Product image of Gonal-F (Follitropin Alfa) supplied by GNH India

Gonal-F

Active Ingredient:
Follitropin Alfa
Origin:
EU

Gonal-F (Follitropin Alfa)

Gonal‑F contains the active ingredient follitropin alfa, a recombinant follicle‑stimulating hormone supplied as a solution for subcutaneous injection. It is a prescription medication marketed in the European Union and is used in fertility treatment protocols. The product is supplied in a vial or pen, with strength varying by formulation, and belongs to the gonadotropin class. It is indicated for women with specific reproductive endocrine disorders and is administered under medical supervision.

Manufacturer / TM Owner

Merck Europe B.V.

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Indications & Clinical Uses

Gonal‑F is prescribed for several fertility‑related conditions where stimulation of ovarian follicle development is required.

  • Anovulatory infertility, such as in polycystic ovary syndrome, to induce ovulation.
  • Controlled ovarian stimulation in assisted reproductive technology (ART) procedures, including in vitro fertilisation.
  • Treatment of hypogonadotropic hypogonadism to restore normal gonadal function.
  • Preparation of the endometrium for embryo transfer in selected protocols.
  • Adjunct therapy in donor‑egg cycles to optimise follicular response.

Side Effects

The safety profile of Gonal‑F includes a range of observed adverse reactions, which are generally classified by frequency.

Common

  • Injection‑site reactions such as redness, swelling, or mild pain.
  • Headache or mild dizziness.
  • Nausea, abdominal discomfort, or bloating.
  • Mild ovarian enlargement with multiple follicular cysts.

Serious

  • Ovarian hyperstimulation syndrome (OHSS), which can be moderate to severe.
  • Multiple pregnancy (twins or higher order).
  • Thromboembolic events, including deep‑vein thrombosis or pulmonary embolism.

Precautions & Warnings

Before initiating Gonal‑F therapy, clinicians should evaluate patient history and monitor specific parameters to minimise risks.

  • Confirm diagnosis of infertility and rule out contraindications such as ovarian cysts or malignancy.
  • Perform baseline ultrasound and hormone assessments to guide dosing.
  • Monitor follicular growth regularly to detect excessive response.
  • Adjust dose or discontinue if signs of ovarian hyperstimulation appear.
  • Counsel patients on the increased likelihood of multiple gestations.
  • Advise against use in uncontrolled thyroid disease or uncontrolled diabetes.
  • Ensure pregnancy testing before starting treatment.

Avoid Interactions

Gonal‑F may interact with other medications or substances that affect ovarian response or coagulation pathways.

Avoid

  • Concurrent use of other gonadotropins or high‑dose estrogen preparations without specialist guidance.
  • Medications that significantly increase the risk of thrombosis, such as hormonal contraceptives containing estrogen.

Use with caution

  • Anticoagulant therapy (e.g., warfarin, direct oral anticoagulants) – monitor coagulation status.
  • Thyroid hormone replacement – adjust dose based on thyroid function tests.
  • Insulin or oral hypoglycaemic agents – monitor glucose control during treatment.
  • Aromatase inhibitors – may alter estrogen feedback and require dose adjustment.

Frequently Asked Questions

Gonal‑F contains recombinant follicle‑stimulating hormone (FSH) that binds to FSH receptors on ovarian granulosa cells, promoting follicular growth, estrogen production, and eventual ovulation.

It is prescribed for women with anovulatory infertility, hypogonadotropic hypogonadism, or those undergoing controlled ovarian stimulation for assisted reproductive technologies such as IVF.

Gonal‑F is given as a subcutaneous injection, usually in a clinical setting or under home‑care guidance, following a dosing schedule determined by the treating physician.

Regular transvaginal ultrasounds and serum hormone measurements are performed to assess follicular development and to detect early signs of ovarian hyperstimulation.

Yes, OHSS is a recognized serious adverse effect; clinicians monitor patients closely and may adjust the dose or discontinue treatment if excessive ovarian response occurs.

Because Gonal‑F stimulates the development of multiple follicles, there is a higher chance of twins or higher‑order multiples, and patients should be counseled about this risk.

Patients may experience mild redness, swelling, bruising, or pain at the injection site, which are usually transient.

Combination with other gonadotropins or high‑dose estrogen preparations should only be done under specialist supervision to avoid excessive ovarian stimulation.

Contraindications include known ovarian cysts, active malignancy, uncontrolled thyroid disease, and severe uncontrolled diabetes.

Patients should contact their healthcare provider immediately; symptoms such as rapid weight gain, abdominal pain, or shortness of breath may indicate OHSS and require prompt evaluation.

Gonal‑F is primarily indicated for female reproductive disorders; its use in men is off‑label and should only be considered under specialist guidance.

All recombinant FSH products contain the same active protein, but they may differ in formulation, vial size, and specific manufacturing processes; clinical efficacy is comparable when dosed appropriately.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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