Gonal-f RFF Side Effects

Please note - some side effects for Gonal-f RFF may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Gonal-f RFF - for the Consumer

Gonal-f RFF Pen Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Gonal-f RFF Pen Solution:

Breast pain; discomfort, pain, or mild bruising at the injection site; headache; mild stomach pain or nausea; sinus inflammation; sore throat; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; calf pain or tenderness; chest pain; confusion; decreased urination; diarrhea; fever; one-sided weakness; severe or persistent stomach pain, upset, or bloating; severe or persistent nausea; severe pelvic or back pain; shortness of breath; slurred speech; sudden, unexplained weight gain; unusual vaginal itching, discharge, or odor; vision changes; vomiting.

Gonal-f RFF Side Effects - for the Professional

Gonal-f RFF

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.

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.

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:

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 therapy:

1. Pulmonary and vascular complications,

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.

Side Effects by Body System

Genitourinary

Mild to moderate uncomplicated ovarian enlargement has been reported to generally regress without treatment within two or three weeks.

Severe OHSS may progress over one to several days to become a serious medical event. Severe OHSS is characterized by an apparent dramatic increase in vascular permeability which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially the pericardium. Early warning signs include severe pelvic pain, nausea, vomiting, and weight gain. Cases of OHSS may include abdominal pain, abdominal distension, nausea, vomiting, diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events. Transient liver function test abnormalities have also been associated with OHSS.

Genitourinary side effects have included mild to moderate ovarian enlargement sometimes accompanied by abdominal distention and/or abdominal pain, severe ovarian hyperstimulation syndrome (OHSS), miscarriage, ectopic pregnancy and ovarian cysts. Other genitourinary side effects have included intermenstrual bleeding, dysmenorrhea, breast tenderness, urinary tract infection, vaginal hemorrhage and moniliasis genital.

Respiratory

Other respiratory tract side effects have included sinusitis, pharyngitis, coughing, rhinitis, dyspnea, tachypnea and upper respiratory tract infection.

Respiratory effects have included atelectasis, pulmonary embolism, pulmonary infarction, and acute respiratory distress syndrome. In rare cases, pulmonary complications have resulted in death.

Cardiovascular

Cardiovascular effects have included venous thrombophlebitis, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb. In rare cases, thromboembolic events have resulted in death.

Other cardiovascular side effects have included chest pain, palpitations, and tachycardia.

Other

Other side effects have included febrile reactions and flu-like symptoms which included fever, chills, musculoskeletal aches, joint pains, malaise, headache, and fatigue.

It is not clear whether the febrile reactions were pyrogenic responses or possible allergic reactions.

Gastrointestinal

Gastrointestinal effects have included anorexia, nausea, vomiting, diarrhea, abdominal pain, flatulence, and dyspepsia.

Local

Local side effects have included pain, rash, swelling, and/or irritation at the site of injection.

Dermatologic

Dermatologic side effects have included dry skin, body rash, hair loss, acne, pruritus and hives.

Psychiatric

Psychiatric side effects have included emotional liability.

Metabolic

Metabolic side effects have included weight gain.

Nervous system

Nervous system side effects have included headache, paresthesias somnolence, anxiety and dizziness.

Musculoskeletal

Musculoskeletal side effects have included myalgia, back pain and joint pains.

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