Pergonal

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.

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.

This section provides information on the proper use of a number of products that contain follicle stimulating hormone and luteinizing hormone. It may not be specific to Pergonal. Please read with care.

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.

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:

• 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

• 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:

• 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:

• 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.