Menotropins

Menotropins are a combination of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). FSH and LH play a key role in the development of follicles (eggs) that the ovaries produce in women.

Menotropins are used to assist your body in producing multiple eggs during ovulation, in preparation for in-vitro fertilization.

Menotropins may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label. Your doctor may sometimes change your dose to ensure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

This medicine is injected under the skin. You may be shown how to give injections at home. Do not self-inject this medicine if you do not understand how to give the injection and how to properly dispose of used needles and syringes.

Menotropins come in a powder form that must be mixed with a liquid (diluent) before use. If you are using the injections at home, make sure you know how to mix and store the medicine correctly.

Read all patient information, medication guides, and instruction sheets given to you. Ask your doctor or pharmacist if you have any questions.

Gently swirl the medicine after mixing. Do not shake the mixed medicine or it may foam. Prepare your dose only when you are ready to give an injection; do not save it for later use. Do not use if the mixture has changed colors or has particles in it. Call your pharmacist for new medicine.

You may need to use more than 1 vial of menotropins for your full dose.

After giving the injection, discard any portion of the mixed medicine that is not used right away. Do not save it for later use.

For the best results from your fertility treatments, follow your doctor's instructions very carefully.

Use a disposable needle and syringe only once. Follow any state or local laws about disposing of used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to dispose of it). Keep this container out of reach of children and pets.

To ensure the medicine is effective, you will need frequent blood tests and ultrasound exams. You may also need to record your temperature on a daily chart.

Store unmixed powder medicine at room temperature away from moisture, heat, and light.

You may also store the powder in a refrigerator. Do not freeze.

Infertility is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

You should not use this medicine if you have primary ovarian failure, abnormal vaginal bleeding, uncontrolled thyroid or adrenal gland disorders, an ovarian cyst, breast cancer, uterine or ovarian cancer, a tumor of your pituitary gland or hypothalamus, or infertility that is not caused by lack of ovulation.

Do not use menotropins if you are pregnant.

You should not use menotropins if you are allergic to menotropins, or if you have:

• a condition called primary ovarian failure;
• cancer of the breast, uterus, or ovary;
• an untreated or uncontrolled disorder of your thyroid or adrenal gland;
• infertility that is not caused by lack of ovulation;
• abnormal vaginal bleeding that has not been checked by a doctor;
• an ovarian cyst or enlarged ovaries;
• a tumor of your pituitary gland or hypothalamus; or
• if you are pregnant or breast-feeding.

Menotropins will not cause ovulation if your ovaries are not functioning properly.

Your doctor will perform blood tests and a pelvic exam to make sure you do not have conditions that would prevent you from safely using menotropins.

Your male sexual partner's fertility should also be checked before you are treated with menotropins.

To make sure menotropins are safe for you, tell your doctor if you have:

• asthma;
• a history of stomach surgery;
• a history of ovarian cyst or "torsion" (twisting) of your ovary; or
• risk factors for blood clots (such as diabetes, smoking, heart disease, coronary artery disease, being overweight, having a family history of coronary artery disease).

Using menotropins can increase your chances of having a multiple pregnancy (twins, triplets, quadruplets, etc). A multiple pregnancy is a high-risk pregnancy for the mother and for the babies. Follow your doctor's instructions about any special care you may need during your pregnancy.

Menotropins may also increase your risk of tubal pregnancy, miscarriage, stillbirth, premature labor, birth defects, or fever after childbirth if you become pregnant after being treated with this medicine. Talk with your doctor if you are concerned about these risks.

Although menotropins can help you become pregnant, this medicine can harm an unborn baby or cause birth defects. Do not use menotropins if you are already pregnant. Tell your doctor right away if you become pregnant during treatment.

It is not known whether menotropins pass into breast milk. Do not use menotropins without first talking to your doctor if you are breast-feeding a baby.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some women using menotropins develop a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment. OHSS can be a life-threatening condition. Stop using menotropins, do not have sexual intercourse, and call your doctor right away if you have any of the following symptoms of OHSS:

• stomach pain, bloating;
• nausea, vomiting, diarrhea;
• rapid weight gain, especially in your face and midsection;
• little or no urinating; or
• pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down).

Also call your doctor at once if you have:

• chest pain, dry cough, feeling short of breath (especially when lying down);
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects of menotropins may include:

• stomach cramps or bloating;
• headache; or
• pain, swelling, or warmth where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Follicle Stimulation:

Assisted reproduction technologies (ART):Initial dose: -225 International Units subcutaneously (SC) or intramuscularly (IM) daily.-Menotropin may be administered together with urofollitropin, and the total combined dose should not exceed 225 international units (150 international units menotropin and 75 international units urofollitropin, or 75 international units menotropin and 150 international units urofollitropin).Maximum dose: -450 international units daily -If given with urofollitropin, the total combined dose of urofollitropin and menotropin should not exceed 450 international units daily. Duration of therapy: 7 to 20 daysComments:-Continue treatment until adequate follicular development is evident, then administer human chorionic gonadotropin (hCG).-Withhold hCG if monitoring on the last day of therapy suggests an increased risk of ovarian hyperstimulation syndrome (OHSS).Ovulation induction:Initial dose: 150 international units SC or IM daily for the first 5 days of treatment.Maximum dose: 450 international units dailyDuration of therapy: 7 to 12 days Comments: -If patient response is appropriate, give hCG 1 day after the last dose of menotropin. -If inadequate follicle development or ovulation without subsequent pregnancy, treatment may be repeated.Uses: -Development of Multiple Follicles and Pregnancy in Ovulatory Women as Part of an Assisted Reproductive Technology (ART) Cycle -Ovulation induction in patients who have previously received pituitary suppression

Call your doctor for instructions if you miss a dose of menotropins.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

Other drugs may interact with menotropins, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform each of your health care providers about all medicines you are currently using and any medicine you begin or discontinue.