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Follitropin alfa

AEMPS

Recombinant follicle-stimulating hormone (FSH)

ATC code: G03GA05

Brand names: Gonal-F, Gonal-F RFF Pen, Ovaleap, Bemfola

Updated · Methodology

Indications

A

Ovulation induction for assisted reproduction

First line

Stimulation of multiple follicular growth for IVF and ICSI in women. Per 2023 and SEGO 2024 – a standard option. Individualized dose: start 150–225 IU/day subcutaneously, adjust by ultrasound monitoring of follicle size and estradiol. Trigger with hCG or GnRH agonist when ≥3 follicles ≥17 mm. In men with hypogonadotropic hypogonadism and impaired spermatogenesis – 150 IU three times weekly combined with hCG for 4–12 months.

Sources

  1. AEMPS: Ficha técnica de Folitropina alfa (2024)
  2. ESHRE: ESHRE guideline: ovarian stimulation for IVF/ICSI (2019)

ICD-10: N97 · ICD-11: GA31

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Follitropin alfa is recombinant human FSH with amino-acid sequence identical to the endogenous hormone. Binds receptors on ovarian granulosa cells in women and Sertoli cells in men. In women stimulates follicular growth and maturation; in men supports spermatogenesis. Subcutaneous T½ 24 h (beta phase); steady state in 3–4 days of injections.

Safety

Contraindications

  • Hypersensitivity
  • Hypothalamic or pituitary tumors
  • Ovarian, uterine, or breast carcinoma
  • Undiagnosed gynecologic bleeding
  • Primary ovarian failure (elevated FSH)
  • Pregnancy and breastfeeding
  • Ovarian cysts or enlargement not due to PCOS

Serious adverse effects

  • Ovarian hyperstimulation syndrome (OHSS)
  • Venous and arterial thromboembolism
  • Ovarian torsion
  • Multiple pregnancy with obstetric risks
  • Ectopic pregnancy

Common adverse effects

  • Injection-site pain and bruising
  • Headache
  • Abdominal and pelvic pain
  • Nausea
  • Breast pain
  • Estrogenic effects (bloating, mood changes)

Pregnancy: can you take Follitropin alfa?

Not used in an already pregnant woman. After conception in IVF, therapy is stopped.

Breastfeeding: can you take Follitropin alfa?

Not indicated during breastfeeding. For repeat IVF programs, restart is possible after weaning.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Monitoring

Ovarian ultrasound every 2–3 days during stimulation; serum estradiol per clinic protocol. With ovarian hyperstimulation signs (>15 follicles ≥11 mm, estradiol >5000 pg/mL) – dose reduction or cycle cancellation. Subcutaneous injection into the abdomen, rotate sides.

Timing and administration

Each injection at the same time daily. Prefilled pens kept refrigerated; after first use, up to 28 days at room temperature.

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Frequently asked

What is Follitropin alfa used for?

Follitropin alfa is evaluated for the following indications with varying evidence strength: Ovulation induction for assisted reproduction (evidence tier A). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Follitropin alfa?

Common side effects of Follitropin alfa (≥ 1 in 100): Injection-site pain and bruising, Headache, Abdominal and pelvic pain, Nausea, Breast pain, Estrogenic effects (bloating, mood changes). See the Safety section for uncommon and serious reactions.

Is Follitropin alfa safe during pregnancy?

Not used in an already pregnant woman. After conception in IVF, therapy is stopped.

Is Follitropin alfa compatible with breastfeeding?

Not indicated during breastfeeding. For repeat IVF programs, restart is possible after weaning.

Who should not take Follitropin alfa?

Follitropin alfa is contraindicated in: Hypersensitivity; Hypothalamic or pituitary tumors; Ovarian, uterine, or breast carcinoma; Undiagnosed gynecologic bleeding; Primary ovarian failure (elevated FSH). Full list in the Safety section.

Official sources

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Other drugs in this group

Levonorgestrel, Medroxyprogesterone acetate depot, Mifepristone, Norelgestromin + Ethinylestradiol (transdermal patch), Norethisterone, Ulipristal acetate, Dydrogesterone, Ethinylestradiol + Desogestrel