Asciminib

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

Asciminib may also be used after other treatments for this condition.

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

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 this medicine without food, at least 2 hours before or 1 hour after a meal.

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

Your blood and blood pressure will need to be tested often. Your cancer treatments may be reduced, delayed, or permanently discontinued based on the results.

Do not change your dose, dosing schedule, or stop taking this medicine without your doctor's advice.

Store this medicine in the original container at room temperature away from moisture and heat.

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

Tell your doctor if you have or have ever had:

• inflammation of your pancreas (pancreatitis); or
• heart problems or blood clots.

May harm an unborn baby. You will need to take a pregnancy test before starting this treatment. Use effective birth control while using asciminib and for at least 1 week after your last dose. Tell your doctor if you are pregnant or think you may be pregnant.

Do not breastfeed while using asciminib, and for at least 1 week after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives, 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, swelling in your ankles or feet, chest pain, irregular heartbeat, rapid weight gain, severe stomach pain;
• high blood pressure--severe headache, blurred vision, pounding in your neck or ears;
• low blood cell counts--chills, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of infection--fever, sore throat, body aches, unusual tiredness, loss of appetite; or
• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of asciminib may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• muscle, bone, or joint pain;
• tiredness;
• headache;
• stomach pain, 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.

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 hoursComments:-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

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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

Tell your doctor about all your other medicines, especially itraconazole oral solution.

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.