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.