February 23, 2017
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Gonal-F

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Gonal-F




Gonal-F Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/5/2016

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. 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.

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. 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 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Gonal-F in Detail - Patient Information: Side Effects

Some women using this medicine have developed a sudden buildup of fluid in the stomach or chest area. This condition is called ovarian hyperstimulation syndrome (OHSS), and can be a life-threatening. Avoid having sex and call your doctor right away if you have any of the following symptoms of OHSS:

  • severe pain in your lower stomach;
  • nausea, vomiting, diarrhea, bloating;
  • feeling short of breath;
  • swelling in your hands or legs;
  • weight gain;
  • urinating less than usual.

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

Stop using follicle stimulating hormone and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness (especially on one side of the body);
  • pain, swelling, warmth, or redness in your arms or legs; or
  • severe pelvic pain on one side.

Less serious side effects may include:

  • headache;
  • mild nausea or stomach pain;
  • mild numbness or tingly feeling;
  • mild pelvic pain, tenderness, or discomfort;
  • runny or stuffy nose, sore throat;
  • breast swelling or tenderness;
  • acne;
  • mild skin rash; or
  • pain, bruising, redness, or irritation where the injection was given.

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)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Gonal-F Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, nausea, vomiting, mild stomach/abdominal pain, bloating, redness/pain at the injection site, or breast tenderness/pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual bleeding from the vagina/uterus, pain/redness/swelling of the calf muscles, cold/numb/pale skin of the arms/legs/hands/feet, swelling of ankles/hands/feet.

Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of the body, slurred speech, vision changes, sudden severe headache, chest pain, shortness of breath.

This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during treatment and after treatment has been stopped. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, difficult/painful breathing, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Gonal-F (Follitropin Alfa)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Gonal-F FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Women

The safety of Gonal-f® was examined in four clinical studies that enrolled 691 patients into two studies for ovulation induction (454 patients) and two studies for ART (237 patients).

Adverse events occurring in more than 10% of patients were headache, ovarian cyst, nausea, and upper respiratory tract infection in the U.S. ovulation induction study and headache in the U.S. ART study. Adverse events (without regard to causality assessment) occurring in at least 2% of patients are listed in Table 13 and Table 14.

Table 13: US Controlled Trial in Ovulation Induction, Study 5727

Body System
Preferred Term
Gonal-f®
Patients (%)
Experiencing Events
Treatment cycles =
288*
n=118
Urofollitropin
Patients (%)
Experiencing Events
Treatment cycles =
277*
n= 114
Reproductive, Female    
  Intermenstrual Bleeding 9.3% 4.4%
  Breast Pain Female 4.2% 6.1%
  Ovarian Hyperstimulation 6.8% 3.5%
  Dysmenorrhea 2.5% 6.1%
  Ovarian Disorder 1.7% 2.6%
  Cervix Lesion 2.5% 0.9%
  Menstrual Disorder 2.5% 0.9%
Gastro-intestinal System    
  Abdominal Pain 9.3% 12.3%
  Nausea 13.6% 3.5%
  Flatulence 6.8% 8.8%
  Diarrhea 7.6% 3.5%
Vomiting 2.5% 2.6%
  Dyspepsia 1.7% 3.5%
Central and Peripheral Nervous System    
  Headache 22.0% 20.2%
  Dizziness 2.5% 0.0%
Neoplas m    
  Ovarian Cyst 15.3% 28.9%
Body as a Whole- General    
  Pain 5.9% 6.1%
  Back Pain 5.1% 1.8%
  Influenza-like Symptoms 4.2% 2.6%
  Fever 4.2% 1.8%
Respiratory System    
  Upper Respiratory Tract Infection 11.9% 7.9%
  Sinusitis 5.1% 5.3%
  Pharyngitis 2.5% 3.5%
  Coughing 1.7% 2.6%
  Rhinitis 0.8% 2.6%
Skin and Appendages    
  Acne 4.2% 2.6%
Psychiatric    
  Emotional Lability 5.1% 2.6%
Urinary System    
  Urinary Tract Infection 1.7% 4.4%
Resistance Mechanism    
  Moniliasis Genital 2.5% 0.9%
Application Site    
  Injection Site Pain 2.5% 0.9%
*up to 3 cycles of therapy
Severe = 0.8% of 118 patients in Study 5727

Additional adverse events not listed in Table 13 that occurred in 1 to 2% of Gonal-f® treated patients in the US ovulation induction study included the following: leukorrhea, vaginal hemorrhage, migraine, fatigue, asthma, nervousness, somnolence, and hypotension.

Table 14: US Controlled Trial in ART, Study 5533

Body System
Preferred Term
Gonal-f®
Patients (%)
Experiencing Events
n=59
Urofollitropin
Patients (%)
Experiencing Events
n= 61
Reproductive, Female    
  Intermenstrual Bleeding 3.6% 5.2%
  Leukorrhea 1.7% 3.4%
  Vaginal Hemorrhage 3.6% 3.4%
Gastro-intestinal System    
  Nausea 5.4% 1.7%
  Flatulence 3.6% 0.0%
Central and Peripheral
Nervous System
   
  Headache 12.5% 3.4%
Body as a Whole- General    
  Abdominal Pain 8.9% 3.4%
  Pelvic Pain Female 7.1% 1.7%
Respiratory System    
  Upper Respiratory Tract Infection 3.6% 1.7%
Metabolic and Nutritional    
  Weight Increase 3.6% 0.0%

Additional adverse events not listed in Table 14 that occurred in 1 to 2% of Gonal-f® treated patients in the U.S. Assisted Reproductive Technology (ART) study included the following: D&C following delivery or abortion, dysmenorrhea, vaginal hemorrhage, diarrhea, tooth disorder, vomiting, dizziness, paraesthesia, abdomen enlarged, chest pain, fatigue, dyspnea, anorexia, anxiety, somnolence, injection site inflammation, injection site reaction, pruritus, pruritus genital, myalgia, thirst, and palpitation. Two additional clinical studies (for ovulation induction and ART, respectively) were conducted in Europe. The safety profiles from these two studies were comparable to that of the data presented above.

Gonal-f® Multi-Dose was examined in twenty-five healthy volunteers who received 300 IU each of Gonal-f® from single- dose ampules and multi-dose vials. Overall, both presentations were well tolerated and local tolerability between the two groups was comparable. Injection site inspections revealed very rare local reactions (mild redness in one patient after single-dose injection and mild bruising in two subjects after multi-dose injection). Subjective assessments indicated minimal or mild transient pain in two and five subjects who received Gonal-f® single-dose and Gonal-f® multi-dose, respectively.

The following medical events have been reported subsequent to pregnancies resulting from gonadotropins in controlled clinical studies:

  1. Spontaneous Abortion
  2. Ectopic Pregnancy
  3. Premature Labor
  4. Postpartum Fever
  5. Congenital Abnormalities

Two incidents of congenital cardiac malformations have been reported in children born following pregnancies resulting from treatment with Gonal-f® and hCG in Gonal-f® clinical studies 5642 and 5727. In addition, a pregnancy occurring in study 5533 following treatment with Gonal-f® and hCG was complicated by apparent failure of intrauterine growth and terminated for a suspected syndrome of congenital abnormalities. No specific diagnosis was made. The incidence does not exceed that found in the general population.

The following adverse reactions have been previously reported during menotropin therapy:

  1. Pulmonary and vascular complications (see WARNINGS),
  2. Adnexal torsion (as a complication of ovarian enlargement),
  3. Mild to moderate ovarian enlargement,
  4. Hemoperitoneum

There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.

Men

The safety of Gonal-f® was examined in 3 clinical studies that enrolled 72 patients for induction of spermatogenesis and fertility of whom 56 patients received Gonal-f® . One hundred and twenty-three adverse events, including 7 serious events, were reported in 34 of the 56 patients during Gonal-f® treatment.

In Study 5844, 21 adverse events, including 4 serious adverse events, were reported by 14 of the 26 patients (53.8%) treated with Gonal-f® . Events occurring in more than one patient were varicocele (4) and injection site reactions (4). The 4 serious adverse events were testicular surgery for cryptorchidism, which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection.

In Study 6410, 3 adverse events were reported in 2 of the 8 patients (24%) treated with Gonal-f® . One serious adverse event was reported, surgery for gynecomastia which existed at baseline.

In the interim analysis of Study 6793, 18 of 22 patients (81.8%) reported a total of 99 adverse events during Gonal-f® treatment. The most common events of possible, probable, or definite relationship to study drug therapy occurring in more than 2 patients were: acne (25 events in 13 patients; 59% of patients); breast pain (4 events in 3 patients; 13.6% of patients); and fatigue, gynecomastia, and injection site pain (each of which was reported as 2 events by 2 patients; 9.1% of patients). Two serious adverse events (hospitalization for drug abuse and depression) were reported by a single patient in the interim analysis.

A total of 12,026 injections of Gonal-f® were administered by the 56 patients who received Gonal-f® in Studies 5844, 6410, and 6793 combined. The injections were well-tolerated, with no or mild reactions (redness, swelling, bruising and itching) reported by patients for 93.3% of injections. Moderate and severe reactions, consisting primarily of pain, were reported for 4.8% of injections, and no self-assessment was available for 1.9% of injections.

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following events 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® , can not be reliably determined.

Body As A Whole

General

Hypersensitivity reactions including anaphylactoid reactions.

Respiratory System

asthma

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

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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