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Etanercept (Enbrel) dosage forms are intended for subcutaneous injection.
Each pre-filled syringe contains 25 mg or 50 mg of Etanercept (active ingredient).
Etanercept is a human tumor necrosis factor receptor (TNFR) p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumor necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. The Fc component of etanercept contains the hinge, CH2 and CH3 regions but not the CH1 region of IgG1.
Solubility: Etanercept is soluble in water.
Molecular weight: (apparent) 150 kilodaltons.
Physical characteristics: The solution for injection in the pre-filled syringe is clear to opalescent, colorless to yellow or pale brown, and liquid may contain trace levels of translucent to white amorphous particles, with a pH of 6.3 ± 0.2.
