FSH150 IU/vial

FSH is a gonadotropin preparation used in the management of infertility. Its approved and guideline-supported uses include:

• Female anovulatory infertility (established use): Induction of ovulation in women with anovulation (e.g., WHO Group I/II anovulation) who have not responded to, or are not candidates for, first-line agents such as clomiphene citrate.
• Controlled ovarian stimulation for Assisted Reproductive Technology (established use, combination therapy): Development of multiple follicles as part of an assisted reproductive technology (ART) program such as in vitro fertilization (IVF), used together with a GnRH agonist/antagonist and, subsequently, human chorionic gonadotropin (hCG) as the ovulation trigger.
• Male infertility due to hypogonadotropic hypogonadism (established use, adjunct/combination therapy): Used together with hCG (which provides LH-like activity) to stimulate spermatogenesis in men with hypogonadotropic hypogonadism.

Treatment with FSH must be initiated and supervised by a physician experienced in the management of fertility disorders, with facilities for hormonal and ultrasound monitoring.

Each vial/pre-filled pen of Follicle Stimulating Hormone contains purified or recombinant follicle-stimulating hormone as the active ingredient, supplied as a lyophilized powder for reconstitution or as a ready-to-use injectable solution, depending on the brand and formulation.

FSH is a gonadotropin hormone preparation (available as a highly purified urinary-derived product or as a recombinant DNA-derived product) used to stimulate the ovaries in women and the testes in men. It replicates the action of the naturally occurring pituitary hormone that regulates follicular development and spermatogenesis.

It is administered exclusively by injection (subcutaneous or intramuscular) under medical supervision and is not available as an oral formulation.

FSH belongs to the therapeutic class of gonadotropins / reproductive hormones, used specifically as an ovulation-stimulating and spermatogenesis-stimulating agent.

Mechanism

Follicle Stimulating Hormone binds to FSH receptors located on ovarian granulosa cells in women and on testicular Sertoli cells in men.

• In women: it stimulates the growth and maturation of ovarian follicles and promotes granulosa cell production of estradiol, leading to follicular development suitable for ovulation induction or oocyte retrieval.
• In men: it acts on Sertoli cells to support spermatogenesis; when combined with hCG (which supplies LH-like activity to Leydig cells), it promotes testosterone-dependent spermatogenic function in men with hypogonadotropic hypogonadism.

Pharmacokinetics

Following subcutaneous or intramuscular injection, Follicle Stimulating Hormone is absorbed with a bioavailability of roughly 70-80%, reaches peak serum concentration within 12-24 hours, and has an elimination half-life of approximately 24-40 hours, allowing once-daily dosing during a treatment cycle.

FSH is given by subcutaneous or intramuscular injection only, never orally. Powder formulations must be reconstituted with the accompanying diluent immediately before use (see Reconstitution). Patients or caregivers may be trained by a healthcare professional to self-administer subcutaneous injections at home, using a fresh injection site each time to reduce local reactions. Pre-filled pen formulations should be used strictly according to the device instructions.

No clinically significant drug-metabolism-based interactions have been well established for FSH, as it is a peptide hormone that is not metabolized via cytochrome P450 pathways.

• Intentional combination therapy: FSH is commonly and deliberately co-administered with clomiphene citrate, human chorionic gonadotropin (hCG), and GnRH agonists/antagonists as part of a structured fertility treatment protocol; this is expected combination use, not an adverse interaction.
• Other fertility medicines: concurrent use of other ovulation-inducing agents outside a physician-directed protocol may increase the risk of ovarian hyperstimulation syndrome (OHSS) and multiple follicular development; see Precautions and Warnings.

Common and important adverse effects reported with FSH include:

• Ovarian hyperstimulation syndrome (OHSS): a potentially serious complication in women involving ovarian enlargement, abdominal pain/distension, nausea, and in severe cases fluid shifts, ascites, and thromboembolic risk; see Precautions and Warnings.
• Injection site reactions (pain, redness, bruising, swelling).
• Headache, fatigue, mood changes.
• Abdominal pain, bloating, nausea, vomiting.
• Ovarian cyst formation.
• Multiple pregnancy (twins or more) due to multi-follicular development.
• In men: gynecomastia, acne, and injection site reactions.
• Rare: thromboembolic events, ectopic pregnancy (related to underlying tubal disease in the treated population), and hypersensitivity reactions.

FSH is not indicated for use during an established pregnancy and should be discontinued once pregnancy is confirmed; it has no therapeutic role after conception and continued use should only occur under direct specialist guidance if ever considered. If pregnancy occurs during a treatment cycle, the treating physician must be informed immediately.

There is limited data on the presence of FSH in human breast milk. As a large peptide hormone it is unlikely to be clinically significant if present, but it should be used during breastfeeding only if clearly needed and if the potential benefit justifies the potential risk, and only under medical supervision, since it is not typically indicated in the postpartum/lactation period outside specific fertility contexts.

Ovarian Hyperstimulation Syndrome (OHSS)

Treatment with FSH carries a risk of OHSS, which can be serious or life-threatening. Regular monitoring with transvaginal ultrasound and serum estradiol levels is required throughout treatment, and the hCG trigger dose should be withheld if excessive ovarian response is detected.

Multiple Pregnancy

Because FSH can stimulate development of multiple follicles, the risk of multiple gestation (twins or more) is increased compared with natural conception; this carries added maternal and perinatal risk.

Specialist Monitoring

Treatment with FSH must only be carried out by, or under the close supervision of, a physician experienced in fertility treatment, with access to appropriate hormonal assay and ultrasound monitoring facilities.

Thromboembolism

Gonadotropin therapy, including FSH, has been associated rarely with thromboembolic events, particularly in women with additional risk factors.

Pulmonary and Vascular Complications

Rare reports of pulmonary complications and torsion of the ovary have occurred in association with gonadotropin therapy including FSH; sudden severe abdominal pain during treatment should be evaluated promptly.

Overdose of FSH may increase the risk of ovarian hyperstimulation syndrome (OHSS) in women. There is no specific antidote. In the event of a suspected overdose, patients should seek immediate medical attention or contact emergency services / a poison control center; treatment is supportive and directed at managing OHSS or other symptoms under specialist care.

Store in a refrigerator (2°C-8°C); do not freeze. Protect from light. Once reconstituted, use only within the time period specified on the product label and discard any unused solution. Keep out of reach of children. If a room-temperature-stable formulation is dispensed, follow the specific storage instructions provided with that product.

Pediatric use: FSH is not indicated for use in children; safety and efficacy in the pediatric population have not been established.

Elderly: FSH is used in reproductive-age adults; it is not indicated in elderly patients as it falls outside the approved population for fertility treatment.

Renal or hepatic impairment: Specific dose adjustment data are not well established; use with caution and under close specialist supervision if used at all in patients with significant renal or hepatic impairment.

The duration of a single stimulation cycle with FSH for ovulation induction or controlled ovarian stimulation is typically 7-14 days, ending once follicles reach the target size and the hCG trigger is given. For male hypogonadotropic hypogonadism, treatment with FSH combined with hCG is generally continued for a minimum of 3-4 months, and may be extended up to 12-18 months, before spermatogenic response can be fully assessed. The total number of treatment cycles/duration should be determined by the treating fertility specialist.

Lyophilized (powder) formulations of FSH must be reconstituted immediately before use with the diluent (typically sterile water for injection) supplied in the pack. Gently swirl (do not shake vigorously) until the powder is fully dissolved into a clear solution. Use the reconstituted solution immediately and discard any unused portion unless the product labeling specifically states an extended in-use storage period. Pre-filled liquid pen formulations of FSH do not require reconstitution.

Follicle Stimulating Hormone is classified under: Gonadotropins; Reproductive/fertility hormones; Follicle-stimulating hormone (FSH) preparations.

Follicle Stimulating Hormone acts by binding to FSH receptors on ovarian granulosa cells (in women) and testicular Sertoli cells (in men), stimulating intracellular signaling that drives follicular growth, granulosa cell estradiol synthesis, and oocyte maturation in women, and supports Sertoli cell function necessary for spermatogenesis in men, particularly when combined with hCG-driven Leydig cell testosterone production.

X (legacy FDA pregnancy category: contraindicated in pregnancy - not indicated for use once pregnancy is confirmed)

FSH is not approved for use in the pediatric population. Safety and efficacy of FSH in children have not been established, and it should not be used in this age group outside of specialist investigational settings.