Elranatamab Injection 76?mg/1.9?mL/Freeze-dried powder

描述

Elranatamab Injection Description

Product name: Enatumab injection (ELREXFIO)
Packaging specification: 76mg (1.9ml) ? Product dosage form: injection ? Packaging unit: bottle/box
Approval number: National Medicine Standard SJ20250011 ? Drug code: 86978718001636
Manufacturer: Pharmacia & Upjohn Company LLC, USA

ELREXFIO® (elranatamab-bcmm) is a next-generation bispecific T-cell engager antibody that binds to BCMA on malignant plasma cells and CD3 on T cells, initiating targeted cytolysis of multiple myeloma cells?. It is produced using recombinant CHO cells and consists of a four-chain IgG2?a structure with a molecular weight ~148.5?kDa

Supplied as a clear to slightly opalescent 40?mg/mL solution, each 1.9?mL vial contains 76?mg elranatamab, with stabilizers such as histidine, sucrose, and polysorbate 80; pH ~5.8?

ELREXFIO® received accelerated FDA approval in August 2023 for relapsed/refractory multiple myeloma and conditional EU approval in December 2023? It’s also approved in Japan (May 2024), Canada, Australia, Switzerland, and several countries under Project Orbis?

? Product Specifications

? Clinical & Pharmacological Profile

• Mechanism: Dual-targeted CD3/BCMA binding triggers T?cell cytotoxicity against myeloma cells?.

• Pharmacokinetics: Steady-state levels at ~76?mg weekly; bioavailability ~56%; Tmax ~7 days after subcutaneous administration?.

• Half-life: ~22 days at 76?mg dose; Vd ~7.8?L?.

• Adverse Events: Common toxicity includes cytokine release syndrome (CRS, ~58%), fatigue (~43%), injection-site reactions (~37%), infections, neurotoxicity (ICANS), cytopenias, and GI symptoms?.

• Risk Management: Administered via step-up dosing and premedication (acetaminophen, dexamethasone, diphenhydramine); hospitalization recommended during initial doses?

• Regulation: Available under REMS programs due to serious CRS/ICANS risks?drugs.com+2pfizer.com+2elrexfio.pfizerpro.com+2.

? Why Choose ELREXFIO?

• First-in-class bispecific T-cell engager for BCMA+ myeloma

• Backed by global regulatory approvals and clinical data

• Packaged in single-dose vials for precise dosing

• Strong relevance for immuno-oncology and T-cell research

? Related Research Agents

• Blinatumomab (CD19-CD3 bispecific)

• CAR-T cell therapies targeting BCMA

• Checkpoint inhibitors (e.g., pembrolizumab)

• Combination agents (e.g. CDK4/6 or IMiD compounds)

? Summary

Elranatamab (ELREXFIO®) is a robust bispecific antibody targeting BCMA and CD3, specifically designed for multiple myeloma and T-cell engagement research. With approved global backing and high-impact use in immunotherapy studies, it’s a valuable addition to any oncology research catalog.
?? For laboratory research or analytical use only — not for human consumption or therapeutic use.