(lou TRO peen aal fa) Brand: 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 search abnormal medical attention if you develop any of these symptoms.
• 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 manufacture a follicle but hormonal stimulation is not sufficient to create the follicle mature.
• Lutropin alfa may also be used for purposes another than those listed in this medicine guide.
• Lutropin alfa will not induce ovulation if the ovaries are not capable of producing an egg.
• Till using this medicine, speak your doctor if you
· might be pregnant;
· have a thyroid problem;
· have adrenal dysfunction;
· have cancer or a tumor of the breast, ovary, uterus, hypothalamus, or pituitary gland;
· have undiagnosed emergency vaginal bleeding; or
· have ovarian cysts or enlargement not due to polycystic ovary malady (PCOD).
• You may not be able to use lutropin alfa, or you may require a dosage adjustment or particular monitoring if you have any of the conditions listed above.
• 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.
• Do not use this medicine if you are pregnant. Lutropin alfa is in the FDA pregnancy category X. This means that lutropin alfa is known to reason birth defects in an unborn child (when used beyond the period of ovulation).
• It is not known whether lutropin alfa passes into breast milk. Do not use lutropin alfa without first talking to your doctor if you are breast-feeding a baby.
• Use lutropin alfa exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.
• Lutropin alfa must only be administered subcutaneously. If you are administering this medicine at house, your doctor will give you detailed instructions on how to mix the solution and give the injection. Do not inject this medicine if you are not certain how.
• Do not shake the vial, but gently swirl before the solution is clear. Do not inject any medicine that is discolored or that has particles in it.
• Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.
• Lutropin alfa must be used immediately after mixing. Any unused portion must be thrown away.
• Contact your doctor if you miss a doze of lutropin alfa.
• An overdose of lutropin alfa is unlikely to threaten life. Notify your doctor immediately or call an abnormal room or poison control center for advice if an overdose is suspected.
• Symptoms of a lutropin alfa overdose are not known.
• There are no restrictions on food, beverages, or activity during treatment with lutropin alfa unless otherwise directed by your doctor.
• Stop using lutropin alfa and search abnormal medical attention or notify your doctor immediately if you experience any of the next serious side effects:
· an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or person; or hives);
· pain, warmth, redness, numbness, or tingling in an hand 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 search abnormal medical attention if you develop any of these symptoms.
• Another 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 another than those listed here may also occur. Conversation to your doctor about any side effect that seems unusual or that is especially bothersome. You may message side effects to FDA at 1-800-FDA-1088.
• It is not known whether another medications will interact with lutropin alfa. Conversation to your doctor and pharmacist till taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
• Your pharmacist has additional information about lutropin alfa written for health professionals that you may read.
Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
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