How it Works
Elranatamab-bcmm is a bispecific B-cell maturation antigen (BCMA)-directed T-cell engaging antibody that binds BCMA on plasma cells, plasmablasts, and multiple myeloma cells and CD3 on T-cells leading to cytolysis of the BCMA-expressing cells. Elranatamab-bcmm activated T-cells, caused proinflammatory cytokine release, and resulted in multiple myeloma cell lysis.
How it’s Administered
Injection:
-
76 mg/1.9 mL (40 mg/mL) in a single-dose vial for subcutaneous injection.
-
44 mg/1.1 mL (40 mg/mL) in a single-dose vial for subcutaneous injection.
Who Should Take Elranatamab
Elranatamab-bcmm is 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.
Who Shouldn’t Take Elranatamab
- Pregnant women (causes fetal harm when administered to a pregnant woman)
- Females and males of reproductive potential (verify pregnancy status prior to initiating elranatamab and advise females of reproductive potential to use effective contraception during treatment with elranatamab and for 4 months after the last dose)
- Females who are breastfeeding (there is no information regarding the presence of elranatamab in human milk, the effect on the breastfed child, or the effect on milk production)
- Children (the safety and efficacy of elranatamab have not been established in pediatric patients)
- Patients of 75 years of age or older (clinical studies did not include sufficient numbers of patients 75 years of age or over to determine whether they respond differently from younger patients)
The Most Common Side Effects of Taking Elranatamab Include:
- Cytokine release syndrome
- Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS)
- Headache
- Encephalopathy
- Motor dysfunction
- Sensory neuropathy
- Guillain-Barré syndrome
- Infections
- Neutropenia
- Hepatotoxicity
- Embryo-fetal toxicity
- Fatigue
- Injection site reaction
- Diarrhea
- Upper respiratory tract infection
- Musculoskeletal pain
- Pneumonia
- Decreased appetite
- Rash
- Cough
- Nausea
- Pyrexia
- Leukopenia
- Neutropenia
- Anemia
- Thrombocytopenia
Currently Being Tested With
- Dexamethasone
- Carfilzomib and Dexamethasone
- Maplirpacept
- Daratumumab
- Daratumumab, Pomalidomide, and Dexamethasone
- Lenalidomide
- Pomalidomide
Learn more about your treatments in Cure Hub
For more information, go to https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761345s000lbl.pdf
Date last updated: 9/19/23
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