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Everolimus

(eh-veh-ROH-lih-mus)

Everolimus (Afinitor®) is used to treat the following: o Hormone receptor–positive (HR+), human epidermal growth factor receptor-2 (HER-2)-negative breast cancer, in combination with the medication exemestane o Pancreatic cancer (i.e., pancreatic neuroendocrine tumor [PNET]) o Neuroendocrine tumo...

Everolimus (Afinitor®) is used to treat the following: o Hormone receptor–positive (HR+), human epidermal growth factor receptor-2 (HER-2)-negative breast cancer, in combination with the medication exemestane ...

ShowAll Page 1 EVEROLIMUS ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — everolimus eh-veh-ROH-lih-mus Brand name — Afinitor® a-FIN-i-tor Approved uses Everolimus is used to treat the following: o Hormone receptor–positive HR+ human epidermal growth factor receptor-2 HER-2 -negative breast cancer in combination with the medication exemestane o Pancreatic cancer i e pancreatic neuroendocrine tumor [PNET] o Neuroendocrine tumor NET of the stomach and intestine gastrointestinal or lung o Kidney cancer called renal cell carcinoma or angiomyolipoma and tuberous sclerosis complex o Brain tumor called subependymal giant cell astrocytoma SEGA Dose and schedule Taking everolimus 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 everolimus is 10 milligrams 10 mg to be taken by mouth at a scheduled time once a day o Your dose is based on many factors including your height and weight overall health and diagnosis o Everolimus can be taken with or without food Choose one with food or without food and take at the same time each day o Everolimus should be taken with a full glass of water o Everolimus is available as regular tablets and tablets used to make a suspension Afinitor® Disperz The regular tablets should be taken whole and not crushed cut or dissolved The tablets used to make a suspension should not be crushed or cut but can be dissolved in water If you are unable to swallow everolimus talk to your care provider or pharmacist for possible options o If you miss a dose of everolimus: Only take the missed dose if it has been less than six hours since you were supposed to take it Then take the next dose at the regularly scheduled time Do not take the missed dose if it has been more than six hours since you should have taken it Simply take the next dose at the regularly scheduled time Do not take two doses at one time Be sure to write down if you miss a dose and let your care provider know about any missed doses Storage and handling Handle everolimus 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 everolimus at room temperature 68°F–77°F in a dry location away from light o Keep everolimus out of reach of children and pets EVEROLIMUS ORAL CHEMOTHERAPY EDUCATION Page 2 o Leave everolimus in the provided packaging until it is ready to be taken o Whenever possible give everolimus to yourself and follow the steps below If a family member friend or caregiver needs to give everolimus 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 everolimus from its package to a small medicine or other disposable cup 4 Administer the medicine immediately by mouth with water 5 Remove gloves and do not use them for anything else 6 Throw gloves and medicine cup in household trash 7 Wash hands with soap and water o A daily pill box or pill reminder is not recommended for use with everolimus o If you have any unused everolimus 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 everolimus o If you are traveling put your everolimus in a sealed plastic bag Ask your pharmacist if any additional travel precautions are needed Handling body fluids and waste Everolimus 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 everolimus 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 everolimus 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 EVEROLIMUS ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Everolimus The common side effects that have been known to happen in more than 30% of patients taking everolimus 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 Changes in electrolyte and other laboratory values High glucose levels High prothrombin time levels High cholesterol levels High triglyceride levels High bicarbonate levels Low phosphate levels Low calcium levels Low albumin levels Changes in some lab values may occur and will be monitored by a simple blood test You may not feel any symptoms if the changes are mild and they usually are not a sign of a serious problem More severe changes may occur which can be a sign of a serious problem Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red- or brown-colored urine Changes in liver function Your liver function will be checked periodically by a simple blood test Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Unusual bleeding or bruising Continued on the next page EVEROLIMUS ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Mouth irritation or sores Practice good mouth care Rinse your mouth frequently Brush your teeth with a soft toothbrush or cotton swab after meals Use a mild nonalcohol mouth rinse at least four times a day after eating and at bedtime For example you can use 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 Rash or itchy skin Keep your skin moisturized with creams and moisturizing lotions to decrease the risk of rash or itchiness and wear loose fitting clothing Avoid using perfumes and cologne as these products may increase rash symptoms Avoid being in the heat for long periods of time Your provider may recommend an over-the-counter antihistamine or a topical cream Sunlight can make symptoms worse Avoid sun exposure as much as possible to decrease the risk of sunburn The highest exposure to ultraviolet UV radiation occurs from 10 am–4 pm Wear long-sleeved clothing with UV protection if possible Wear broad-brimmed hats Apply broad-spectrum sunscreen UVA/UVB with at least SPF 30 as often as directed on the bottle If your rash or itching continues to worsen contact your care provider 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 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 Continued on the next page EVEROLIMUS ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Changes in kidney function Your kidney renal function will be checked periodically by a simple blood test Contact your care provider if you notice either of the following: Decreased amount of urination Unusual swelling in your legs and feet Decreased white blood cells WBCs and increased risk for infection including respiratory tract infections 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 Report symptoms of a respiratory infection like a cough sneezing runny nose fever and scratchy or sore throat to your provider Check with your care provider before taking any medicine for a fever or chills 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 EVEROLIMUS ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Fatigue You may be more tired than usual or have less energy Stay as active as possible but know it is okay to rest as needed too Try to do some activity every day Plan your activities and do them at a time of day when you feel a bit more energetic Avoid operating heavy machinery if you feel too tired Fluid retention or swelling Do not stand for long periods of time Keep your legs elevated when sitting or lying down Avoid eating salty foods which can increase swelling Avoid wearing tight-fitting clothing and shoes Weigh yourself daily Contact your care provider if you notice any of the following: Swelling in the hands feet or legs Shortness of breath Weight gain of five pounds or more in a week Abdominal pain Abdominal pain or discomfort may occur Report any serious pain or symptoms to your care provider immediately Headache Ask your provider what you may use to ease headaches Contact your care provider immediately if your headache: Follows a head injury Is severe 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 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 Continued on the next page EVEROLIMUS ORAL CHEMOTHERAPY EDUCATION Page 7 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 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 Cough or shortness of breath A cough that does not produce any mucous or congestion relief dry cough may occur while taking this medication If you experience any breathing problems or shortness of breath notify your care provider immediately This may be a serious side effect of the medication Decreased appetite or weight loss Talk to your provider if you notice a decrease in your weight while taking this medication When you don’t feel like eating try the following: Eat frequent meals instead of three large meals each day Keep snacks nearby so you can eat when you feel hungry Drink liquid nutritional supplements Drink 8–10 glasses of water or fluid each day especially if you are not eating unless your care provider has instructed you to limit your fluid intake Drug and food interactions o Everolimus 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 Grapefruit or grapefruit juice may interact with everolimus; avoid eating or drinking these during treatment with everolimus o Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines o Avoid live vaccines during treatment with everolimus If you experience ANY uncontrolled side effect call your physician or healthcare center immediately: _ INSTITUTIONAL CONTACT INFO EVEROLIMUS ORAL CHEMOTHERAPY EDUCATION Page 8 Important notice: The Association of Community Cancer Centers ACCC Hematology/Oncology Pharmacy Association HOPA National Community Oncology Dispensing Association Inc NCODA and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources This guide does not cover all existing information related to the possible uses directions doses precautions warnings interactions adverse effects or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional Provision of this guide is for informational purposes only and does not constitute or imply endorsement recommendation or favoring of this medication by ACCC HOPA NCODA or ONS who assume no liability for and cannot ensure the accuracy of the information presented The collaborators are not making any representations with respect to the medications whatsoever and any and all decisions with respect to such medications are at the sole risk of the individual consuming the medication All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise easy-to-understand information about oral cancer drugs Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information However commercial reproduction or reuse as well as rebranding or reposting of any type are strictly prohibited without permission of the copyright holder Please email permission requests and licensing inquiries to Contact@NCODA org Copyright © 2017 by Hematology/Oncology Pharmacy Association All rights reserved Pregnancy sexual activity and contraception o Women should not become pregnant and men should not get a partner pregnant while taking everolimus Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of eight weeks after the last dose of everolimus o Do not breastfeed while taking everolimus and for two weeks after the last dose of everolimus 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 everolimus and you are encouraged to ask your care provider Obtaining medication Talk with your care provider about how to obtain your everolimus PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www us afinitor com Product prescribing information: www pharma us novartis com/sites/www pharma us novartis com/files/afinitor pdf Product resources: www us afinitor com/sega-tuberous-sclerosis www us afinitor com/angiomyolipoma-tsc www us afinitor com/progressive-nonfunctional-gi-neuroendocrine-tumor www us afinitor com/lung-neuroendocrine-tumors www us afinitor com/advanced-pancreatic-neuroendocrine-tumors Updated – August 20 2017 EVEROLIMUS ORAL CHEMOTHERAPY EDUCATION Page 9 Additional instructions

Exemestane

(EK-seh-MEH-stayn)

Exemestane (Aromasin®) is used in the treatment of certain types of hormone-dependent breast cancer in postmenopausal women.

Exemestane (Aromasin®) is used in the treatment of certain types of hormone-dependent breast cancer in postmenopausal women.

Page 1 EXEMESTANE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — exemestane (EK seh MEH stayn) Brand name — Aromasin® (uh ROH muh sin) Approved uses Exemestane is used in the treatment of certain types of hormone dependent breast cancer in postmenopausal women. Dose and schedule Taking exemestane 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 exemestane is 25 milligrams (25 mg) to be taken by mouth at a scheduled time once a day. Exemestane should be taken after a meal at the same time each day. Exemestane should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow exemestane, talk to your care provider or pharmacist for possible options. If you miss a dose of exemestane, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions Exemestane has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Exemestane should not be taken with estrogen containing products. Contact your healthcare team with questions. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle exemestane 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 exemestane at room temperature (68°F–77°F) in a dry location away from light. Keep exemestane out of reach of children and pets. Leave exemestane in the provided packaging until it is ready to be taken. Whenever possible, give exemestane to yourself and follow the steps below. If a family member, friend, or caregiver needs to give exemestane 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 exemestane 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. EXEMESTANE ORAL CHEMOTHERAPY EDUCATION Page 2 Side Effects of Exemestane Below are common side effects that have been known to happen in about one third or more of patients taking exemestane 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 Hot flashes (sudden sweating and feelings of warmth) If hot flashes are bothersome: • Mild, regular exercise program may help. Consult first with your care provider. • Try staying in a cool environment. • Wear layers so that you can remove outer layers when experiencing a hot flash. • Avoid or limit caffeine, spicy food, alcohol, and stress, which may worsen hot flashes. Inform your care provider if your hot flashes are bothersome as there may be medications that can help. 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 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 exemestane, 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 exemestane. If you are traveling, put your exemestane’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Serious side effects of exemestane Exemestane may decrease your bone density making you more likely to have a fracture. Your care provider may prescribe medication to help prevent fractures. Be sure to ask your doctor about vitamin D and/or calcium supplementation before starting. Exemestane can cause changes in your blood work. Ask your care team how this will be monitored. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) EXEMESTANE ORAL CHEMOTHERAPY EDUCATION Page 3 Handling body fluids and waste Because exemestane 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 exemestane, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or exemestane 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 exemestane. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of exemestane. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking exemestane and for one month after the last dose of exemestane. 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 exemestane. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) EXEMESTANE ORAL CHEMOTHERAPY EDUCATION Page 4 Additional resources Product website: www.pfizer.com/products/product detail/aromasin Product prescribing information: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=61d86c55 9946 273f 4f22 42d3fc33d143 Product resources: www.aromasin.com/tools and resources Updated – July 15, 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.

fedratinib

(fed-RA-ti-nib)

fedratinib (Inrebic®) is used to treat myelofibrosis.

fedratinib (Inrebic®) is used to treat myelofibrosis.

Page 1 FEDRATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name fedratinib (fed RA ti nib) Brand name Inrebic® (inn REH bik) Approved uses Fedratinib is used to treat myelofibrosis. Dose and schedule Taking fedratinib 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 fedratinib is 400 milligrams (400 mg) to be taken by mouth at a scheduled time once a day. Fedratinib can be taken with or without food, but at the same time each day. Fedratinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow fedratinib, talk to your care provider or pharmacist for possible options. If you miss a dose of fedratinib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions Fedratinib has many drug interactions. Please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with fedratinib; avoid eating or drinking this during treatment with fedratinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle fedratinib 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 fedratinib at room temperature (68°F–77°F) in a dry location away from light. Keep fedratinib out of reach of children and pets. Leave fedratinib in the provided packaging until it is ready to be taken. Whenever possible, you should give fedratinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the fedratinib 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 fedratinib from its package to a small medicine or other disposable cup. FEDRATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder is used, contact your care provider 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. Side Effects of Fedratinib Below are common side effects that have been known to happen in about one third or more of patients taking fedratinib; these are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Continued on the next page FEDRATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if either of the following occurs: The number of bowel movements you have in a day increases by 4 or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Changes in kidney function Your kidney (renal) function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Decreased amount of urination Unusual swelling in your legs and feet Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: A bloody nose that bleeds for more than 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, notice blood in your urine or stool, cough up blood, or have prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page FEDRATINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following. Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising 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 with the nausea or vomiting. Changes in electrolytes and other laboratory values High pancreas enzyme levels Changes in some laboratory values may occur and will be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs and feet Red or brown colored urine Serious side effects Fedratinib may cause a serious and sometimes fatal brain problem called encephalopathy (including Wernicke encephalopathy). Wernicke encephalopathy is a medical emergency and can happen if you do not have enough vitamin B1 (thiamine) in your body. You care team will do a blood test to check your vitamin B1 levels before starting and during treatment with fedratinib. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) FEDRATINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Handling body fluids and waste Since fedratinib 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 fedratinib, it is important to adhere to the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or fedratinib 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 There are no scientific data on the safety of fedratinib during pregnancy. Discuss with your healthcare team before using fedratinib if you plan to become pregnant or get a partner pregnant, or if you are pregnant or breastfeeding. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care team for assistance. Obtaining medication Talk with your care provider about the process for obtaining your fedratinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2019/212327s000lbl.pdf Updated – October 30, 2019 FEDRATINIB 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 © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional instructions

Flutamide

(FLOO-tuh-mide)

Flutamide (N-A) is used to treat prostate cancer.

Flutamide (N-A) is used to treat prostate cancer.

ShowAll FLUTAMIDE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — flutamide FLOO-tuh-mide Brand name — none Approved uses Flutamide is used to treat prostate cancer Dose and schedule Taking flutamide 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 flutamide is 250 milligrams 250 mg to be taken by mouth at scheduled times three times a day every eight hours o Flutamide can be taken with or without food but at the same time each day o Flutamide should be taken whole and not crushed cut or dissolved If you are unable to swallow flutamide talk to your care provider or pharmacist for possible options o If you miss a dose of flutamide 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 flutamide 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 flutamide at room temperature 68°F–77°F in a dry location away from light o Keep flutamide out of reach of children and pets o Leave flutamide in the provided packaging until it is ready to be taken o Whenever possible give flutamide to yourself and follow the steps below If a family member friend or caregiver needs to give flutamide 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 flutamide 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 FLUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 2 o If a daily pill box or pill reminder is used a separate one should be used for flutamide Do not mix other medications into the box with flutamide 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 flutamide 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 flutamide o If you are traveling put your flutamide in a sealed plastic bag Ask your pharmacist if any additional travel precautions are needed Handling body fluids and waste Flutamide 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 flutamide 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 flutamide 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 Flutamide 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 Serious side effects o Flutamide can cause liver damage Speak to your care provider to know when you need to have laboratory tests done to monitor your liver function You may need to take a break or “hold” your medication if changes in liver function occur FLUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Flutamide The common side effects that have been known to happen in more than 30% of patients taking flutamide 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: Follow a regular exercise program Even mild exercise may help Try staying in a cool environment Wear layers so that you can remove outer layers when experiencing a hot flash Avoid or limit caffeine spicy food alcohol and stress which may worsen hot flashes Inform your care provider if your hot flashes are bothersome as there may be medications that can help Decreased sex drive and/or impotence Talk to your care provider about available options 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 If you experience ANY uncontrolled side effect call your physician or healthcare center immediately: _ INSTITUTIONAL CONTACT INFO FLUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 4 Pregnancy sexual activity and contraception o Women should not become pregnant and men should not get a partner pregnant while taking flutamide Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of flutamide 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 flutamide and you are encouraged to ask your care provider Obtaining medication Talk with your care provider about how to obtain your flutamide PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product prescribing information: https://dailymed nlm nih gov/dailymed/drugInfo cfm?setid=d037fb0c-881f -43d2-8693-aa1342d0130a Updated – August 20 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

Fostamatinib

(FOS-tuh-MA-tih-nib)

Fostamatinib (Tavalisse®) is used to treat adult patients with chronic immune thrombocytopenia (ITP).

Fostamatinib (Tavalisse®) is used to treat adult patients with chronic immune thrombocytopenia (ITP).

Page 1 FOSTAMATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name fostamatinib (FOS tuh MA tih nib) Brand name Tavalisse® (TA vah lees) Approved uses Fostamatinib is used to treat adult patients with chronic immune thrombocytopenia (ITP). Dose and schedule Taking fostamatinib 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 fostamatinib is 100 milligrams (100 mg) to 150 milligrams (150 mg) to be taken by mouth twice a day. Fostamatinib can be taken with or without food, but at the same time each day. Fostamatinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow fostamatinib, talk to your care provider or pharmacist for possible options. If you miss a dose of fostamatinib, 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 fostamatinib 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 fostamatinib at room temperature (68°F–77°F) in a dry location away from light. Keep fostamatinib out of reach of children and pets. Leave fostamatinib in the provided packaging until it is ready to be taken. Whenever possible, you should give fostamatinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the fostamatinib 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 fostamatinib 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. FOSTAMATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for fostamatinib. Do not mix other medications into the box with fostamatinib. 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 fostamatinib, 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 fostamatinib. If you are traveling, put your fostamatinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since fostamatinib 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 fostamatinib, it is important to follow the instructions below every day for as long as your treatment lasts. This will keep you, your 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 fostamatinib 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 Fostamatinib has many drug interactions. Please inform your care providers of all prescription medications, over thecounter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with fostamatinib; avoid eating or drinking this during your treatment with fostamatinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. FOSTAMATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Fostamatinib The common side effects that have been known to happen in more than 30% of patients taking fostamatinib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if either of the following occurs: The number of bowel movements you have in a day increases by 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. Serious side effects Decrease in your white blood cell counts (neutropenia) can occur and can be severe with fostamatinib. Speak to your care provider to know when you need to have laboratory tests done to monitor your blood cell counts. You may have a rise in blood pressure while taking fostamatinib. Take your blood pressure on a regular basis, and let your doctor know of any big increases in blood pressure. Fostamatinib may cause liver problems. Contact your care provider if you notice yellowing of the skin or whites of your eyes, dark or brown urine, or abnormal bleeding or bruising. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking fostamatinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 30 days after the last dose of fostamatinib. Do not breastfeed while taking fostamatinib and for 30 days after the last dose of fostamatinib. Please inform your care provider if you become pregnant. FOSTAMATINIB ORAL CHEMOTHERAPY EDUCATION Page 4 It is safe to hug and kiss. Special precautions may be needed for sexual activity while on fostamatinib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your fostamatinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://tavalisse.com Product prescribing information: https://tavalisse.com/downloads/pdf/Tavalisse Full Prescribing Information.pdf Product resources: https://tavalisse.com/patient resources Updated – July 11, 2018 Additional instructions Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.

Futibatinib

(FYOO-tih-BA-tih-nib)

Futibatinib is used to treat intrahepatic cholangiocarcinoma that has spread or cannot be removed by surgery and has a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement. Futibatinib may also be used for other treatments.

Futibatinib is used to treat intrahepatic cholangiocarcinoma that has spread or cannot be removed by surgery and has a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement. Futibatinib may also be used for other treatments.

Page 1 FUTIBATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — futibatinib (FYOO-tih-BA-tih-nib) Brand name — Lytgobi® (lite-GOH-bee) Common uses Futibatinib is used to treat intrahepatic cholangiocarcinoma that has spread or cannot be removed by surgery and has a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement. Futibatinib may also be used for other treatments. Dose and schedule Taking futibatinib 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 futibatinib is 20 milligrams (20 mg) to be taken by mouth once daily. o Futibatinib can be taken with or without food, but at the same time each day. o Futibatinib should be taken whole and not crushed, chewed, cut, or dissolved. If you are unable to swallow futibatinib, talk to your care provider or pharmacist for possible options. o If you miss a dose of futibatinib: • Do not take the missed dose if it has been more than 12 hours since you should have taken it or if vomiting occurs. Simply take the next dose at the regularly scheduled time. • Do not take two doses at one time. • Be sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions o Futibatinib 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 futibatinib; avoid eating or drinking these during treatment with futibatinib. o Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines. Page 2 FUTIBATINIB ORAL CHEMOTHERAPY EDUCATION Storage and handling Handle futibatinib 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 futibatinib at room temperature (68 to 77 F) in a dry location away from light. o Keep futibatinib out of reach of children and pets. o Leave futibatinib in the provided packaging until it is ready to be taken. o Whenever possible, you should give futibatinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the futibatinib 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 futibatinib 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 futibatinib, 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 futibatinib. o If you are traveling, put your futibatinib’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Page 3 FUTIBATINIB ORAL CHEMOTHERAPY EDUCATION Side Effects of Futibatinib Common side effects that have been known to happen in about one third or more of patients taking futibatinib are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in electrolytes and other laboratory values • High or low phosphate level • High or low glucose level • High calcium level • Low sodium level Changes in some lab values may occur and will be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild and they usually are not a sign of a serious problem. • More severe changes may occur which can be a sign of a serious problem. Notify your care provider if you have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs or feet • Red or brown colored urine Changes in kidney function Your kidney (renal) function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Decreased amount of urination • Unusual swelling in your legs and feet Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Yellowing of the skin or whites of your eyes • Dark or brown urine • Bleeding or bruising Continued on the next page Page 4 FUTIBATINIB ORAL CHEMOTHERAPY EDUCATION 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 to 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: • Shortness of breath • Dizziness • Palpitations Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. • Wash your hands often, especially before eating and after using the bathroom. • Avoid crowds and people with fevers, flu, or other infection. • Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection 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 Page 5 FUTIBATINIB ORAL CHEMOTHERAPY EDUCATION Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. • Use caution to avoid bruises, cuts, or burns. • Blow your nose gently and do not pick your nose. • Brush your teeth gently with a soft toothbrush and maintain good oral hygiene. • When shaving use an electronic razor instead of razor blades. • Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: • A bloody nose that bleeds for more than 5 minutes despite pressure • A cut that continues to ooze despite pressure • Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, 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. Nail changes Usually this change starts at the cuticle and may affect the skin around the nail. • Biting, chewing, or picking at your nails can increase the risk of getting an infection • Talk to your care provider if you notice any changes in your nails Muscle or joint pain or weakness • Keep a diary of your pain including a description of when and where the pain is occurring, what it feels like, and how long it lasts. • Stay as active as possible, but know that it is okay to rest as needed, too. • Tell your care provider if pain interferes with your activity. If the pain or weakness bothers you, ask your provider what you may use to help with this discomfort. Take only pain medication that has been prescribed or recommended by your care provider. Continued on the next page Page 6 FUTIBATINIB ORAL CHEMOTHERAPY EDUCATION Possible Side Effect Management Constipation 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. • Stay active and exercise, if possible. • Eat foods high in fiber like raw fruits and vegetables. Contact your care provider if you have not had a bowel movement in 3 or more days. Your care provider may recommend over-the-counter medications to help with your constipation. A daily stool softener such as docusate (Colace®) and/or laxative such as senna (Senakot®) may be helpful. If these do not help within 48 hours, tell your provider. Diarrhea (loose and/ or urgent bowel movement) Monitor how many bowel movements you have each day. • Drink 8-10 glasses of water/fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low-fiber foods (such as bananas, applesauce, potatoes, chicken, rice, and toast). • Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. • Avoid foods that cause gas, such as broccoli and beans. • Avoid lactose-containing foods, such as yogurt and milk. • Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: • The number of bowel movements you have in a day increases by 4 or more. • You feel dizzy or lightheaded. Your care provider may recommend an over-the-counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Continued on the next page Page 7 FUTIBATINIB ORAL CHEMOTHERAPY EDUCATION 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. 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. Hair loss (alopecia) Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with stress of hair loss. Dry mouth 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 non-alcohol mouth rinse at least 4 times a day (after eating and at bedtime). One example is a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm (not hot) water. • If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care provider if you experience pain or sores in your mouth or throat. Abdominal pain Abdominal pain/discomfort may occur. Report any serious pain or symptoms to your care provider immediately. Serious side effects o Futibatinib may be harmful to your eyes. Call your care team if you have any issue with your vision, or if you have pain in your eyes. o Your phosphate levels may be higher while taking futibatinib. Your provider may prescribe a medication to lower your phosphate level. Speak to your care team to know when you need to have blood tests done to monitor your phosphate level. o Futibatinib can cause serious birth defects. Do not take futibatinib if you are pregnant or think you might be pregnant. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: Handling body fluids and waste Since futibatinib 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 futibatinib, 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. Page 8 FUTIBATINIB ORAL CHEMOTHERAPY EDUCATION 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 futibatinib 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 futibatinib. Males and females of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 week after the last dose of futibatinib. o Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. o Do not breastfeed while taking futibatinib and 1 week after the last dose of futibatinib. 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 futibatinib. Page 9 FUTIBATINIB 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. Additional resources Product website: www. lytgobi.com Product prescribing information: https://taihocorp-media-release.s3.us-west-2.amazonaws.com/documents/ LYTGOBI_Prescribing_Information.pdf Product resources: https://www.taihopatientsupport.com Updated – April 27, 2023 Additional instructions

Gefitinib

(geh-FIH-tih-nib)

Gefitinib (Iressa®) is used to treat adults with metastatic non-small cell lung cancer (NSCLC) that has a genetic mutation called epidermal growth factor receptor (EGFR).

Gefitinib (Iressa®) is used to treat adults with metastatic non-small cell lung cancer (NSCLC) that has a genetic mutation called epidermal growth factor receptor (EGFR).

Page 1 GEFITINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — gefitinib geh FIH tih nib Brand name — Iressa® i REH suh Approved uses Gefitinib is used to treat adults with metastatic non small cell lung cancer NSCLC that has a genetic mutation called epidermal growth factor receptor EGFR . Dose and schedule Taking gefitinib 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 gefitinib is 250 milligrams 250 mg to be taken by mouth at a scheduled time once a day. Gefitinib can be taken with or without food at the same time each day. Gefitinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow gefitinib, talk to your care provider or pharmacist for possible options. If you miss a dose of gefitinib: – Only take the missed dose if it has been less than 12 hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. – Do not take the missed dose if it has been more than 12 hours since you should have taken it. Simply take your next dose at the regularly scheduled time. – Do not take two doses at one time. – Be sure to write down if you miss a dose and notify your care provider about any missed doses. Storage and handling Handle gefitinib 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 gefitinib at room temperature 68°F–77°F in a dry location away from light. Keep gefitinib out of reach of children and pets. Leave gefitinib in the provided packaging until it is ready to be taken. Whenever possible, you should give gefitinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the gefitinib 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 gefitinib 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. GEFITINIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for gefitinib. Do not mix other medications into the box with gefitinib. 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 gefitinib, 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 gefitinib. If you are traveling, put your gefitinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Gefitinib 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 gefitinib, 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 gefitinib 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 Gefitinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with gefitinib, so avoid eating or drinking these during treatment with gefitinib. Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines. GEFITINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Gefitinib The common side effects that have been known to happen in more than 30% of patients taking gefitinib 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 Acne like rash A rash that looks like acne may develop on your face, chest, and upper back while taking this medication. Your doctor may prescribe medication to help prevent or manage the rash. If you do get a rash, keep the surrounding area clean and dry. Check with your care provider before using anything to treat the rash. Do not use over the counter acne treatments, such as benzoyl peroxide or salicylic acid, or soaps containing alcohol. Oatmeal baths and unscented moisturizers may help with itching. Sunlight can make symptoms worse. – Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to 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 Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Kidney damage Your care provider will monitor your kidney function by checking the amount of protein in your urine. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO GEFITINIB 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 gefitinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of two weeks after the last dose of gefitinib. Do not breastfeed while taking gefitinib and for two weeks after the last dose of gefitinib. 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 gefitinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.iressa usa.com Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2015/206995s000lbl.pdf Product resources: www.iressa usa.com/lung cancer support/nsclc resources.html Updated – February 4, 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.

Gilteritinib

(GIL-teh-RIH-tih-nib)

Gilteritinib (Xospata®) is used to treat adult patients with FMS-like tyrosine kinase 3 (FLT3) mutation-positive acute myeloid leukemia.

Gilteritinib (Xospata®) is used to treat adult patients with FMS-like tyrosine kinase 3 (FLT3) mutation-positive acute myeloid leukemia.

Page 1 GILTERITINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name gilteritinib (GIL teh RIH tih nib) Brand name Xospata® (zoh SPAH tuh) Approved uses Gilteritinib is used to treat adult patients with FMS like tyrosine kinase 3 (FLT3) mutation positive acute myeloid leukemia. Dose and schedule Taking gilteritinib 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 gilteritinib is 120 milligrams (120 mg) to be taken by mouth at a scheduled time once daily. Gilteritinib can be taken with or without food. Gilteritinib should be taken whole with a cup of water and not opened, crushed, cut, or dissolved. If you are unable to swallow gilteritinib, talk to your care provider or pharmacist for possible options. Only take the missed dose if it has been less than 12 hours since you were supposed to take it and on the same day. Then take the next dose at the regularly scheduled time. Do not take the missed dose if it has been more than 12 hours since you should have taken it or is not the same day you should have taken it. Simply take the next dose at the regularly scheduled time. Do not take two doses on the same day. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle gilteritinib 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 gilteritinib at room temperature (68°F–77°F) in a dry location away from light. Keep gilteritinib out of reach of children and pets. Leave gilteritinib in the provided packaging until it is ready to be taken. Whenever possible, you should give gilteritinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the gilteritinib 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 gilteritinib 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. GILTERITINIB ORAL CHEMOTHERAPY EDUCATION Page 2 A daily pill box or pill reminder is not recommended to be used with gilteritinib. If you have any unused gilteritinib, 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 gilteritinib. If you are traveling, put your gilteritinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since gilteritinib 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 gilteritinib, 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 gilteritinib 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 Gilteritinib 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. GILTERITINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Gilteritinib The common side effects that have been known to happen in more than 30% of patients taking gilteritinib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in electrolytes and other laboratory values Serum creatinine High glucose High triglycerides High liver enzyme values Low calcium Low albumin Increased creatine kinase Low phosphorus Low potassium Low sodium 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. Your healthcare provider should check your potassium and magnesium levels. 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 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 it is okay to rest as needed. Tell your care provider if pain interferes with your activity. If the pain 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. Changes in liver function Your liver function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Continued on the next page GILTERITINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Fluid retention or swelling Do not stand for long periods of time. Keep your legs elevated when sitting or lying down. Try not to eat salty foods, which can increase swelling. Avoid tight fitting clothing and shoes. Weigh yourself daily. Contact your provider if you notice any of the following: Swelling in the hands, feet, or legs Shortness of breath Weight gain of five pounds or more in one week Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if either of the following occurs: The number of bowel movements you have in a day increases by 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. Cough or shortness of breath A cough that does not produce any mucous or congestion relief (dry cough) may occur while taking this medication. If you experience any breathing problems or shortness of breath, notify your care provider immediately. This may be a serious side effect of the medication. Respiratory tract infection Wash your hands often, especially before eating and after using the bathroom. Avoid people with fevers, flu, or other infections. Maintain good personal hygiene. Report symptoms of a respiratory infection (e.g., cough, sneezing, runny nose, fever, scratchy or sore throat) to your provider. Continued on the next page GILTERITINIB ORAL CHEMOTHERAPY EDUCATION Page 5 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 colognes as these products may increase rash symptoms. Avoud 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 10 am to 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. Serious side effects Posterior reversible encephalopathy syndrome (PRES) may rarely occur when taking gilteritinib. Tell your healthcare provider right away if you have a seizure or a quickly worsening headache, confusion, or vision problems. Gilteritinib can cause changes to the electrical activity of your heart called QTc prolongation. Tell your healthcare provider right away if you feel faint, lightheaded, or dizzy. Gilteritinib may be harmful to your pancreas. Seek medical attention if you have severe abdominal pain or tenderness, fever, or vomiting. 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 gilteritinib. Men and women of childbearing age and potential should use effective contraception during therapy. Women should continue contraception for a minimum of six months after the last dose of gilteritinib. Men should continue contraception for a minimum of four months after the last dose of gilteritinib. Do not breastfeed while taking gilteritinib and for two months after the last dose of gilteritinib. 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 gilteritinib, and you are encouraged to ask your care provider. GILTERITINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Obtaining medication Talk with your care provider about the process for obtaining your gilteritinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.xospata.com Product prescribing information: https://astellas.us/docs/xospata.pdf Product resources: https://www.xospata.com/resources for you/# Updated – December 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 © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.

Glasdegib

(glas-DEH-gib)

Glasdegib (Daurismo®) is used to treat acute myeloid leukemia (AML) in combination with other chemotherapy agents.

Glasdegib (Daurismo®) is used to treat acute myeloid leukemia (AML) in combination with other chemotherapy agents.

Page 1 GLASDEGIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name glasdegib (glas DEH gib) Brand name Daurismo® (DOOR is moe) Approved uses Glasdegib is used to treat acute myeloid leukemia (AML) in combination with other chemotherapy agents. Dose and schedule Taking glasdegib 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 glasdegib is 100 milligrams (100 mg) to be taken by mouth at a scheduled time once a day. Glasdegib may be taken with or without food, but at the same time each day. Glasdegib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow glasdegib, talk to your care provider or pharmacist for possible options. If you miss a dose of glasdegib, you may take the dose as soon as possible as long as it is at least 12 hours prior to the next scheduled dose. Do not take two doses within the same 12 hour time frame. Storage and handling Handle glasdegib 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 glasdegib at room temperature (68°F–77°F) in a dry location away from light. Keep glasdegib out of reach of children and pets. Leave glasdegib in the provided packaging until it is ready to be taken. Whenever possible, you should give glasdegib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the glasdegib 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 glasdegib 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. GLASDEGIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for glasdegib. Do not mix other medications into the box with glasdegib. 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 glasdegib, 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 glasdegib. If you are traveling, put your glasdegib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since glasdegib 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 glasdegib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or glasdegib 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 Glasdegib 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. Serious side effects Glasdegib can cause serious birth defects. Do not take glasdegib if you are pregnant or think you might be pregnant. GLASDEGIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Glasdegib The common side effects that have been known to happen in more than 30% of patients taking glasdegib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in kidney function Your kidney (renal) function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Decreased amount of urination Swelling in your legs and feet Changes in electrolytes and other laboratory values Low sodium levels Low magnesium levels Changes in some lab values may occur and will be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red or brown colored urine Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your health care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Continued on the next page GLASDEGIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Continued on the next page GLASDEGIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever (temperature more than 100.4°F or 38°C) Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Fluid retention or swelling Do not stand for long periods of time. Keep your legs elevated when sitting or lying down. Try not to eat salty foods, which can increase swelling. Avoid tight fitting clothing and shoes. Weigh yourself daily. Contact your provider if you notice any of the following: Swelling in the hands, feet, or legs Shortness of breath Weight gain of five pounds or more in one week Muscle or joint pain Keep a diary of your pain (or spasms), including a description of when and where the pain is occurring, what it feels like, and how long it lasts. Stay as active as possible, but know it is okay to rest as needed. Tell your care provider if pain (or spasms) interferes with your activity. If the pain 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. Warnings and precautions Do not donate blood or blood products during treatment with glasdegib and for at least 30 days after the last dose. Changes in the electrical activity of your heart are called QT prolongation. Tell your healthcare provider right away if you feel faint, lightheaded, or dizzy, or if you feel your heart beating irregularly or fast while taking glasdegib. GLASDEGIB ORAL CHEMOTHERAPY EDUCATION Page 6 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 glasdegib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 30 days after the last dose of glasdegib. Do not breastfeed while taking glasdegib and for 30 days after the last dose of glasdegib. 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 glasdegib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2018/210656s000lbl.pdf Updated – November 26, 2018 Additional instructions Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.

Hydroxyurea

(hy-DROK-see-yoo-REE-uh)

Hydroxyurea (Hydrea®)

Hydroxyurea (Hydrea®)

Page 1 HYDROXYUREA ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — hydroxyurea hy DROK see yoo REE uh Brand name — Hydrea® hy DREE uh , Droxia™ DROK see uh Approved uses Hydroxyurea is used to treat adult patients with chronic myeloid leukemia, sickle cell anemia, and head and neck cancer when used with radiation. Dose and schedule Taking hydroxyurea 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. Hydroxyurea can be taken with or without food but at the same time each day. Hydroxyurea should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow hydroxyurea, talk to your care provider or pharmacist for possible options. If you miss a dose of hydroxyurea, 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 hydroxyurea 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 hydroxyurea at room temperature 68°F–77°F in a dry location away from light. Keep hydroxyurea out of reach of children and pets. Leave hydroxyurea in the provided packaging until it is ready to be taken. Whenever possible, give hydroxyurea to yourself and follow the steps below. If a family member, friend, or caregiver needs to give hydroxyurea 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 hydroxyurea 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. HYDROXYUREA ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for hydroxyurea. Do not mix other medications into the box with hydroxyurea. 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 hydroxyurea, 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 hydroxyurea. If you are traveling, put hydroxyurea in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Because hydroxyurea 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 hydroxyurea, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or hydroxyurea 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 Hydroxyurea has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Avoid live vaccines during treatment with hydroxyurea. Serious side effects of hydroxyurea Hydroxyurea can cause bone marrow suppression, or a decrease in the number of white blood cells, red blood cells, and platelets, which can be severe. Speak to your care provider to know when you need to have laboratory tests done to monitor your blood cell counts. Hydroxyurea may lead to a secondary malignancy, or the growth of a cancer, months or years after treatment with hydroxyurea is complete. HYDROXYUREA ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Hydroxyurea The common side effects that have been known to happen in more than 30% of patients taking hydroxyurea 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. Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page HYDROXYUREA ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored 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 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 hydroxyurea. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of 6 months after the last dose of hydroxyurea. Men of childbearing age and potential should use effective contraception during therapy and for a minimum of one year after the last dose of hydroxyurea. Do not breastfeed while taking hydroxyurea and for one month after the last dose of hydroxyurea. 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 hydroxyurea. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.bms.com Product prescribing information: http://packageinserts.bms.com/pi/pi droxia.pdf http://packageinserts.bms.com/pi/pi hydrea.pdf Product resources: www.bms.com/patient and caregivers.html Updated – September 8, 2017 HYDROXYUREA ORAL CHEMOTHERAPY EDUCATION Page 5 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to 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.

Ibrutinib

(i-BROO-tih-nib)

Ibrutinib (Imbruvica®) is used to treat adults with certain types of leukemias and lymphomas, specifically the following:

  • Chronic lymphocytic leukemia (CLL)
  • Small lymphocytic lymphoma (SLL)
  • Wal...

Ibrutinib (Imbruvica®) is used to treat adults with certain types of leukemias and lymphomas, specifically the following:

  • Chronic lymphocytic leukemia...

Page 1 IBRUTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — ibrutinib i BROO tih nib Brand name — Imbruvica® im BROO vih kuh Approved uses Ibrutinib is used to treat adults with certain types of leukemias and lymphomas, specifically the following: Chronic lymphocytic leukemia CLL Mantle cell lymphoma MCL Marginal zone lymphoma MZL Small lymphocytic lymphoma SLL Waldenstrom macroglobulinemia WM Ibrutinib can also be used to treat adults who have received a bone marrow transplant and now have chronic graft versus host disease cGVHD . Dose and schedule Taking ibrutinib 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 ibrutinib is 420 milligrams 420 mg or 560 milligrams 560 mg to be taken by mouth at a scheduled time once a day. Ibrutinib can be taken with or without food, but at the same time each day. Ibrutinib should be taken whole and not opened, crushed, cut, or dissolved. If you are unable to swallow ibrutinib, talk to your care provider or pharmacist for possible options. If you miss a dose of ibrutinib, take your missed dose as soon as possible on the same day and then return to your normal schedule the next day. Do not take an extra dose or two doses at one time to make up for the missed dose. 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 ibrutinib 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 ibrutinib at room temperature 68°F–77°F in a dry location away from light. Keep ibrutinib out of reach of children and pets. Leave ibrutinib in the provided packaging until it is ready to be taken. Whenever possible, you should give ibrutinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the ibrutinib 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 ibrutinib from its package to a small medicine or other disposable cup. IBRUTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder is used, a separate one should be used for ibrutinib. Do not mix other medications into the box with ibrutinib. 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 ibrutinib, 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 ibrutinib. If you are traveling, put your ibrutinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since ibrutinib 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 ibrutinib, 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 ibrutinib 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 Ibrutinib has many drug interactions. Inform your care provider of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice and Seville oranges often found in marmalades may interact with ibrutinib; avoid eating or drinking these during treatment with ibrutinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. IBRUTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Ibrutinib The common side effects that have been known to happen in more than 30% of patients taking ibrutinib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Continued on the next page IBRUTINIB 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 due to some other health problem. 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. 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. Respiratory tract infection Wash your hands often, especially before eating and after using the bathroom. Avoid people with fevers, flu, or other infections. Maintain good personal hygiene. Report symptoms of a respiratory infection, like cough, sneezing, runny nose, fever, and scratchy or sore throat, to your 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 okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Continued on the next page IBRUTINIB 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 ibrutinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of ibrutinib. Do not breastfeed while taking ibrutinib and for one month after the last dose of ibrutinib. 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. 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. Fluid retention or swelling Do not stand for long periods of time. Keep your legs elevated when sitting or lying down. Avoid eating salty foods, which can increase swelling. Avoid wearing tight fitting clothing and shoes. Weigh yourself daily. Contact your care provider if you notice any of the following: Swelling in the hands, feet, or legs Shortness of breath Weight gain of five pounds or more in a week 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. IBRUTINIB 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. 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 ibrutinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.imbruvica.com Product prescribing information: www.imbruvica.com/docs/librariesprovider7/default document library/prescribing information.pdf Product resources: www.imbruvica.com/you i support Updated – January 16, 2018 Additional instructions

Idelalisib

(i-deh-luh-LIH-sib)

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

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

Page 1 IDELALISIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — idelalisib i deh luh LIH sib Brand name — Zydelig® zy DEH lig Approved uses Idelalisib is used to treat adults with certain types of leukemias and lymphomas, specifically the following: Chronic lymphocytic leukemia CLL Follicular B cell non Hodgkin lymphoma FL Small lymphocytic lymphoma SLL Dose and schedule Taking idelalisib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of idelalisib is 150 milligrams 150 mg to be taken by mouth at a scheduled time twice a day. Idelalisib can be taken with or without food, but at the same time each day. Idelalisib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow idelalisib, talk to your care provider or pharmacist for possible options. If you miss a dose of idelalisib, follow these guidelines: Only take the missed dose if it has been less than six hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. Do not take the missed dose if it has been more than six hours since you should have taken it. Simply take the next dose at the regularly scheduled time. Do not take two doses at one time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle idelalisib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store idelalisib at room temperature 68°F–77°F in a dry location away from light. Keep idelalisib out of reach of children and pets. Leave idelalisib in the provided packaging until it is ready to be taken. Whenever possible, you should give idelalisib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the idelalisib to you, they also need to follow these steps. 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. IDELALISIB ORAL CHEMOTHERAPY EDUCATION Page 2 3. Gently transfer the idelalisib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder is used, a separate one should be used for idelalisib. Do not mix other medications into the box with idelalisib. The person filling the box or reminder should wear gloves. Gloves are not necessary if you are filling the box or reminder. When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused idelalisib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of idelalisib. If you are traveling, put your idelalisib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since idelalisib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take idelalisib, it is important to know the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or idelalisib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Idelalisib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Avoid live vaccines during treatment with idelalisib. IDELALISIB ORAL CHEMOTHERAPY EDUCATION Page 3 Serious side effects Idelalisib can cause serious liver damage. Idelalisib can cause severe diarrhea, inflammation of the colon commonly called colitis , or perforation hole of the intestine. Idelalisib can cause inflammation of the lungs commonly called pneumonitis . Idelalisib can increase your risk for infections that are very serious and may lead to death. Side Effects of Idelalisib The common side effects that have been known to happen in more than 30% of patients taking idelalisib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Changes in liver function Your liver function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Abdominal pain Continued on the next page IDELALISIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Problems with your lungs Contact your provider if you have any new or worsening lung problems, including cough, shortness of breath, wheezing, or difficult breathing. This may be a sign of pneumonia an infection in the lungs or pneumonitis inflammation of the lungs . Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. You have diarrhea along with severe abdominal pain, nausea or vomiting, chills, or fever. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking idelalisib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of idelalisib. Do not breastfeed while taking idelalisib and for one month after the last dose of idelalisib. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. IDELALISIB ORAL CHEMOTHERAPY EDUCATION Page 5 Obtaining medication Talk with your care provider about the process for obtaining your idelalisib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.zydelig.com Product prescribing information: www.gilead.com/~/media/Files/pdfs/medicines/oncology/zydelig/zydelig pi.pdf Product resources: www.zydeligaccessconnect.com/hcp Updated – January 15, 2018 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.

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