Pronunciation:

loo-TROE-pin AL-fa

Brand Names:

• Luveris

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Human Luteinizing Hormone

Uses of This Medicine:

Lutropin alfa is a drug whose actions are almost the same as those of luteinizing 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 was available only with your doctor's prescription.

Lutropin alfa (Luveris®) injections were withdrawn from the U.S. market by EMD Serono, Inc. on July 16, 2012.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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
• Brain tumor 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 doctor 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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 14 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 24 hours later. If abdominal or stomach 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—

Call your doctor or pharmacist for instructions.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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 or stomach 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.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

bloating

diarrhea

stomach or pelvic discomfort, aching, or heaviness

Incidence not known (Observed after pregnancy)

Congenital abnormalities

ectopic pregnancy

postpartum fever

premature labor

spontaneous abortion

Incidence not known (Observed during menotropin therapy)

Adnexal torsion as a complication of ovarian enlargement

blood in the peritoneal cavity

changes in skin color

cold hands and feet

ovarian enlargement (mild to moderate)

pain, redness, or swelling in the arm or leg

troubled breathing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Abdominal or stomach pain

bloating

multiple gestation

rapid weight gain

severe nausea

vomiting

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bloated or full feeling

breast pain

excess air or gas in the stomach or intestines

headache

pain

passing gas

unusual tiredness or weakness

Less common

Body aches or pain

chills

cough

cramps

difficulty having a bowel movement (stool)

difficulty with breathing

ear congestion

fever

heavy bleeding

loss of voice

nasal congestion

ovarian disorder

pain

runny nose

sneezing

sore throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.