ABSTRACT

Description: Puregon (Follistim in the U.S.) is a recombinant human follicle-stimulating hormone (FSH). Like the native human molecule, puregon is a heterodimeric glycoprotein, consisting of a 92-amino acid α-subunit and a 111-amino acid βsubunit. Both are glycosylated and are held together by noncovalent interactions. Puregon is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. It is provided for subcutaneous and intramuscular administration in different formulations: as a lyophilized form to be reconstituted before administration with the solvent provided, as a solution ready for injection, and as a solution for use in a multidose device.