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 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.

Use Fertinex (Injectable) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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 this medicine 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 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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.