Follitropin Alfa

Introduction: Follitropin alfa is a human FSH preparation of recombinant DNA origin. It stimulates ovarian follicular growth in women who do not have primary ovarian failure and stimulates spermatogenesis in men with hypogonadotrophic hypogonadism.

How it works: Follitropin alfa stimulates ovarian follicular growth. For final follicle maturation and ovulation, hCG must be given. It stimulates spermatogenesis in men when administered with hCG.

Important Information: Dosing must be individualized. The initial starting dose for the first cycle is fixed and adjusted based on response. Be aware of the risk of ovarian hyperstimulation syndrome (OHSS).

• 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.

Drugs for Infertility

Recombinant FSH

Follitropin alfa is a human FSH preparation of recombinant DNA origin. It stimulates ovarian follicular growth in women who do not have primary ovarian failure. To bring about final maturation of the follicle and ovulation, hCG must be given. Follitropin Alfa stimulates spermatogenesis in men with hypogonadotropic hypogonadism when administered with hCG.

Follitropin alfa stimulates the growth and maturation of ovarian follicles. In men, it stimulates spermatogenesis in combination with hCG.

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

Subcutaneous injection. First injection should be performed under direct medical supervision. Powder should be reconstituted immediately prior to use with the solvent provided. Self-administration only for adequately trained patients.

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

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.

Contraindications:

• Hypersensitivity to recombinant FSH products or excipients
• High FSH levels indicating primary gonadal failure
• Uncontrolled non-gonadal endocrinopathies
• Sex hormone dependent tumors of the reproductive tract
• Tumors of pituitary gland or hypothalamus
• In women: abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement of undetermined origin

Drug Interactions:

• Other ovulation stimulating agents (e.g., hCG, clomiphene citrate) may potentiate the follicular response.
• Concurrent use of GnRH agonist-induced pituitary desensitisation may increase the dosage needed for adequate ovarian response.

Food Interactions: No interaction found/established.

Use in Pregnancy: Not indicated in pregnant women. The incidence of congenital malformations after some ART may be slightly higher than spontaneous conception.

Use in Lactation: No data on presence in human milk. Secretion of prolactin during lactation can result in inadequate response to ovarian stimulation; advise women not to breast feed during treatment.

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

Geriatric Use: Safety and effectiveness in postmenopausal women have not been established and it is not indicated in this population.

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: Lyophilized Multi-Dose vials may be stored refrigerated or at room temperature (2°-25°C).

Follitropin Alfa Injection