Follitropin

FOLLISTIM ® AQ Cartridge (follitropin beta) injection, is indicated: In Women for: FOLLISTIM AQ Cartridge is a gonadotropin indicated: In Women for: Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure. Pregnancy in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle. In Men for: Induction of Spermatogenesis in Men with Primary and Secondary Hypogonadotropic Hypogonadism (HH) in Whom the Cause of Infertility is Not Due to Primary Testicular Failure

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.

See Dose Conversion Table 1 for FOLLISTIM AQ Cartridge with Pen Injector. In Anovulatory Women Undergoing Ovulation Induction: Starting daily dose of 50 international units of FOLLISTIM AQ Cartridge is administered subcutaneously for at least the first 7 days. The dose is increased by 25 or 50 international units at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate response. When an acceptable pre-ovulatory state is achieved, final oocyte maturation is achieved with 5,000 to 10,000 international units of urinary human chorionic gonadotropin (hCG). The woman and her partner should have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent.

FOLLISTIM AQ Cartridge is contraindicated in women and men who exhibit: Prior hypersensitivity to recombinant hFSH products or any component of FOLLISTIM AQ Cartridge. Reactions including anaphylaxis have been reported High levels of FSH indicating primary gonadal failure Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) Hypersensitivity reactions to streptomycin or neomycin.

FOLLISTIM AQ Cartridge should be used only by physicians who are experienced in infertility treatment. FOLLISTIM AQ Cartridge contains a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) with or without pulmonary or vascular complications and multiple births. Gonadotropin therapy requires the availability of appropriate monitoring facilities. Careful attention should be given to the diagnosis of infertility and in the selection of candidates for FOLLISTIM AQ Cartridge therapy. Switching to FOLLISTIM AQ Cartridge from other brands (manufacturer), types (recombinant, urinary), and/or methods of administration (FOLLISTIM Pen, conventional syringe) may necessitate an adjustment of the dose. Treatment with FOLLISTIM AQ may result in: Abnormal Ovarian Enlargement. Ovarian Hyperstimulation Syndrome (OHSS). Pulmonary and Vascular Complications.

The following serious adverse reactions are discussed elsewhere in the labeling: Abnormal Ovarian Enlargement Ovarian Hyperstimulation Syndrome Atelectasis Thromboembolism Ovarian Torsion Multi-fetal Gestation and Birth Congenital Anomalies Ectopic Pregnancy Spontaneous Abortion Ovarian Neoplasms The most common adverse reactions (≥2%) in women undergoing ovulation induction are ovarian hyperstimulation syndrome, ovarian cyst, abdominal discomfort, abdominal pain and lower abdominal pain. The most common adverse reactions (≥2%) in women undergoing controlled ovarian stimulation as part of an IVF or ICSI cycle are pelvic discomfort, headache, ovarian hyperstimulation syndrome, pelvic pain, nausea and fatigue.

No drug-drug interaction studies have been performed.

Store refrigerated 36°F to 46°F (2°C to 8°C) until dispensed. Do not freeze. Patient Storage: Store unused cartridge refrigerated at 36°F to 46°F (2°C to 8°C) until the expiration date, or at room temperature at up to 77°F (25°C) for 3 months or until expiration date, whichever occurs first. After first use, store at 36°F to 77°F (2°C to 25°C) and discard after 28 days. Do not freeze. Store in the original carton to protect from light.