INDICATIONS AND USAGE（适应症）

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Acute Myeloid Leukemia

VENCLEXTA is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

DOSAGE（服用剂量）

Assess patient-specific factors for level of risk of tumor lysis syndrome (TLS) and provide prophylactic hydration and anti-hyperuricemics to patients prior to first dose of VENCLEXTA to reduce risk of TLS.

Recommended Dosage for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

VENCLEXTA dosing begins with a 5-week ramp-up. The 5-week ramp-up dosing schedule is designed to gradually reduce tumor burden (debulk) and decrease the risk of TLS.

VENCLEXTA 5-week Dose Ramp-Up Schedule

Administer VENCLEXTA according to the 5-week ramp-up dosing schedule to the recommended dosage of 400 mg orally once daily

Recommended Dosage for Acute Myeloid Leukemia

The recommended dosage and ramp-up of VENCLEXTA depends upon the combination agent. Follow the dosing schedule, including the 3-day or 4-day dose ramp-up. Start VENCLEXTA administration on Cycle 1 Day 1 in combination with:

Azacitidine 75 mg/m2 intravenously or subcutaneously once daily on Days 1-7 of each 28-day cycle; OR

Decitabine 20 mg/m2 intravenously once daily on Days 1-5 of each 28-day cycle; OR

Cytarabine 20 mg/m2 subcutaneously once daily on Days 1-10 of each 28-day cycle.

ADVERSE REACTIONS（不良反应）

Tumor Lysis Syndrome

Neutropenia

Infections

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/b118a40d-6b56-cee3-10f6-ded821a97018/spl-doc?hl=Venclexta

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