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BESPONSA™ (inotuzumab ozogamicin)

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BESPONSA™ safely and effectively. See full prescribing information for BESPONSA.

BESPONSA (inotuzumab ozogamicin) for injection, for intravenous use
Initial U.S. Approval: 2017

WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME and INCREASED RISK OF POST- HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY

See full prescribing information for complete boxed warning.

  • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA. (5.1)
  • A higher post-HSCT non-relapse mortality rate occurred in patients receiving BESPONSA (5.2)

INDICATIONS AND USAGE

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)

DOSAGE AND ADMINISTRATION

  • 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)

DOSAGE FORMS AND STRENGTHS

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

CONTRAINDICATIONS

None (4)

WARNINGS AND PRECAUTIONS

  • 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)

ADVERSE REACTIONS

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.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2018

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Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch