INDICATIONS AND USAGE（适应症）

VYXEOS is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

DOSAGE（服用剂量）

Recommended Dosage

A full VYXEOS course consists of 1-2 cycles of Induction and up to 2 cycles of Consolidation at the dose and schedule. Prior to initiating each cycle of VYXEOS, calculate the prior cumulative anthracycline exposure for the patient. Administer prophylactic anti-emetics before treatment with VYXEOS.

For the first cycle of induction, the recommended dose of VYXEOS is (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) liposome administered via intravenous infusion over 90 minutes on days 1, 3, and 5. Prior to initiating induction, assess cardiac function and obtain liver and renal function studies. For patients who do not achieve remission with the first induction cycle, a second induction cycle may be administered 2 to 5 weeks after the first if there was no unacceptable toxicity with VYXEOS. The recommended dose for the second induction cycle of VYXEOS is (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) liposome administered via intravenous infusion over 90 minutes on days 1 and 3.

Administer the first consolidation cycle 5 to 8 weeks after the start of the last induction. The recommended dose for each cycle of consolidation therapy is VYXEOS (daunorubicin 29 mg/m2 and cytarabine 65 mg/m2) liposome administered via intravenous infusion over 90 minutes on days 1 and 3.

Assess cardiac function, complete blood counts, liver and renal function before each consolidation cycle. Do not start VYXEOS consolidation until the absolute neutrophil count recovers to greater than 0.5 Gi/L and the platelet count recovers to greater than 50 Gi/L in the absence of unacceptable toxicity. Administer the second consolidation cycle 5 to 8 weeks after the start of the first consolidation cycle in patients who do not show disease progression or unacceptable toxicity to VYXEOS.

ADVERSE REACTIONS（不良反应）

Hemorrhage

Cardiotoxicity

Hypersensitivity Reactions

Copper Overload

Tissue Necrosis

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/7ea701ce-e7d3-4349-a9c2-642a501d45c8/spl-doc?hl=Cytarabine

cytosarinformation