Asciminib

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.

Asciminib comes as a tablet to take by mouth. It is usually taken once or twice a day on an empty stomach (at least 1 hour before or 2 hours after a meal). Take asciminib at around the same time 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 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.

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

Before taking asciminib,

• tell your doctor and pharmacist if you are allergic to asciminib, any other medications, or any of the ingredients in asciminib. 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 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.
• do 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.

If you normally take the medication 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.

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
• 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
• fever or signs of an infection
• sudden stomach pain or discomfort, nausea or vomiting
• confusion, headaches, dizziness, chest pain, or shortness of breath
• rash, difficulty breathing or swallowing, swelling of face, lips or tongue, rash or skin flushing, dizziness or feeling faint, fever, fast heartbeat
• shortness of breath, chest pain or pressure, feeling of rapid 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, 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).

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

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.

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.

Symptoms of overdose may include:

• unusual bruising or bleeding
• fever, sore throat, chills, and/or other signs of infection
• shortness of breath
• fast heartbeat
• headache
• pale skin
• confusion
• tiredness

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Scemblix®