Follitropin
What is Gonal-f (Follitropin)?
For many people struggling with infertility, the journey to parenthood can be emotionally and physically challenging. The uncertainty, waiting, and repeated disappointments can take a toll on couples and individuals hoping to conceive. Gonal-f (follitropin alfa) is a medication that offers new hope helping stimulate the body’s natural reproductive process and improving the chances of successful ovulation and pregnancy.
Gonal-f is a recombinant human follicle-stimulating hormone (FSH) used to promote the growth and development of ovarian follicles, the small sacs that contain eggs, in women undergoing fertility treatments. It is also used in men to stimulate sperm production when infertility is due to hormonal deficiency. As one of the most widely prescribed fertility medications worldwide, Gonal-f plays a central role in assisted reproductive technologies (ART) such as in vitro fertilization (IVF) and intrauterine insemination (IUI).
Approved by the U.S. Food and Drug Administration (FDA), Gonal-f represents a targeted and scientifically advanced therapy that helps many people overcome hormonal barriers to conception.
What does Gonal-f do?
Gonal-f is used to stimulate egg production in women and sperm production in men.
In women, it’s prescribed for:
- Ovulation induction: helping women who do not ovulate regularly (such as those with polycystic ovary syndrome, or PCOS) produce a mature egg for fertilization.
- Assisted reproductive technologies (ART): such as IVF, where multiple eggs are needed for retrieval and fertilization in a laboratory setting.
In men, Gonal-f may be prescribed for hypogonadotropic hypogonadism, a condition where the body produces low levels of reproductive hormones, resulting in decreased sperm count and fertility.
Clinical studies have shown Gonal-f increases the likelihood of successful ovulation and pregnancy when used under careful medical supervision (NIH, 2024). Many patients experience improved reproductive outcomes when Gonal-f is part of a coordinated fertility treatment plan that may also include other hormones or reproductive procedures.
The ultimate goal of Gonal-f therapy is to give individuals and couples a better chance at achieving a healthy pregnancy while keeping the process safe and closely monitored.
How does Gonal-f work?
Gonal-f contains follitropin alfa, a laboratory-made version of follicle-stimulating hormone (FSH), one of the body’s natural reproductive hormones. FSH plays a crucial role in regulating reproductive function in both men and women.
In women, FSH stimulates the growth of ovarian follicles, encouraging one or more eggs to mature. By providing the body with additional FSH, Gonal-f helps the ovaries develop multiple eggs, which can then be released or retrieved for fertilization.
In men, FSH stimulates the testes to produce sperm, often used alongside human chorionic gonadotropin (hCG) to optimize sperm development.
From a clinical standpoint, this mechanism helps address infertility caused by hormonal insufficiency. By promoting the normal growth of eggs or sperm, Gonal-f restores the biological conditions needed for conception giving individuals a better chance to start or expand their families.
Gonal-f side effects
As with all hormone-based treatments, Gonal-f may cause side effects, though most are temporary and manageable with proper monitoring.
Common side effects in women may include:
- Mild abdominal discomfort or bloating
- Headache or fatigue
- Breast tenderness
- Mild nausea or injection site reactions (such as redness or bruising)
Less common but serious side effects include:
- Ovarian hyperstimulation syndrome (OHSS): a rare but potentially serious reaction where the ovaries become swollen and painful, causing fluid buildup in the abdomen. Symptoms may include severe abdominal pain, rapid weight gain, or difficulty breathing.
- Multiple pregnancy: because Gonal-f can stimulate the release of more than one egg, there’s a higher chance of twins or triplets.
- Allergic reactions: such as rash, swelling, or difficulty breathing. Though rare, these require immediate medical attention.
In men, mild side effects like injection site pain or breast tenderness can occur.
Because hormone levels and ovarian response can vary greatly between individuals, careful medical supervision is essential during Gonal-f treatment. Regular ultrasounds and blood tests help doctors track follicle growth and adjust dosing to minimize risks while maximizing effectiveness.
Gonal-f dosage
Gonal-f, a subcutaneous injection, is administered daily via pre-filled pens or vials. Dosage and duration vary based on the patient’s condition and treatment goal (ovulation induction or IVF). Healthcare providers train patients on proper preparation and injection; never alter the dose without medical advice.
During treatment, doctors monitor hormone levels (especially estradiol), ovarian follicle development via ultrasound, and signs of ovarian overstimulation to optimize egg growth and minimize OHSS risk. For men, sperm counts and hormone levels are checked. Older adults and individuals with thyroid, adrenal, or pituitary disorders may need additional testing.
Does Gonal-f have a generic version?
Yes. The active ingredient in Gonal-f, follitropin alfa is available in both brand-name and biosimilar (generic-like) forms.
In the U.S., EMD Serono markets Gonal-f. However, FDA-approved biosimilar versions, such as Follitropin Alfa Injection, are clinically equivalent. Gonal-f is a biologic, so its generic equivalents are called biosimilars. Patients can use either brand-name or FDA-approved biosimilar formulations confidently, based on availability, insurance, and doctor recommendations.
Conclusion
Gonal-f is a scientifically advanced fertility medication that helps women produce eggs and men produce sperm when natural hormone levels are insufficient. By mimicking the body’s natural follicle-stimulating hormone, it enhances the chances of conception for individuals and couples facing infertility challenges.
While requiring monitoring and having potential mild side effects, Gonal-f is a safe and successful treatment in reproductive medicine. With expert guidance, support, and adherence to care, Gonal-f can help achieve parenthood.
References
- U.S. Food and Drug Administration (FDA). (2024). Gonal-f (follitropin alfa) prescribing information. Retrieved from https://www.accessdata.fda.gov
- Mayo Clinic. (2024). Follitropin (injection route) description and precautions. Retrieved from https://www.mayoclinic.org
- MedlinePlus. (2024). Follitropin alfa injection: Uses, side effects, and precautions. National Library of Medicine. Retrieved from https://medlineplus.gov
- National Institutes of Health (NIH). (2024). Assisted reproductive technology and ovulation induction overview. Retrieved from https://www.nih.gov
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Brand Information
- For Injection: 450 International Units of white lyophilized powder in a multiple-dose vial
- For Injection: 1050 International Units of white lyophilized powder in a multiple-dose vial
- Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis
- High levels of FSH indicating primary gonadal failure
- The presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)
- Sex hormone dependent tumors of the reproductive tract and accessory organs
- Tumors of pituitary gland or hypothalamus
- Abnormal uterine bleeding of undetermined origin
- Ovarian cyst or enlargement of undetermined origin
- Hypersensitivity Reactions and Anaphylaxis
- Ovarian Hyperstimulation Syndrome
- Pulmonary and Vascular Complication
- Ovarian Torsion
- Abnormal Ovarian Enlargement
- Multi-fetal Gestation and Birth
- Embryofetal Toxicity
- Ectopic Pregnancy
- Spontaneous Abortion
- Ovarian Neoplasms
(follitropin alfa) for injection
for subcutaneous use
- Read these instructions completely before you begin.
- GONAL-f is for use under the skin only (subcutaneous).
- Only use GONAL-f if your healthcare provider trains you on how to use it correctly.
- Do not reuse needles.
- Do not share your GONAL-f needles or syringes with another person. You may get a serious infection from other people or other people may get a serious infection from you.
- The syringes and needles that come with your GONAL-f are meant for use with GONAL-f only.
- a clean flat surface like a table
- 1 GONAL-f Multi-Dose vial
- 1 GONAL-f Multi-Dose Custom Dosing Injection Syringe
- 1 Prefilled Syringe of Bacteriostatic Water for Injection, USP
- 1 FDA-cleared sharps container
- 2 alcohol pads
- 1 gauze or cotton ball
- Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
If the vial with the GONAL-f liquid mixed (reconstituted) solution is stored in the refrigerator, allow at least 30 minutes before you inject to let it warm to room temperature.
- Wash your hands with soap and water.
Using your thumb, flip off the plastic cap of the GONAL-f vial. Wipe the top of the vial stopper with an alcohol pad. Carefully twist and pull off the protective cap of the prefilled syringe of Bacteriostatic Water. Do not touch the needle or allow it to touch any surface. - Hold the vial of GONAL-f powder firmly on a flat surface.
- Position the prefilled syringe of Bacteriostatic Water in a straight, upright position over the marked center circle of the rubber stopper on the vial of the GONAL-f powder.
Insert the needle through the center circle of the rubber stopper on the vial of the GONAL-f powder while keeping it in a straight, upright position. Slowly inject the Bacteriostatic Water into the vial of GONAL-f powder by pressing down on the syringe plunger. - Gently, rotate the vial between your fingers until the powder is dissolved.
When all of the Bacteriostatic Water has been injected into the vial of GONAL-f powder, remove your finger from the syringe plunger and withdraw the needle from the vial. Immediately throw away (dispose of) the needle and syringe into your FDA-cleared sharps container (See
- Check that the GONAL-f liquid solution is clear. Do not use if the liquid is discolored or contains any particles. If this happens, throw it away and call your healthcare provider or pharmacist right away.
- Allow the liquid solution to come to room temperature before giving your injection.
- Wipe the rubber stopper of the vial with an alcohol swab.
- Remove the wrapper and carefully, pull the needle cap off the Custom-Dosing Injection Syringe.
Firmly hold the vial of GONAL-f liquid mixed (reconstituted) solution on a flat surface and insert the needle through the marked center circle of the rubber stopper. While keeping the needle in the vial, lift the vial and turn it upside down so that the needle points towards the ceiling. With the needle tip in the liquid, slowly pull back the plunger until the syringe fills to slightly more than the mark for your prescribed dose. Next, with the syringe pointing upward and keeping the needle in the vial, slowly push the syringe plunger to your prescribed dose and until all air bubbles are gone and a drop of liquid appears on the tip of the needle. - Remove the syringe needle from the vial and recap the needle and set on a clean, flat surface.
- The syringe is now ready for giving your prescribed dose of GONAL-f.
- Your healthcare provider should show you how to set the prescribed dose and use the syringe.
- Change your injection site each day to decrease discomfort. GONAL-f is injected under the skin (subcutaneously) of your stomach area, upper arm, or upper leg.
Uncap the syringe and inject the prescribed dose as directed by your healthcare provider. - Lightly press a cotton ball or gauze on the site if needed.
Put used needles and syringes in an FDA-cleared sharps disposal container immediately after use.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
- Store all vials with GONAL-f away from light.
- Store vials in the refrigerator between 36° F and 46° F (2°C and 8° C) until the expiration date, or at room temperature between 68° F and 77° F (20°C and 25°C) until the expiration date.
- If you have medicine left in a vial after injecting, store it in the refrigerator or at room temperature for a maximum of 28 days from the day the powder was mixed with Bacteriostatic Water. After 28 days, you must throw away (discard) your vial with unused solution.
- Keep the GONAL-f vials and all medicines out of the reach of children.
