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At a glance

Follitropin Alfa is a recombinant FSH preparation used for ovulation induction in women and spermatogenesis stimulation in men.

Indications
  • 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.
Pharmacology

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.

Dosage

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

Side effects

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.

Use in pregnancy

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

Pregnancy Category: X — always consult a doctor before taking during pregnancy.

Precautions & warnings

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.
Overdose effects

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

Storage conditions

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

Follitropin Alfa — see the full informationPharmacology, precautions, pregnancy, overdose and the rest on the generic page
⚠️ This information is for educational purposes only — not a substitute for medical advice. Consult a registered physician before taking any medicine.