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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
Treatment cycles =
Treatment cycles =
|Breast Pain Female||4.2%||6.1%|
|Central and Peripheral Nervous System|
|Body as a Whole- General|
|Upper Respiratory Tract Infection||11.9%||7.9%|
|Skin and Appendages|
|Urinary Tract Infection||1.7%||4.4%|
|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
|Central and Peripheral
|Body as a Whole- General|
|Pelvic Pain Female||7.1%||1.7%|
|Upper Respiratory Tract Infection||3.6%||1.7%|
|Metabolic and Nutritional|
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:
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:
- Pulmonary and vascular complications (see WARNINGS),
- Adnexal torsion (as a complication of ovarian enlargement),
- Mild to moderate ovarian enlargement,
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.
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.
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
Hypersensitivity reactions including anaphylactoid reactions.
Read the Gonal-F (follitropin alfa) Side Effects Center for a complete guide to possible side effects
No drug/drug interaction studies have been performed.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/7/2016
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