Page 1 NERATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — neratinib (neh RA tih nib) Brand name — Nerlynx® (NAYR links) Approved uses Neratinib is used to treat adult patients with human epidermal growth factor receptor 2 (HER2)–overexpressed early stage and metastatic breast cancer. Dose and schedule Taking neratinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. oYour dose may vary, but the usual dose of neratinib is 240 milligrams (240 mg) to be taken by mouth once daily. The dosemay be adjusted by your care provider based upon your individual needs. oNeratinib should be taken with food, at the same time each day. oNeratinib should be taken whole and not crushed, cut, opened, or dissolved. If you are unable to swallow neratinib, talk toyour care provider or pharmacist for possible options. oIf you miss a dose of neratinib, do not take an extra dose or two doses at one time. Simply take your next dose at theregularly scheduled time. oBe sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions oNeratinib has the potential for drug interactions. Inform your care provider of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. oSeparate taking neratinib and antacids by at least 3 hours; neratinib can be taken 2 hours before or 10 hours afterantihistamines oGrapefruit or grapefruit juice may interact with neratinib. Avoid eating or drinking these during your treatment withneratinib. oNeratinib should be taken with food. oTalk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle neratinib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. oStore neratinib at room temperature (68°F–77°F) in a dry location away from light. oKeep neratinib out of reach of children and pets. oLeave neratinib in the provided packaging until it is ready to be taken. NERATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Side Effects of Neratinib Below are common side effects that have been known to happen in about one third or more of patients taking neratinib are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Whenever possible, you should give neratinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the neratinib to you, they also need to follow these steps. 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the neratinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder will be used, contact your care team before using: The person filling the box or reminder should wear gloves (gloves are not necessary if you are filling the box or reminder). When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused neratinib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of neratinib. If you are traveling, put your neratinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Possible Side Effect Management Nausea or vomiting • Eat and drink slowly. • Drink 8 10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t lie down immediately after eating. • Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Continued on the next page NERATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Diarrhea (loose and/ or urgent bowel movements) Prevention of diarrhea by taking an over the counter medication called loperamide (Imodium®) is recommended for most patients. Talk with your care provider about this before beginning neratinib. The recommended loperamide schedule to prevent diarrhea with neratinib is as follows: • Neratinib days 1–14: Take 4 mg loperamide three times daily by mouth. • Neratinib days 15–56: Take 4 mg loperamide twice daily by mouth. *Speak with your care team if following methods are possible: • Budesonide 9 mg a day for 1 cycle with 4 mg loperamide schedule above • Colestipol 2 mg twice a day for 1 cycle with 4 mg loperamide as needed or: • Neratinib days 1 14: Take 4 mg loperamide three times daily by mouth. • Neratinib days 15–28: Take 4 mg loperamide twice daily by mouth. Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. • Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. • Avoid foods that cause gas, such as broccoli and beans. • Avoid lactose containing foods, such as yogurt and milk. • Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: • The number of bowel movements you have in a day increases by four or more. • You feel dizzy or lightheaded. *Hurvitz S, Chan A, Iannotti N, et al. Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib associated diarrhea in patients with HER2+ early stage breast cancer: the CONTROL trial. Abdominal pain Abdominal pain or discomfort may occur. Report any serious pain or symptoms to your care provider immediately. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Serious side effects Neratinib may be harmful to your liver. Speak to your care provider to know when you need to have laboratory tests done to monitor your liver function. If your get this side effect, your doctor may change your dose or stop treatment for some time. NERATINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Handling body fluids and waste Neratinib remains in your body for several days after it is taken, so some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take neratinib, it is important to follow the instructions below every day for as long as your treatment lasts. This will keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or neratinib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking neratinib. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of neratinib. Men of reproductive age and potential should use effective contraception during therapy and for a minimum of three months after the last dose of neratinib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking neratinib and for one month after the last dose of neratinib. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on neratinib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your neratinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) NERATINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional resources Product website: https://nerlynx.com Product prescribing information: https://nerlynx.com/pdf/full prescribing information.pdf Product resources: https://nerlynx.com/access and support Updated – January 1, 2020 Additional instructions