Follicle Stimulating Hormone

Introduction: FSH is a highly purified preparation of human follicle stimulating hormone (FSH-HP) extracted from the urine of postmenopausal women. It is a sterile, lyophilized powder intended for subcutaneous or intramuscular injection.

How it works: FSH consists of two non-covalently linked glycoproteins (alpha and beta subunits). It stimulates ovarian follicular growth in women and stimulates spermatogenesis in men.

Important Information: There is great inter-individual variation in ovarian response, so dosage must be individualized. Ultrasound and estradiol monitoring are required during treatment.

• Ovulation Induction in Women: in patients who have previously received pituitary suppression.
• Multi-follicular Development: during ART cycles (controlled ovarian stimulation).
• Polycystic Ovarian Syndrome (PCOS): treatment of PCOS-related infertility.
• Male Infertility: in combination with HCG for spermatogenesis deficiency due to hypogonadotrophic-hypogonadism.

Drugs for Infertility, Trophic Hormones & Related Synthetic Drugs

Glycoprotein hormone

FSH is a highly purified preparation of human follicle stimulating hormone (FSH-HP) extracted from the urine of postmenopausal women. FSH consists of two non-covalently linked glycoproteins designated as the alpha and beta subunits. The alpha subunit has 92 amino acids (two modified by carbohydrates) and the beta subunit has 111 amino acids (two modified by carbohydrates). It is a sterile, lyophilized powder intended for subcutaneous or intramuscular injection.

FSH stimulates the growth and maturation of ovarian follicles. In men, it stimulates spermatogenesis in combination with HCG.

Ovulation Induction in Women:

• Starting dose: 50 IU/day for at least the first 7 days SC or IM.
• Increase by 25 or 50 IU at weekly intervals.
• When pre-ovulatory state achieved, administer HCG (5,000-10,000 IU).

ART (Women):

• Starting dose: 150-225 IU/day for at least first 4 days IM.
• Adjust dose based on ovarian response.

PCOS:

• Start with 50 IU daily (4-6 days).
• Increase to 75, 112, 150 and 225 IU if needed.

Male Spermatogenesis:

• Pre-treatment with HCG (1,500 IU twice weekly).
• When serum testosterone normalised, FSH 450 IU/week (2-3 times weekly) with HCG.

* Use as directed by the registered physician

Subcutaneous or intramuscular injection. Administer slowly (to prevent pain and leakage). Alternate subcutaneous injection sites to prevent lipoatrophy. First injection should be performed under direct medical supervision.

If you miss a dose, consult your doctor. Do not double the dose.

Common Side Effects:

• Headache
• Vaginal bleeding
• Nausea
• Hot flashes
• Injection site reaction (bruising, pain, redness)
• Pelvic pain
• Ovarian hyperstimulation
• Breathing problems

Serious Side Effects: Ovarian hyperstimulation syndrome (OHSS), blood clots, stroke, ectopic pregnancy, multiple births.

Precautions:

• Exclude uncontrolled non-gonadal endocrinopathies (thyroid, adrenal or pituitary disorders).
• Increased risk of multiple gestations.
• Ovarian hyperstimulation (OHSS) - requires ultrasound and estradiol monitoring.
• Increased risk of ectopic pregnancy - early ultrasound confirmation important.
• In men, semen analysis is recommended 4 to 6 months after beginning treatment.

Contraindications:

• Tumours of the ovary, breast, uterus, pituitary or hypothalamus
• Pregnancy or lactation
• Undiagnosed vaginal bleeding
• Hypersensitivity
• Primary ovarian failure
• Fibroid tumors of the uterus incompatible with pregnancy
• Primary testicular failure

Drug Interactions: No drug/drug interaction studies have been conducted in humans.

Food Interactions: No interaction found/established.

Use in Pregnancy: Pregnancy Category X. Must not be used during pregnancy.

Use in Lactation: Must not be used during lactation.

Pediatric Use: Safety and efficacy in pediatric patients have not been established.

Geriatric Use: Safety and efficacy in postmenopausal women have not been established.

Renal & Hepatic Impairment: No known restrictions. However, consult your doctor.

Overdose: Too high a dosage may lead to ovarian hyperstimulation. No specific antidote. Give supportive care.

Storage: Store at 2°C to 8°C (in a refrigerator). Do not keep in deep freeze. Can be stored below 25°C for a maximum of 3 months. Protect from light and keep in dry place.

Follicle Stimulating Hormone Injection