Ziftomenib

Ziftomenib may cause a serious or life-threatening condition called differentiation syndrome (a condition that affects blood cells). Differentiation syndrome can occur 3 days after you start treatment or at any time during your treatment. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: fever; joint or bone pain; chest pain; dizziness; shortness of breath; trouble breathing; cough; sudden weight gain; rash; decreased urination; or swelling of hands, feet, ankles or legs.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Talk to your doctor about the risks of taking ziftomenib.

Ziftomenib is used to treat a certain type of acute myeloid leukemia (AML; a type of that begins in the white blood cells). Ziftomenib 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.

Ziftomenib comes as a capsule to take by mouth. Take once a day on an empty stomach, 1 hour before meals or 2 hours after meals. Take ziftomenib at around the same time every day.

Take ziftomenib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them.

Your doctor may lower your dose or temporarily stop your treatment depending on your response and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

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

Before taking ziftomenib,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• 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 ziftomenib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking an H₂blocker medication for indigestion, heartburn, or ulcers such as cimetidine, famotidine, nizatidine, or ranitidine, take ziftomenib 2 hours before or 10 hours after your take one of these medications.
• if you are taking antacids, such as aluminum/magnesium hydroxide, calcium carbonate, or calcium carbonate and magnesium, take them 2 hours before or 2 hours after you take ziftomenib.
• the following nonprescription or herbal products may interact with ziftomenib: esomeprazole, lansoprazole, omeprazole or St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking ziftometinib. Do not start any of these medications while taking without discussing with your healthcare provide
• tell your doctor if you or anyone in your family has or has ever had a prolonged QT interval (a rare heart condition that may cause irregular heartbeat, dizziness, fainting, or sudden death). Also, tell your doctor if you have or have ever had low levels of potassium or magnesium in your blood, heart failure or any other heart problems, high blood pressure, or kidney or liver problems.
• tell your doctor if you or your partner are pregnant or plan to become pregnant. You or you partner should not become pregnant while you are taking ziftomenib. You may have to take a pregnancy test before starting treatment. Your should use effective birth control to prevent pregnancy during your treatment and for 6 months after your final dose.Your partner should use effective birth control to prevent pregnancy during your treatment and for 3 months after your final dose. Talk to your doctor about the best birth control method for you. If you or your partner become pregnant while taking ziftomenib, call your doctor immediately. Ziftomenib may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed during your treatment with ziftomenib and for 2 weeks after your final dose.
• if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking ziftomenib.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about this risks of taking zifotmenib.

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

Take the missed dose as soon as you remember it. However, if it is within 12 hours of your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Do not take 2 doses within 12 hours.

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

• diarrhea
• nausea
• vomiting
• unusual tiredness or weakness
• swelling of arms, hands, feet, ankles, or lower legs
• muscle, joint, or bone pain
• itching

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:

• unusual bruising and bleeding
• fever; chills; sore throat; cough; warm, red, or painful skin or sores on your body; frequent, urgent, or painful urination; or other signs of infection
• dizziness, fainting, shortness of breath, or fast or irregular heartbeat

Ziftomenib 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).

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 excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

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 https://goo.gl/c4Rm4p for more information.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to ziftomenib. Your doctor will also order a lab test before you begin your treatment to see whether your cancer can be treated with ziftomenib.

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.

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