February 27, 2017
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Gonal-F

"The woman who received the nation's first transplanted uterus on February 24 at the Cleveland Clinic in Ohio had to have the organ removed because of a "sudden complication," the clinic announced today.

The transplant recipient, a 26-"...

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Gonal-F




Side Effects
Interactions

SIDE EFFECTS

Women

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

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%
Neoplas m    
  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 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

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 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:

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

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:

  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.

Men

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.

Postmarketing Experience

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

General

Hypersensitivity reactions including anaphylactoid reactions.

Respiratory System

asthma

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.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 10/7/2016

Side Effects
Interactions

Report Problems to the Food and Drug Administration

 

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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