Generic Name: urofollitropin (UE roe FOL i TROE pin)Brand Names: Bravelle
Urofollitropin is a purified form of a hormone called follicle-stimulating hormone (FSH). FSH is important in the development of follicles (eggs) that are produced by the ovaries in women.
Urofollitropin is used to treat infertility in women whose own natural FSH is not sufficient in stimulating follicles to mature. Urofollitropin also is used to help the ovaries produce multiple eggs for use in "in vitro" fertilization.
Urofollitropin may also be used for other purposes not listed in this medication guide.What is the most important information I should know about Bravelle (urofollitropin)?Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS). This syndrome may be more likely to occur within the first 10 days after receiving the last dose in a treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any symptoms of OHSS: severe pelvic pain, swelling of the hands or legs, stomach pain and swelling, shortness of breath, weight gain, diarrhea, nausea or vomiting, and urinating less than usual.
Using this medicine 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.Although urofollitropin can help you become pregnant, this medication is in the FDA pregnancy category X. This means that using the medication once you are pregnant can cause birth defects in the baby. Do not use this medication if you are pregnant. Tell your doctor right away if you become pregnant during treatment.What should I discuss with my healthcare provider before using Bravelle (urofollitropin)?
Urofollitropin will not cause ovulation (production of an egg by the ovaries). You may need to receive other medications to stimulate ovulation.You should not use this medication if you are allergic to urofollitropin medications, or if you have:
infertility that is not caused by lack of ovulation;
a condition called primary ovarian failure;
unusual vaginal bleeding;
an ovarian cyst;
a tumor of your pituitary gland;
an untreated or uncontrolled disorder of your thyroid or adrenal gland; or
if you are pregnant.
Using this medicine 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.Although urofollitropin can help you become pregnant, this medication is in the FDA pregnancy category X. This means that using the medication once you are pregnant can cause birth defects in the baby. Do not use this medication 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. Do not use urofollitropin without telling your doctor if you are breast-feeding a baby.
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Urofollitropin is given as an injection under the skin or into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Urofollitropin comes as a powder and liquid (diluent) that must be mixed together before you draw your dose into a syringe.Do not shake the mixture. Vigorous shaking can ruin the medicine. Do not draw your urofollitropin dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it does not clear after mixing, or if it has any particles in it. Call your doctor for a new prescription.
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.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
To be sure this medication is helping your condition, your doctor will need to check you on a regular basis. Do not miss any scheduled appointments.
Infertility is often treated with a combination of different drugs. For best results, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.If you store urofollitropin at home, keep it at room temperature away from light, moisture, and heat.
Call your doctor if you miss a dose of urofollitropin.
Symptoms of a urofollitropin overdose are not known.
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using urofollitropin.
severe pelvic pain;
swelling of your hands or legs;
stomach pain and swelling;
shortness of breath;
nausea, vomiting, diarrhea; or
urinating less than usual.
Less serious side effects may include:
mild stomach upset, constipation;
mild pelvic pain, cramps;
pain, swelling, redness, itching, or irritation where the medicine was injected.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
There may be other drugs that can interact with urofollitropin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.