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Dosing and Administration

Dosing and Administration

BESPONSA is administered as a 1-hour infusion in 21- or 28-day cycles.1

Recommended management before treatment1

When considering the use of BESPONSA as a treatment for relapsed or refractory B-cell ALL, baseline CD22 positivity of >0% using a validated and sensitive assay is required prior to initiating treatment.

For patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids, and/or vincristine to a peripheral blast count ≤10,000/mm3; is recommended prior to the first dose

Premedication with a corticosteroid, antipyretic and antihistamine is recommended prior to dosing to minimize the risk of infusion reactions. For patients with a high tumour burden, premedication to reduce uric acid levels and hydration are recommended prior to dosing.

Patients should be observed during and for at least 1 hour after the end of the infusion for symptoms of infusion-related reactions.

ALL, acute lymphoblastic leukaemia; PBC, peripheral blast count

Treatment schedule1

Figures adapted from BESPONSA Hong Kong Prescribing Information November 2018

Day 8 and 15 doses can be administered ±2 days (maintain minimum of 6 days between doses).

For patients who achieve a complete remission (CR) or complete remission with incomplete haematological recovery (CRi), or to allow for recovery from toxicity, the first cycle length may be extended up to 28 days (i.e. 7-day treatment-free interval starting on Day 21).

CR is defined as <5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, full recovery of peripheral blood counts (platelets ≥100 ×109/l and absolute neutrophil count (ANC) ≥1 ×109/l) and resolution of any extramedullary disease.

CRi is defined as <5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, incomplete recovery of peripheral blood counts (platelets <100 ×109/l and/or ANC <1 ×109/l) and resolution of any extramedullary disease.

Table adapted from BESPONSA Hong Kong Prescribing Information November 2018

Patients who do not achieve a CR/CRi within three cycles should discontinue treatment.

BESPONSA outpatient administration

Professor David Marks discusses the benefit of using BESPONSA in an outpatient setting.
  1. BESPONSA® Prescribing Information. Pfizer Corporation Hong Kong Limited. Version Nov 2018.