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 is a prescription medication that contains the recombinant follicle‑stimulating hormone follitropin alfa. It is supplied as a sterile solution for subcutaneous injection. The product is marketed in the European Union and is used in fertility treatment protocols. As a recombinant form of FSH, Gonal‑F mimics the natural hormone to support ovarian follicle development and ovulation in women undergoing assisted reproductive care.

Manufacturer / TM Owner

Merck Europe B.V.

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Indications & Clinical Uses

Gonal‑F is indicated for several reproductive‑health conditions where stimulation of follicular growth is required.

  • Treatment of infertility caused by anovulation, such as in polycystic ovary syndrome, by promoting follicle growth.
  • Controlled ovarian stimulation for assisted reproductive technologies, including in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), to obtain multiple mature oocytes.
  • Ovulation induction in women with hypogonadotropic hypogonadism, helping to restore normal menstrual cycles and improve chances of conception.
  • Use in combination with luteinising hormone (LH) preparations for certain stimulation protocols, enhancing follicular response and luteal phase support.
  • Support of follicular development in donor egg cycles, facilitating the retrieval of high‑quality oocytes for donation programmes.

Side Effects

The safety profile of Gonal‑F includes a range of observed adverse events that vary in frequency and severity.

Common

  • Injection‑site reactions such as redness, swelling, or mild pain at the administration site.
  • Headache or mild dizziness that may occur during the stimulation cycle.
  • Abdominal discomfort, bloating, or mild nausea often reported in early treatment weeks.
  • Mild ovarian hyperstimulation symptoms, including mild pelvic pain and transient weight gain.
  • Nausea or vomiting, generally mild and self‑limiting.

Serious

  • Ovarian hyperstimulation syndrome (OHSS) presenting with rapid weight gain, abdominal distension, ascites, or shortness of breath, requiring medical attention.
  • Multiple pregnancy (twins or higher‑order gestations) increasing obstetric risk for both mother and fetuses.
  • Severe allergic reactions such as rash, itching, swelling, or anaphylaxis that may necessitate emergency care.

Precautions & Warnings

Before initiating Gonal‑F therapy, clinicians should evaluate patient history and monitor specific risk factors.

  • Assess for ovarian cysts, endometriosis, or uterine abnormalities that may increase complication risk.
  • Perform baseline transvaginal ultrasound to determine ovarian size and follicle count prior to stimulation.
  • Monitor serum estradiol levels and follicular development regularly throughout the treatment cycle.
  • Adjust dose or discontinue therapy if signs of moderate to severe ovarian hyperstimulation appear.
  • Counsel patients on the increased likelihood of multiple gestations and associated obstetric risks.
  • Avoid use in patients with known hypersensitivity to any component of the formulation.

Avoid Interactions

Gonal‑F may interact with other medications or substances that affect ovarian response or hormone metabolism.

Avoid

  • Concurrent use of high‑dose gonadotropins or other FSH preparations without specialist guidance.
  • Use with medications that significantly increase estrogen levels, such as high‑dose oral contraceptives, during stimulation cycles.
  • Avoid simultaneous use of aromatase inhibitors that may alter estrogen synthesis during treatment.

Use with caution

  • Co‑administration of clomiphene citrate or letrozole, which also influence follicular development.
  • Use alongside anticoagulants, as OHSS may increase thrombotic risk.
  • Concomitant use of corticosteroids, which can affect hormone levels and response to stimulation.
  • Use with caution when prescribing thyroid hormone replacement, as thyroid status can influence ovarian response.

Frequently Asked Questions

Gonal-F contains follitropin alfa, a recombinant follicle‑stimulating hormone that binds to FSH receptors on ovarian granulosa cells, stimulating follicular development and estrogen production, which promotes folliculogenesis and ovulation.

Gonal-F is supplied as a sterile solution for subcutaneous injection. The dose and timing are individualized by the treating specialist and are usually given once daily during the ovarian stimulation phase.

Gonal-F is primarily indicated for female reproductive indications such as anovulation and controlled ovarian stimulation. It is not approved for the treatment of male infertility.

Patients typically undergo serial transvaginal ultrasounds to assess follicle size and number, as well as serum estradiol measurements to evaluate ovarian response and adjust dosing if needed.

Yes, because Gonal-F stimulates the development of multiple follicles, the likelihood of twins or higher‑order gestations is higher compared with natural conception.

Symptoms may include rapid weight gain, abdominal bloating, nausea, vomiting, shortness of breath, and decreased urine output. Severe cases can involve ascites, pleural effusion, or thromboembolic events and require prompt medical attention.

Co‑administration is possible but should be done under specialist supervision, as both agents affect follicular development and may increase the risk of OHSS.

The patient should stop the injection immediately and seek emergency medical care, especially if symptoms include rash, swelling, difficulty breathing, or anaphylaxis.

Clinicians should evaluate the severity of endometriosis before starting treatment, as ovarian stimulation may exacerbate pelvic pain or increase the risk of complications.

The stimulation phase usually lasts 8‑14 days, after which ovulation is triggered and oocyte retrieval is scheduled if the cycle is part of an assisted reproductive technology program.

Gonal-F should be refrigerated (2‑8 °C) before reconstitution. After preparation, the solution may be kept at room temperature for a limited period as specified in the product labeling.

Gonal-F is contraindicated in patients with known hypersensitivity to follitropin alfa or any excipients, and it should not be used in uncontrolled ovarian cysts, active ovarian or breast cancer, or severe uncontrolled endocrine disorders.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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