BeneFIX Description

BeneFIX 250 IU powder and solvent for solution for injection: Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 50 IU nonacog alfa.
BeneFIX 500 IU powder and solvent for solution for injection: Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 100 IU nonacog alfa.
BeneFIX 1,000 IU powder and solvent for solution for injection: Each vial contains nominally 1,000 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 200 IU nonacog alfa.
The potency (IU) is determined using the European Pharmacopoeia one-stage clotting assay. The specific activity of BeneFIX is not less than 200 IU/mg protein.
BeneFIX contains recombinant coagulation factor IX, (INN = nonacog alfa). Nonacog alfa is a purified protein that has 415 amino acids in a single chain. It has a primary amino acid sequence that is comparable to the Ala¹⁴⁸ allelic form of plasma-derived factor IX, and some post-translational modifications of the recombinant molecule are different from those of the plasma-derived molecule. Recombinant coagulation factor IX is a glycoprotein that is secreted by genetically engineered mammalian cells derived from a Chinese hamster ovary (CHO) cell line.
Excipients/Inactive Ingredients: Powder: Sucrose, Glycine, L-Histidine, Polysorbate 80, Hydrochloric acid, Nitrogen gas.
Solvent: Sodium chloride solution, Water for injection.