Recombinant FSH
Pregnancy: There is no indication for use during pregnancy and it is not indicated during breastfeeding. Data on a limited number of exposed pregnancies (fewer than 300 outcomes) indicate no malformative or feto/neonatal toxicity, and no teratogenic effect was seen in animal studies, but clinical data are not sufficient to exclude a teratogenic effect in case of exposure during pregnancy.
Follitropin alfa
Brand names: Gonal-F, Bemfola, Ovaleap
A recombinant human follicle-stimulating hormone (follitropin alfa) used for ovarian stimulation in assisted reproduction and for ovulation induction and male hypogonadotrophic infertility.
Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.
Adult dose
Dose:75 to 150 IU FSH daily (starting dose in women with anovulation, including polycystic ovarian syndrome)
Route: Injection, as a course of daily injections (the fetched eMC posology extract is truncated before the method of administration section; the product is 'Bemfola 150 IU/0.25 ml solution for injection in pre-filled pen' and the US Gonal-f label in the same bundle specifies subcutaneous administration in the abdomen, upper arm or upper leg)
Frequency: Once daily; increase preferably by 37.5 or 75 IU at 7 or preferably 14-day intervals if necessary to obtain an adequate but not excessive response
Max: Anovulation: in cases of low response the daily dose should not exceed 225 IU FSH. Ovarian stimulation for multiple follicular development prior to IVF/ART: starting dose may be adjusted stepwise to not higher than 450 IU daily, and in cases of low response the daily dose should not exceed 450 IU FSH.
Treatment must be initiated under the supervision of a physician experienced in fertility disorders. Doses, regimens and monitoring should be individualised to optimise follicular development and minimise unwanted ovarian hyperstimulation. ANOVULATION (incl. PCOS): in menstruating women commence within the first 7 days of the menstrual cycle; registration-trial regimen commenced at 75-150 IU FSH daily. The starting dose can be adjusted stepwise (a) lower than 75 IU/day if an excessive ovarian response is anticipated from the patient's clinical profile (age, BMI, ovarian reserve), or (b) higher than 75 up to a maximum of 150 IU/day if a low ovarian response is anticipated. If an excessive response occurs, stop treatment, withhold hCG and recommence the next cycle at a lower dose. OVARIAN STIMULATION FOR IVF/ART: commonly 150 to 225 IU daily commencing on day 2 or 3 of the cycle; if excessive response is expected the starting dose may be decreased below 150 IU. May be given alone or, to prevent premature luteinisation, with a GnRH agonist or antagonist. SEVERE LH AND FSH DEFICIENCY: give as daily injections simultaneously with lutropin alfa; recommended regimen commences at 75 IU lutropin alfa daily with 75 to 150 IU FSH; if an FSH dose increase is appropriate, adapt preferably at 7 to 14-day intervals and preferably by 37.5 to 75 IU increments; it may be acceptable to extend stimulation in any one cycle to up to 5 weeks. If amenorrhoeic with low endogenous estrogen secretion, treatment can commence at any time. Luteal phase support may be considered. FINAL FOLLICULAR MATURATION (all female indications): when an optimal ovarian response is obtained, a single injection of 250 micrograms recombinant human choriogonadotropin alfa (r-hCG) or 5 000 IU up to 10 000 IU hCG is administered 24 to 48 hours after the last follitropin alfa injection; coitus is recommended on the day of and the day following hCG, or intrauterine insemination may be performed. Monitor response by follicle size and number on ultrasound and/or estrogen secretion. MEN WITH HYPOGONADOTROPHIC HYPOGONADISM: the fetched eMC extract is truncated mid-sentence ('Follitropin alfa should be given at a dose of ...') so the UK male dose is NOT available and must be sourced separately — for cross-reference only, the US Gonal-f label in the same bundle states that after serum testosterone is normalised with hCG pre-treatment, 150 International Units is given subcutaneously three times a week together with 1,000 USP units hCG three times a week. Patients must be provided with the correct number of pens and taught proper injection technique.
Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.
Contraindications
Hypersensitivity to the active substance or to any of the excipients
Tumours of the hypothalamus or pituitary gland
Ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin
Gynaecological haemorrhages of unknown origin
Ovarian, uterine or mammary carcinoma
Must not be used where an effective response cannot be obtained: primary ovarian failure; malformations of sexual organs incompatible with pregnancy; fibroid tumours of the uterus incompatible with pregnancy; primary testicular insufficiency
Thromboembolism, and mild to severe hypersensitivity reactions including anaphylaxis and shock (very rare)
Clinical monograph
How it works
As recombinant FSH it stimulates ovarian follicular growth via FSH receptors on granulosa cells, and supports spermatogenesis in men.
Prescribing in practice
Ovarian hyperstimulation syndrome is the principal serious risk and mandates specialist supervision with response monitoring.
Multiple pregnancy and, less commonly, thromboembolic events are increased risks during stimulation cycles.
Administered by subcutaneous injection, often via pre-filled pen; exclude pituitary/ovarian tumours and untreated endocrine disease first.
Monitoring
Track follicular development with ultrasound and serum oestradiol to titrate dose and minimise hyperstimulation.
Counselling the patient
If self-injecting, follow the pen instructions on technique and storage.
Report abdominal pain, bloating, breathlessness or reduced urine output urgently.
Be aware of the increased chance of multiple pregnancy.
Evidence & guidelines
Recombinant FSH is an established gonadotrophin option within NICE-recommended assisted reproduction pathways.
Reference: NICE CG156; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing.
The structured dose values shown have been reviewed by a clinician.
Monograph status: clinician-reviewed (2026-07-04).
Related
Curated clinical cross-links plus same-class fallbacks.