Besponsa (Inotuzumab Ozogamicin)
- Medicine Name: Besponsa
- Generic Name: Inotuzumab Ozogamicin
- Dosage Form & Strength: For Injection: 0.9 mg as a white to off-white lyophilized powder in a single-dose vial for reconstitution
- Manufactured By: Pfizer Inc.
Besponsa is a CD22-directed antibody-drug conjugate (ADC) used for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Recommended Dosage: Pre-medicate all the respective patients prior to each dose.
For the first cycle: The recommended total dose of Besponsa injection for all patients is 1.8 mg/m2 per cycle, given as three divided doses on Day 1’st (0.8 mg/m2), Day 8’th (0.5 mg/m2), and Day 15’th (0.5 mg/m2). Cycle-1 is 21 days (three weeks) in duration, but may be extended to four weeks in case the respective patient achieves a CR (complete remission) or complete remission (CR) with incomplete hematologic recovery (CRi), or to enable recovery from toxicity.
For subsequent cycles: In those who achieve a CR/CRi, the recommended total dose is 1.5 mg/m2 per cycle, administered as 3 divided doses on Day-1’st (0.5 mg/m2), Day-8’th (0.5 mg/m2), and Day-15’th (0.5 mg/m2). Subsequent cycles are 28 days (four weeks) in duration.
In those who do not achieve a CR/CRi, the recommended total dose is 1.8 mg/m2 per cycle given as 3 divided doses on Day 1’st (0.8 mg/m2), Day 8’th (0.5 mg/m2), and Day 15’th (0.5 mg/m2). Subsequent cycles are 4 weeks in duration. Those who do not achieve a CR/CRi within three cycles should interrupt or discontinue treatment.
For those proceeding to hematopoietic stem cell transplant (HSCT), the recommended duration of treatment is 2 cycles. A 3’rd cycle may be considered for those who do not achieve CR/CRi and minimal residual disease (MRD) negativity after two cycles.
For those not proceeding to HSCT, additional cycles of treatment with Besponsa, up to a maximum of six cycles, may be administered.
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