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General Information

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Brand Name(s):

IMPORTANT WARNING:

Revumenib may cause a serious or life-threatening group of symptoms called differentiation syndrome. Your doctor will monitor you carefully to see whether you are developing this syndrome. If you experience any of the following symptoms, call your doctor immediately: fever; cough; rash; sudden weight gain; decreased urination; swelling of arms, legs, neck, groin, or underarm area; dizziness or lightheadedness, shortness of breath, difficulty breathing, severe headache, or confusion. These symptoms may occur 3 days to 6 weeks after starting treatment with revumenib. At the first sign that you are developing differentiation syndrome, your doctor will prescribe medications to treat the syndrome, and may tell you to stop taking revumenib for some time.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with revumenib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Use

WHY is this medicine prescribed?

Revumenib is used to treat a certain type of acute leukemia (a type of cancer of blood cells that begins in the bone marrow) that has worsened or returned after treatment with other chemotherapy medications. Revumenib is in a class of medications called menin inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply.

HOW should this medicine be used?

Revumenib comes as a tablet to take by mouth. It is usually taken twice a day, about 12 hours apart. Revumenib may be taken without food or with a low-fat meal (containing about 400 calories and less than 20% of calories from fat). Take revumenib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take revumenib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with a cup of water; do not split or chew them.

If you are giving the medication to a child or if you cannot swallow the tablets whole, the tablets may be crushed with a pill crusher and dispersed in water. Ask your doctor or pharmacist how to prepare and take revumenib tablets dispersed in water. Carefully read the written instructions for use that come with revumenib tablets.

If you vomit after taking revumenib do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease your dose or temporarily or permanently stop your treatment depending on if you experience any side effects. Be sure to tell your doctor how you are feeling during your treatment with revumenib.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special

What SPECIAL PRECAUTIONS should I follow?

Before taking revumenib,

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your normal dosing schedule. Do not take 2 doses within 12 hours. Do not take a double dose to make up for a missed one.

Side Effects

What SIDE EFFECTS can this medicine cause?

Revumenib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

Revumenib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Overdose

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Storage

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

Miscellaneous

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and laboratory. Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with revumenib. Your doctor will also order certain lab tests before and during your treatment to check your body's response to revumenib. Your doctor may also order an electrocardiogram (ECG; test that measures the electrical activity in the heart) before and during your treatment.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking revumenib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS® Patient Medication Information Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 15, 2025.