Dosing and Administration

BESPONSA offers 1-hour dosing by IV infusion and can be administered in the outpatient setting1

BESPONSA is dosed on Days 1, 8, and 15 of each 3- to 4-week cycle

  • Dosing for BESPONSA is based on a patient’s body surface area (m2)

 

aThe first cycle of BESPONSA is 21 days in length, while Cycles 2-6 are each 28 days in length. Cycle 1 may be extended to 28 days for patients achieving CR/CRi or if recovery from toxicity is needed.

b+/- 2 days (maintain a minimum of 6 days between doses).

c7-day treatment-free interval starting on Day 21.

Treatment duration1,2

  • Among patients receiving BESPONSA in the INO-VATE ALL trial, all responses occurred within 3 cycles
    • The median number of treatment cycles was 3
    • The median duration of treatment exposure was 8.9 weeks (range, 0.1-26.4)

 

Patients who do not achieve CR/CRi within 3 cycles should discontinue treatment.1

CR=complete remission; CRi=complete remission with incomplete hematologic recovery; HSCT=hematopoietic stem cell transplant; MRD=minimal residual disease.

Premedication and cytoreduction1

  • Premedication with a corticosteroid, antipyretic, and antihistamine is recommended prior to each dose
  • For patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids, and/or vincristine to a peripheral blast count of ≤10,000/mm3 is recommended prior to the first dose of Cycle 1
References
  1. BESPONSA Prescribing Information. New York, NY: Pfizer Inc.
  2. Data on file. Pfizer Inc, New York, NY.

 

Modify the dose of BESPONSA for toxicities. If the dose is reduced due to BESPONSA-related toxicity, the dose must not be re-escalated1

  • Doses within a treatment cycle (ie, on Days 8 and/or 15) do not need to be interrupted due to neutropenia or thrombocytopenia
  • Dose interruptions within a treatment cycle are recommended for nonhematologic toxicities

ANC=absolute neutrophil count.

aPlatelet count used for dosing should be independent of blood transfusion.

 

 

ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; VOD=hepatic veno-occlusive disease.

bSeverity grade according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.

Duration of dose interruption for nonhematologic toxicities1

Reference
  1. BESPONSA Prescribing Information. New York, NY: Pfizer Inc.