ADVERSE REACTIONS SECTION
The safety of Gonal-f® RFF 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 | Patients (%) Experiencing Events |
| Preferred Term | Treatment cycles = 176* |
| | n=83† |
| * up to 3 cycles of therapy |
| † total patients treated with Gonal-f® RFF |
| 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%) |
Headache occurred in greater than 20% of patients receiving Gonal-f® RFF 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 | Patients (%) Experiencing Events |
| Preferred Term | n=237† |
| † total patients treated with Gonal-f® RFF |
| 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 oedema | 6 (2.5%) |
| Reproductive, Female | |
| Ovarian Hyperstimulation | 11 (4.6%) |
| Intermenstrual Bleeding | 9 (3.8%) |
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 therapy in controlled clinical studies:
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Spontaneous Abortion
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Ectopic Pregnancy
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Premature Labor
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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 therapy:
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Pulmonary and vascular complications (see " Warnings "),
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Adnexal torsion (as a complication of ovarian enlargement),
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Mild to moderate ovarian enlargement,
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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.
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