Elrexfio Generic Name & Formulations
Single-dose vial (1.1mL, 1.9mL)—1
Mechanism of Action
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.
In adults with relapsed or refractory multiple myeloma who have received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Elrexfio Dosage and Administration
Give by SC inj into abdomen (preferred inj site), or alternatively at other sites (eg, thigh). Premedicate with dexamethasone, diphenhydramine, and APAP approx. 1hr prior to each dose in the step-up dosing schedule (see full labeling). Step-up dosing schedule: 12mg (step-up dose 1) on Day 1, 32mg (step-up dose 2) on Day 4, 76mg (first treatment dose) on Day 8; followed by weekly dosing schedule: 76mg (subsequent treatment doses) on Day 15 and weekly thereafter through week 24. Biweekly dosing schedule (for responders only): 76mg on Week 25 and every 2 weeks thereafter. All: continue until disease progression or unacceptable toxicity. Restarting therapy after dose delay, dose modifications for adverse reactions, others: see full labeling.
Elrexfio Boxed Warnings
Cytokine release syndrome (CRS). Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).
Must be administered by a qualified healthcare professional. Have appropriate medical support available. Risk for CRS, neurologic toxicity (including ICANS). Initiate Elrexfio therapy with step-up dosing schedule and premedicate to reduce the risk of CRS. Monitor and evaluate immediately if CRS (may need hospitalization) or neurologic toxicity (including ICANS) occurs; manage according to guidelines, and provide supportive care; withhold or discontinue based on severity (see full labeling). Active infections: do not initiate. Monitor for infections (may be serious) prior to and during therapy; treat appropriately based on severity. Monitor CBCs, liver enzymes, bilirubin at baseline and during treatment as indicated. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).
Mean bioavailability when given subcutaneously: 56.2%.
Median Tmax after SC administration: 7 (3–7) days.
Volume of distribution at steady state: 7.76 L (33%).
Half-life: 22 days.
May affect certain CYP substrates; monitor for toxicity or drug levels if concomitant use.
Elrexfio Adverse Reactions
CRS, fatigue, inj site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, pyrexia, lab abnormalities; hepatotoxicity.
Elrexfio Clinical Trials
Elrexfio Patient Counseling