ELREXFIO (elranatamab-bcmm) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It is a bispecific,humanized immunoglobulin 2-alanine (IgG2Δa) kappa antibody derived from two monoclonal antibodies (mAbs), an anti-BCMA mAb and an anti-CD3 mAb. ELREXFIOTM (elranatamab-bcmm) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brown liquid solution for subcutaneous administration. ELREXFIO (elranatamab-bcmm) is supplied at a concentration of 40 mg/mL in either 76 mg/1.9 mL or 44 mg/1.1 mL single-dose vials. Each mL of solution contains 40 mg elranatamab-bcmm, edetate disodium (0.045 mg), histidine (1.12 mg), L-histidine hydrochloride monohydrate (2.67 mg), polysorbate 80 (0.2 mg), sucrose (85 mg) and Water for Injection. The pH is 5.8.
ELREXFIO (elranatamab-bcmm) - 76 mg/1.9 mL (40 mg/mL) in a single-dose vial. • 44 mg/1.1 mL (40 mg/mL) in a single-dose vial.
Plesae click here- https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761345s000lbl.pdf
ELREXFIO (elranatamab-bcmm) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.