ENBRELÒ (etanercept) is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgGl. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgGl. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino
ENBRELÒ is supplied in a single-use prefilled 1 mL syringe as a sterile, preservative-free solution for subcutaneous injection. The solution of ENBRELÒ is clear and colorless and is formulated at pH 6.3 ¡À 0.2. Each ENBRELÒ single-use prefilled syringe contains 0.98 mL of a 50 mg/mL solution of etanercept with 10 mg/mL sucrose, 5.8 mg/mL sodium chloride, 5.3 mg/mL L-arginine hydrochloride, 2.6 mg/mL sodium phosphate monobasic monohydrate and 0.9 mg/mL sodium phosphate dibasic anhydrous. Administration of one 50 mg/mL prefilled syringe of ENBRELÒ provides a dose equivalent to two 25 mg vials of lyophilized ENBRELÒ, when vials are reconstituted and administered as recommended.
ENBRELÒ multiple-use vial contains sterile, white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the supplied Sterile Bacteriostatic Water for Injection (BWFI), USP (containing 0.9% benzyl alcohol) yields a multiple-use, clear, and colorless solution with a pH of 7.4 ¡À 0.3 containing 25 mg etanercept, 40 mg mannitol, 10 mg sucrose, and 1.2 mg tromethamine.
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