BESPONSA is a CD22-directed antibody-drug conjugate (ADC) indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). (1)

• Pre-medicate with a corticosteroid, antipyretic, and antihistamine prior to all infusions. (2.2)
• Dosing regimens for Cycle 1 and subsequent cycles, depending on the response to treatment, are shown below. See full prescribing information for dosing details. (2)

  	Day 1	Day 8	Day 15
  * 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).
  Dosing regimen for Cycle 1
  All patients:
  Dose	0.8 mg/m2	0.5 mg/m2	0.5 mg/m2
  Cycle length	21 days*
  Dosing regimen for subsequent cycles depending on response to treatment
  Patients who have achieved a CR or CRi:
  Dose	0.5 mg/m2	0.5 mg/m2	0.5 mg/m2
  Cycle length	28 days
  Patients who have not achieved a CR or CRi:
  Dose	0.8 mg/m2	0.5 mg/m2	0.5 mg/m2
  Cycle length	28 days

• See full prescribing information for instructions on reconstitution of lyophilized powder, and preparation and administration of reconstituted drug. (2.4)

For injection: 0.9 mg lyophilized powder in a single-dose vial for reconstitution and further dilution. (3)

None (4)

• Myelosuppression: Monitor complete blood counts; for signs and symptoms of infection; bleeding/hemorrhage; or other effects of myelosuppression during treatment; manage appropriately. (5.3)
• Infusion related reactions: Monitor for infusion related reactions during and for at least 1 hour after infusion ends. (5.4)
• QT interval prolongation: Obtain electrocardiograms (ECGs) and electrolytes at baseline and monitor during treatment. Monitor more frequently when using concomitant mediations known to prolong QT interval. (5.5)
• Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.6)

The most common (≥ 20%) adverse reactions are thrombocytopenia, neutropenia, infection, anemia, leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, transaminases increased, abdominal pain, gamma-glutamyltransferase increased, and hyperbilirubinemia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Lactation: Advise not to breastfeed. (8.2)