Follistim^® AQ (follitropin beta injection) is indicated for the development of multiple follicles in ovulatory patients participating in an assisted reproductive technology (ART) program. Follistim^® AQ is also indicated for the induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.

Important Safety Information

Follistim^® AQ Cartridge administered with Follistim Pen^® delivers on average an 18% higher amount of follitropin beta compared to lyophilized preparation administered using conventional syringes. A lower dose should be considered when using Follistim^® AQ Cartridge.

Follistim^® AQ (follitropin beta injection) is contraindicated in women who exhibit: prior hypersensitivity to recombinant hFSH products; a high circulating FSH level indicating primary ovarian failure; uncontrolled thyroid or adrenal dysfunction; tumor of the ovary, breast, uterus, hypothalamus, or pituitary gland; pregnancy; heavy or irregular vaginal bleeding of undetermined origin; ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS); and hypersensitivity reactions to streptomycin or neomycin. Follistim^® AQ may contain traces of these antibiotics and may cause hypersensitivity reactions in susceptible persons.

Follistim^® AQ, like all gonadotropins, is a potent substance capable of causing ovarian hyperstimulation syndrome (OHSS), with or without pulmonary or vascular complications. OHSS is a medical entity distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event. During clinical trials with Follistim^® and Follistim^® AQ Cartridge therapy, OHSS occurred in 60 (5.3%) of the 1132 women treated and of these 33 (2.9%) were hospitalized.

Follistim^® AQ should be prescribed only by physicians who are experienced in infertility treatment, and patients should be advised of treatment risks, including OHSS and multiple births.

Multiple births have been reported for all FSH treatments including Follistim^® AQ (follitropin beta injection) treatment. The patient and her partner should be advised of the potential risk of multiple births before starting treatment.

For Follistim^® AQ Cartridge:

Adverse reactions occurring in ≥5% of patients in clinical trials undergoing ART with Follistim^® AQ Cartridge included: abdominal pain 28%, flatulence 27%, abdominal pain (gynecological) 25%, nausea 17%, breast pain (female) 15%, injection site reaction 10%, abdomen enlarged 8%, back pain 7%, constipation 5%, headache 5%, and ovarian pain 5%.

Adverse reactions occurring in ≥5% of patients in clinical trials undergoing ovulation induction with Follistim^® AQ Cartridge included: ovarian hyperstimulation syndrome 9%, abdominal pain 5%, injection site reaction 5%, sinusitis 5%, and upper respiratory tract infection 5%.

For Follistim^® AQ Vial:

Adverse reactions occurring in >1% of patients in clinical trials undergoing ART with Follistim® included: miscarriage 11%, OHSS 5.2%, ectopic pregnancy 3.0%, abdominal pain 2.5%, injection site pain 1.7%, and vaginal hemorrhage 1.5%.

Adverse reactions occurring in >1% of patients in clinical trials undergoing ovulation induction with Follistim^® included: miscarriage 9.5%, OHSS 7.6%, abdominal discomfort 2.9%, abdominal pain (lower) 2.9%, abdominal pain 1.9%, and ovarian cyst 2.9%.

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Pregnyl^® is indicated for induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.

Important Safety Information

Pregnyl^® is contraindicated in patients with prior allergic reaction to human chorionic gonadotropin (HCG). Pregnyl^® should be used in conjunction with human menopausal gonadotropins. Only physicians experienced in infertility treatment should prescribe Pregnyl^®.

Serious adverse reactions associated with Pregnyl^® include, (1) ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion, (2) rupture of ovarian cysts with resultant hemoperitoneum, (3) multiple births, and (4) arterial thromboembolism.

Other adverse reactions associated with Pregnyl^® use include, headache, restlessness, depression, fatigue, edema, and pain at the site of injection.

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Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.

Important Safety Information

Ganirelix Acetate Injection is contraindicated in patients with a known hypersensitivity to ganirelix acetate or to any of its components, to GnRH or any other GnRH analog, and in patients with known or suspected pregnancy.

Only physicians experienced in infertility treatment should prescribe Ganirelix Acetate Injection. Before starting treatment with ganirelix, pregnancy must be excluded.

Cases of hypersensitivity reactions, including anaphylactoid reactions with the first dose, have been reported during post-marketing surveillance. The packaging of this product contains natural rubber latex which may cause allergic reactions.

The most common adverse events occurring in ≥1% of patients treated with ganirelix in clinical trials (N=794) include: abdominal pain (gynecological) 4.8%, fetal death 3.7%, headache 3.0%, ovarian hyperstimulation syndrome (OHSS) 2.4%, vaginal bleeding 1.8%, injection site reaction 1.1%, nausea 1.1%, abdominal pain (gastrointestinal) 1.0%.

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