Follifactor75 IU/vial

Follifactor is a purified urinary gonadotropin preparation used in fertility management. Its approved and guideline-supported uses are:

• Ovulation induction in women with anovulatory infertility who have not responded to clomiphene citrate, after primary ovarian failure has been excluded (established use).
• Controlled ovarian stimulation (superovulation) for assisted reproductive technology (ART) cycles such as IVF, typically combined with human chorionic gonadotropin (hCG) for final oocyte maturation (established use, requires specialist reproductive endocrinology supervision).
• Induction of spermatogenesis in men with hypogonadotropic hypogonadism, used in combination with hCG (established use; adjunct/combination therapy required, as Follifactor alone does not restore spermatogenesis without adequate intratesticular testosterone from hCG).

Follifactor is not indicated for use in patients with primary ovarian or testicular failure, as it cannot substitute for functioning gonadal tissue.

Each vial of Follicle Stimulating Hormone [Urofollitropin] contains purified follicle-stimulating hormone (urofollitropin) extracted and purified from the urine of postmenopausal women, supplied as a lyophilized powder for reconstitution and injection, standardized in International Units (IU) of FSH bioactivity.

Follifactor is a urinary-derived gonadotropin hormone preparation. It consists of FSH purified from the urine of postmenopausal women (urofollitropin), with the luteinizing hormone (LH) activity largely removed during purification. It is administered by injection under specialist supervision to stimulate ovarian follicular development in women or testicular spermatogenesis in men whose own gonadotropin production is inadequate.

Gonadotropin; fertility-enhancing hormone preparation (Follicle Stimulating Hormone class).

Follicle Stimulating Hormone [Urofollitropin] exerts its pharmacological effect by binding to FSH receptors on ovarian granulosa cells (in women) and Sertoli cells (in men).

• In women, it stimulates the growth and maturation of ovarian follicles and increases estradiol production; when follicles reach an adequate size, hCG is typically given to trigger final oocyte maturation and ovulation.
• In men, it stimulates Sertoli cell function to support spermatogenesis, generally in conjunction with hCG, which stimulates Leydig cells to produce intratesticular testosterone.

Because Follicle Stimulating Hormone [Urofollitropin] is purified from urine, trace amounts of other urinary proteins may be present in small quantities compared with recombinant FSH products.

Follifactor is administered by subcutaneous or intramuscular injection, generally self-administered at home after proper training or given in a clinic. Injection sites should be rotated. Patients must attend scheduled visits for transvaginal ultrasound and blood hormone monitoring throughout treatment, as dose adjustments and timing of the hCG trigger injection depend on this monitoring. Follifactor should never be self-adjusted by the patient without physician guidance.

No clinically significant pharmacokinetic drug-drug interaction studies have established major interactions for Follifactor. It is commonly and intentionally used together with clomiphene citrate or hCG as part of combination fertility protocols under specialist supervision. Concurrent use with other fertility-enhancing agents should only occur under direct medical supervision, as combined gonadotropic stimulation increases the risk of ovarian hyperstimulation syndrome (see Precautions and Warnings).

Common and serious adverse effects reported with Follifactor include:

• Injection site pain, redness, bruising or swelling.
• Headache, mood swings, fatigue.
• Abdominal pain, bloating, nausea, and ovarian enlargement.
• Ovarian hyperstimulation syndrome (OHSS) - a potentially life-threatening condition marked by ovarian enlargement, abdominal pain/distension, fluid shifts, and in severe cases ascites, pleural effusion, thromboembolism, and renal impairment; see Precautions and Warnings.
• Multiple pregnancy (twins or higher-order multiples).
• Ectopic pregnancy.
• Rarely, hypersensitivity/allergic reactions.

Follifactor is contraindicated in pregnancy; it has no indication once pregnancy is confirmed and must be discontinued immediately if pregnancy occurs during treatment. There is no indication for use of Follifactor during breastfeeding; because it is used specifically to achieve pregnancy in non-pregnant, non-lactating patients, breastfeeding women should not receive this medicine. Any use should occur only under the direct supervision of a fertility specialist, and patients should consult their physician immediately if pregnancy is suspected.

Follifactor requires close specialist reproductive-endocrinology monitoring (serial ultrasound and serum estradiol) throughout each treatment cycle; it should never be self-titrated by patients.

• Ovarian hyperstimulation syndrome (OHSS): a potentially life-threatening complication; risk increases with higher doses and higher estradiol levels. Warning signs (severe abdominal pain, rapid weight gain, marked abdominal distension, shortness of breath, decreased urination) require immediate medical attention.
• Multiple pregnancy: the risk of twin or higher-order multiple pregnancy is significantly increased with gonadotropin therapy, with attendant maternal and perinatal risks.
• Thromboembolism: gonadotropin therapy, particularly with OHSS, is associated with an increased risk of venous thromboembolic events.
• Pulmonary and vascular complications have been reported in association with severe OHSS.
• Pretreatment evaluation for infertility causes and exclusion of pregnancy, primary ovarian failure, and reproductive tract tumors is required before starting therapy.

Overdose of Follifactor can precipitate or worsen ovarian hyperstimulation syndrome (OHSS), causing severe abdominal pain, distension, nausea, vomiting, rapid weight gain, breathing difficulty, or reduced urination. If overdose is suspected or these symptoms occur, seek immediate medical attention or contact emergency services; do not attempt to manage severe symptoms at home.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children. Do not freeze. Once reconstituted, use the solution immediately as directed by the pharmacist or physician, and discard any unused portion.

Renal/hepatic impairment: well-established dosing adjustments for renal or hepatic impairment have not been established for Follifactor; use with caution and close monitoring if such impairment is present.

Elderly: not applicable, as Follifactor is used only in patients of reproductive age.

Pediatric: safety and efficacy in children have not been established; see Pediatric Uses.

Duration of Follifactor therapy is individualized. In women, a single stimulation cycle typically lasts about 7-12 days depending on ovarian response, followed by an hCG trigger. In men undergoing spermatogenesis induction, treatment is prolonged, commonly 3-12 months or longer, since spermatogenesis takes several months to occur.

Follifactor is supplied as a lyophilized powder that must be reconstituted before use. Reconstitute using the accompanying diluent (typically sterile water or bacteriostatic water for injection as supplied), gently swirling the vial to dissolve the powder completely without vigorous shaking (to avoid protein denaturation). Multiple vials may be reconstituted together with the same diluent if a higher dose is required, per physician instructions. Use the reconstituted solution immediately; do not store for later use unless the product labeling specifically states otherwise.

Gonadotropins; fertility agents; ovulation stimulants.

Follicle Stimulating Hormone [Urofollitropin] binds to FSH receptors on ovarian granulosa cells and testicular Sertoli cells, mimicking the action of endogenous pituitary FSH. In women this drives follicular recruitment, growth, and estradiol production; in men it supports Sertoli cell function needed for spermatogenesis, generally alongside hCG-driven Leydig cell testosterone production.

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Follifactor is not indicated for use in children. It is used exclusively in adults of reproductive age for fertility indications; safety and efficacy in the pediatric population have not been established.