Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
ELREXFIO 40 mg/mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear to slightly opalescent, colourless to pale brownish solution, pH of 5.8, and osmolarity of approximately 301 mOsm/L. |
ELREXFIO 40 mg/mL solution for injection: One vial contains 44 mg of elranatamab in 1.1 mL (40 mg/mL).
ELREXFIO 40 mg/mL solution for injection: One vial contains 76 mg of elranatamab in 1.9 mL (40 mg/mL).
Elranatamab is an IgG2 kappa bispecific antibody derived from two monoclonal antibodies (mAbs). Elranatamab is produced using two recombinant Chinese hamster ovary (CHO) cell lines.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Elranatamab |
Elranatamab is a bi-specific T-cell engaging antibody that binds CD3-epsilon on T-cells and B-cell maturation antigen (BCMA) on plasma cells, plasmablasts, and multiple myeloma cells. Binding of elranatamab to BCMA on tumour cells and CD3 on T-cells is independent of native T-cell receptor (TCR) specificity or reliance on major histocompatibility (MHC) Class 1 molecules. Elranatamab activated T-cells, led to proinflammatory cytokine release, and resulted in multiple myeloma cell lysis. |
| List of Excipients |
|---|
|
Edetate disodium |
ELREXFIO 40 mg/mL solution for injection: 1.1 mL solution in a vial (Type 1 glass) with a stopper (butyl rubber) and an aluminium seal with a flip-off cap containing 44 mg of elranatamab. Pack size of 1 vial.
ELREXFIO 40 mg/mL solution for injection: 1.9 mL solution in a vial (Type 1 glass) with a stopper (butyl rubber) and an aluminium seal with a flip-off cap containing 76 mg of elranatamab. Pack size of 1 vial.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/23/1770/001
EU/1/23/1770/002
| Drug | Countries | |
|---|---|---|
| ELREXFIO | Austria, Estonia, France, Croatia, Lithuania, Romania, United States |
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