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Gonal-F

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Gonal-F

Gonal-F Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Gonal-F (follitropin alfa) Injection is used to stimulate a follicle (egg) to develop and mature. It 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. FSH is a naturally occurring hormone. Common side effects include headache, nausea, vomiting, mild stomach/abdominal pain, bloating, redness/pain at the injection site, or breast tenderness/pain.

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 breast-feeding.

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

The safety of Gonal-F® (follitropin alfa) 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 US ovulation induction study and headache in the US ART study. Adverse events (without regard to causality assessment) occurring in at least 2% of patients are listed in Table 10 and Table 11.

Table 10: 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%

Neoplasm
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 10 that occurred in 1 to 2% of Gonal-F® (follitropin alfa) treated patients in the US ovulation induction study included the fol lowing: leukorrhea, vaginal hemorrhage, migraine, fatigue, asthma, nervousness, somnolence, and hypotension.

Table 11: 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 11 that occurred in 1 to 2% of Gonal-F® (follitropin alfa) treated patients in the US 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.

The following medical events have been reported subsequent to pregnancies resulting from Gonal-F® (follitropin alfa) therapy in controlled clinical studies:

TWO incidents of congenital cardiac malformations have been reported in children born following pregnancies resulting from treatment with Gonal-F® (follitropin alfa) and hCG in Gonal-F® (follitropin alfa) clinical studies 5642 and 5727. In addition, pregnancy occurring in study 5533 following treatment with Gonal-F® (follitropin alfa) 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.

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

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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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