BESPONSA doses within a treatment cycle (i.e., Days 8 and/or 15) do not need to be interrupted due to neutropenia or thrombocytopenia, but dosing interruptions within a cycle are recommended for non-hematologic toxicities. Modify the dose of BESPONSA for toxicities (see Tables 2–4). Patients who have not achieved a CR § or CRi ¶: Patients who have achieved a CR § or CRi ¶: # 7-day treatment-free interval starting on Day 21.ĭosing regimen for subsequent cycles depending on response to treatment
¶ CRi is defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets < 100 × 10 9/L and/or ANC < 1 × 10 9/L) and resolution of any extramedullary disease.
§ CR is defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets ≥ 100 × 10 9/L and absolute neutrophil counts ≥ 1 × 10 9/L) and resolution of any extramedullary disease. ‡ For patients who achieve a CR or a CRi, and/or to allow for recovery from toxicity, the cycle length may be extended up to 28 days (i.e., 7-day treatment-free interval starting on Day 21). † Dose is based on the patient's body surface area (m 2). * +/- 2 days (maintain minimum of 6 days between doses). Dosing Regimen for Cycle 1 and Subsequent Cycles Depending on Response to TreatmentĪbbreviations: CR=complete remission CRi=complete remission with incomplete hematologic recovery. Table 1 shows the recommended dosing regimens.
Patients who do not achieve a CR or CRi within 3 cycles should discontinue treatment. Subsequent cycles are 4 weeks in duration. In patients who do not achieve a CR or CRi, the recommended total dose of BESPONSA is 1.8 mg/m 2 per cycle given as 3 divided doses on Day 1 (0.8 mg/m 2), Day 8 (0.5 mg/m 2), and Day 15 (0.5 mg/m 2).