Luveris is a purified form of a hormone called luteinizing (LOO-tin-eye-zing) hormone, or LH. This hormone is important in the development of follicles (eggs) produced by the ovaries in women.

Luveris is used together with follitropin alfa to treat infertility in women with LH deficiency.

Luveris will not cause ovulation (production of an egg by the ovaries). You will need to receive other medicines to stimulate ovulation.

You should not use Luveris if you have primary ovarian failure, abnormal vaginal bleeding, uncontrolled thyroid or adrenal gland disorders, an ovarian cyst, uterine or ovarian cancer, a pituitary gland tumor, or infertility that is not caused by lack of ovulation.

Do not use Luveris if you are pregnant.

Stop using Luveris, do not have sexual intercourse, and call your doctor right away if you have any of the following symptoms: stomach pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, little or no urinating, or pain when you breathe, rapid heart rate, or shortness of breath.

Treatment with Luveris 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.

Luveris is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Luveris is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Gently swirl the medicine after mixing. Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine is cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Luveris is usually given daily for up to 14 days. To be sure the medicine is effective, you will need frequent blood tests and ultrasound exams. You may also need to record your temperature on a daily chart.

For the best results from your fertility treatments, follow your doctor's instructions very carefully.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Store unmixed powder medicine at room temperature away from moisture, heat, and light.

You may also store the powder in a refrigerator. Do not freeze.

Infertility is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

You should not use Luveris if you are allergic to lutropin alfa or similar medicines (such as follitropin, menotropin, urofollitropin), or if you have:

• infertility that is not caused by lack of ovulation;

• a condition called primary ovarian failure;

• abnormal vaginal bleeding that has not been checked by a doctor;

• an untreated or uncontrolled disorder of your thyroid or adrenal gland;

• an ovarian cyst;

• cancer of the uterus or ovary;

• a tumor of your pituitary gland; or

• if you are pregnant.

Your doctor will perform blood tests and a pelvic exam to make sure you do not have conditions that would prevent you from safely using Luveris.

Your male sexual partner's fertility should also be checked before you are treated with Luveris.

To make sure Luveris is safe for you, tell your doctor if you have risk factors for coronary artery disease, such as:

• diabetes;

• high blood pressure or high cholesterol;

• a family history of coronary artery disease;

• smoking; or

• being overweight.

Using Luveris can increase your chances of having a multiple pregnancy (twins, triplets, quadruplets, etc). A multiple pregnancy is a high-risk pregnancy for the mother and for the babies. Follow your doctor's instructions about any special care you may need during your pregnancy.

Luveris may also increase your risk of tubal pregnancy, miscarriage, stillbirth, premature labor, birth defects, or fever after childbirth if you become pregnant after being treated with this medicine. Talk with your doctor if you are concerned about these risks.

Luveris may increase your risk of developing uterine cancer. Ask your doctor about your specific risk. Report any unusual vaginal bleeding right away.

FDA pregnancy category X. Although Luveris can help you become pregnant, this medicine can harm an unborn baby or cause birth defects. Do not use Luveris if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

It is not known whether lutropin alfa passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Call your doctor for instructions if you miss a dose of Luveris.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction to Luveris: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine develop a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment. OHSS can be a life threatening condition. Stop using Luveris, do not have sexual intercourse, and call your doctor right away if you have any of the following symptoms of OHSS:

• stomach pain, bloating;

• nausea, vomiting, diarrhea;

• rapid weight gain, especially in your face and midsection;

• little or no urinating; or

• pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down).

Also call your doctor at once if you have signs of a stroke or blood clot, such as:

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• pain, swelling, warmth, or redness in one or both legs.

Common Luveris side effects may include:

• nausea, stomach pain, diarrhea, constipation, gas;

• pelvic pain, menstrual cramps;

• breast pain;

• headache;

• pain or irritation where the injection was given;

• tired feeling; or

• cold symptoms such as stuffy nose, sneezing, sore throat;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.