INDICATIONS AND USAGE（适应症）

BESPONSA is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

DOSAGE（服用剂量）

Pre-medicate before each dose.

For the first cycle, the recommended total dose of BESPONSA for all patients is 1.8 mg/m2 per cycle, administered as 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Cycle 1 is 3 weeks in duration, but may be extended to 4 weeks if the patient achieves a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), and/or to allow recovery from toxicity.

For subsequent cycles:

In patients who achieve a CR or CRi, the recommended total dose of BESPONSA is 1.5 mg/m2 per cycle, administered as 3 divided doses on Day 1 (0.5 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Subsequent cycles are 4 weeks in duration.

OR

In patients who do not achieve a CR or CRi, the recommended total dose of BESPONSA is 1.8 mg/m2 per cycle given as 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Subsequent cycles are 4 weeks in duration. Patients who do not achieve a CR or CRi within 3 cycles should discontinue treatment.

For patients proceeding to hematopoietic stem cell transplant (HSCT), the recommended duration of treatment with BESPONSA is 2 cycles. A third cycle may be considered for those patients who do not achieve CR or CRi and minimal residual disease (MRD) negativity after 2 cycles.

For patients not proceeding to HSCT, additional cycles of treatment, up to a maximum of 6 cycles, may be administered.

ADVERSE REACTIONS（不良反应）

Hepatotoxicity, including hepatic VOD (also known as SOS)

Increased risk of post-transplant non-relapse mortality

Myelosuppression

Infusion related reactions

QT interval prolongation

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/cc7014b1-c775-411d-b374-8113248b4077/spl-doc?hl=Besponsa

Besponsainformation