Gonal-F Injection: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Gonal-F Injection (follitropin alfa) is a recombinant form of follicle stimulating hormone (FSH) given as an injection under the skin. It is used to help women ovulate, to stimulate multiple egg development for assisted reproductive technology such as IVF, and to help men with certain hormone deficiencies produce sperm. It requires close monitoring by a fertility specialist and carries risks such as ovarian hyperstimulation syndrome, blood clots, and multiple pregnancy.

What is Gonal-F Injection

Gonal-F is an injectable medicine containing follicle stimulating hormone (FSH), a hormone naturally involved in reproduction. It is made using recombinant DNA technology to closely match human FSH. It is given as an injection under the skin.

Gonal-F Injection uses

• Helping women who cannot ovulate on their own to develop and release a mature egg
• Stimulating the ovaries to develop multiple eggs as part of assisted reproductive technology (ART) programs such as IVF
• Helping men with a hormone deficiency condition (hypogonadotropic hypogonadism) produce sperm, usually combined with another hormone called hCG

Benefits of Gonal-F Injection

• Can help women with ovulation problems achieve pregnancy
• Can help produce multiple eggs for IVF and similar fertility treatments
• Can help men with certain hormone deficiencies develop sperm production

How Gonal-F Injection works

Gonal-F contains a lab-made copy of follicle stimulating hormone (FSH). In women, FSH tells the ovaries to grow and mature egg-containing follicles. In men, FSH helps the testicles produce sperm.

Gonal-F Injection dosage

Gonal-F is given as an injection under the skin, usually in the stomach, upper arm, or upper leg. Change the injection site each time to reduce discomfort. The powder must be mixed with the liquid provided before use, and the mixed solution should look clear without particles before injecting. Let the medicine reach room temperature before injecting if it has been stored in the refrigerator.

Use the medicine at the same time each day, exactly as your doctor directs, and do not change your dose or schedule unless told to. Women are usually given this injection once a day; men usually receive it a few times a week. You will need regular blood tests, and possibly ultrasound scans (for women) or semen tests (for men), while using this medicine. Timing of intercourse with your doctor's instructions matters for this medicine to help you get pregnant.

If you miss a dose, do not double the next dose; contact your doctor for instructions.

Available forms and strengths

• Injection (lyophilized powder for reconstitution in a multiple-dose vial)
• Prefilled pen for injection

Side effects of Gonal-F Injection

Common

• Headache
• Nausea
• Vomiting
• Mild stomach or abdominal pain
• Pelvic pain or tenderness
• Bloating
• Injection site reactions such as redness, pain, bruising, or irritation
• Breast swelling, tenderness, or pain
• Numbness or tingly feeling
• Runny or stuffy nose
• Sore throat
• Acne
• Skin rash
• Ovarian cysts
• Tiredness (in men)
• Growth of breast tissue (in men)
• Oily, flaky skin (in men)
• Passing gas

Serious

• Severe pain in the lower stomach, nausea, vomiting, diarrhea, bloating, and rapid weight gain (possible signs of ovarian hyperstimulation syndrome)
• Little or no urination
• Trouble breathing
• Severe pelvic pain on one side
• Cough with bloody mucus
• Fever, sore throat, or swollen glands
• Lump or swelling in the testicles
• Fever with shortness of breath or rapid breathing
• Sudden numbness or weakness, problems with vision or speech, or swelling/redness in an arm or leg (possible signs of a blood clot or stroke)
• Signs of a severe allergic reaction such as hives, difficulty breathing, or swelling of the face, lips, tongue, or throat
• Unusual bleeding from the vagina or uterus
• Pain, redness, or swelling of the calf muscles
• Cold, numb, or pale skin of the arms, legs, hands, or feet
• Swelling of the ankles, hands, or feet
• Signs of ectopic pregnancy such as one-sided abdominal or pelvic pain, shoulder or neck pain, and nausea and vomiting

Warnings and precautions

• Gonal-F can cause a serious condition called ovarian hyperstimulation syndrome (OHSS), where the ovaries become overstimulated. 
• This can cause fluid buildup in the abdomen, chest, and around the heart, and blood clots, and in rare cases has caused death. Seek medical attention for severe pelvic/abdominal pain, rapid weight gain, severe nausea/vomiting, abdominal swelling, difficulty breathing, or reduced urine output.
• Serious lung problems can occur, including fluid in the lungs, trouble breathing, and worsening asthma. Gonal-F may increase the risk of blood clots, which can lead to stroke, loss of a limb, a blood clot in the lung, or heart attack. Fertility treatment can increase the risk of venous or arterial blood clots; report sudden chest pain, breathing difficulty, or limb swelling.
• There is an increased chance of becoming pregnant with more than one baby, which is a higher-risk pregnancy for both mother and babies. Ovarian torsion (twisting of the ovary) can occur, which can cut off blood flow to the ovary. There is a slightly higher chance of ectopic pregnancy (pregnancy outside the womb), especially in women with fallopian tube problems.
• There have been infrequent reports of ovarian tumors, both benign and cancerous, in women who have used multiple courses of fertility drugs, though a direct link has not been proven. Serious allergic reactions, including anaphylaxis, have occurred, especially in people who have used this medicine before. Stop treatment and seek immediate medical attention for difficulty breathing, facial swelling, severe itching, or hives.
• Do not use if allergic to recombinant FSH, or in certain conditions such as primary ovarian failure, uncontrolled thyroid/adrenal/pituitary disorders, or certain hormone-dependent tumors. Abnormal ovarian enlargement or unexplained ovarian cysts may require treatment to be stopped and hCG withheld.
• Gonal-F must not be used during pregnancy. Treatment should stop as soon as pregnancy is confirmed, and a negative pregnancy test is usually required before starting. Gonal-F is used to achieve pregnancy and should not be continued after pregnancy is established unless specifically directed by a specialist.
• It is not known whether Gonal-F passes into breast milk. Because of possible harm to a nursing baby, you should not breastfeed while using this medicine; talk with your doctor about the choice between treatment and breastfeeding.
• Use only under fertility-specialist supervision. Gonal-F requires monitoring with ultrasound and/or hormone testing to reduce the risk of excessive ovarian stimulation.
• If you miss a dose, do not double the next dose; contact the fertility specialist for instructions.

Storage

• Before use, store vials in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date, or at room temperature between 68°F to 77°F (20°C to 25°C) until the expiration date
• Store away from light
• Do not freeze
• After mixing, store in the refrigerator or at room temperature for up to 28 days, then discard any unused solution
• Do not store the medicine in the syringe
• Dispose of used needles and syringes in a puncture-proof sharps container, following your local rules for disposal
• Keep out of reach of children and pets

When to see a doctor

• Stop using Gonal-F and get medical help right away if you have severe pain in the lower stomach, nausea, vomiting, diarrhea, bloating, rapid weight gain, little or no urination, or trouble breathing — these can be signs of OHSS
• Get emergency medical help right away for signs of a severe allergic reaction, such as hives, difficulty breathing, or swelling of the face, lips, tongue, or throat
• Call your doctor right away if you have severe pelvic pain on one side, a cough with bloody mucus, fever with sore throat or swollen glands, a lump or swelling in the testicles, or fever with shortness of breath or rapid breathing
• Seek immediate medical attention for signs of a blood clot, such as sudden numbness or weakness, problems with vision or speech, or swelling or redness in an arm or leg
• If you become pregnant and have one-sided abdominal or pelvic pain, shoulder, neck, or rectal pain, or nausea and vomiting, seek immediate medical attention as this could indicate an ectopic pregnancy

Alternatives

• Follistim (follitropin beta)
• Menopur (menotropins)
• Bravelle (urofollitropin)