Olutasidenib

　　【Indications】

　　This product is an isocitrate dehydrogenase-1(IDH1)inhibitor,indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia(AML).

　　【Recommended Dosage】

　　Patients are selected for treatment based on the presence of IDH1 mutation.

　　✯The recommended dose is 150 mg orally twice daily,continued until disease progression or unacceptable toxicity occurs.

　　✯Take on an empty stomach,at least 1 hour before or 2 hours after a meal.

　　【Precautions】

　　Hepatotoxicity:Liver function parameters should be monitored during treatment with this product.If hepatotoxicity develops,interrupt dosing,adjust the dose or discontinue the product as appropriate.

　　【Adverse Reactions】

　　The most common adverse reactions(≥20%),including laboratory abnormalities,are increased aspartate aminotransferase,increased alanine aminotransferase,decreased potassium,decreased sodium,increased alkaline phosphatase,nausea,increased creatinine,fatigue/malaise,arthralgia,constipation,increased lymphocytes,increased bilirubin,leukocytosis,increased uric acid,dyspnea,pyrexia,rash,increased lipase,mucositis,diarrhea and increased transaminases.

　　【Storage】

　　Store at 20°C to 25°C(68°F to 77°F);excursions between 15°C and 30°C(59°F and 86°F)are permitted.