FOLLITROPIN

12.1 Mechanism of Action Women: Follicle-stimulating hormone (FSH), the active component in FOLLISTIM AQ Cartridge, is required for normal follicular growth, maturation, and gonadal steroid production. In women, the level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching maturity. FOLLISTIM AQ Cartridge stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to effect the final phase of follicle maturation, resumption of meiosis and rupture of the follicle in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following treatment with FOLLISTIM AQ Cartridge when patient monitoring indicates appropriate follicular development parameters have been reached. Men: FOLLISTIM when administered with hCG stimulates spermatogenesis in men with hypogonadotropic hypogonadism. FSH, the active component of FOLLISTIM, is the pituitary horm

Contraindications

• • thyroid
• • adrenal
• • or pituitary disorders) [see Indications and Usage (1.1
• • 1.2
• • 1.3) ] Hypersensitivity reactions to streptomycin or neomycin. FOLLISTIM AQ may contain traces of these antibiotics Tumors of the ovary