Luveris

Luveris

Luveris

What is Luveris?

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

Luveris does not trigger ovulation (production of an egg by the ovaries). You will need to be given other medications to stimulate ovulation.

Warnings

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

Do not use Luveris if you are pregnant.

Stop using Luveris, do not have sex, and call your doctor immediately if you notice any of the following symptoms: stomach pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, little or no urination or pain when breathing, fast heartbeat, or shortness of breath.

Treatment with Luveris increases the chance of multiple births. Multiple births carry additional risk for both the mother and the fetuses. Discuss the risk of multiple births with your doctor.

Before you take this medicine

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 not due to lack of ovulation;

• a condition called primary ovarian failure;

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

• an untreated or uncontrolled disease 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 do blood tests and a pelvic exam to make sure you do not have any medical conditions that would prevent you from using Luveris safely.

The fertility of your male sexual partner 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;

• Smoke; or

• be overweight.

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

Luveris may also increase your risk of ectopic pregnancy, miscarriage, stillbirth, premature labor, birth defects, or fever after birth if you become pregnant after treatment with this medicine. Talk to 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 immediately.

FDA pregnancy categoryDo not use Luveris if you are pregnant.Tell your doctor immediately if you become pregnant during treatment.

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

How is Luveris administered?

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

Follow all instructions 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 instructions carefully. If you have any questions, contact your doctor or pharmacist.

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

After mixing the medicine, stir it gently.Do not shake the medication bottleor you could ruin the medicine. Do not prepare your dose until you are ready to give an injection. Do not use if the medicine is cloudy, has changed color, or contains particles. Call your pharmacist for a new medicine.

Luveris is usually given daily for up to 14 days. To ensure that the medicine is effective, frequent blood tests and ultrasounds are required. You may also need to record your temperature on a daily chart.

To get the best results from your fertility treatments, follow your doctor's instructions carefully.

Use a disposable needle only once. Follow all state or local laws about throwing away used needles and syringes. Use a puncture-resistant 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 medications at room temperature, away from moisture, heat, and light.

You can also store the powder in the refrigerator. Do not freeze.

Infertility is often treated with a combination of medications. Use all medications as directed by your doctor. Read the Medication Guide or Patient Instructions included with each medication. Do not change your dosage or medication schedule without your doctor's advice.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid when using Luveris?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

Side effects of Luveris

Get emergency medical help if you have any of these problemsSigns 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 sex, and call your doctor immediately if you have any of the following symptoms of OHSS:

• stomach pain, flatulence;

• nausea, vomiting, diarrhea;

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

• little or no urination; or

• Pain when breathing, fast heartbeat, shortness of breath (especially when lying down).

Additionally, call your doctor immediately if you notice any 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, vision or balance problems;

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

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

Common side effects of Luveris may include:

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

• pelvic pain, menstrual cramps;

• chest pain;

• Headache;

• pain or irritation at the injection site;

• 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 can report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Luveris?

Other medications may interact with lutropin alfa, including prescription and over-the-counter medications, vitamins, and herbal products. Tell each of your healthcare providers about all medications you are taking now and any medications you are starting or stopping taking.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and only use Luveris for the prescribed indication.