Page 1 NILUTAMIDE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — nilutamide ny LOO tuh mide Brand name — Nilandron® nih LAN drun Approved uses Nilutamide is used to treat prostate cancer. Dose and schedule Taking nilutamide as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of nilutamide is 300 milligrams 300 mg to be taken by mouth at a scheduled time once a day for 30 days, followed by 150 milligrams 150 mg daily. Nilutamide should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow nilutamide, talk to your care provider or pharmacist for possible options. If you miss a dose of nilutamide, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle nilutamide with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store nilutamide at room temperature 68°F to 77°F in a dry location away from light. Keep nilutamide out of reach of children and pets. Leave nilutamide in the provided packaging until it is ready to be taken. Whenever possible, you should give nilutamide to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the nilutamide to you, they also need to follow these steps. 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the nilutamide from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If you have any unused nilutamide, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of nilutamide. NILUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 2 If you are traveling, put your nilutamide in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. A daily pill box or pill reminder is not recommended to be used with nilutamide. Handling body fluids and waste Nilutamide remains in your body for several days after it is taken, and some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take nilutamide, it is important to know the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or ivosidenib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Nilutamide has many drug interactions. Please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Drinking alcohol while taking nilutamide can lead to facial flushing, low blood pressure, and feeling poorly overall. Serious side effects Nilutamide can increase your risk of developing lung disease; report any shortness of breath, cough, chest pain, or fever. Nilutamide may cause changes in liver function; report any yellowing of the skin or whites of your eyes, dark or brown urine, or bleeding or bruising. NILUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Nilutamide The common side effects that have been known to happen in more than 30% of patients taking nilutamide are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Hot flashes sudden sweating and feelings of warmth If hot flashes are bothersome, consider the following recommendations: Mild, regular exercise may help after consulting with your care provider. Try staying in a cool environment. Avoid or limit caffeine, spicy food, alcohol, and stress, which may cause hot flashes to worsen. Inform your care provider if this side effect is bothersome as there may be medications that can help with hot flashes. Eye changes This medication may cause blurred vision, dry eyes, or eye pain. Report changes in eyesight to your care provider. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Men should not get a partner pregnant while taking nilutamide. Males and females of childbearing age and potential should use effective contraception during therapy and for a minimum of 30 days after the last dose of nilutamide. Do not breastfeed while taking nilutamide and for 30 days after the last dose of nilutamide. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your nilutamide. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO NILUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 4 Additional resources Product website: https://medlineplus.gov/druginfo/meds/a697044.html Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2017/020169s008lbl.pdf Updated – September 6, 2018 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.