Gonal-F 450IU

• Induction of ovulation: in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure.
• Development of multiple follicles: as part of an assisted reproductive technology (ART) cycle.
• Induction of spermatogenesis: in infertile men with azoospermia and primary or secondary hypogonadotropic hypogonadism.

Ovulation Induction (Women):

• First cycle starting dose: 75 IU/day for 14 days SC.
• Individualize doses after 14 days.
• Maximum 300 IU/day.

Multiple Follicles in ART (Women):

• First cycle starting dose: 150 IU/day SC.
• Adjust by 75-150 IU every 3-5 days.
• Maximum 450 IU/day.

Males with Hypogonadotropic Hypogonadism and Azoospermia:

• Pre-treat with hCG (1,000-2,250 USP units 2-3 times weekly) for 3-6 months.
• After testosterone normalization: 150 IU three times weekly + hCG 1,000 USP units three times weekly.

* Use as directed by the registered physician

Common Side Effects (≥5%):

• Ovarian cyst
• Headache
• Abdominal pain
• Ovarian hyperstimulation syndrome (OHSS)
• Nausea
• Flatulence
• Injection site pain
• Fatigue
• Gynecomastia

Serious Side Effects: Severe OHSS, ovarian torsion, thromboembolism, anaphylaxis.

Precautions:

• If hypersensitivity or anaphylaxis occurs, discontinue and initiate appropriate therapy.
• Ovarian hyperstimulation syndrome (OHSS) - if serious, stop HCG and may require hospitalization.
• Pulmonary and vascular complications - monitor for thromboembolic events.
• Risk of multiple gestations - inform patient before starting therapy.
• Increased risk of ectopic pregnancy - early ultrasound confirmation important.