Patient and Healthcare Provider Resource

Patient and Healthcare Providers Resource

OralChemoEdSheets.com, Patient + Healthcare Providers Resource

OralChemoEdSheets.com, the Patient and Healthcare Providers Resource

Generic

Olutasidenib

(oh-LOO-tuh-SIH-deh-nib)

Brand

Rezlidhia®

(rez-LIH-dee-uh)

Olutasidenib (Rezlidhia™) is used to treat relapsed/refractory acute myeloid leukemia (AML) with a genetic variant called isocitrate dehydrogenase-1 (IDH1) and may also be used for other treatments.

 
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Page 1 OLUTASIDENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — olutasidenib (oh-LOO-tuh-SIH-deh-nib) Brand name — Rezlidhia® (rez-LIH-dee-uh) Common uses Olutasidenib is used to treat relapsed/refractory acute myeloid leukemia (AML) with a genetic variant called isocitrate dehydrogenase-1 (IDH1). Olutasidenib may also be used for other treatments. Dose and schedule Taking olutasidenib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. o Your dose may vary, but the usual dose of olutasidenib is 150 milligrams (150 mg) to be taken by mouth at a scheduled time twice a day at least 8 hours apart. o Olutasidenib should be taken on an empty stomach at least 1 hour before or 2 hours after a meal at the same time each day. o Olutasidenib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow olutasidenib talk to your care provider or pharmacist for possible options. o If you miss a dose of olutasidenib: • Take the missed dose as soon as possible, then take the next dose at least 8 hours later. Return to your normal schedule the following day. • If a dose of olutasidenib is vomited, do not take a replacement dose. • 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. Drug and food interactions o Olutasidenib has many drug interactions, please inform your care providers of all prescription medications, over-the counter medications, vitamins, and herbal products. o Grapefruit or grapefruit juice may interact with olutasidenib; avoid eating or drinking these during treatment with olutasidenib. o Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Page 2 OLUTASIDENIB ORAL CHEMOTHERAPY EDUCATION Storage and handling Handle olutasidenib 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. o Store olutasidenib at room temperature (68°F–77°F) in a dry location away from light. o Keep olutasidenib out of reach of children and pets. o Whenever possible, give olutasidenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the olutasidenib 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 olutasidenib 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. o 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 o If you have any unused olutasidenib, 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 olutasidenib. o If you are traveling, put your olutasidenib’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Page 3 OLUTASIDENIB ORAL CHEMOTHERAPY EDUCATION Common side effects that have been known to happen in about one third or more of patients taking olutasidenib 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. Possible Side Effect Management 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 Changes in electrolytes and other laboratory values • Low potassium levels • Low sodium levels Changes in some lab values may occur and will 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/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 Page 4 OLUTASIDENIB ORAL CHEMOTHERAPY EDUCATION Possible Side Effect Management Changes in kidney function Your kidney (renal) function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Decreased amount of urination • Unusual swelling in your legs and feet 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. o Plan your activities, and do them at a time of day when you feel a bit more energetic. o Avoid operating heavy machinery if you feel too tired. Serious side effects o Olutasidenib can cause a very serious side effect known as differentiation syndrome. Patients with differentiation syndrome may have a fever, shortness of breath or trouble breathing, swelling, and weight gain. Be sure to let your care team know if you experience a fever, have trouble breathing, or have sudden weight gain. o Olutasidenib may be harmful to your liver. Seek medical attention if you notice yellowing of the skin or whites of your eyes, dark or brown urine, bleeding, or bruising. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: Handling body fluids and waste Because olutasidenib 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 olutasidenib 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. o Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. o 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. o 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. o 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. o Wash any skin that has been exposed to body waste or olutasidenib with soap and water. Page 5 OLUTASIDENIB ORAL CHEMOTHERAPY EDUCATION o 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. o Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception o Women should not become pregnant and men should not get a partner pregnant while taking olutasidenib. o Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. o Do not breastfeed while taking olutasidenib and for 2 weeks after the last dose of olutasidenib. o Please inform your care provider if you become pregnant. o 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 team for assistance. Obtaining medication o Talk with your care provider about the process for obtaining your olutasidenib. Additional resources Product website: https://www.rezlidhia.com Product prescribing information: https://www.rezlidhia.com/downloads/pdf/REZLIDHIA-Full-Prescribing -Information.pdf Product resources: N/A Updated – January 25, 2023 Additional instructions Page 6 OLUTASIDENIB ORAL CHEMOTHERAPY EDUCATION 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 © 2023 by Hematology/Oncology Pharmacy Association. All rights reserved.