Asciminib

　　【Indications】

　　SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with:

　　•Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia(Ph+CML)in the chronic phase(CP).

　　•Previously treated Ph+CML in the chronic phase(CP).

　　•Ph+CML in the chronic phase(CP)harboring the T315I mutation.

　　【Recommended Dosage】

　　•For Ph+CML in the chronic phase:The recommended dosage is 80 mg orally once daily or 40 mg orally twice daily.

　　•For Ph+CML in the chronic phase with the T315I mutation:The recommended dosage is 200 mg orally twice daily.

　　•Administration with food:Avoid food intake for at least 2 hours before and 1 hour after taking SCEMBLIX.

　　•Swallowing instructions:Tablets must be swallowed whole.Do not split,crush,or chew the tablets.

　　【Adverse Reactions】

　　The most common adverse reactions(≥20%)include musculoskeletal pain,rash,fatigue,upper respiratory tract infection,headache,abdominal pain,and diarrhea.

　　The most common selected laboratory abnormalities(≥20%)include decreased lymphocyte count,decreased white blood cell count,decreased platelet count,decreased neutrophil count,decreased corrected calcium,increased lipase,increased cholesterol,increased uric acid,increased alanine aminotransferase(ALT),increased alkaline phosphatase(ALP),decreased hemoglobin,increased triglycerides,increased creatine kinase,increased amylase,and increased aspartate aminotransferase(AST).

　　【Mechanism of Action】

　　SCEMBLIX is an ABL/BCR-ABL1 tyrosine kinase inhibitor.It inhibits the ABL1 kinase activity of the BCR-ABL1 fusion protein by specifically binding to the ABL myristoyl pocket.In vitro studies and animal models of chronic myeloid leukemia have demonstrated that SCEMBLIX exhibits activity against wild-type BCR-ABL1 and several mutant forms,including the T315I mutation.

　　【Storage】

　　Store at 20°C to 25°C(68°F to 77°F);excursions permitted between 15°C and 30°C(59°F and 86°F).Keep in the original container to protect from moisture.