Urofollitropin is a purified form of a hormone called follicle-stimulating hormone (FSH). This hormone is important in the development of follicles (eggs) that are produced by the ovaries in women.

Urofollitropin is used together with other medicines to treat infertility in women with FSH deficiency. Urofollitropin is also used to help the ovaries produce multiple eggs for use in "in-vitro" fertilization.

Urofollitropin alone will not cause ovulation (production of an egg by the ovaries). You will need to receive other medicines to stimulate ovulation.

Urofollitropin may also be used for purposes not listed in this medication guide.

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 pituitary gland tumor, or infertility that is not caused by lack of ovulation.

Do not use urofollitropin if you are pregnant.

Stop using urofollitropin, do not have sexual intercourse, and call your doctor right away if you have any of the following symptoms: stomach pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, little or no urinating, or pain when you breathe, rapid heart rate, or shortness of breath.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Urofollitropin is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Gently swirl the medicine after mixing. Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine is cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

After giving the injection, throw away 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 throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

To be sure 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.

Usual Adult Dose for Follicle Stimulation:

Ovulation induction:
Initial dose: 150 international units per day for 5 days, subcutaneously (SC) or intramuscularly (IM)
Maximum dose: 450 international units per day
Duration of therapy: 12 days

Comments:
-When pre-ovulatory conditions are reached, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation.
-Withhold hCG when monitoring suggests an increased risk of ovarian hyperstimulation syndrome (OHSS) on the last day of therapy.
-Encourage daily intercourse, beginning on the day prior to hCG and until ovulation becomes apparent.
-Discourage intercourse when the risk for OHSS is increased.

Assisted reproduction:
Initial dose: 225 international units per day for 5 days, subcutaneously
-If given with menotropin, the total combined dose should not exceed 225 international units (150 international units urofollitropin and 75 international units menotropin, or 75 international units urofollitropin and 150 international units menotropin).
Maximum dose: 450 international units per day
-If given with menotropin, the total combined dose of urofollitropin and menotropin should not exceed 450 international units per day.
Duration of therapy: 12 days

Comments:
-Beginning on cycle day 2 or 3, administer daily until sufficient follicular development is attained, as determined by ultrasound and measurement of serum estradiol levels.
-Continue treatment until adequate follicular development is evident, and then administer hCG.
-Withhold hCG where monitoring suggests an increased risk of OHSS on the last day of therapy.

Uses:
-Induction of ovulation in women who have previously received pituitary suppression - intramuscular and subcutaneous administration.
-Development of multiple follicles as part of an Assisted Reproductive Technology (ART) cycle in ovulatory women who have previously received pituitary suppression.

You should not use urofollitropin if you are allergic to urofollitropin or similar medicines (such as follitropin, lutropin alfa, menotropin), 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;

• a tumor of your pituitary gland; or

• if you are pregnant.

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 urofollitropin.

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

To make sure urofollitropin is 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 urofollitropin 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.

Urofollitropin 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.

Urofollitropin may increase your risk of developing uterine cancer. Ask your doctor about your specific risk. Report any unusual vaginal bleeding right away.

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

It is not known whether urofollitropin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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

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, beverages, or activity.

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

Some women using urofollitropin develop a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment. OHSS can be a life threatening condition. Stop using urofollitropin, 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 signs of a stroke or blood clot, such as:

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• pain, swelling, warmth, or redness in one or both legs.

Common side effects of urofollitropin may include:

• stomach cramps or bloating;

• headache, general pain;

• nausea;

• trouble breathing;

• hot flashes; or

• mild pelvic pain, pain after an egg is removed for in-vitro fertilization.

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.

Other drugs may interact with urofollitropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.