Educational reference

Peptide library

RFSH (Follitropin)

Your guide to this compound.

Mechanism illustrationEnlarge
RFSH (Follitropin): Medical scientific diagram. Open full size to read labels; evidence and limitations appear in the profile.
Educational illustration · Read the evidence and limitations below.

Evidence in perspective

The named U.S. product label is the appropriate source for its approved use, contraindications and handling. GONAL-f subcutaneous follitropin alfa: terminal half-life was about 24 hours in healthy down-regulated women, 32 hours in IVF/embryo-transfer patients, and 32–41 hours in healthy men depending on repeated versus single dosing. Absorption affects the observed elimination rate; one generic value would obscure these differences. A label extraction is not an independent appraisal of every supporting trial or approval of other products with the same ingredient.

About this assessment

Named U.S. product label sections assessed.

Product-specific editorial extraction. Complete clinical review and clinician sign-off remain pending; other jurisdictions are not inferred.

Editorial assessment · 2026-09-07

Source 1 · dailymed.nlm.nih.gov

Who was studied

The population specified by this product label; other indications and jurisdictions remain outside this check.

What the sources found

Selected infertility indications in women and men, with specialist assessment and monitoring.

Regulatory scope

U.S. label record for BLA020378. This does not confer authorization on other products using the ingredient name.

What remains unknown

Named-product label sections were expanded for pharmacokinetics, contraindications and selected handling or interaction details on September 7, 2026. This is not a complete trial-program appraisal or clinician sign-off. Other formulations, patient-specific decisions and other jurisdictions require separate assessment.

How it works

GONAL-f follitropin alfa multidose powder vials

Consult the product label for pharmacology. A mechanism does not extend its approved indications.

Approved product exists

Approval applies to a particular product and indication. It does not extend to every use, route, compounded preparation or research vial sold under the same compound name. Check the current prescribing information.

Understanding the evidence

Reported adverse effects

  • Ovarian hyperstimulation, vascular complications and serious hypersensitivity are important warnings.

Named U.S. presentation only; selected label sections.

Source · Warnings and precautions / boxed warning

Contraindications

  • GONAL-f: recombinant FSH/excipient hypersensitivity; primary gonadal failure; uncontrolled non-gonadal endocrine disorders; sex-hormone-dependent or hypothalamic/pituitary tumors. In women: unexplained uterine bleeding or ovarian cyst/enlargement.

Approved product exists

Approval applies to a particular product and indication. It does not extend to every use, route, compounded preparation or research vial sold under the same compound name. Check the current prescribing information.

Understanding the evidence

Sources used for this snapshot

Source 1 · dailymed.nlm.nih.gov

Claim-by-claim evidence

Benefits

Selected infertility indications in women and men, with specialist assessment and monitoring.

Named U.S. presentation only; selected label sections.

Indications and usage

Adverseeffects

Ovarian hyperstimulation, vascular complications and serious hypersensitivity are important warnings.

Named U.S. presentation only; selected label sections.

Warnings and precautions / boxed warning

Storage

These GONAL-f vials: 2–8°C or 20–25°C; protect from light. Reconstituted solution: same ranges, discard unused portion after 28 days. Pen instructions are separate.

Named U.S. presentation only; selected label sections.

How supplied / storage and handling; instructions for use

Pharmacokinetics

GONAL-f subcutaneous follitropin alfa: terminal half-life was about 24 hours in healthy down-regulated women, 32 hours in IVF/embryo-transfer patients, and 32–41 hours in healthy men depending on repeated versus single dosing. Absorption affects the observed elimination rate; one generic value would obscure these differences.

Named U.S. product only; label revision 20250902. Educational extraction, not complete clinical review.

Clinical Pharmacology / 12.3

Contraindications

GONAL-f: recombinant FSH/excipient hypersensitivity; primary gonadal failure; uncontrolled non-gonadal endocrine disorders; sex-hormone-dependent or hypothalamic/pituitary tumors. In women: unexplained uterine bleeding or ovarian cyst/enlargement.

Named U.S. product only; label revision 20250902. Educational extraction, not complete clinical review.

Contraindications / 4; warnings / 5 where distinguished

References

  1. GONAL-f follitropin alfa multidose powder vials. U.S. structured product label, effective 20250902. Selected sections only.

    Open

Catalog review date: Sep 7, 2026. This date alone does not establish independent clinical review.

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