Asciminib

WHY is this medicine prescribed?

Asciminib is used to treat a certain type of chronic myeloid leukemia (CML; a type of cancer of the white blood cells) as a first treatment and in people who can no longer benefit from other leukemia medications. Asciminib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

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?

Asciminib comes as a tablet to take by mouth. It is usually taken once or twice a day (approximately 12 hours apart) on an empty stomach (at least 1 hour before or 2 hours after a meal). Take asciminib at around the same time(s) every day. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take asciminib 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; do not split, chew, or crush them.

Your doctor may adjust your dose or temporarily or permanently stop your treatment of asciminib depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take asciminib even if you feel well. Do not stop taking asciminib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking asciminib,

• tell your doctor and pharmacist if you are allergic to asciminib, any other medications, or any of the ingredients in asciminib tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking ascinimib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had pancreatitis (swelling of the pancreas); low white blood cell counts; anemia (a lower than normal number of red blood cells); bleeding problems; high blood pressure; high cholesterol; blood clots; a stroke; heart failure; a heart attack; a slow, fast, or irregular heartbeat; or any other heart problem.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking asciminib and for 1 week after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking asciminib, call your doctor. Asciminib may harm the fetus.

• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking asciminib and for 1 week after your final dose.

• you should know that this medication may decrease fertility in women. Talk to your doctor about the risks of taking asciminib.

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

If you normally take the medication once daily and it has been more than 12 hours since the time you usually take it, then skip the dose and resume the usual schedule the next day. If you normally take the medication twice daily and it has been more than 6 hours from the time you normally take your medicine, then skip the dose and resume your usual schedule with the next dose. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

• muscle, bone, or joint pain
• tiredness
• headache
• nausea
• diarrhea

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• unexpected bleeding or easy bruising, blood in urine or stools
• sore throat; cough; fever; chills; difficult, frequent, or painful urination; or other signs of infection
• ongoing pain that begins in the stomach area, but may spread to the back, nausea or vomiting
• pale skin, excessive tiredness, or weakness
• confusion, sudden severe headache, dizziness, chest pain, or shortness of breath
• rash; redness; difficulty breathing or swallowing; swelling of face, lips or tongue; dizziness or feeling faint; fever; or fast heartbeat
• shortness of breath; chest pain or pressure; fast or irregular heart beat; ankle or feet swelling; weight gain; numbness or weakness on one side of the body; decreased vision or loss of vision; trouble talking; or pain in arms, legs, back, neck, or jaw

Asciminib 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 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.

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 OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to asciminib.

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

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

This medication may increase your blood pressure. You may be asked to monitor your blood pressure frequently while taking this medication. Please let your doctor know if you notice any changes in you blood pressure.

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.