Pronunciation:

LOO-ten-eye-zing HOR-mone, FOL-i-kul STIM-yoo-lay-ting HOR-mone

Brand Names:

• Menopur
• Pergonal
• Repronex

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Human Luteinizing Hormone

Uses of This Medicine:

Menotropins injection is used to treat infertility in women. Menotropins are a mixture of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) that are produced in the body by the pituitary gland.

Menotropins injection is used in women with healthy ovaries who are enrolled in a fertility program called assisted reproductive technology (ART). ART uses procedures such as in vitro fertilization (IVF). Menotropins is used together with human chorionic gonadotropin (hCG) in these procedures.

Many women choosing treatment with menotropins have already tried clomiphene (eg, Serophene) and have not been able to conceive yet. Menotropins may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

This medicine is available only with your doctor's prescription.

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of menotropins injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of menotropins injection have not been performed in the geriatric population.

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 or unusual vaginal bleeding or
• Adrenal gland problems, uncontrolled or
• Cysts in the ovaries or enlarged ovaries or
• High levels of FSH or
• Pituitary gland problems, uncontrolled or
• Thyroid gland problems, uncontrolled or
• Tumor in the brain (hypothalamus area or pituitary gland) or
• Tumor in the breast or
• Tumor in the ovary or uterus—Should not be used in patients with these conditions.

• Blood clots (eg, pulmonary embolism, venous thromboembolism), or history of or
• Blood vessel problems or
• Lung or breathing problems or
• Ovarian torsion (twisting of the ovary), history of or
• Stroke, or history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under the skin.

Menotropins injection is used with another hormone called human chorionic gonadotropin (hCG). At the proper time, your doctor or nurse will give you this medicine.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You might be taught how to give your medicine at home. If you are using this medicine at home:

• Wash your hands with soap and water and use a clean work area to prepare your injection.
• Make sure you understand and carefully follow your doctor's instructions on how to give yourself an injection, including the proper use of a needle and syringe.
• Check the solution in the vial. It should be clear and colorless. If it is cloudy, discolored, or contains large particles, do not use it.
• Do not inject more or less of the medicine than your doctor ordered.
• You will be shown the body areas (eg, stomach) where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will prevent skin problems.
• Use a new needle and syringe each time you inject your medicine.
• It is very important that you keep track of each dose you inject. Your doctor or nurse will help you with this.

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 help in becoming pregnant while using other pregnancy-promoting methods (assisted reproductive technology [ART]):
    • Adults—At first, 225 International Units (IU) (150 IU of Menopur® and 75 IU of Bravelle® or 75 IU of Menopur® and 150 IU of Bravelle®) injected under the skin once a day. Your doctor will adjust your dose after 5 days, if needed. However, the dose is usually not more than 450 IU per day. Do not use this medicine for more than 20 days.
    • Children—Use is not recommended.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

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.

Store the unused medicine in the refrigerator or at room temperature until it is mixed. Protect it from light.

Throw away used needles and syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Blood and urine tests, and ultrasound examinations are needed to check for any unwanted effects caused by this medicine.

Call your doctor right away if you think you have become pregnant while you are using this medicine. You may have a higher risk of an ectopic pregnancy or miscarriage if you get pregnant while undergoing IVF procedures. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

If your doctor has asked you to record your basal body temperatures (BBTs) daily, make sure that you know how to do this. Carefully follow your doctor's instructions.

This medicine may increase your risk of having a problem with the ovaries called ovarian hyperstimulation syndrome (OHSS). OHSS is a serious problem that can be life-threatening. Call your doctor right away if you have severe pain in the lower stomach area, nausea, vomiting, weight gain, diarrhea, decreased urine output, or trouble breathing.

This medicine may increase your risk of having a blood clot, heart attack, or stroke. This is more likely in people who already have heart disease. Contact your doctor right away if you have chest pain, tightness in the chest, a fast or irregular heartbeat, unusual flushing or warmth of the skin, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart problems or blood clots.

This medicine may cause more than one egg to be released from your ovary at the same time. This means you may become pregnant with more than one baby. Talk with your doctor about this possibility before you start using this medicine.

This medicine may increase your risk of having ovarian cancer if you received it more than one time to get pregnant. Talk to your doctor about this risk.

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 immediately if any of the following side effects occur:

For females only

Less common

Back pain

breast tenderness

feeling of warmth, redness of the face, neck, arms, and occasionally, upper chest

menstrual changes

muscle aches and pains

unusual tiredness or weakness

Less common or rare

Abdominal or stomach pain (severe)

bloating (moderate to severe)

chest pain or trouble breathing

decreased amount of urine

feeling of indigestion

general feeling of discomfort or illness

headache, severe and throbbing

nausea, vomiting, or diarrhea (continuing or severe)

pain or swelling in the arms or legs

pelvic pain (severe)

severe cramping of the uterus

shortness of breath or wheezing

swelling of the lower legs

weight gain (rapid)

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:

For females only

Less common

Enlargement of the breasts

headache

pain, swelling, or irritation at the injection site

rash at the injection site

stomach cramps, fullness, or pain

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

For females only

Abdominal or stomach pain (severe)

bloating (moderate to severe)

decreased amount of urine

feeling of indigestion

nausea, vomiting, or diarrhea (continuing or severe)

pelvic pain (severe)

shortness of breath

weight gain (rapid)

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.