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Gonal-F

Last reviewed on RxList: 2/25/2021
Gonal-F Side Effects Center

What Is Gonal-F?

Gonal-F (follitropin alfa) Injection is a naturally occurring hormone used to stimulate a follicle (egg) to develop and mature. Gonal-F is used when a woman desires pregnancy and her ovaries can produce a follicle but hormonal stimulation is not sufficient to make the follicle mature. Follicle stimulating hormone (FSH) is also used to stimulate the development of multiple eggs for in vitro fertilization. FSH can be used by men to increase the production of sperm.

What Are Side Effects of Gonal-F?

Common side effects of Gonal-F include:

  • headache,
  • nausea,
  • vomiting,
  • mild stomach/abdominal pain,
  • pelvic pain or tenderness,
  • bloating,
  • injection site reactions (redness, pain, bruising, irritation),
  • breast swelling/tenderness/pain,
  • numbness or tingly feeling,
  • runny or stuffy nose,
  • sore throat,
  • acne, or
  • skin rash.

Tell your doctor if you have unlikely but serious side effects of Gonal-F including:

  • unusual bleeding from the vagina/uterus,
  • pain/redness/swelling of the calf muscles,
  • cold/numb/pale skin of the arms/legs/hands/feet, or
  • swelling of ankles/hands/feet.

Dosage for Gonal-F

The dose of Gonal-F to stimulate development of the follicle is individualized. The recommended initial dose of the first cycle is 75 IU. Doses may range up to 300 IU per day depending on patient response.

What Drugs, Substances, or Supplements Interact with Gonal-F?

It is not known if other medications will interact with Gonal-F. Tell doctor all prescription or over-the-counter medicines and supplements you use.

Gonal-F During Pregnancy and Breastfeeding

Gonal-F must not be used during pregnancy. Stop using Gonal-F when you become pregnant. It is unknown if this drug passes into breast milk. Because of possible harm to a nursing infant, consult your doctor before breastfeeding.

Additional Information

Our Gonal-F (follitropin alfa) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Men and women are equally likely to have fertility problems. See Answer
Gonal-F Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine develop ovarian hyperstimulation syndrome (OHSS), a potentially life-threatening condition. Stop using this medicine and call your doctor right away if you have symptoms of OHSS during or shortly after using follicle stimulating hormone:

  • severe pain in your lower stomach, nausea, vomiting, diarrhea;
  • bloating, rapid weight gain;
  • little or no urination; or
  • trouble breathing.

Also call your doctor at once if you have:

  • severe pelvic pain on one side;
  • a cough with bloody mucus;
  • fever, sore throat, swollen glands;
  • a lump or swelling in your testicles;
  • signs of acute respiratory distress syndrome--fever with shortness of breath or rapid breathing; or
  • signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common side effects may include:

  • redness, swelling, or bruising where an injection was given;
  • an ovarian cyst;
  • headache, tiredness;
  • breast pain or swelling;
  • stuffy nose, sneezing, sinus pain;
  • acne; or
  • nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Gonal-F (Follitropin Alfa)

SLIDESHOW

Fertility Options: Types, Treatments, and Costs See Slideshow
Gonal-F Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Hypersensitivity Reactions and Anaphylaxis [see WARNINGS AND PRECAUTIONS]
  • Ovarian Hyperstimulation Syndrome [see WARNINGS AND PRECAUTIONS]
  • Pulmonary and Vascular Complication[see WARNINGS AND PRECAUTIONS]
  • Ovarian Torsion [see WARNINGS AND PRECAUTIONS]
  • Abnormal Ovarian Enlargement [see WARNINGS AND PRECAUTIONS]
  • Multi-fetal Gestation and Birth [see WARNINGS AND PRECAUTIONS]
  • Embryofetal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Ectopic Pregnancy [see WARNINGS AND PRECAUTIONS]
  • Spontaneous Abortion [see WARNINGS AND PRECAUTIONS]
  • Ovarian Neoplasms [see WARNINGS AND PRECAUTIONS]

Clinical Study Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

Women

The safety of GONAL-F was examined in four clinical trials that enrolled 691 women [two trials for ovulation induction (454 women) and two trials for ART (237 women)].

Induction of Ovulation

In a randomized, open-labeled, multicenter, active-controlled trial in oligo-anovulatory infertile women, conducted in the U.S., a total of 118 oligo-anovulatory infertile women were randomized to and underwent ovulation induction with GONAL-F versus a comparator urofollitropin. Adverse reactions occurring in at least 5.0% of women receiving GONAL-F are listed in Table 1.

Table 1: Common Adverse Reactions Reported at a Frequency of ≥ 5% in an U.S. Ovulation Induction Trial

System Organ Class/Adverse ReactionsGONAL-F
N=118a (288 treatment cyclesb)
nc (%)
Body as a Whole -General
  Pain6 (5.1%)
Central and Peripheral Nervous System
  Headache12 (10.2%)
Gastrointestinal System
  Abdominal Pain9 (7.6%)
  Nausea7 (5.9%)
  Flatulence7 (5.9%)
Reproductive, Female
  Intermenstrual Bleeding6 (5.1)
  Ovarian Hyperstimulation8 (6.8%)
  Ovarian Cyst17 (14.4%)
a total number of women treated with GONAL-F
b up to 3 treatment cycles per woman
c number of women with the adverse reaction

Development of Multiple Follicles as part of an Assisted Reproductive Technology (ART) Cycle

In a randomized, open-labeled, active-comparator trial conducted in the U.S., a total of 56 normal ovulatory infertile women were randomized and received GONAL-F versus a urofollitropin comparator as part of an ART [in vitro fertilization (IVF) or intracytoplasmic sperm injection cycle (ICSI)] cycle. All women received pituitary down-regulation with gonadotropin releasing hormone (GnRH) agonist before stimulation. Adverse Reactions occurring in at least 5.0% of women are listed in Table 2.

Table 2: Common Adverse Reactions Reported at a Frequency of ≥ 5% in an U.S. ART Trial

System Organ Class/Adverse ReactionsGONAL-F
(N=56a)
nb (%)
Central and Peripheral Nervous System
  Headache7 (12.5%)
Gastrointestinal System
  Abdominal Pain3 (5.4%)
  Nausea4 (7.1%)
Reproductive, Female
  Pelvic Pain4 (7.1)
a total number of women treated with GONAL-F
b number of women with the adverse reaction

Induction Of Spermatogenesis

The safety of GONAL-F for induction of spermatogenesis in men with primary or secondary hypogonadotropic hypogonadism was examined in 3 open-label, non-randomized, multi-center, multi-national, escalating dose clinical trials (Trials 1, 2 and 3) conducted in in 76 adult men (aged 16 to 48 years) with primary or secondary hypogonadotropic hypogonadism (defined as serum testosterone <100 ng/mL and low or normal FSH and LH) and azoospermia (sperm concentration <0.1x106/mL). Of the 76 men enrolled, 63 received treatment with GONAL-F.

During these trials, there was one serious adverse reaction of gynecomastia requiring surgical excision of breast tissue in a 50 year old man who received 9 months of therapy with Gonal-F. Pathology report showed gynecomastia with no atypia.

There were no discontinuations due to adverse reactions.

Adverse reactions reported in Trials 1, 2 and 3 by ≥2 patients during treatment with Gonal-f are shown in Table 3.

Table 3. Common Adverse Reactions in Men with Azoospermia and Primary orSecondary Hypogonadotropic Hypogonadism Receiving Gonal-F in Trials 1, 2 and 3 for Induction for Spermatogensis

N=63
n (%)
Acne17 (27)
Injection site pain7 (11)
Gynecomastia4 (6)
Seborrhea3 (5)
Fatigue6 (10)
Libido decreased2 (3)

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following adverse reactions have been reported during postmarketing use of GONAL-F. Because these reactions were reported voluntarily from a population of uncertain size, the frequency or a causal relationship to GONAL-F cannot be reliably determined.

Body as a Whole -General: Hypersensitivity reactions including anaphylaxis

Respiratory System: Asthma exacerbation

Vascular Disorders: Thromboembolism

Read the entire FDA prescribing information for Gonal-F (Follitropin Alfa)

Related Resources for Gonal-F

Related Health

© Gonal-F Patient Information is supplied by Cerner Multum, Inc. and Gonal-F Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Men and women are equally likely to have fertility problems. See Answer

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