Asciminib is used in adults to treat a type of blood cancer called Philadelphia chromosome-positive chronic myeloid leukemia (CML).

Asciminib is usually given after other treatments have failed.

Asciminib may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take without food.

Swallow the tablet whole and do not crush, chew, or break it.

Your blood will need to be tested often.

You should not stop using asciminib without your doctor's advice.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Chronic Myelogenous Leukemia:

Philadelphia chromosome-positive chronic myeloid leukemia I chronic phase (Ph+ CML-CP)

Ph+ CML-CP Previously Treated with 2 or More TKIs (tyrosine kinase inhibitors):
Recommended dose: 80 mg orally once a day OR 40 mg orally every 12 hours
Duration of therapy: Continue as long as clinical benefit is observed or until unacceptable toxicity occurs

Ph+ CML-CP with the T315I Mutation:
Recommended dose:: 200 mg orally every 12 hours

Comments:
-This drug is approved under accelerated approval based on major molecular response; continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials
-For recommended dosage modifications for the management of adverse reactions; see Dose Adjustments.

Uses:
-Treatment of Ph+ CML in CP, previously treated with 2 or more tyrosine kinase inhibitors (TKIs)
-Treatment of Ph+ CML in CP with the T315I mutation

Tell your doctor if you have ever had:

• inflammation of your pancreas (pancreatitis); or

• heart problems or blood clots.

You may need to have a negative pregnancy test before starting this treatment.

It may be harder for you to get pregnant while you are using asciminib.

Asciminib may harm an unborn baby. Use effective birth control while you are using this medicine, and for at least 1 week after your last dose. Tell your doctor right away if you become pregnant.

You should not breastfeed while using this medicine, and for at least 1 week after your last dose.

If you take asciminib once a day: Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

If you take asciminib twice a day: Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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. http://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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Avoid eating for at least 2 hours before and 1 hour after taking asciminib.

Get emergency medical help if you have signs of an allergic reaction: hives, rash; feeling dizzy or faint; fever; fast heartbeat; difficult breathing; swelling of your face, lips, tongue, or throat.

Asciminib may cause serious side effects. Call your doctor at once if you have:

• heart problems--pain in your arms, legs, back, neck or jaw, numbness or weakness on one side of your body, problems with speech or vision, dizziness, headache, swelling in your ankles or feet, chest pain, irregular heartbeat, rapid weight gain, feeling short of breath, severe stomach pain;

• high blood pressure--severe headache, blurred vision, pounding in your neck or ears;

• low blood cell counts--fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet; or

• pancreas problems--sudden stomach pain or discomfort, nausea, or vomiting.

Common side effects of asciminib may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• muscle, bone, or joint pain;

• tiredness;

• nausea, diarrhea;

• rash; or

• abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Many drugs can affect asciminib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

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.