Brand name: ALIASSIMINI
Composition:
Each tablet contains:
Asciminib hydrochloride…………………………………40mg
Indications:
This product is a kinase inhibitor, suitable for the treatment of
• Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), Previously treated with two or more tyrosine kinase inhibitors (TKls).
• Ph+ CML in CP with T315I mutation.
Dosage:
- Recommended Dosage in Ph+ CML in CP; oral, 80 mg once at the same time daily or 40mg twice daily at approximately 12-hour intervals.
- Recommended Dosage in Ph+ CML in CP with the T315I Mutation: 200mg orally twice daily at approximately 12-hour intervals.
- Take orally on an empty stomach, at least 2 hours after your last meal or at least 1 hour before your next meal.
- Continue treatment with ALIASSIMINI until disease progression or unacceptable toxicity occurs.
Contraindications:
- Patients who are allergic to the active ingredients or any excipients of this product.
Warnings:
- Myelosuppression: Severe thrombocytopenia and neutropenia events may occur. Monitor complete blood counts regularly during therapy and manage by treatment interruption or dose reduction.
- Pancreatic toxicity: Monitor serum lipase and amylase. Interrupt, then resume at reduced dose or stop administration based on severity.
- Hypersensitivity: May cause hypersensitivity reactions.
- Cardiovascular Toxicity: Cardiovascular toxicity may occur.
- Embryo-Fetal Toxicity: Can cause fetal harm.
Adverse Effects:
Upper respiratory tract infection, musculoskeletal pain, high blood pressure, low blood cell count, elevated uric acid, headache, fatigue, nausea, rash, diarrhea.
Dosage form: Light red tablets.
Expiry date: 24 months after date of manufacture.
Packaging:
- 60 tablets/bottle.
Storage:
- Protected from light, sealed, and stored at 20℃- 25℃.
- Keep out of reach of children.
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