Menopur

Generic Name: follicle stimulating hormone and luteinizing hormone (Intramuscular route, Subcutaneous route)

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

Commonly used brand name(s):

In the U.S.

• Menopur
• Pergonal
• Repronex

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Human Luteinizing Hormone

Uses For Menopur

Menotropins are a mixture of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) that are naturally produced by the pituitary gland.

Use in females—FSH is primarily responsible for stimulating growth of the ovarian follicle, which includes the developing egg, the cells surrounding the egg that produce the hormones needed to support a pregnancy, and the fluid around the egg. As the follicle grows, an increasing amount of the hormone estrogen is produced by the cells in the follicle and released into the bloodstream. Estrogen causes the endometrium (lining of the uterus) to thicken before ovulation occurs. The higher blood levels of estrogen will also tell the hypothalamus and pituitary gland to slow the production and release of FSH.

LH also helps to increase the amount of estrogen produced by the follicle cells. However, its main function is to cause ovulation. The sharp rise in the blood level of LH that triggers ovulation is called the LH surge. After ovulation, the group of hormone-producing follicle cells become the corpus luteum, which will produce estrogen and large amounts of another hormone, progesterone. Progesterone causes the endometrium to mature so that it can support implantation of the fertilized egg or embryo. If implantation of a fertilized egg does not occur, the levels of estrogen and progesterone decrease, the endometrium sloughs off, and menstruation occurs.

Menotropins are usually given in combination with human chorionic gonadotropin (hCG). The actions of hCG are almost the same as those of LH. It is given to simulate the natural LH surge. This results in ovulation at an expected time.

Many women choosing treatment with menotropins have already tried clomiphene (e.g., 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).

Use in males—Menotropins are used to stimulate the production of sperm in some forms of male infertility.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, menotropins are used in certain patients with the following medical conditions:

• For causing ovulation in women to help them become pregnant
• For producing sperm in men

Before Using Menopur

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.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of menotropins in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of menotropins in the elderly with use in other age groups.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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:

• Adrenal gland or thyroid disease (not controlled) or
• Tumor, brain or
• Tumor, sex hormone-dependent—Menotropins should not be used in patients with these medical problems.

• Cyst on ovary—Menotropins can cause further growth of cysts on the ovary

• Primary ovarian failure—Menotropins will not work in patients whose ovaries no longer develop eggs.

• Unusual vaginal bleeding—Some irregular vaginal bleeding is a sign that the endometrium is growing too rapidly, possibly of endometrial cancer, or some hormone imbalances; the increases in estrogen production caused by menotropins can make these problems worse. If a hormonal imbalance is present, it should be treated before beginning menotropins therapy

Proper Use of follicle stimulating hormone and luteinizing hormone

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 Menopur. Please read with care.

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—225 Units of FSH and 225 Units of LH injected under the skin below your belly button. Your doctor will adjust your daily dose after checking your blood and your ovaries. Usually your doctor will give you another medicine called human chorionic gonadotropin (hCG) the day after the last dose of menotropins.

Precautions While Using Menopur

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. Your doctor will likely want to watch the development of the ovarian follicle(s) by measuring the amount of estrogen in your bloodstream and by checking the size of the follicle(s) with ultrasound examinations.

For females only:

• If your doctor has asked you to record your basal body temperatures (BBTs) daily, make sure that you do this every day. It is important that intercourse take place around the time of ovulation to give you the best chance of becoming pregnant. Follow your doctor's instructions carefully.
• If you become pregnant as a result of using this medicine, there is an increased chance of a multiple pregnancy.

Menopur Side Effects

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 as soon as possible if any of the following side effects occur:

• Bloating (mild)
• pain, swelling, or irritation at place of injection
• rash at place of injection or on body
• stomach or pelvic pain

• 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
• swelling of the lower legs
• weight gain (rapid)

• Dizziness
• fainting
• headache
• irregular heartbeat
• loss of appetite
• more frequent nosebleeds
• shortness of breath

• Coughing
• headache
• mild nausea
• sneezing
• sore throat
• stuffy or runny nose

• Back pain
• breast tenderness
• chills
• difficulty having a bowel movement (stool)
• dizziness
• feeling of warmth, redness of the face, neck, arms and occasionally, upper chest
• fever
• general feeling of discomfort or illness
• headache, severe and throbbing
• joint pain
• loss of appetite
• menstrual changes
• mild diarrhea
• mild vomiting
• muscle aches and pains
• pain
• severe cramping of the uterus
• shivering
• sweating
• trouble sleeping
• unusual tiredness or weakness

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 breasts

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.

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