Asciminib
Generic name: asciminib [ as-KIM-i-nib ]
Brand name: Scemblix
Dosage form: oral tablet (20 mg; 40 mg)
Drug class: BCR-ABL tyrosine kinase inhibitors
What is asciminib?
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.
Asciminib side effects
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:
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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;
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high blood pressure--severe headache, blurred vision, pounding in your neck or ears;
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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
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pancreas problems--sudden stomach pain or discomfort, nausea, or vomiting.
Common side effects of asciminib may include:
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cold symptoms such as stuffy nose, sneezing, sore throat;
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muscle, bone, or joint pain;
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tiredness;
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nausea, diarrhea;
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rash; or
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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.
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Warnings
Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.
Before taking this medicine
Tell your doctor if you have ever had:
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inflammation of your pancreas (pancreatitis); or
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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.
How should I take asciminib?
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.
Asciminib dosing information
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
What happens if I miss a 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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking asciminib?
Avoid eating for at least 2 hours before and 1 hour after taking asciminib.
What other drugs will affect asciminib?
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.
More about asciminib
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- Drug class: BCR-ABL tyrosine kinase inhibitors
- En español
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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