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Brand Names: Luveris

Generic Name: lutropin alfa (Pronunciation: lou TRO peen aal fa)

• What is lutropin alfa (Luveris)?
• What are the possible side effects of lutropin alfa (Luveris)?
• What is the most important information I should know about lutropin alfa (Luveris)?
• What should I discuss with my healthcare provider before using lutropin alfa (Luveris)?
• How should I use lutropin alfa (Luveris)?
• What happens if I miss a dose (Luveris)?
• What happens if I overdose (Luveris)?
• What should I avoid while using lutropin alfa (Luveris)?
• What other drugs will affect lutropin alfa (Luveris)?
• Where can I get more information?

What is lutropin alfa (Luveris)?

Lutropin alfa is a hormone used to support Follicle Stimulating Hormone (FSH) therapy.

Lutropin alfa is used with follitropin alfa (Gonal-F) to stimulate a follicle(egg) to develop and mature. The therapy used when a woman desires pregnancy and her ovaries can produce a follicle but hormonal stimulation is not sufficient to make the follicle mature.

Lutropin alfa may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of lutropin alfa (Luveris)?

Stop using lutropin alfa and seek emergency medical attention or notify your doctor immediately if you experience any of the following serious side effects:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• pain, warmth, redness, numbness, or tingling in an arm or leg (which may indicate a blood clot);
• confusion, severe dizziness, severe headache; or
• difficulty breathing.

Patients treated with lutropin alfa may develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include severe pelvic pain, swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low urine output, diarrhea, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these symptoms.

Other side effects may also occur. Notify your doctor if you experience

• ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;
• nausea, vomiting, diarrhea, or flatulence (gas);
• fever or chills;
• headache;
• dizziness;
• rapid pulse or heart rate;
• muscle or joint weakness or aching;
• breast tenderness;
• spotting or menstrual changes;
• pain, swelling, or irritation at the injection site; or
• dry skin, a rash, or hair loss.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about lutropin alfa (Luveris)?

Treatment with lutropin alfa increases the likelihood of multiple births. Multiple births carry additional risk both for the mother and for fetuses. Discuss the risk of multiple births with your healthcare provider.

Patients treated with lutropin alfa may develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include severe pelvic pain, swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low urine output, diarrhea, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these symptoms.

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