Enbrel Description

Physical Characteristics: Powder and Solvent for Solution for Injection: Reconstituted ENBREL solution is clear to slightly opalescent and colourless to slightly yellow or pale brown, with a pH of 7.4±0.3.
Solution for Injection in Pre-filled Syringe and Solution of Injection in Pre-filled Pen: The solution for injection in the pre-filled syringe and pen is clear to opalescent, colourless 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.
Active Ingredients, Active Moieties: Etanercept (INN).
ENBREL (etanercept) is a human tumour necrosis factor receptor (TNFR) p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. ENBREL is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand-binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. This Fc component contains the hinge, CH₂ and CH₃ regions, but not the CH₁ region of the IgG1. ENBREL contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. The potency is determined by measuring the ability of ENBREL to neutralise the TNFα-mediated growth inhibition of A375 cells. The specific activity of ENBREL is 1.7 x 10⁶ units/mg.
Powder and Solvent for Solution for Injection: ENBREL is supplied in a carton containing four dose trays. Each dose tray contains one 25 mg single-use vial of ENBREL, one syringe (1 mL Sterile Water for Injection), one stainless steel needle, 1 vial adaptor, and two alcohol swabs. Clear glass vial (2 mL or 4 mL, type I glass) with rubber stopper, aluminium seal, and flip-off plastic cap.
The excipients in ENBREL lyophilised powder are mannitol, nitrogen, sucrose, trometamol and water for injections.
Solution for Injection in Pre-filled Syringe: ENBREL is supplied in a carton containing four dose trays. Each dose tray contains one pre-filled syringe 25 mg (single use) or 50 mg (single use) of etanercept and one alcohol swab.
The excipients in the pre-filled syringe are sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate and water for injections.
Excipients/Inactive Ingredients: Powder and Solvent for Solution for Injection: Mannitol, Sucrose, Trometamol (Tromethamine).
Solution for Injection in Pre-filled Syringe: Sucrose, Sodium chloride, L-arginine hydrochloride, Sodium phosphate monobasic dihydrate, Sodium phosphate dibasic dihydrate, Water.