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