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Gonal-F

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Gonal-F

Side Effects
Interactions

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 Gonal-F (follitropin alfa) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No drug/drug interaction studies have been performed.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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