BLENREP 100 MG

Generic Name/API: belantamab mafodotin-blmf

Manufacturer: GSK

Dosage Forms & Strength & Pack Size:
For injection: 100 mg as a lyophilized powder in a single-dose vial for reconstitution and further dilution.

Storage:
Store vials refrigerated at 36ºF to 46ºF (2ºC to 8ºC).

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE
BLENREP is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have
received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

WARNINGS AND PRECAUTIONS

Thrombocytopenia: Perform complete blood counts at baseline and during treatment as clinically indicated. Consider withholding and/or reducing the dose based on severity. (2.3, 5.3)
Infusion-Related Reactions: Monitor patients for infusion-related reactions. Interrupt and then reduce the rate or permanently discontinue based on the severity. (2.3, 5.4)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.5, 8.1, 8.3)

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