follitropin alfa - Generic Medications

Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f (follitropin alfa) for injection is a sterile, lyophilized powder intended for subcutaneous injection after reconstitution. Each multiple-dose vial of GONAL-f containing either 450 International Units (33 mcg) or 1050 International Units (77 mcg) follitropin alfa and the inactive ingredients dibasic sodium phosphate (0.89 mg), monobasic sodium phosphate (0.39 mg), and sucrose (30 mg). Phosphoric acid and/or sodium hydroxide may be used prior to lyophilization for pH adjustment. After reconstitution with supplied 1 mL of with Bacteriostatic Water for Injection (0.9% benzyl alcohol), USP, the resultant concentration is 600 IU/mL with a pH of approximately 6.5 to 7.5. Under current storage conditions, GONAL-f may contain up to 10% of oxidized follitropin alfa.