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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (F's) » Follitropin Alfa


Gonal-F ® (follitropin alfa for Injection)
For subcutaneous injection

Gonal-F® (follitropin alfa for Injection) is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the a- and b- subunits. The a- and b- subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structure are indistinguishable from those of human follicle stimulating hormone. Recombinant FSH production occurs in genetically modified Chinese Hamster Ovary (CHO) cells cultured in bioreactors. Purification by immunochromatography using an antibody specifically binding FSH results in a highly purified preparation with a consistent FSH isoform profile, and a high specific activity. The biological activity of follitropin alfa is determined by measuring the increase in ovary weight in female rats. The in vivo biological activity of follitropin alfa has been calibrated against the second International Reference Preparation for Human Menopausal Gonadotrophins established in September 1964 by the Expert Committee on Biological Standards of the World Health Organization. Gonal-F® contains no luteinizing hormone (LH) activity. Based on available data derived from physicochemical tests and bioassays, follitropin alfa and follitropin beta, another recombinant follicle stimulating hormone product, are indistinguishable.

Gonal-F® is a sterile, lyophilized powder intended for subcutaneous injection after reconstitution with Sterile Water for Injection, USP. Each ampule of Gonal-F® contains either 75 IU or 150 IU recombinant FSH, 30 mg sucrose, 1.11 mg dibasic sodium phosphate and 0.45 mg monobasic sodium phosphate monohydrate. O-phosphoric acid and/or sodium hydroxide may be used prior to lyophilization for pH adjustment. Under current storage conditions, Gonal-F® may contain up to 15% of oxidized follitropin alfa.

Therapeutic Class: Infertility

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