Fertinex Side Effects

Generic name: urofollitropin

Note: This document contains side effect information about urofollitropin. Some of the dosage forms listed on this page may not apply to the brand name Fertinex.

Some side effects of Fertinex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to urofollitropin: injectable powder for injection, intramuscular powder for injection, subcutaneous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking urofollitropin (the active ingredient contained in Fertinex) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS). This syndrome may be more likely to occur within the first 10 days after receiving the last dose in a treatment cycle. OHSS can be a life-threatening condition.

Stop using urofollitropin and call your doctor at once if you have any symptoms of OHSS:

• severe pelvic pain;

• swelling of your hands or legs;

• stomach pain and swelling;

• shortness of breath;

• weight gain;

• nausea, vomiting, diarrhea; or

• urinating less than usual.

Less serious side effects of urofollitropin may include:

• mild stomach upset, constipation;

• mild pelvic pain, cramps;

• breast tenderness;

• skin rash;

• hot flashes;

• acne; or

• pain, swelling, redness, itching, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to urofollitropin: injectable powder for injection, intramuscular powder for injection, subcutaneous powder for injection

Cardiovascular

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

Dermatologic

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

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, diarrhea, abdominal cramps, and bloating.

General

General side effects have included headache and abdominal pain.

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 (20%), severe ovarian hyperstimulation syndrome (OHSS)(6%), breast tenderness, and ovarian cysts.

Local

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

Oncologic

Oncologic side effects have included infrequent reports of neoplasms (both benign and malignant) in women who have undergone multiple drug regimens for ovulation induction. However, a causal relationship has not been established.

Other

Other side effects have included reactions including chills, musculoskeletal aches, joint pains, malaise, headache, and fatigue.

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

Respiratory

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

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