Follitropin
Also known as: Bravelle, Follistim, follitropin alfa/beta/delta, FSH, Gonal-F, Gonal‑F, Puregon, recombinant human FSH, Rekovelle, rFSH
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Summary
Recombinant human follicle‑stimulating hormone (rFSH) used to treat infertility in women undergoing assisted reproductive technology and to stimulate spermatogenesis in men with hypogonadotropic hypogonadism.
Mechanism of Action
Binds the FSH receptor on ovarian granulosa cells and testicular Sertoli cells, activating Gs‑protein signaling to stimulate follicular development, estradiol production, and spermatogenesis.
Routes of Administration
Goals & Uses
- Male infertility (hypogonadotropic hypogonadism)ReproductiveModerate
- Ovulation induction in anovulatory womenReproductive EndocrinologyHigh
- Treatment of male infertility due to hypogonadotropic hypogonadismMale Reproductive HealthHigh
- Female infertility (ovulation induction)ReproductiveHigh
- Controlled ovarian stimulation for ARTReproductive EndocrinologyHigh
- Stimulation of spermatogenesisMale Reproductive HealthModerate
Contraindications
- Hormone-sensitive tumors (ovarian, uterine, breast, pituitary)OncologyHigh
- Severe ovarian hyperstimulation syndrome (OHSS) riskReproductiveHigh
- Uncontrolled thyroid diseaseEndocrineModerate
- Known hypersensitivity to FSH or any excipientAllergyHigh
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Hormone‑dependent tumors (e.g., estrogen‑dependent breast cancer)OncologyHigh
- Primary ovarian failure / hypergonadotropic hypogonadismEndocrineHigh
- Uncontrolled thyroid or adrenal dysfunctionEndocrinologyHigh
- Ovarian cysts or enlargement of undetermined originGynecologicHigh
- Hypersensitivity to FSH or excipientsImmunologicHigh
Adverse Effects
- Abdominal discomfortGastrointestinalUncommon
- Injection site reactionsLocalCommon
- Multiple gestationReproductiveUncommon
- HeadacheNeurologicUncommonPain in the head or upper neck
- Ovarian hyperstimulation syndromeReproductive / EndocrineCommon
- Thromboembolic eventsCardiovascularRare
- Ovarian torsionReproductiveRare
- Multiple pregnancyReproductiveUncommon
- Injection‑site reactionsLocalCommon
- Ovarian hyperstimulation syndrome (OHSS)ReproductiveUncommon
Drug Interactions
- Anticoagulants (e.g., warfarin)Low
- Oral contraceptivesModerateDelayed gastric emptying may affect absorption timing
- Human Chorionic Gonadotropin (hCG)Low
- GnRH antagonists (e.g., cetrorelix, ganirelix)Low
- GnRH agonists/antagonistsModerate
- Clomiphene citrateLow
- GnRH agonists (e.g., leuprolide)Low
Population Constraints
- Pediatric patientsAgeAbsolute
- Patients with thrombophiliaHematologicRelative
- Women of advanced reproductive age (>40 years)AgeRelative
- Pregnant womenReproductiveAbsolute
- Elderly (>65)AgeRelative
- Patients with polycystic ovary syndrome (PCOS)EndocrineRelative
- ChildrenPediatricRelative
- Renal or hepatic impairmentOrgan DysfunctionRelative
Regulatory Status
- European UnionApprovedApproved: same as USEMA‑approved biosimilars available.
- United StatesApprovedApproved: female infertility (ovulation induction, IVF), male infertility (hypogonadotropic hypogonadism)Multiple brand products (Gonal‑F, Follistim).
- United KingdomApprovedApproved: same as USRegulated by MHRA.
Approved as several biosimilar products; indications vary slightly between jurisdictions.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Follitropin?
Recombinant human follicle‑stimulating hormone (rFSH) used to treat infertility in women undergoing assisted reproductive technology and to stimulate spermatogenesis in men with hypogonadotropic hypogonadism.
What is Follitropin used for?
Follitropin is educationally associated with: Male infertility (hypogonadotropic hypogonadism), Ovulation induction in anovulatory women, Treatment of male infertility due to hypogonadotropic hypogonadism, Female infertility (ovulation induction), Controlled ovarian stimulation for ART, Stimulation of spermatogenesis. Educational only — not medical advice.
How is Follitropin administered?
Recorded routes of administration: Intramuscular, Subcutaneous.
What are the potential side effects of Follitropin?
Reported adverse effects include: Abdominal discomfort, Injection site reactions, Multiple gestation, Headache, Ovarian hyperstimulation syndrome, Thromboembolic events, Ovarian torsion, Multiple pregnancy, Injection‑site reactions, Ovarian hyperstimulation syndrome (OHSS). This list is not exhaustive — consult a qualified clinician.
Who should avoid Follitropin?
Recorded contraindications: Hormone-sensitive tumors (ovarian, uterine, breast, pituitary), Severe ovarian hyperstimulation syndrome (OHSS) risk, Uncontrolled thyroid disease, Known hypersensitivity to FSH or any excipient, Pregnancy, Hormone‑dependent tumors (e.g., estrogen‑dependent breast cancer), Primary ovarian failure / hypergonadotropic hypogonadism, Uncontrolled thyroid or adrenal dysfunction, Ovarian cysts or enlargement of undetermined origin, Hypersensitivity to FSH or excipients. Consult a qualified clinician before use.