INDICATIONS AND USAGE;

Asciminib is indicated for the treatment of adult patients with: ⚫ Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKI). This indication is approved under accelerated approval based on major molecular response (MMR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirma- tory trial(s) Ph+ CML in CP with the T3151 mutation. 

DOSAGE AND ADMINISTRATIONRecommended Dosage in Patients with Ph+ CML-CP, Previously Treated with Two or More TKIS The recommended dose of Asciminib is 80 mg taken orally once daily at approximately the same time each day or 40 mg twice daily at approximately 12-hour intervals. The recommended dose of Asciminib is taken orally without food. Avoid food consumption for at least 2 hours before and 1 hour after taking Asciminib. Continue treatment with Asciminib as long as clinical benefit is observed or until unacceptable toxicity occurs. Recommended Dosage in Patients with Ph+ CML-CP with the T3151 Mutation The recommended dose of Asciminib is 200 mg taken orally twice daily at approximately 12-hour intervals. The recommended dose of Asciminib is taken orally without food. Avoid food consumption for at least 2 hours before and 1 hour after taking Asciminib. Missed Dose Once Daily Dosage Regimen: If a Asciminib dose is missed by more than approximately 12 hours, skip the dose and take the next dose as scheduled. Twice Daily Dosage Regimens: If a Asciminib dose is missed by more than approximately 6 hours, skip the dose and take the next dose as scheduled

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