handle selumetinib 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. SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Store selumetinib at room temperature (68°F–77°F) in a dry location away from light. Keep selumetinib out of reach of pets or other children. Leave selumetinib in the provided packaging until it is ready to be taken. When you, a family member, a friend, or a caregiver needs to give the selumetinib to your child, these steps should be followed: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. 3. Gently transfer the selumetinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. A daily pill box or pill reminder is not recommended to be used with selumetinib. If you have any unused selumetinib, 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 selumetinib. If you are traveling, put your selumetinib’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Selumetinib Below are common side effects that have been known to happen in about one third or more of patients taking selumetinib; these are listed on the left side of this table. Your child 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 your child experiences any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Nausea or vomiting • Eat and drink slowly. • Ensure that your child is drinking water or fluid each day unless your care provider has instructed you to limit your child’s fluid intake. Contact your care team for instructions on how much water or fluid your child should drink each day. • 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 your child experiences nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Continued on the next page SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Rash/dry skin/itching If your child gets dry or itchy skin while taking selumetinib, • Keep your child’s 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. If your child gets a rash that looks like acne on their face, chest, and upper back while taking selumetinib, • Your doctor may prescribe medication to help prevent or manage the rash. • If they do get a rash, keep the area around the rash 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 or 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. If your child’s rash or itching continues to worsen, contact your care provider. Changes in electrolytes and other laboratory values including • Increased creatine phosphokinase • Decreased albumin • Increased lipase Changes in some laboratory values may occur and will be monitored by a simple blood test. • Your child 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 they have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of the legs or feet • Red or brown colored urine Continued on the next page SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Abdominal pain Abdominal pain/discomfort may occur. Report any serious pain or symptoms to your care provider immediately. Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements your child has each day. • Ensure that your child is drinking water or fluid each day unless your care provider has instructed you to limit your child’s fluid intake. Contact your care team for instructions on how much water or fluid your child should drink each day. • 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 either of the following occurs: • The number of bowel movements your child has in a day increases by 4 or more. • They feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your child’s diarrhea, but talk to your care provider before starting this medication. Stomatitis Practice good mouth care. • Rinse your child’s mouth frequently. • Brush your child’s teeth with a soft toothbrush or cotton swab after meals. • Use a mild non alcohol 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 your child has sores in their mouth, avoid using mouthwashes that contain alcohol. Call your care provider if your child experiences pain or sores in their mouth or throat. Muscle or joint pain or weakness • Keep a diary of your child’s pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. • Have your child stay as active as possible, but know that it is okay to rest as needed. • Tell your care provider if pain interferes with their activity. If the pain or weakness bothers them, ask your provider what you may use to help with this discomfort. Use only pain medication that has been prescribed or recommended by your care provider. Continued on the next page SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Fatigue Your child may be more tired than usual or have less energy. • Have them stay as active as possible, but know it is okay to rest as needed. • Try to have them do some activity every day. • Plan their activities, and have them do them at a time of day when they feel a bit more energetic. Pyrexia Your child 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 they have a fever of 100.4°F. Ask your doctor if they can take medicine to help with the fever. Headache Ask your provider what you may use to help with this discomfort. Contact your care provider right away if your child’s headache has any of the following characteristics: • 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 Nail changes (paronchyia) Usually, this change starts at the cuticle and may affect the skin around the nail. • Biting, chewing, and picking at the nails can increase the risk of getting an infection. • Talk to your care provider if you notice any changes in your child’s nails. Changes in liver function Your child’s 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 their eyes • Dark or brown urine • Bleeding or bruising Continued on the next page SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Decreased hemoglobin, the part of the red blood cells that carries iron and oxygen Your child’s hemoglobin should be monitored by a simple blood test. When their hemoglobin is low, you may notice that they get tired or fatigued more easily. • Try to get 7–8 hours of sleep per night. • Stay as active as possible, but know that it is okay to rest as needed. • You might notice that your child becomes more pale than usual. Let your care provider know right away if they experience any of the following: • Shortness of breath • Dizziness • Palpitations Constipation Monitor how many bowel movements your child has each day. • Ensure that your child is drinking water or fluid each day unless your care provider has instructed you to limit your child’s fluid intake. Contact your care team for instructions on how much water or fluid your child should drink each day. • Stay active and exercise, if possible. • Eat foods high in fiber like raw fruits and vegetables. Contact your care provider if your child has not had a bowel movement in 3 or more days. Your care provider may recommend over the counter medications to help with their constipation. A daily stool softener such as docusate (Colace®) and/or laxative such as senna (Senokot®) may be helpful. If these do not help within 48 hours, tell your provider. Decreased white blood cells (WBCs) and increased risk for infection Your child’s WBCs should be monitored by a simple blood test. When your child’s WBCs are low, they are at a greater risk of having an infection. Take the following precautions to protect them from infection. • Have them wash their 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 they 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 they take any medicine for a fever or chills. Continued on the next page SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 7 Serious side effects Selumetinib can make your child’s heart work harder to pump blood to the rest of their body. Notify your child’s care team if your child is having shortness of breath or chest pain. Selumetinib may be harmful to your child’s eyes. Call your child’s care team if your child is having any issue with vision or if your child has pain in their eyes. If your child experiences ANY uncontrolled side effect, call your child’s physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since selumetinib 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 your child has started to take selumetinib, it is important to adhere to the following instructions every day for as long as their 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 • Your child may use the same toilet, septic tank, and/or sewer that they usually use. If your child uses 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. • Have your child wash their hands with soap and water after using the toilet. If your child needs a bedpan, be sure the caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If your child does 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 selumetinib 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. Possible Side Effect Management Hair changes Your child may experience hair loss. Your child’s hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with the stress of hair loss. Changes to your child’s hair color may occur during treatment. The hair usually returns to normal after treatment, but for some, the change is permanent. SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 8 Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking selumetinib. 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 selumetinib. Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking selumetinib and for 7 days after the last dose of selumetinib. Please inform your care provider if they 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 team for assistance. Obtaining medication Talk with your care provider about the process for obtaining your selumetinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.koselugo.com Product prescribing information: https://www.azpicentral.com/koselugo/koselugo.pdf Product resources: https://www.myaccess360.com/patient/koselugo selumetinib.html Updated – April 2020 Additional instructions SELUMETINIB 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 © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved.

Sonidegib

(soh-NIH-deh-gib)

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

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

Page 1 SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — sonidegib (soh NIH deh gib) Brand name — Odomzo® (oh DOM zoh) Approved uses Sonidegib is used to treat patients with basal cell carcinoma. Dose and schedule Taking sonidegib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of sonidegib is 200 milligrams (200 mg) to be taken by mouth at a scheduled time once a day. Sonidegib should be taken on an empty stomach (1 hour before or 2 hours after a meal or snack) and at the same time each day. Sonidegib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow sonidegib, talk to your care provider or pharmacist for possible options. If you miss a dose of sonidegib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions Sonidegib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with sonidegib; avoid eating or drinking these during treatment with sonidegib. Talk with your care team or pharmacist before taking new medications or supplements, or receiving any vaccines. SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 2 Storage and handling Handle sonidegib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store sonidegib at room temperature (68°F–77°F) in a dry location away from light. Keep sonidegib out of reach of children and pets. Leave sonidegib in the provided packaging until it is ready to be taken. Whenever possible, give sonidegib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give sonidegib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the sonidegib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. 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 sonidegib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of sonidegib. If you are traveling, put sonidegib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Sonidegib Below are common side effects that have been known to happen in about one third or more of patients taking sonidegib 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 kidney function Your kidney (renal) function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Decreased amount of urination • Swelling in your legs and feet Changes in electrolytes and other laboratory values • High creatine phosphokinase levels • High glucose levels • High lipase levels Changes in some laboratory values may occur and will be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your healthcare provider if you have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs or feet • Red or brown colored urine Muscle spasms and pain, joint pain, or weakness • Keep a diary of your pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. • Stay as active as possible, but know that it is okay to rest as needed, too. • Tell your care provider if pain interferes with your activity. If the pain or weakness bothers you, ask your provider what you may use to help with this discomfort. Hair loss (alopecia) Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with stress of hair loss. Continued on the next page SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Taste changes Some people experience a metallic or bitter taste in their mouth. To help with taste changes, try the following: • Choose and prepare foods that look and smell good to you. • Use plastic utensils if food tastes like metal. • Flavor foods with spices to change taste. • Suck on mints or chew gum to mask taste. • Brush teeth with a soft bristle toothbrush before and after eating. • Avoid smoking. Notify your doctor if you are having trouble eating or are losing weight. Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is okay to rest as needed. • Try to do some activity every day. • Plan your activities, and do them at a time of day when you feel a bit more energetic. • Avoid operating heavy machinery if you feel too tired. Nausea or vomiting • Eat and drink slowly. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t lie down immediately after eating. • Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication that can help. Diarrhea (loose and/or urgent bowel movements) Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low fiber foods (e.g., bananas, applesauce, potatoes, chicken, rice, toast). • Avoid high fiber foods (e.g., raw vegetables, raw fruits, whole grains). • Avoid foods that cause gas (e.g., broccoli, beans). • Avoid lactose containing foods (e.g., yogurt, milk). • Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: • The number of bowel movements you have in a day increases by four or more. • You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Continued on the next page SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. • Try to get 7–8 hours of sleep per night. • Avoid operating heavy machinery if you feel too tired. • Find a balance between work and rest. • Stay as active as possible, but know that it is okay to rest as needed. • You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: • Shortness of breath • Dizziness • Palpitations Weight loss Talk to your care provider if you notice a sudden decrease in weight while taking this medication. When you do not feel like eating, try the following: • Eat small frequent meals instead of 3 large meals each day. • Keep snacks nearby so you can eat when you feel hungry. • Take liquid nutritional supplements. • Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Serious side effects of sonidegib Sonidegib can cause serious birth defects. Do not take sonidegib if you are pregnant or think you might be pregnant. Women should use effective contraception. Men should always use a condom (even if you have had a vasectomy) during sex with female partners who are pregnant or are able to become pregnant. See pregnancy, sexual activity, and contraception section for more details. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 6 Handling body fluids and waste Because sonidegib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take sonidegib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or sonidegib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking sonidegib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 8 months for men and 20 months for women after the last dose of sonidegib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking sonidegib and for 20 months after the last dose of sonidegib. Inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Blood product donation Do not donate blood while on sonidegib and for at least 20 months after your last dose. SONIDEGIB 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 © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved. Obtaining medication Talk with your care provider about the process for obtaining your sonidegib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.odomzo.com Product prescribing information: www.odomzo.com/themes/custom/odomzo/global/pdfs/pi.pdf Product resources: www.odomzo.com/support you need Updated – March 8, 2020 Additional instructions

Sorafenib

(sor-A-feh-nib)

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

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

Page 1 SORAFENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — sorafenib (sor A feh nib) Brand name — Nexavar® (NEK suh var) Approved uses Sorafenib is used to treat patients with unresectable hepatocellular carcinoma, advanced kidney cancer (renal cell carcinoma), or differentiated thyroid carcinoma. Dose and schedule Taking sorafenib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of sorafenib is 400 milligrams (400 mg) to be taken by mouth at a scheduled time twice daily continuously without a scheduled off treatment period. Sorafenib should be taken on an empty stomach (one hour before or two hours after a meal or snack) at the same time each day. Sorafenib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow sorafenib, talk to your care provider or pharmacist for possible options. If you miss a dose of sorafenib: • Do not take an extra dose or two doses at one time. Simply take the next dose at the regularly scheduled time. • Be sure to write down if you miss a dose, and let your care provider know about any missed doses. If you need to have surgery, tell your care provider you are taking sorafenib. Sorafenib may need to be stopped until your wound heals after some surgeries. Drug and food interactions Sorafenib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines. SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 2 Storage and handling Handle sorafenib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store sorafenib at room temperature (68°F–77°F) in a dry location away from light. Keep sorafenib out of reach of children and pets. Leave sorafenib in the provided packaging until it is ready to be taken. Whenever possible, give sorafenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give sorafenib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the sorafenib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. 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 sorafenib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of sorafenib. If you are traveling, put your sorafenib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Sorafenib Below are common side effects that have been known to happen in about one third or more of patients taking sorafenib 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 Diarrhea (loose and/or urgent bowel movements) Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low fiber foods (e.g., bananas, applesauce, potatoes, chicken, rice, toast). • Avoid high fiber foods (e.g., raw vegetables, raw fruits, whole grains). • Avoid foods that cause gas (e.g., broccoli, beans). • Avoid lactose containing foods (e.g., yogurt, milk). • Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: • The number of bowel movements you have in a day increases by four or more. • You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Pain or discomfort in hands and/or feet Hand foot skin reaction (HFSR) appears on the palms of the hands and soles of the feet. It can appear as a rash, callus, or peeling skin, and the area has increased sensitivity to heat or a “pins and needles” sensation. Let your care provider know right away if you experience this side effect. To prevent HFSR, you can do the following: • Soak your feet in a water bath with Epsom salt and gently pumice any callused skin. • Exfoliate and keep hands and feet moisturized. • Avoid tight fitting shoes or socks. • Use cushioning (i.e., gloves) when performing activities that increase pressure on the palms of your hands. Hair loss (alopecia) Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with the stress of hair loss. Continued on the next page SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Yellowing of the skin or whites of your eyes • Dark or brown urine • Bleeding or bruising Changes in electrolytes and other laboratory values • Low albumin levels • Low phosphate levels • High lipase levels • High thyroid levels • Low calcium levels • High international normalized ratio levels • High amylase levels Changes in some laboratory values may occur and should be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs or feet • Red or brown colored urine Decreased appetite or weight loss Talk to your care provider if you notice a decrease in weight while taking this medication. When you do not feel like eating, try the following: • Eat small, frequent meals instead of three large meals each day. • Keep snacks nearby so you can eat when you feel hungry. • Take liquid nutritional supplements. • Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is okay to rest as needed. • Try to do some activity every day. • Plan your activities, and do them at a time of day when you feel a bit more energetic. • Avoid operating heavy machinery if you feel too tired. Continued on the next page SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. • Wash your hands often, especially before eating and after using the bathroom. • Avoid crowds and people with fevers, flu, or other infection. • Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: • Fever (temperature more than 100.4°F or 38°C) • Chills • Sore throat • Burning with urination • Unusual tiredness • A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. • Use caution to avoid bruises, cuts, or burns. • Blow your nose gently, and do not pick your nose. • Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. • When shaving, use an electronic razor instead of razor blades. • Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: • A bloody nose that bleeds for more than five minutes despite pressure • A cut that continues to ooze despite pressure • Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. • Try to get 7–8 hours of sleep per night. • Avoid operating heavy machinery if you feel too tired. • Find a balance between work and rest. • Stay as active as possible, but know that it is okay to rest as needed. • You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: • Shortness of breath • Dizziness • Palpitations Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal/diary and report these to your physician. Contact your healthcare provider for high blood pressure or if the following symptoms occur: • Headache • Dizziness • Chest pain • Shortness of breath • Fluid retention, weight gain, or swelling Rash or itchy skin • Keep your skin moisturized with creams and moisturizing lotions to decrease the risk of rash or itchiness, and wear loose fitting clothing. • Avoid using perfumes and cologne as these products may increase rash symptoms. • Avoid being in the heat for long periods of time. • Your provider may recommend an over the counter antihistamine or a topical cream. Sunlight can make symptoms worse. • Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to ultraviolet (UV) radiation occurs from 10 am–4 pm. • Wear long sleeved clothing, with UV protection if possible. • Wear broad brimmed hats. • Apply broad spectrum sunscreen (UVA/UVB) with at least SPF 30 as often as directed on bottle. • Use lip balm with at least SPF 30. If your rash or itching continues to worsen, contact your care provider. Abdominal pain Abdominal pain/discomfort may occur. Report any serious pain or symptoms to your care provider immediately. SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 7 Serious side effects of sorafenib You may be at a higher risk of bleeding while taking Sorafenib. Be sure to seek medical attention right away if you have any major bleeding. Also be sure to check for any signs of bleeding in your stool. Sorafenib can increase your risk of having a heart attack. Be aware of the signs of a heart attack and seek medical attention immediately at the first sign of a heart attack. Sorafenib can cause a Hand foot skin reaction that causes redness, pain, swelling, or blisters on the palms of your hands or soles of your feet. If you get this side effect, your doctor may change your dose or stop treatment for some time. Sorafenib can cause severe diarrhea or perforation (hole) of the intestine. Tell your doctor right away if you develop fever, severe abdominal pain or diarrhea that lasts longer than a day. Sorafenib can cause increases in plasma concentrations of drugs that are substrates of UGT1A1. Sorafenib may cause a condition called QT or QTc prolongation, which is a heart rhythm that can cause fast, irregular heartbeats. These fast heartbeats may cause you to faint or have a seizure. In rare cases, this could be life threatening. Tell your care team right away if you feel faint, lightheaded, or dizzy, or if you feel your heart beating irregularly or fast while taking sorafenib. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Because sorafenib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take sorafenib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or sorafenib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 8 Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking sorafenib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of two weeks after the last dose of sorafenib. Men taking sorafenib should use condoms (even after a vasectomy) during therapy and for a minimum of two weeks after the last dose. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking sorafenib and for one month after the last dose of sorafenib. Inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your sorafenib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.nexavar us.com/?WHGRedir=1 Product prescribing information: http://labeling.bayerhealthcare.com/html/products/pi/Nexavar PI.pdf Product resources: www.nexavar us.com/resources/?p=liver Updated – March 8, 2020 Additional instructions

Sunitinib

(soo-NIH-tih-nib MA layt)

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

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

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

Talazoparib

(TA-luh-ZOH-puh-rib)

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

Talazoparib (Talzenna®) 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.

Tamoxifen Citrate

(tuh-MOK-sih-FEN SIH-trayt)

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

Tamoxifen Citrate (Soltamox®) 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

Tazemetostat

(TA-zeh-MEH-toh-stat)

Tazemetostat (Tazverik™) is used to treat patients with sarcoma.

Tazemetostat (Tazverik™) is used to treat patients with sarcoma.

Page 1 TAZEMETOSTAT ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name tazemetostat (TA zeh MEH toh stat) Brand name Tazverik™ (taz VAYR ik) Approved uses Tazemetostat is used to treat patients with sarcoma. Dose and schedule Taking tazemetostat 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 tazemetostat is 800 milligrams (800 mg) to be taken by mouth at a scheduled time twice a day. Tazemetostat can be taken with or without food, but at the same time each day. Tazemetostat should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow tazemetostat, talk to your care provider or pharmacist for possible options. If you miss a dose of tazemetostat, 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 Tazemetostat 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 may interact with tazemetostat; avoid eating or drinking these during treatment with tazemetostat. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle tazemetostat 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 tazemetostat at room temperature (68°F–77°F) in a dry location away from light. Keep tazemetostat out of reach of children and pets. Leave tazemetostat in the provided packaging until it is ready to be taken. Whenever possible, you should give tazemetostat to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the tazemetostat 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 tazemetostat from its package to a small medicine or other disposable cup. TAZEMETOSTAT 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 tazemetostat, 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 tazemetostat. If you are traveling, put your tazemetostat’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Tazemetostat Below are common side effects that have been known to happen in about one third or more of patients taking tazemetostat; 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 Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations 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 heavy machinery if you feel too tired. Continued on the next page TAZEMETOSTAT ORAL CHEMOTHERAPY EDUCATION Page 3 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. Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever (temperature more than 100.4°F or 38°C) Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Changes in electrolytes and other laboratory values including High triglyceride levels High glucose levels Low sodium 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 TAZEMETOSTAT ORAL CHEMOTHERAPY EDUCATION Page 4 Serious side effects Secondary malignancy is the growth of a cancer months or years after treatment. This is a rare but possible side effect of treatment with tazemetostat. Tazemetostat can cause serious birth defects. Do not take tazemetostat if you are pregnant or think you might be pregnant. Tazemetostat can lower your white blood cells and your platelets, increasing your risk of infection and bleeding. Bone marrow suppression is a decrease in the number of white blood cells, red blood cells, and platelets that can be severe with tazemetostat. Speak to your care provider to know when you need to have laboratory tests done to monitor your blood cell counts. You also 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 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Because tazemetostat 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 tazemetostat, 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. 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 tazemetostat 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 tazemetostat. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of six months after the last dose of tazemetostat. Men with female partners of reproductive potential should use effective contraception during therapy and for a minimum of three months after the last dose of tazemetostat. TAZEMETOSTAT ORAL CHEMOTHERAPY EDUCATION Page 5 oBirth control pills may not work as well when taking tazemetostat; other methods of protection, such as condoms, should beused. oDo not breastfeed while taking tazemetostat and for one week after the last dose of tazemetostat. oPlease inform your care provider if you become pregnant. oIt is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you areencouraged to ask your care provider. Obtaining medication oTalk with your care provider about the process for obtaining your tazemetostat. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: http://www.epizyme.com/programs/tazverik Product prescribing information: http://www.epizyme.com/wp content/uploads/2020/01/ TAZVERIK Prescribing Information.pdf Updated – January 28, 2020 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 © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved.

Temozolomide

(teh-moh-ZOH-loh-mide)

Temozolomide (Temodar®) is used to treat anaplastic astrocytoma and glioblastoma multiforme.

Temozolomide (Temodar®) is used to treat anaplastic astrocytoma and glioblastoma multiforme.

Page 1 TEMOZOLOMIDE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — temozolomide teh moh ZOH loh mide Brand name — Temodar® TEH moh dar Approved uses Temozolomide is used to treat anaplastic astrocytoma and glioblastoma multiforme. Dose and schedule Taking temozolomide 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. Temozolomide should be taken on an empty stomach approximately 1 hour before or 2 hours after eating a meal or snack , with a full glass of water, and at the same time each day. Temozolomide should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow temozolomide, talk to your care provider or pharmacist for possible options. If you miss a dose of temozolomide, 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 temozolomide 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 temozolomide at room temperature 68°F–77°F in a dry location away from light. Keep temozolomide out of reach of children and pets. Leave temozolomide in the provided packaging until it is ready to be taken. Whenever possible, you should give temozolomide to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the temozolomide 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 temozolomide 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. TEMOZOLOMIDE ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for temozolomide. Do not mix other medications into the box with temozolomide. 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 temozolomide, 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 temozolomide. If you are traveling, put your temozolomide in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Temozolomide 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 temozolomide, 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 temozolomide 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 Temozolomide has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Temozolomide should be taken on an empty stomach 1 hour before or 2 hours after eating a meal or snack . Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines. TEMOZOLOMIDE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Temozolomide The common side effects that have been known to happen in more than 30% of patients taking temozolomide 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 Hair loss alopecia Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with the stress of hair loss. 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 TEMOZOLOMIDE 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, too. Try to do some activity every day. – Plan your activities, and do them at a time of day when you feel a bit more energetic. – Avoid operating heavy machinery if you feel too tired. Nausea or vomiting Eat and drink slowly. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods. Avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t 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. 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. Constipation Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Stay active and exercise, if possible. Eat foods high in fiber like raw fruits and vegetables. Contact your care provider if you have not had a bowel movement in 3 or more days. Your care provider may recommend over the counter medications to help with your constipation. A daily stool softener such as docusate Colace® and/or laxative such as senna Senokot® may be helpful. If these do not help within 48 hours, tell your provider. Continued on the next page TEMOZOLOMIDE ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored 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, too. 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 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 temozolomide. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 month after the last dose of temozolomide. Do not breastfeed while taking temozolomide and for one month after the last dose of temozolomide. 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 temozolomide. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.merck.com/product/home.html Product prescribing information: www.merck.com/product/usa/pi circulars/t/temodar capsules/temodar pi.pdf Product resources: www.merck.com/product/usa/pi circulars/t/temodar capsules/temodar ppi.pdf Updated – January 14, 2018 TEMOZOLOMIDE 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. Additional instructions

Tepotinib

(teh-POH-tih-nib)

Tepotinib (Tepmetko®) is used to treat adults with non-small cell lung cancer that has spread to other parts of the body and has a certain mutation (change) in the MET gene.

Tepotinib (Tepmetko®) is used to treat adults with non-small cell lung cancer that has spread to other parts of the body and has a certain mutation (change) in the MET gene.

Page 1 TEPOTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — tepotinib (teh POH tih nib) Brand name — Tepmetko® (tep MET koh) Approved uses Tepotinib is used to treat adults with non small cell lung cancer that has spread to other parts of the body and has a certain mutation (change) in the MET gene. Dose and schedule Taking tepotinib 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 tepotinib is 450 milligrams (450 mg) to be taken by mouth at a scheduled time once a day. Tepotinib should be taken with food, at the same time each day. Tepotinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow tepotinib, talk to your care provider or pharmacist for possible options. If you miss a dose of tepotinib, follow this guidance: • Do not make up a missed dose within eight hours of the next scheduled dose. • Be sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions Tepotinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle tepotinib 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 tepotinib at room temperature (68°F–77°F) in a dry location away from light. Keep tepotinib out of reach of children and pets. Leave tepotinib in the provided packaging until it is ready to be taken. Whenever possible, you should give the tepotinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the tepotinib 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 tepotinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. TEPOTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. A daily pill box or reminder is not recommended to be used with tepotinib. If you have any unused tepotinib, 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 tepotinib. If you are traveling, put your tepotinib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Tepotinib Below are common side effects that have been known to happen in about one third or more of patients taking tepotinib 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 albumin levels Albumin is a protein found in the blood. You may not have any symptoms, unless your blood albumin levels are significantly lowered. Contact your care provider if you notice any of the following: • Swelling in any part of your body especially your legs • Muscle weakness, fatigue, or cramping • Severe diarrhea (more than five stools in a 24 hour period) • Nausea that is unrelieved by prescription anti nausea medication • Vomiting more than four or five times in a 24 hour period • Fluid accumulation or swelling in your belly Fluid retention or swelling • Do not stand for long periods of time. • Keep your legs elevated when sitting or lying down. • Try not to eat salty foods, which can increase swelling. • Avoid tight fitting clothing and shoes. • Weigh yourself daily. Contact your 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 one week Continued on the next page TEPOTINIB 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 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 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. Changes in electrolytes and other laboratory values • Low sodium 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 TEPOTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Serious side effects of tepotinib Tepotinib may cause rare but serious side effects, including the following: • Scarring of the lung tissue, 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. • Harm to your liver; seek medical attention if you notice yellowing of the skin or whites of your eyes, dark or brown urine, bleeding, or bruising. • Birth defects; do not take tepotinib if you are pregnant or think you might be pregnant. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since tepotinib 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 tepotinib, 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 tepotinib 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 tepotinib. Males and females of childbearing age and potential should use effective contraception during therapy and for a minimum of one week after the last dose of tepotinib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking tepotinib and for one week after the last dose of tepotinib. TEPOTINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2021 by Hematology/Oncology Pharmacy Association. All rights reserved. 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 how to obtain your tepotinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.tepmetko.com/us en/home.html Product prescribing information: https://www.emdserono.com/us en/pi/tepmetko pi.pdf Product resources: https://www.oncnavigationcenter.com/en/home.html Updated — February 12, 2021 Additional instructions

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