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OralChemoEdSheets.com, Patient + Healthcare Providers Resource

OralChemoEdSheets.com, the Patient and Healthcare Providers Resource

Generic

Enasidenib

(EH-nuh-SIH-deh-nib)

Brand

Idhifa®

(ide-HEE-fuh)

Enasidenib (Idhifa®) is used to treat patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH-2) mutation.

 
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Page 1 ENASIDENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — enasidenib EH nuh SIH deh nib Brand name — Idhifa® ide HEE fuh Approved uses Enasidenib is used to treat patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 2 IDH 2 mutation. Dose and schedule Taking enasidenib 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 enasidenib is 100 milligrams 100 mg to be taken by mouth once daily. The dose may be adjusted by your care provider based upon your individual needs. Enasidenib can be taken with or without food, but at the same time each day. Enasidenib should be swallowed whole with 1 cup 8 ounces of water. Do not crush, cut, or dissolve the tablet. If you are unable to swallow enasidenib, talk to your care provider or pharmacist for possible options. If you miss or vomit immediately after a dose of enasidenib, take an extra dose as soon as possible and return to your normal schedule the following day. 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 enasidenib 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 enasidenib at room temperature 68°F–77°F in a dry location away from light in its original bottle with the desiccant canister i.e., moisture controller . Keep enasidenib out of reach of children and pets. Leave enasidenib in the provided packaging until it is ready to be taken. Whenever possible, give enasidenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give enasidenib 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 enasidenib 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. ENASIDENIB ORAL CHEMOTHERAPY EDUCATION Page 2 A daily pill box is not recommended to be used with enasidenib. You should keep the medication in the original bottle. If you have any unused enasidenib, 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 enasidenib. If you are traveling, put your enasidenib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Enasidenib 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 enasidenib, 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 enasidenib 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 Enasidenib has the potential for drug interactions. Inform your care providers of all prescription medications, over thecounter medications, vitamins, and herbal products that you are taking. Enasidenib can be taken with or without food. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Serious side effects Differentiation syndrome is a condition that affects your blood cells and may be life threatening or lead to death if not treated. Go to the nearest hospital emergency room or call 911 if you develop any of these symptoms: fever, cough, shortness of breath, bone pain, fast weight gain 10 lbs within one week , or swelling of arms and legs, around the neck, groin, or underarm. ENASIDENIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Enasidenib The common side effects that have been known to happen in more than 30% of patients taking enasidenib 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 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 Changes in electrolytes and other laboratory values Low calcium levels Low potassium levels Changes in some laboratory values may occur and should 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 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 ENASIDENIB 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. 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. Decreased appetite or weight loss Talk to your care provider if you notice a decrease in weight while taking this medication. When you do not feel like eating, try the following: Eat small, frequent meals instead of 3 large meals each day. Keep snacks nearby so you can eat when you feel hungry. Take 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. 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 enasidenib. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of enasidenib. Men of reproductive age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of enasidenib. Do not breastfeed while taking enasidenib and for one month after the last dose of enasidenib. Inform your care provider if you become pregnant. ENASIDENIB ORAL CHEMOTHERAPY EDUCATION Page 5 It is safe to hug and kiss. Special precautions may be needed for sexual activity while on enasidenib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your enasidenib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: https://www.idhifa.com Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2017/209606s000lbl.pdf Product resources: https://idhifapro.com/access and support/#patientResources Updated — March 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.

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