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Methotrexate

(meh-thuh-TREK-sayt)

Methotrexate is used alone or in combination with other anticancer agents to treat many cancers, including breast cancer, head and neck cancer, cutaneous T-cell lymphoma, lung cancer, and non-Hodgkin lymphoma. Methotrexate may be used in treating noncancerous conditions and autoimmune dise...

Methotrexate () is used alone or in combination with other anticancer agents to treat many cancers, including breast cancer, head and neck cancer, cutaneous T-cell lymphoma, lung cancer, and non-Hodgkin ...

Page 1 METHOTREXATE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name methotrexate (meh thuh TREK sayt) Approved uses Methotrexate is used alone or in combination with other anticancer agents to treat many cancers, including breast cancer, head and neck cancer, cutaneous T cell lymphoma, lung cancer, and non Hodgkin lymphoma. Methotrexate may be used in treating noncancerous conditions and autoimmune diseases. Dose and schedule Taking methotrexate 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. Methotrexate can be taken with or without food, but at the same time each week. Methotrexate should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow methotrexate, talk to your care provider or pharmacist for possible options. If you miss a dose of methotrexate, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. If you miss a dose of this medication, contact your care team for further information. Storage and handling Handle methotrexate 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 methotrexate at room temperature (68°F–77°F) in a dry location away from light. Keep methotrexate out of reach of children and pets. Leave methotrexate in the provided packaging until it is ready to be taken. Whenever possible, you should give methotrexate to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the methotrexate 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 methotrexate 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. METHOTREXATE ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for methotrexate. Do not mix other medications into the box with methotrexate. 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 methotrexate, 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 methotrexate. If you are traveling, put your methotrexate in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since methotrexate 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 methotrexate, 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 methotrexate 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 Methotrexate 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. Avoid live vaccines during treatment with methotrexate. METHOTREXATE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Methotrexate The common side effects that have been known to happen in more than 30% of patients taking methotrexate are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever (temperature more than 100.4°F or 38°C) Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Serious side effects Methotrexate can cause serious side effects that can be life threatening. Your doctor may do tests regularly to check how methotrexate is affecting your body. It is important that you remain in your doctor’s care while taking methotrexate. Liver problems can occur. Contact your healthcare team if you notice yellowing of the skin or whites of your eyes, dark or brown urine, or unusual bleeding or bruising. Your kidney function will be checked periodically with a blood test. Contact your care team if you notice decreased urination or unusual swelling in your legs and feet. Lung problems can occur. Report any shortness of breath or difficulty breathing. Severe skin reactions can occur. Report any new rashes. Methotrexate can cause diarrhea and mouth sores. Contact your care team if you experience these. Infertility can occur. METHOTREXATE ORAL CHEMOTHERAPY EDUCATION Page 4 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking methotrexate. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of three months after the last dose of methotrexate. Do not breastfeed while taking methotrexate and for three months after the last dose of methotrexate. Please inform your care provider if you become pregnant or plan to have a baby after taking methotrexate. 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 methotrexate. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2016/008085s066lbl.pdf Updated – October 19, 2018 Additional instructions METHOTREXATE 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 © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.

Midostaurin

(MY-doh-STAW-rin)

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

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

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

Mitotane

(MY-toh-tane)

Mitotane (Lysodren™) is used to treat adrenal cortical carcinoma.

Mitotane (Lysodren™) is used to treat adrenal cortical carcinoma.

Page 1 TER MITOTANE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — mitotane MY toh tane Brand name — Lysodren™ Approved uses Mitotane is used to treat adrenal cortical carcinoma. Dose and schedule Taking mitotane 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 mitotane is between 2,000 milligrams 2,000 mg and 6,000 milligrams 6,000 mg per day to be divided into three or four doses. Mitotane can be taken with or without food at the same times each day. Mitotane should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow mitotane, talk to your care provider or pharmacist for possible options. If you miss a dose of mitotane, 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 mitotane 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 mitotane at room temperature 68°F–77°F in a dry location away from light. Keep mitotane out of reach of children and pets. Leave mitotane in the provided packaging until it is ready to be taken. Whenever possible, give mitotane to yourself and follow the steps below. If a family member, friend, or caregiver needs to give mitotane 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 mitotane 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. MITOTANE ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for mitotane. Do not mix other medications into the box with mitotane. 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 mitotane, 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 mitotane. If you are traveling, put your mitotane in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Because mitotane 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 mitotane, 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 mitotane 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 Mitotane 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. Serious side effects Adrenal crisis may develop if shock or severe trauma occurs, which impairs your body’s response. Notify your provider of any planned surgeries. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO MITOTANE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Mitotane The common side effects that have been known to happen in more than 30% of patients taking mitotane 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 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 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 three large meals each day. Keep snacks nearby so you can eat when you feel hungry. Drink liquid nutritional supplements. Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. 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 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. MITOTANE ORAL CHEMOTHERAPY EDUCATION Page 4 Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking mitotane. Men and women of childbearing age and potential should use effective contraception during therapy and for as long as mitotane levels are detectable. Do not breastfeed while taking mitotane and while mitotane levels are detectable. 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 mitotane, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your mitotane. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resource Product prescribing information: https://packageinserts.bms.com/pi/pi lysodren.pdf Updated — May 3, 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.

Mobocertinib

(MOH-boh-SER-tih-nib)

Mobocertinib (Exkivity™) is used to treat non-small cell lung cancer that has an epidermal growth factor exon 20 genetic variant.

Mobocertinib (Exkivity™) is used to treat non-small cell lung cancer that has an epidermal growth factor exon 20 genetic variant.

Page 1 MOBOCERTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — mobocertinib (MOH-boh-SER-tih-nib ) Brand name — Exkivity™ (ek-SKIH-vih-tee) Approved uses Mobocertinib is used to treat non-small cell lung cancer that has an epidermal growth factor exon 20 genetic variant. Dose and schedule Taking mobocertinib 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 mobocertinib is 160 milligrams (160 mg) to be taken by mouth at a scheduled time once a day. o Mobocertinib can be taken with or without food, but at the same time each day. o Mobocertinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow mobocertinib, talk to your care provider or pharmacist for possible options. o If you miss a dose of mobocertinib, follow these guidelines: • Only take the missed dose if it has been less than six hours since you were supposed to take it. Then, take the next dose at the regularly scheduled time. • Be sure to write down if you miss a dose, and let your care provider know about any missed doses. Drug and food interactions o Mobocertinib has many drug interactions. Please inform your care providers of all prescription medications, over-thecounter medications, vitamins, and herbal products. o Grapefruit or grapefruit juice or foods may interact with mobocertinib; avoid eating or drinking these during treatment with mobocertinib. o Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle mobocertinib 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 mobocertinib at room temperature (68°F–77°F) in a dry location away from light. o Keep mobocertinib out of reach of children and pets. o Leave mobocertinib in the provided packaging until it is ready to be taken. o Whenever possible, you should give mobocertinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the mobocertinib 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.) MOBOCERTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Side Effects of Mobocertinib Below are common side effects that have been known to happen in about one third or more of patients taking mobocertinib 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. Continued on the next page 3. Gently transfer the mobocertinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. o 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. MOBOCERTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Rash or itchy skin • Keep your skin moisturized with creams and moisturizing lotions to decrease the risk of rash or itchiness, and wear loose-fitting clothing. • Avoid using perfumes and cologne because these products may increase rash symptoms. • Avoid being in the heat for long periods of time. • Your provider may recommend an over-the-counter antihistamine or a topical cream. Sunlight can make symptoms worse. • Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to ultraviolet (UV) radiation occurs between 10 am and 4 pm. • Wear long-sleeved clothing, with UV protection if possible. • Wear broad-brimmed hats. • Apply broad-spectrum sunscreen (UVA/UVB) with at least an SPF of 30 as often as directed on the bottle. • Use lip balm with at least an SPF of 30. If your rash or itching continues to worsen, contact your care provider. 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 OK 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 Continued on the next page MOBOCERTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. • Wash your hands often, especially before eating and after using the bathroom. • Avoid crowds and people with fevers, flu, or other infection. • Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection such as: • Fever (temperature more than 100.4°F or 38°C) • Chills • Sore throat • Burning with urination • Unusual tiredness • A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Decreased 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 MOBOCERTINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Mouth irritation or sores Practice good mouth care. • Rinse your mouth frequently. • Brush your teeth with a soft toothbrush or cotton swab after meals. • Use a mild mouth rinse at least four times a day (after eating and at bedtime). One example is a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm (not hot) water. • If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care provider if you experience pain or sores in your mouth or throat. 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 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. Nail changes Usually changes start at the cuticle and may affect the skin around the nail. • Biting, chewing, or picking at your nails can increase the risk for infection. • Talk to your care provider if you notice any changes in your nails. 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 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 MOBOCERTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Changes in electrolytes and other laboratory values • Low potassium levels • High lipase levels • High amylase 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 • Vomiting • Fever Muscle or joint pain • Keep a diary of your pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. • Stay as active as possible, but know that it is OK to rest as needed. • Tell your care provider if pain or a spasm interferes with your activity. If the pain, weakness, or spasms bother you, ask your provider what you may use to help with this discomfort. Take only pain medication only that has been prescribed or recommended by your care provider. Serious side effects o Mobocertinib may cause your lung tissue to scar, which is called interstitial lung disease. Call your care team if you are feeling short of breath, have a fever, or have a lasting dry cough. o Mobocertinib can cause cardiotoxicity, which is a condition involving damage to your heart muscle. Seek medical attention right away if you have any chest pain or tightness. o Mobocertinib 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 mobocertinib. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) MOBOCERTINIB ORAL CHEMOTHERAPY EDUCATION Page 7 Handling body fluids and waste Because mobocertinib 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 mobocertinib, it is important to follow these instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. o Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. o Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low-flow toilet, close the lid and flush twice to ensure 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. 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 mobocertinib with soap and water. o Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. o Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception o Women should not become pregnant and men should not get a partner pregnant while taking mobocertinib. Males and females of childbearing age and potential should use effective nonhormonal contraception during therapy and for a minimum of 7 days for men and 1 month for women after the last dose of mobocertinib. o Mobocertinib may cause hormonal contraceptives to be ineffective. Effective contraception should be nonhormonal and may include 1 or more of the following: barrier methods, copper intrauterine device (IUD), etc. Speak with your care provider if you are unsure of effective nonhormonal contraception. o Do not breastfeed while taking mobocertinib and for 1 week after the last dose of mobocertinib. o Please inform your care provider if you become pregnant. o It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care team for assistance. Obtaining medication o Talk with your care provider about the process for obtaining your mobocertinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) MOBOCERTINIB ORAL CHEMOTHERAPY EDUCATION Page 8 Additional resources Product website: www.exkivity.com Product prescribing information: https://takeda.info/Exkivity-Prescribing-Information Product resources: www.here2assist.com/patient/home Updated – October 12, 2021 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 © 2021 by Hematology/Oncology Pharmacy Association. All rights reserved.

Neratinib

(neh-RA-tih-nib)

Neratinib (Nerlynx®) is used to treat adult patients with human epidermal growth factor receptor 2 (HER2)–overexpressed breast cancer.

Neratinib (Nerlynx®) is used to treat adult patients with human epidermal growth factor receptor 2 (HER2)–overexpressed breast cancer.

Page 1 NERATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — neratinib (neh RA tih nib) Brand name — Nerlynx® (NAYR links) Approved uses Neratinib is used to treat adult patients with human epidermal growth factor receptor 2 (HER2)–overexpressed early stage and metastatic breast cancer. Dose and schedule Taking neratinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. oYour dose may vary, but the usual dose of neratinib is 240 milligrams (240 mg) to be taken by mouth once daily. The dosemay be adjusted by your care provider based upon your individual needs. oNeratinib should be taken with food, at the same time each day. oNeratinib should be taken whole and not crushed, cut, opened, or dissolved. If you are unable to swallow neratinib, talk toyour care provider or pharmacist for possible options. oIf you miss a dose of neratinib, do not take an extra dose or two doses at one time. Simply take your next dose at theregularly scheduled time. oBe sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions oNeratinib has the potential for drug interactions. Inform your care provider of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. oSeparate taking neratinib and antacids by at least 3 hours; neratinib can be taken 2 hours before or 10 hours afterantihistamines oGrapefruit or grapefruit juice may interact with neratinib. Avoid eating or drinking these during your treatment withneratinib. oNeratinib should be taken with food. oTalk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle neratinib 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. oStore neratinib at room temperature (68°F–77°F) in a dry location away from light. oKeep neratinib out of reach of children and pets. oLeave neratinib in the provided packaging until it is ready to be taken. NERATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Side Effects of Neratinib Below are common side effects that have been known to happen in about one third or more of patients taking neratinib 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. Whenever possible, you should give neratinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the neratinib 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 neratinib 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 neratinib, 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 neratinib. If you are traveling, put your neratinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Possible Side Effect Management Nausea or vomiting • Eat and drink slowly. • Drink 8 10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t lie down immediately after eating. • Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Continued on the next page NERATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Diarrhea (loose and/ or urgent bowel movements) Prevention of diarrhea by taking an over the counter medication called loperamide (Imodium®) is recommended for most patients. Talk with your care provider about this before beginning neratinib. The recommended loperamide schedule to prevent diarrhea with neratinib is as follows: • Neratinib days 1–14: Take 4 mg loperamide three times daily by mouth. • Neratinib days 15–56: Take 4 mg loperamide twice daily by mouth. *Speak with your care team if following methods are possible: • Budesonide 9 mg a day for 1 cycle with 4 mg loperamide schedule above • Colestipol 2 mg twice a day for 1 cycle with 4 mg loperamide as needed or: • Neratinib days 1 14: Take 4 mg loperamide three times daily by mouth. • Neratinib days 15–28: Take 4 mg loperamide twice daily by mouth. Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. • Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. • Avoid foods that cause gas, such as broccoli and beans. • Avoid lactose containing foods, such as yogurt and milk. • Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: • The number of bowel movements you have in a day increases by four or more. • You feel dizzy or lightheaded. *Hurvitz S, Chan A, Iannotti N, et al. Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib associated diarrhea in patients with HER2+ early stage breast cancer: the CONTROL trial. Abdominal pain Abdominal pain or discomfort may occur. Report any serious pain or symptoms to your care provider immediately. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Serious side effects Neratinib may be harmful to your liver. Speak to your care provider to know when you need to have laboratory tests done to monitor your liver function. If your get this side effect, your doctor may change your dose or stop treatment for some time. NERATINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Handling body fluids and waste Neratinib 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 neratinib, 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 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 neratinib 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 neratinib. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of neratinib. Men of reproductive age and potential should use effective contraception during therapy and for a minimum of three months after the last dose of neratinib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking neratinib and for one month after the last dose of neratinib. 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 neratinib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your neratinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) NERATINIB 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 © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional resources Product website: https://nerlynx.com Product prescribing information: https://nerlynx.com/pdf/full prescribing information.pdf Product resources: https://nerlynx.com/access and support Updated – January 1, 2020 Additional instructions

Nilotinib

(ny-LOH-tih-nib)

Nilotinib (Tasigna®) is used to treat adult and pediatric patients greater than or equal to 1 year of age with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+).

Nilotinib (Tasigna®) is used to treat adult and pediatric patients greater than or equal to 1 year of age with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+).

Page 1 NILOTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — nilotinib ny LOH tih nib Brand name — Tasigna® tuh SIG nuh Approved uses Nilotinib is used to treat adult and pediatric patients greater than or equal to 1 year of age with chronic myeloid leukemia CML that is Philadelphia chromosome–positive Ph+ . Dose and schedule Taking nilotinib 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 adult dose of nilotinib is 300 milligrams 300 mg to 400 milligrams 400 mg to be taken by mouth at a scheduled time twice daily. The pediatric dose is based on many factors, including height and weight, overall health, and diagnosis. Nilotinib should be taken on an empty stomach at least one hour before or two hours after a meal or snack , but at the same time each day. Nilotinib should be taken whole and not crushed, cut, opened, or dissolved. If you are unable to swallow nilotinib, talk to your care provider or pharmacist for possible options. If you miss a dose of nilotinib, 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 nilotinib 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 nilotinib at room temperature 68°F–77°F in a dry location away from light. Keep nilotinib out of reach of children and pets. Leave nilotinib in the provided packaging until it is ready to be taken. Whenever possible, give nilotinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give nilotinib 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 nilotinib 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. NILOTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for nilotinib. Do not mix other medications into the box with nilotinib. 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 nilotinib, 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 nilotinib. If you are traveling, put your nilotinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since nilotinib 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 nilotinib, 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 nilotinib 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 Nilotinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Nilotinib should be taken on an empty stomach at least one hour before or two hours after a meal or snack . Grapefruit or grapefruit juice may interact with nilotinib; avoid eating or drinking these during your treatment with nilotinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. NILOTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Nilotinib The common side effects that have been known to happen in more than 30% of patients taking nilotinib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in liver function Your liver function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Unusual bleeding or bruising Changes in electrolytes and other laboratory values High glucose 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 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 UV ultraviolet radiation occurs between 10 am–4 pm. Wear long sleeved clothing, with UV protection if possible. Wear broad brimmed hats. Apply broad spectrum sunscreen UVA/UVB with at least SPF 30 as often as directed on the bottle. Use lip balm with at least SPF 30. If your rash or itching continues to worsen, contact your care provider. Continued on the next page NILOTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Nausea or vomiting Eat and drink slowly. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. 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. 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 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or hold your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page NILOTINIB 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 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. 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 nilotinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 14 days after the last dose of nilotinib. Do not breastfeed while taking nilotinib and for 14 days after the last dose of nilotinib. 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 nilotinib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your nilotinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO NILOTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Additional resources Product website: www.us.tasigna.com Product prescribing information: www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/ tasigna.pdf Product resources: www.us.tasigna.com/patient support2/download helpful materials Updated — April 20, 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.

Nilutamide

(ny-LOO-tuh-mide)

Nilutamide (Nilandron®) is used to treat prostate cancer.

Nilutamide (Nilandron®) is used to treat prostate cancer.

Page 1 NILUTAMIDE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — nilutamide ny LOO tuh mide Brand name — Nilandron® nih LAN drun Approved uses Nilutamide is used to treat prostate cancer. Dose and schedule Taking nilutamide 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 nilutamide is 300 milligrams 300 mg to be taken by mouth at a scheduled time once a day for 30 days, followed by 150 milligrams 150 mg daily. Nilutamide should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow nilutamide, talk to your care provider or pharmacist for possible options. If you miss a dose of nilutamide, 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 nilutamide 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 nilutamide at room temperature 68°F to 77°F in a dry location away from light. Keep nilutamide out of reach of children and pets. Leave nilutamide in the provided packaging until it is ready to be taken. Whenever possible, you should give nilutamide to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the nilutamide 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 nilutamide 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 you have any unused nilutamide, 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 nilutamide. NILUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 2 If you are traveling, put your nilutamide in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. A daily pill box or pill reminder is not recommended to be used with nilutamide. Handling body fluids and waste Nilutamide remains in your body for several days after it is taken, and some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take nilutamide, it is important to know the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or ivosidenib 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 Nilutamide has many drug interactions. Please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Drinking alcohol while taking nilutamide can lead to facial flushing, low blood pressure, and feeling poorly overall. Serious side effects Nilutamide can increase your risk of developing lung disease; report any shortness of breath, cough, chest pain, or fever. Nilutamide may cause changes in liver function; report any yellowing of the skin or whites of your eyes, dark or brown urine, or bleeding or bruising. NILUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Nilutamide The common side effects that have been known to happen in more than 30% of patients taking nilutamide 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, consider the following recommendations: Mild, regular exercise may help after consulting with your care provider. Try staying in a cool environment. Avoid or limit caffeine, spicy food, alcohol, and stress, which may cause hot flashes to worsen. Inform your care provider if this side effect is bothersome as there may be medications that can help with hot flashes. Eye changes This medication may cause blurred vision, dry eyes, or eye pain. Report changes in eyesight to your care provider. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Men should not get a partner pregnant while taking nilutamide. Males and females of childbearing age and potential should use effective contraception during therapy and for a minimum of 30 days after the last dose of nilutamide. Do not breastfeed while taking nilutamide and for 30 days after the last dose of nilutamide. 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 nilutamide. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO NILUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 4 Additional resources Product website: https://medlineplus.gov/druginfo/meds/a697044.html Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2017/020169s008lbl.pdf Updated – September 6, 2018 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.

Niraparib

(nih-RA-puh-rib )

Niraparib (Zejula™) is used to treat adult patients with recurrent fallopian tube cancer, ovarian cancer, or primary peritoneal cancer.

Niraparib (Zejula™) is used to treat adult patients with recurrent fallopian tube cancer, ovarian cancer, or primary peritoneal cancer.

ShowAll NIRAPARIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — niraparib nih-RA-puh-rib Brand name — Zejula™ zeh-JOO-luh Approved uses Niraparib is used to treat adult patients with recurrent fallopian tube cancer ovarian cancer or primary peritoneal cancer Dose and schedule Taking niraparib 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 niraparib is 300 milligrams 300 mg to be taken by mouth once daily The dose may be adjusted by your care provider based on your individual needs o Niraparib can be taken with or without food but at the same time each day o Taking niraparib at bedtime can decrease the risk of nausea and/or vomiting o Niraparib should be taken whole and not crushed cut or dissolved If you are unable to swallow niraparib talk to your care provider or pharmacist for possible options o If you miss a dose of niraparib do not take an extra dose or two doses at one time Simply take your next dose at the regularly scheduled time o Be sure to write down if you miss a dose and let your care provider know about any missed doses Storage and handling Handle niraparib 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 niraparib at room temperature 68°F–77°F in a dry location away from light o Keep niraparib out of reach of children and pets o Leave niraparib in the provided packaging until it is ready to be taken o Whenever possible give niraparib to yourself and follow the steps below If a family member friend or caregiver needs to give niraparib 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 niraparib 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 NIRAPARIB ORAL CHEMOTHERAPY EDUCATION Page 2 o If a daily pill box or pill reminder is used a separate one should be used for niraparib Do not mix other medications into the box with niraparib 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 niraparib 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 niraparib o If you are traveling put your niraparib in a sealed plastic bag Ask your pharmacist if any additional travel precautions are needed Handling body fluids and waste Niraparib 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 niraparib it is important to follow the instructions below every day for as long as your treatment lasts This will keep yourself loved ones and the environment as safe as possible o Pregnant women should avoid touching anything that may be soiled with body fluids from the patient o Toilet and septic systems You may use the same toilet septic tank and/or sewer that you usually use If you have a low-flow toilet close the lid and flush twice to ensure all waste has been discarded If the toilet or toilet seat becomes soiled with urine stool or vomit clean the surfaces before other people use the toilet Wash hands with soap and water after using the toilet o If you need a bedpan be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day o If you do not have good control of bladder or bowels use a disposable pad with a plastic back a diaper or a sheet to absorb body waste o Wash any skin that has been exposed to body waste or niraparib 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 Niraparib has many drug interactions Inform your care providers of all prescription medications over-the-counter medications vitamins and herbal products that you are taking o Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines NIRAPARIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Niraparib The common side effects that have been known to happen in more than 30% of patients taking niraparib 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 too You might notice that you are more pale than usual Let your healthcare provider know right away if you experience: Shortness of breath Dizziness Palpitations Nausea or vomiting Eat and drink slowly Drink 8–10 glasses of water 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 that can help Continued on the next page NIRAPARIB 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: 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 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 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 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 Continued on the next page NIRAPARIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Constipation Monitor how many bowel movements you have each day Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake Stay active and exercise if possible Eat foods high in fiber like raw fruits and vegetables Contact your care provider if you have not had a bowel movement in three or more days Your care provider may recommend over-the-counter medications to help with your constipation A daily stool softener such as docusate Colace® and/or laxative such as senna Senakot® may be helpful If these do not help within 48 hours tell your provider 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 Abdominal pain Abdominal pain or discomfort may occur Report any serious pain or symptoms to your care provider immediately If you experience ANY uncontrolled side effect call your physician or healthcare center immediately: _ INSTITUTIONAL CONTACT INFO Pregnancy sexual activity and contraception o Women should not become pregnant and men should not get a partner pregnant while taking niraparib Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of six months after the last dose of niraparib o Do not breastfeed while taking niraparib and for one month after the last dose of niraparib 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 niraparib and you are encouraged to ask your care provider Obtaining medication Talk with your care provider about how to obtain your bicalutamide PHARMACY OR SPECIALTY PHARMACY CONTACT INFO NIRAPARIB ORAL CHEMOTHERAPY EDUCATION Page 6 Additional resources Product website: http://zejula com Product prescribing information: http://zejula com/docs/Zejula_ niraparib _Full_Prescribing_Information pdf Product resources: http://zejula com/resources Updated — August 4 2017 Additional instructions Important notice: The Association of Community Cancer Centers ACCC Hematology/Oncology Pharmacy Association HOPA National Community Oncology Dispensing Association Inc NCODA and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources This guide does not cover all existing information related to the possible uses directions doses precautions warnings interactions adverse effects or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional Provision of this guide is for informational purposes only and does not constitute or imply endorsement recommendation or favoring of this medication by ACCC HOPA NCODA or ONS who assume no liability for and cannot ensure the accuracy of the information presented The collaborators are not making any representations with respect to the medications whatsoever and any and all decisions with respect to such medications are at the sole risk of the individual consuming the medication All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise easy-to-understand information about oral cancer drugs Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information However commercial reproduction or reuse as well as rebranding or reposting of any type are strictly prohibited without permission of the copyright holder Please email permission requests and licensing inquiries to Contact@NCODA org Copyright © 2017 by Hematology/Oncology Pharmacy Association All rights reserved

Niraparib and Abiraterone

(nih-RA-puh-rib and A-bih-RA-tehrone)

The combination of niraparib/abiraterone acetate (AKEEGA®) is used to treat prostate cancer that has a variant in the BRCA genes and may also be used for other treatments.

The combination of niraparib/abiraterone acetate (AKEEGA®) is used to treat prostate cancer that has a variant in the BRCA genes and may also be used for other treatments.

NIRAPARIB AND ABIRATERONE Page 1 Name of your medication Generic name — niraparib (nih-RA-puh-rib) / abiraterone acetate (A-bih-RA-tehrone A-seh-tayt) Brand name — AKEEGA® (uh-KEE-guh) Common uses The combination of niraparib/abiraterone acetate is used to treat prostate cancer that has a variant in the BRCA genes. Niraparib/abiraterone acetate may also be used for other treatments. Dose and schedule Taking niraparib/abiraterone acetate as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. o Your dose may vary, but the usual dose of niraparib/abiraterone acetate is 2 tablets (200 milligrams niraparib and 1000 milligrams abiraterone) to be taken by mouth at a scheduled time once daily in combination with prednisone (10 milligrams) daily. o Niraparib/abiraterone acetate should be taken on an empty stomach. Take niraparib/abiraterone acetate 1 hour before or at least 2 hours after a meal. o Niraparib/abiraterone acetate should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow niraparib/abiraterone acetate, talk to your care provider or pharmacist for possible options. o When taking niraparib/abiraterone acetate, 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. o Do not take an additional dose of either medication if vomiting occurs after administration. Continue with the next scheduled dose. Drug and food interactions o Niraparib/abiraterone acetate have many drug interactions. Inform your care providers of all prescription medications, over-the counter medications, vitamins, and herbal products that you are taking. o Niraparib/abiraterone acetate should be taken without food (administer abiraterone and niraparib at least 1 hour before or at least 2 hours after eating). o Talk with your care provider or pharmacist before taking new medications or supplements, or before receiving any vaccines. ORAL CANCER TREATMENT EDUCATION NIRAPARIB AND ABIRATERONE ORAL CANCER TREATMENT EDUCATION Page 2 Storage and handling Handle niraparib/abiraterone acetate with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. o Store niraparib/abiraterone acetate at room temperature (68°F to 77°F) in a dry location away from light. o Keep niraparib/abiraterone acetate out of reach of children and pets. o Leave niraparib/abiraterone acetate in the provided packaging until it is ready to be taken. o Whenever possible, you should give niraparib/abiraterone acetate to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the niraparib/abiraterone acetate to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the niraparib/abiraterone acetate from its package to a small medicine cup or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. o If a daily pill box or pill reminder will be used, contact your care team before using, and follow these guidelines: • The person filling the pill box or pill reminder should wear gloves (gloves are not necessary if you are filling the box or reminder). • When empty, the pill box or pill 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 niraparib/abiraterone acetate, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of niraparib/abiraterone acetate. o If you are traveling, put your niraparib/abiraterone acetate in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. NIRAPARIB AND ABIRATERONE ORAL CANCER TREATMENT EDUCATION Page 3 Side Effects of Niraparib/Abiraterone Acetate Below are common side effects that have been known to happen in about one-third or more of patients taking niraparib/ abiraterone acetate; 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 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, too. • You might notice that you are more pale than usual. Let your care provider know right away if you experience the following symptoms: • 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 infections. • Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any of the following 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 NIRAPARIB AND ABIRATERONE ORAL CANCER TREATMENT EDUCATION Page 4 Possible Side Effect Management Muscle or joint pain or weakness Keep a diary of your pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. Take the following precautions: • Stay as active as possible, but know that it is OK 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. Take only pain medication that has been prescribed or recommended by your care provider. Fatigue You may be more tired than usual or have less energy. Take the following precautions: • 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. • Stay as active as possible, but know that it is okay to rest as needed, too. • 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. Take the following precautions: • 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, blood in your urine or stool, blood when you cough, 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 NIRAPARIB AND ABIRATERONE ORAL CANCER TREATMENT EDUCATION Page 5 Possible Side Effect Management Constipation Monitor how many bowel movements you have each day. Take the following precautions: • 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 a laxative such as senna (Senokot®) may be helpful. If these do not help within 48 hours, tell your provider. Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal or diary, and report your findings to your physician. Contact your healthcare provider if you have high blood pressure or if the following or similar symptoms occur: • Headache • Dizziness • Chest pain • Shortness of breath • Fluid retention, weight gain, or swelling 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 symptoms: • Yellowing of the skin or whites of your eyes • Dark or brown urine • Bleeding or bruising 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 that can help. Continued on the next page NIRAPARIB AND ABIRATERONE ORAL CANCER TREATMENT EDUCATION Page 6 Possible Side Effect Management Changes in electrolytes and other laboratory values • Increased serum creatinine • Increased or decreased potassium • Decreased blood sugar 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 experience any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • Headaches • Dizziness • Increased thirst or hunger • Increased urination Serious side effects o Niraparib/abiraterone acetate may increase your risk for certain blood cancers. Be sure to alert your physician if you notice any abnormal bruising or bleeding. o There is a low risk that you may develop a rare condition called posterior reversible leukoencephalopathy syndrome (PRES) while taking niraparib/abiraterone acetate. Seek care immediately if you have severe headaches, seizures, confusion, or changes in vision. o Niraparib/abiraterone acetate can alter your body’s ability to make the right amount of steroids. Tell your healthcare provider if you have any of the following symptoms: dizziness, fast heartbeat, feelings of being faint or lightheaded, headache, confusion, muscle weakness, pain in your legs, or swelling in your legs or feet. o Niraparib/abiraterone acetate may be harmful to your adrenal glands. Speak to your care provider to know when you need to have laboratory tests done to monitor your adrenal glands. Steroid medication is often prescribed to help with this side effect. o Niraparib/abiraterone acetate may be harmful to your liver. Speak to your care provider to know when you need to have laboratory tests done to monitor your liver function. If you experience this side effect, your doctor may change your dosage or stop treatment for some time. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: NIRAPARIB AND ABIRATERONE ORAL CANCER TREATMENT EDUCATION Page 7 Handling body fluids and waste Because niraparib/abiraterone acetate 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 niraparib/abiraterone acetate, 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. 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 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. 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 niraparib/abiraterone acetate with soap and water. o Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washing machine, place the soiled linens in a plastic bag until they can be washed. o Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception o Niraparib/abiraterone acetate is not for use by women. Men should not get a partner pregnant while taking niraparib/ abiraterone acetate. o Males with female partners of childbearing age and potential should use effective contraception during therapy and for a minimum of 4 months after the last dose of niraparib/abiraterone acetate. o It is safe to hug and kiss. Special precautions may be needed for sexual activity while taking oral chemotherapy, and you are encouraged to ask your care team for assistance. Obtaining medication o Talk with your care provider about the process for obtaining your niraparib/abiraterone acetate. NIRAPARIB AND ABIRATERONE ORAL CANCER TREATMENT EDUCATION Page 8 Additional resources Product website: https://www.akeega.com Product prescribing information: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/AKEEGA-pi.pdf Product resources: https://www.akeega.com/patient-resources Updated – November 10, 2023 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 Cancer Treatment 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 © 2023 by Hematology/Oncology Pharmacy Association. All rights reserved.

Olaparib

((oh LA puh rib))

Olaparib (Lynparza®) is used to treat ovarian, fallopian tube, or primary peritoneal cancer.

Olaparib (Lynparza®) is used to treat ovarian, fallopian tube, or primary peritoneal cancer.

Page 1 OLAPARIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — olaparib (oh LA puh rib) Brand name — Lynparza® (lin PAR zuh) Approved uses Olaparib is used to treat ovarian, fallopian tube, or primary peritoneal cancer. Dose and schedule Taking olaparib 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 olaparib is 300 milligrams (300 mg) or 400 milligrams (400 mg) to be taken by mouth at a scheduled time two times a day. Olaparib comes as capsules and tablets. Capsules and tablets are not the same. If your care provider prescribes capsules for you, do not take tablets instead. If your care provider prescribes tablets, do not take capsules instead. Olaparib can be taken with or without food, but at the same time each day. Olaparib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow olaparib, talk to your care provider or pharmacist for possible options. If you miss a dose of olaparib, 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 olaparib 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 olaparib at room temperature (68°F–77°F) in a dry location away from light. Keep olaparib out of reach of children and pets. Leave olaparib in the provided packaging until it is ready to be taken. Whenever possible, give olaparib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give olaparib 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 olaparib 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. OLAPARIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for olaparib. Do not mix other medications into the box with olaparib. 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 olaparib, 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 olaparib. If you are traveling, put your olaparib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Olaparib 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 olaparib, 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 olaparib 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 Olaparib 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, grapefruit juice, and Seville oranges may interact with olaparib; avoid eating or drinking these during treatment with olaparib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. OLAPARIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Olaparib The common side effects that have been known to happen in more than 30% of patients taking olaparib 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 by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience: Shortness of breath Dizziness Palpitations Nausea or vomiting Eat and drink slowly. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication that can help. Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed, too. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Continued on the next page OLAPARIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection such as: Fever (temperature more than 100.4°F or 38°C) Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Abdominal pain Abdominal pain or 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 you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake related to some other health problem. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods (e.g., bananas, applesauce, potatoes, chicken, rice, toast). Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Continued on the next page OLAPARIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Muscle or joint pain or weakness Keep a diary of your pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. Stay as active as possible, but know that it is okay to rest as needed, too. Tell your care provider if pain interferes with your activity. If the pain or weakness bothers you, ask your provider how you may ease this discomfort. Only take medication that has been prescribed or recommended by your care provider. Changes in kidney function Your kidney (renal) function will be checked periodically by a simple blood test. Contact your care provider if you notice either of the following: Decreased amount of urination Unusual swelling in your legs and feet 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 bleeding 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 will not 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 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 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 If you experience ANY uncontrolled side effect call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) OLAPARIB ORAL CHEMOTHERAPY EDUCATION Page 6 Pregnancy sexual activity and contraception Women should not become pregnant and men should not get a partner pregnant while taking olaparib Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of six months after the last dose of olaparib Do not breastfeed while taking olaparib and for one month after the last dose of olaparib 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 olaparib and you are encouraged to ask your care provider Obtaining medication Talk with your care provider about how to obtain your olaparib (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www lynparza com Product prescribing information: https://www azpicentral com/Lynparza/pi lynparza pdf#page=1 Product resources: https://www lynparza com/support for patients/support for patients html Updated – November 20 2017 OLAPARIB 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 Contact@NCODA org Copyright © 2017 by Hematology/Oncology Pharmacy Association All rights reserved Additional instructions

Olutasidenib

(oh-LOO-tuh-SIH-deh-nib)

Olutasidenib (Rezlidhia™) is used to treat relapsed/refractory acute myeloid leukemia (AML) with a genetic variant called isocitrate dehydrogenase-1 (IDH1) and may also be used for other treatments.

Olutasidenib (Rezlidhia™) is used to treat relapsed/refractory acute myeloid leukemia (AML) with a genetic variant called isocitrate dehydrogenase-1 (IDH1) and may also be used for other treatments.

Page 1 OLUTASIDENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — olutasidenib (oh-LOO-tuh-SIH-deh-nib) Brand name — Rezlidhia® (rez-LIH-dee-uh) Common uses Olutasidenib is used to treat relapsed/refractory acute myeloid leukemia (AML) with a genetic variant called isocitrate dehydrogenase-1 (IDH1). Olutasidenib may also be used for other treatments. Dose and schedule Taking olutasidenib 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 olutasidenib is 150 milligrams (150 mg) to be taken by mouth at a scheduled time twice a day at least 8 hours apart. o Olutasidenib should be taken on an empty stomach at least 1 hour before or 2 hours after a meal at the same time each day. o Olutasidenib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow olutasidenib talk to your care provider or pharmacist for possible options. o If you miss a dose of olutasidenib: • Take the missed dose as soon as possible, then take the next dose at least 8 hours later. Return to your normal schedule the following day. • If a dose of olutasidenib is vomited, do not take a replacement dose. • 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 o Olutasidenib has many drug interactions, please inform your care providers of all prescription medications, over-the counter medications, vitamins, and herbal products. o Grapefruit or grapefruit juice may interact with olutasidenib; avoid eating or drinking these during treatment with olutasidenib. o Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Page 2 OLUTASIDENIB ORAL CHEMOTHERAPY EDUCATION Storage and handling Handle olutasidenib 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 olutasidenib at room temperature (68°F–77°F) in a dry location away from light. o Keep olutasidenib out of reach of children and pets. o Whenever possible, give olutasidenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the olutasidenib 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 olutasidenib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. o 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 o If you have any unused olutasidenib, 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 olutasidenib. o If you are traveling, put your olutasidenib’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Page 3 OLUTASIDENIB ORAL CHEMOTHERAPY EDUCATION Common side effects that have been known to happen in about one third or more of patients taking olutasidenib 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 Changes in electrolytes and other laboratory values • Low potassium levels • Low sodium levels Changes in some lab values may occur and will be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs or feet • Red- or brown-colored urine Nausea or vomiting • Eat and drink slowly. • Drink 8–10 glasses of water/fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t 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. Continued on the next page Page 4 OLUTASIDENIB ORAL CHEMOTHERAPY EDUCATION 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 • Unusual swelling in your legs and feet Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is okay to rest as needed. • Try to do some activity every day. o Plan your activities, and do them at a time of day when you feel a bit more energetic. o Avoid operating heavy machinery if you feel too tired. Serious side effects o Olutasidenib can cause a very serious side effect known as differentiation syndrome. Patients with differentiation syndrome may have a fever, shortness of breath or trouble breathing, swelling, and weight gain. Be sure to let your care team know if you experience a fever, have trouble breathing, or have sudden weight gain. o Olutasidenib 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. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: Handling body fluids and waste Because olutasidenib 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 olutasidenib it is important to know the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. o Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. o Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low-flow toilet, close the lid and flush twice to ensure 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. 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 olutasidenib with soap and water. Page 5 OLUTASIDENIB ORAL CHEMOTHERAPY EDUCATION o Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. o Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception o Women should not become pregnant and men should not get a partner pregnant while taking olutasidenib. o Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. o Do not breastfeed while taking olutasidenib and for 2 weeks after the last dose of olutasidenib. o Please inform your care provider if you become pregnant. o It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy and you are encouraged to ask your care team for assistance. Obtaining medication o Talk with your care provider about the process for obtaining your olutasidenib. Additional resources Product website: https://www.rezlidhia.com Product prescribing information: https://www.rezlidhia.com/downloads/pdf/REZLIDHIA-Full-Prescribing -Information.pdf Product resources: N/A Updated – January 25, 2023 Additional instructions Page 6 OLUTASIDENIB ORAL CHEMOTHERAPY EDUCATION Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy-to-understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2023 by Hematology/Oncology Pharmacy Association. All rights reserved.

Osimertinib

(oh-si-MER-ti-nib)

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

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

Page 1 OSIMERTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — osimertinib oh si MER ti nib Brand name — Tagrisso® tuh GRIH soh Approved uses Osimertinib is used to treat non small cell lung cancer NSCLC that has a genetic mutation called epidermal growth factor EGFR . Dose and schedule Taking osimertinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of osimertinib is 80 milligrams 80 mg to be taken by mouth at a scheduled time each day. Osimertinib should be taken with or without food at the same time each day. Osimertinib should be taken whole and not crushed or cut. If you are unable to swallow osimertinib, talk to your care provider or pharmacist for possible options. If you miss a dose of osimertinib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle osimertinib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store osimertinib at room temperature 68°F–77°F in a dry location away from light. Keep osimertinib out of reach of children and pets. Leave osimertinib in the provided packaging until it is ready to be taken. Whenever possible, you should give osimertinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the osimertinib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the osimertinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. OSIMERTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for osimertinib. Do not mix other medications into the box with osimertinib. The person filling the box or reminder should wear gloves. Gloves are not necessary if you are filling the box or reminder. When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused osimertinib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of osimertinib. If you are traveling, put your osimertinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Osimertinib remains in your body for several days after it is taken, so some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take osimertinib, it is important to follow the instructions below every day for as long as your treatment lasts. This will keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or osimertinib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Osimertinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines. OSIMERTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Osimertinib The common side effects that have been known to happen in more than 30% of patients taking osimertinib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased white blood cells WBCs and increased risk of infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at greater risk for infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection such as: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently and do not pick your nose. Brush your teeth gently with a soft toothbrush and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: A bloody nose that bleeds for more than 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, blood in your urine or stool, coughing up blood, or prolonged and uncontrollable bleeding. You may need to take a break or hold your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page OSIMERTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake related to some other health problem. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods e.g., bananas, applesauce, potatoes, chicken, rice, toast . Avoid high fiber foods e.g., raw vegetables, raw fruits, whole grains . Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest, too. You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Rash or dry/itchy skin Keep your skin moisturized with creams and moisturizing lotions to decrease the risk of rash or itchiness, and wear loose fitting clothing. Avoid using perfumes and cologne as these products may increase rash symptoms. Avoid being in the heat for long periods of time. Your provider may recommend an over the counter antihistamine or a topical cream. Sunlight can make symptoms worse. – Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to UV ultraviolet radiation occurs from the hours of 10 am through 4 pm. – Wear long sleeved clothing with UV protection, if possible. – Wear broad brimmed hats. – Apply broad spectrum sunscreen UVA/UVB with at least SPF 30 as often as directed on the bottle. – Use lip balm with at least SPF 30. If your rash or itching continues to worsen, contact your care provider. OSIMERTINIB ORAL CHEMOTHERAPY EDUCATION Page 5 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking osimertinib. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of six weeks after the last dose of osimertinib. Men with female partners of childbearing age and potential should use effective contraception during therapy and for a minimum of four months after the last dose of osimertinib. Do not breastfeed while taking osimertinib and for two weeks after the last dose of osimertinib. Inform your care provider if you become pregnant. It is safe to hug and kiss, but special precautions may be needed for sexual activity while on oral chemotherapy. You are encouraged to talk to your care provider. Obtaining medication Talk with your care provider about how to obtain your osimertinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.tagrisso.com Product prescribing information: www.azpicentral.com/tagrisso/tagrisso.pdf#page=1 Product resources: www.tagrisso.com/lung cancer resources.html Updated – February 4, 2018 Additional instructions OSIMERTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.

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