Dosing and Administration

BESPONSA offers convenient 1-hour dosing by IV infusion and can be administered in the outpatient setting2,3

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

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

*+/– 2 days (maintain a minimum of 6 days between doses).

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

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

Treatment duration2,3

  • 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.2

Premedication and cytoreduction2

  • 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

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

References
  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Acute Lymphoblastic Leukemia V.1.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed February 26, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content or its use or application and disclaims any responsibility for its use or application in any way.
  2. BESPONSA Prescribing Information. New York, NY: Pfizer Inc.
  3. 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-escalated2

  • 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

*Platelet count used for dosing should be independent of blood transfusion.

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

Duration of dose interruption for nonhematologic toxicities2

ANC=absolute neutrophil count; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; VOD=veno-occlusive disease.

References
  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Acute Lymphoblastic Leukemia V.1.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed February 26, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content or its use or application and disclaims any responsibility for its use or application in any way.
  2. BESPONSA Prescribing Information. New York, NY: Pfizer Inc.