ELREXFIO

Elrexfio Generic Name & Formulations

Legal Class

General Description

Elranatamab-bcmm 40mg/mL; soln for SC inj; preservative-free.

Pharmacological Class

BCMA-directed CD3 T-cell engager.

How Supplied

Single-dose vial (1.1mL, 1.9mL)—1

Manufacturer

Pfizer Inc.

Generic Availability

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.

Elrexfio Indications

Indications

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

Adult

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.

Children

Not established.

Elrexfio Contraindications

Not Applicable

Elrexfio Boxed Warnings

Boxed Warning

Cytokine release syndrome (CRS). Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).

Elrexfio Warnings/Precautions

Warnings/Precautions

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).

REMS

YES

Elrexfio Pharmacokinetics

Absorption

Mean bioavailability when given subcutaneously: 56.2%.

Median T_max after SC administration: 7 (3–7) days.

Distribution

Volume of distribution at steady state: 7.76 L (33%).

Metabolism

Catabolic pathways.

Elimination

Half-life: 22 days.

Elrexfio Interactions

Interactions

May affect certain CYP substrates; monitor for toxicity or drug levels if concomitant use.

Elrexfio Adverse Reactions

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

See Literature

Elrexfio Note