Urofollitropin, Injection

What are other names for this medicine?

Type of medicine: gonadotropin; infertility therapy; ovulation stimulator

Generic and brand names: urofollitropin, injection; Bravelle

What is this medicine used for?

This medicine is a fertility drug given by injection (shot) to help a woman get pregnant. It helps a woman's body release eggs from her ovaries so that they can be fertilized during intercourse.

It may also be used to help men produce sperm.

It is also used for in vitro fertilization, where eggs are taken out of the woman's body, fertilized by sperm, and put back into her uterus.

It is used with another fertility medicine.

What should my healthcare provider know before I take this medicine?

Before using this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• primary ovarian failure (your ovaries no longer make eggs)
• primary testicular failure
• thyroid or adrenal gland problems
• tumors of the ovary, uterus, breast, testicles, brain, or pituitary gland
• unusual vaginal bleeding
• an ovarian cyst or any unusual growth in the ovaries

Females of childbearing age: Do not have shots of this medicine if you are already pregnant or breast-feeding because it may seriously harm the baby. Birth defects have occurred in babies born to women who had these shots during pregnancy. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I use it?

Shots of this medicine are timed with your monthly periods. Your healthcare provider will determine the dosage and the number of shots you will receive based on your response to the first few shots. You will be given these shots over several days or weeks.

You will receive several shots of this medicine. The number of shots you receive depends on your response. Your healthcare provider will decide when you should receive a shot of a second hormone. Follow your healthcare provider's instructions about when to have intercourse if you are not having in vitro fertilization. It may take several courses of treatment for pregnancy to occur. Sometimes you can give yourself these shots or have someone at home give them to you. Be sure you know how and when to have shots and how much medicine to use. Use sterile, disposable syringes and needles. Use each syringe and needle only once and dispose of them safely, following your healthcare provider's instructions.

Do not shake the medicine.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

If you are not having in vitro fertilization, your healthcare provider will tell you on which days each month you need to have sexual intercourse. It may take several months to become pregnant.

You may need many tests, including ultrasound exams and blood tests, during treatment with this medicine. You may also receive shots of other medicines. Keep all your appointments for treatment and tests.

Your ovaries may become enlarged, which may cause mild abdominal bloating and pain. Contact your healthcare provider if these symptoms last more than 2 to 3 weeks or if they become severe.

Rarely, this medicine causes a condition called ovarian hyperstimulation syndrome. The symptoms are severe abdominal bloating and pain, nausea, vomiting, rapid weight gain, shortness of breath, and reduced urination. If you have these symptoms, or if you have burning when you urinate, contact your healthcare provider right away because you need special treatment.

Multiple births (two or more babies from one pregnancy) may occur as a result of treatment with this medicine. Talk with your healthcare provider about the possibility of multiple births.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Sudden severe headache or vomiting; dizziness or fainting; problems with vision or speech; weakness, tingling, or numbness in an arm or leg; chest pain; pain in the calf; vaginal bleeding that continues; severe abdominal bloating and pain; shortness of breath; reduced urination; rapid weight gain; severe nausea; severe diarrhea.

Other: Minor abdominal bloating and pain, dizziness, diarrhea, gas, irritation where the shots are given, breast tenderness, hot flashes, headache, dry skin, hair loss, increased thirst, loss of appetite, sore throat, back pain, breast enlargement in men.

What products might interact with this medicine?

No significant drug interactions have been reported.

Be sure that you tell your healthcare provider if you are having shots of other hormones.

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature or in the refrigerator. Keep the vial tightly closed. Use the medicine immediately after mixing. Discard any unused medicine. Protect the medicine from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.