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Gonal-f RFF

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Gonal-f RFF

SIDE EFFECTS

The safety of Gonal-f® RFF (follitropin alfa injection) was examined in two clinical studies [(one ovulation induction study (n=83) and one study in ART (n=237)].

Adverse events (without regard to causality assessment) occurring in at least 2.0% of patients in Study 22240 (ovulation induction) are listed in Table 4.

Table 4: Safety Profile in Ovulation Induction Study 22240

Body System
Preferred Term
Gonal-f® RFF (follitropin alfa injection)
Patients (%) Experiencing Events
Treatment cycles = 176*
n=83†
Central and Peripheral Nervous System
Headache 22 (26.5%)
Dizziness 2 (2.4%)
Migraine 3 (3.6%)
Gastro-intestinal System
Abdominal Pain 10 (12.0%)
Nausea 3 (3.6%)
Flatulence 3 (3.6%)
Diarrhea 3 (3.6%)
Toothache 3 (3.6%)
Dyspepsia 2 (2.4%)
Constipation 2 (2.4%)
Stomatitis Ulcerative 2 (2.4%)
Neoplasm
Ovarian Cyst 3 (3.6%)
Reproductive, Female
Ovarian Hyperstimulation 6 (7.2%)
Breast Pain Female 5 (6.0%)
Vaginal Haemorrhage 5 (6.0%)
Gynecological-related pain 2 (2.4%)
Uterine haemorrhage 2 (2.4%)
Respiratory System
Sinusitis 5 (6.0%)
Pharyngitis 6 (7.2%)
Rhinitis 6 (7.2%)
Coughing 2 (2.4%)
Application Site
Injection Site Pain 4 (4.8%)
Injection Site Inflammation 2 (2.4%)
Body as a Whole- General
Back Pain 3 (3.6%)
Pain 2 (2.4%)
Fever 2 (2.4%)
Hot Flushes 2 (2.4%)
Malaise 2 (2.4%)
Skin and Appendages
Acne 3 (3.6%)
Urinary System
Micturition Frequency 2 (2.4%)
Cystitis 2 (2.4%)
Resistance Mechanism
Infection viral 2 (2.4%)
* up to 3 cycles of therapy
† total patients treated with Gonal-f® RFF

Headache occurred in greater than 20% of patients receiving Gonal-f® RFF (follitropin alfa injection) in this study.

Adverse events (without regard to causality assessment) occurring in at least 2.0% of patients in Study 21884 (ART) are listed in Table 5.

Table 5: Safety Profile in Assisted Reproductive Technologies Study 21884

Body System
Preferred Term
Gonal-f® RFF (follitropin alfa injection)
Patients (%) Experiencing
Events
n=237†
Gastro-intestinal System
Abdominal Pain 55 (23.2%)
Nausea 19 (8.0%)
Body as a Whole- General
Abdomen Enlarged 33 (13.9%)
Pain 7 (3.0%)
Central and Peripheral Nervous System
Headache 44 (18.6%)
Dizziness 5 (2.1)%
Application Site Disorders
Injection site bruising 23 (9.7%)
Injection site pain 13 (5.5%)
Injection site inflammation 10 (4.2%)
Injection site reaction 10 (4.2%)
Application site edema 6 (2.5%)
Reproductive, Female
Ovarian Hyperstimulation 11 (4.6%)
Intermenstrual Bleeding 9 (3.8%)
† total patients treated with Gonal-f® RFF

Headache and abdomen enlargement occurred in more than 10% of patients and abdominal pain occurred in more than 20% of patients.

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

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

There are no indications that use of gonadotropins during ART is associated with an increased risk of congenital malformations.

The following adverse reactions have been previously reported during Gonal-f® RFF (follitropin alfa injection) 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.

Post Marketing Reports

During post-market surveillance, reports of hypersensitivity reactions including anaphylactoid reactions have been reported with the use of Gonal-f® RFF (follitropin alfa injection) .

Read the Gonal-f RFF (follitropin alfa injection) 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: 7/26/2007
This monograph has been modified to include the generic and brand name in many instances.

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