Skip to content

Elranatamab

    Brands

    DAE Class; Rx

    Common Brand Names; Elranatamab-bcmm, Elrexfio

    • Anti-BCMA Antibodies

    Bispecific BCMA-directed CD3 T-cell engaging antibody
    Used in adult patients with heavily pretreated relapsed or refractory multiple myeloma
    Boxed warning for cytokine release syndrome and severe neurologic toxicity

    Indicated for relapsed or refractory multiple myeloma in adults who have received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

    For the treatment of multiple myeloma.

    None

    >10%

    All grades

    • Lymphocyte count decreased (91%)
    • White blood cell decreased (69%)
    • Hemoglobin decreased (68%)
    • Neutrophil count decreased (62%)
    • Platelet count decreased (61%)
    • CRS (58%)
    • Albumin decreased (55%)
    • Fatigue (43%)
    • AST increased (40%)
    • Creatinine increased (38%)
    • Injection site reaction (37%)
    • Diarrhea (36%)
    • Potassium decreased (36%)
    • ALT increased (36%)
    • Upper respiratory tract infection (34%)
    • Alkaline phosphatase increased (34%)
    • Musculoskeletal pain (34%)
    • Pneumonia (32%)
    • Creatinine clearance (32%)
    • Decreased appetite (26%)
    • Rash (25%)
    • Cough (24%)
    • Nausea (22%)
    • Pyrexia (21%)
    • Headache (19%)
    • Edema (18%)
    • Cardiac arrhythmia (16%)
    • Constipation (15%)
    • Dyspnea (15%)
    • Sepsis (15%)
    • Encephalopathy (15%)
    • Vomiting (14%)
    • Hypogammaglobulinemia (13%)
    • Dry skin (13%)
    • Sensory neuropathy (13%)
    • Motor dysfunction (13%)
    • Hemorrhage (13%)
    • Insomnia (13%)
    • Urinary tract infection (12%)

    Grade 3 or 4

    • Lymphocyte count decreased (84%)
    • Neutrophil count decreased (51%)
    • Hemoglobin decreased (43%)
    • White blood cell decreased (40%)
    • Platelet count decreased (32%)
    • Pneumonia (19%)
    • Sepsis (11%)

    1-10%

    All grades

    • Skin exfoliation (10%)
    • Fall (10%)

    Black Box Warnings

    Cytokine release syndrome (CRS)

    • CRS reported, including life-threatening or fatal reactions
    • Initiate with step-up dosing to reduce risk of CRS
    • If CRS occurs, withhold elranatamab until resolved or permanently discontinue based on severity

    Neurologic toxicity

    • Neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur
    • Monitor for signs and symptoms of neurologic toxicity including ICANS during treatment, and treat promptly
    • Withhold or permanently discontinue elranatamab based on severity

    REMS

    • Owing to risk of CRS and neurologic toxicity, drug is available only through a restricted program called the Elrexfio Risk Evaluation and Mitigation Strategy (REMS) or by telephone at 1-844-923-7845
    • REMS requirements
      • Prescribers must be certified with the program by enrolling and completing training
      • Prescribers must counsel patients receiving elranatamab about the risk of CRS and neurologic toxicity, including ICANS, and provide patients with patient wallet card
      • Pharmacies and healthcare settings that dispense elranatamab must be certified with the ELREXFIO REMS program and must verify that prescribers are certified through the ELREXFIO REMS program
      • Wholesalers and distributors must distribute drug only to certified pharmacies

    Cautions

    Drug available only through restricted Risk Evaluation and Mitigation Strategy (REMS) program

    On the basis of its mechanism of action, drug may cause fetal harm when administered to pregnant females

    Pregnancy

    On the basis of its mechanism of action, drug may cause fetal harm when administered to pregnant females

    Advise women of the potential risk to the fetus

    Elranatamab causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance

    Additionally, based on finding of B-cell depletion in nonpregnant animals, elranatamab can cause B-cell lymphocytopenia in infants exposed in utero

    Contraception

    • Females of reproductive potential: Use effective contraception during treatment and for 4 months after last dose

    Lactation

    Data are not available regarding presence of elranatamab in human milk, effects on breastfed children, or effect on milk production

    Maternal IgG is known to be present in human milk; effects of local gastrointestinal exposure and limited systemic exposure in breastfed children are unknown

    Do not breastfeed during treatment and for 4 months after last dose

    Adults

    76 mg once per week subcutaneously.

    Geriatric

    76 mg once per week subcutaneously.

    Adolescents

    Safety and efficacy not established.

    Children

    Safety and efficacy not established.

    Infants

    Safety and efficacy not established.

    Elranatamab

    injectable solution for SC

    • 40mg/mL (1.1-mL or 1.9-mL single-dose vial)
    • Ready-to-use SC solution