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|Luveris

LUTROPIN ALFA (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Luveris

† Not commercially available in Canada.

Category

• Gonadotropin
• infertility therapy agent

Description

Lutropin alfa (LOO-troe-pin alfa) is a drug whose actions are almost the same as those of luteinizing (loo-te-in-eye-ZING) hormone (LH), which is produced by the pituitary gland. It is a hormone also normally produced by the placenta in pregnancy.

Lutropin alfa is used to help conception occur. It is usually given in combination with follitropin alfa. Many women being treated with these drugs usually have not been able to conceive yet.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Parenteral
• For injection (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For lutropin alfa, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to lutropin alfa. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Lutropin alfa is not recommended for use during pregnancy. Since women using lutropin alfa may be more likely to have more than one child at a time, the problems of multiple births may be increased for women using this medicine. Also, this medicine has been shown to overstimulate the ovaries (ovarian hyperstimulation syndrome) for a longer time in some women who conceive than in women developing this syndrome who do not become pregnant. Before you use this medicine, make sure your doctor knows if you are pregnant.

Breast-feeding—It is not known whether lutropin alfa passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of lutropin alfa. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal bleeding of genitals or uterus (unknown cause)—Use of lutropin alfa may make the diagnosis of this problem more difficult

• Adrenal gland or thyroid disease (not controlled) or
• Tumor, brain or
• Tumor, sex hormone-dependent—Use of lutropin alfa may make these conditions worse

• Ovarian cyst or enlarged ovaries—Use of lutropin alfa may increase the size of a cyst on an ovary or increase the size of enlarged ovaries

• Primary ovarian failure—Lutropin alfa will not work in patients whose ovaries no longer develop eggs
• Thrombophlebitis, active—Lutropin alfa may increase the risk of side effects

Proper Use of This Medicine

To make using lutropin alfa as safe and reliable as possible, you should understand how and when to use this medicine and what effects may be expected. A paper with information for the patient will be given to you with your filled prescription and will provide many details concerning the use of lutropin alfa. Read this paper carefully and ask your health care professional for any additional information or explanation.

Sometimes lutropin alfa can be given by injection at home. If you are using this medicine at home:

• Understand and use the proper method of safely preparing the medicine if you are going to prepare your own medicine.
• Wash your hands with soap and water and use a clean work area to prepare your injection.
• Make sure you clearly understand and carefully follow your doctor"s instructions on how to give yourself an injection, including using the proper needle and syringe.
• Do not inject more or less of the medicine than your doctor ordered.
• Remember to move the site of injection to different areas to prevent skin problems from developing.
• Throw away needles, syringes, bottles, and unused medicine after the injection in a safe manner.

Tell your doctor when you use the last dose of lutropin alfa . Follitropin alfa often requires that another hormone called human chorionic gonadotropin (hCG) be given as a single dose the day after the last dose of lutropin alfa is given. Your doctor will give you this medicine or arrange for you to get this medicine at the right time.

Dosing—The dose of lutropin alfa will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of lutropin alfa. If your dose is different, do not change it unless your doctor tells you to do so.

• For injection dosage form
  • For treatment of female infertility:
    • Adults—75 international units (IU) injected under the skin once a day for approximately fourteen days. Lutropin alfa is administered together with 75 to 150 IU of follitropin alfa as two separate injections. Using lutropin alfa for longer than fourteen days may be needed, but only if directed by your doctor. Report when you receive your last dose of lutropin alfa because you may be given an injection of hCG twenty-four hours later. If abdominal pain occurs with the use of lutropin alfa, report it to your doctor immediately, discontinue treatment, do not receive the dose of hCG, and avoid sexual intercourse.
    • Children—Not for use in children.

Missed dose—If you miss a dose of this medicine, discuss with your doctor when you should receive your next dose. Do not double doses. If you have any questions about this, check with your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress often at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will probably want to follow the developing eggs inside the ovaries by doing an ultrasound examination and measuring hormones in your blood stream. After you no longer receive lutropin alfa and follitropin alfa therapy, your progress still must be checked for at least 2 weeks .

If your doctor has asked you to record your basal body temperatures (BBTs) daily, make sure that you do this every day. Using a BBT record or some other method, your doctor will help you decide when you are most fertile and when ovulation occurs. It is important that sexual intercourse take place around the time when you are most fertile to give you the best chance of becoming pregnant. Follow your doctor"s directions carefully .

If abdominal pain occurs with use of lutropin alfa, discontinue treatment and report the problem to your doctor immediately. Do not receive the injection of human chorionic gonadotropin (hCG) and avoid sexual intercourse .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

More common

Less common

Developed: 11/17/2004

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