Revumenib

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..

Are there other uses for this medicine?

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

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.

What special precautions should I follow?

Before taking revumenib,

• tell your doctor and pharmacist if you are allergic to revumenib, any other medications, or any of the ingredients in revumenib tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking revumenib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription or herbal products may interact with revumenib: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking revumenib. Do not start any of these medications while taking revumenib without discussing with your healthcare provider.
• tell your doctor if you have or have ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), heart failure or other heart problems, a low level of magnesium or potassium in your blood, bleeding problems, blood clots, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are taking revumenib. You may be required to have a pregnancy test at least 7 days before you start treatment. You or your partner should use birth control during your treatment and for 4 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while taking revumenib call your doctor. Revumenib may harm the fetus
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are 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 and Do not take a double dose to make up for a missed one.

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 https://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.

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:

• nausea
• vomiting
• constipation
• diarrhea
• decreased appetite
• muscle, joint, or bone pain
• tiredness
• swelling in the arms and legs

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:

• dizziness, lightheadedness, or fainting
• fast, pounding, or irregular heartbeat
• nosebleeds or bleeding from your gums; coughing up or vomiting blood or material that looks like coffee grounds; unusual bleeding or bruising; increased menstrual flow or vaginal bleeding; pink, red, or dark brown urine; or red or tarry black bowel movements
• sore throat, cough, fever, chills, or other signs of infection
• frequent, urgent, or painful urination
• warm, red, or painful skin or sores on your body
• pain, swelling, warmth, redness, or tenderness in one leg only
• shortness of breath, coughing up blood, or sudden sharp chest pain
• sudden severe headache; difficulty speaking or understanding; weakness or numbness in your face, arm or leg, especially on one side of your body; or sudden difficulty seeing in one or both eyes

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 ( https://www.fda.gov/Safety/MedWatch ) or by phone (

1-800-332-1088).

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).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( https://goo.gl/c4Rm4p ) for more information if you do not have access to a take-back program.

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.