Bravelle

Bravelle is a prescription medication used to promote ovulation and pregnancy as part of fertility treatment programs in women who are unable to become pregnant.

Bravelle belongs to a group of drugs called hormonal fertility agents. These drugs work by stimulating the production of follicles and eggs and prepare a woman's body for pregnancy.

This medication is available in an injectable form to be given directly into a muscle (IM) by a healthcare professional or directly under the skin (SC) daily for a duration determined by your physician.

Common side effects of Bravelle include abdominal pain, nausea, and headache.

Bravelle is a prescription medication used to promote ovulation and pregnancy in women who are unable to develop and release eggs on their own and who have already received a medicine to control their pituitary gland. Bravelle is also used in women with healthy ovaries to promote development of multiple follicles as part of a fertility treatment program to increase the chances of becoming pregnant.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Bravelle to promote ovulation is 150 International Units per day for 5 days, administered under the skin (subcutaneously) or into the muscle (intramuscularly). After 5 days, your doctor will individualize the dose for you. The maximum dose is 450 International Units per day. 

The recommended dose of Bravelle for use in the Assisted Reproductive Technology (ART) fertility treatment program is 225 International Units per day for 5 days, administered under the skin (subcutaneously). After 5 days, your doctor will individualize the dose for you. The maximum dose is 450 International Units per day. 

Serious side effects have been reported with Bravelle including the following:

• Serious allergic reactions. Discontinue using Bravelle and get emergency medical attention immediately if you experience rash, swelling or your face and throat, rapid swelling all over your body, and/or trouble breathing
• Enlarged ovaries. Bravelle may cause your ovaries to be abnormally large. Symptoms of large ovaries include bloating or pain in your lower stomach (pelvic) area. If your ovaries become too large your healthcare provider may tell you that you should not have intercourse (sex) so you do not rupture an ovarian cyst.
• Ovarian Hyperstimulation Syndrome (OHSS). Discontinue using Bravelle and get  medical attention immediately if you experience severe pelvic or stomach pain, nausea, vomiting, sudden weight gain, swollen stomach, diarrhea, trouble breathing, and/or decreased or no urine.
• Lung problems. Bravelle may cause serious lung problems that can sometimes lead to death including fluid in the lungs, trouble breathing, and worsening of asthma. Talk to your doctor about your risk for developing lung problems while taking Bravelle.
• Twisting (torsion) of your ovaries. Bravelle may increase the risk of twisting of the ovaries, especially if you already have OHSS, are pregnant and/or have had previous abdominal surgery.
• Pregnancy with multiple babies. Bravelle may increase your risk of having a pregnancy with more than 1 baby. Having a pregnancy with, and giving birth to, more than 1 baby at a time increases the health risk for you and your babies. Speak with your physician about your risk of multiple births before you start Bravelle.
• Birth defects. Babies born after using fertility treatments may have an increased risk of birth defects. Your age, certain sperm problems, you and your partners genetic backgrounds, and pregnancy with more than 1 baby at a time may increase the risk of birth defects.
• Ectopic pregnancy (pregnancy outside your womb). Bravelle may increase your risk of having a pregnancy that occurs abnormally, outside of your womb. Your risk of having a pregnancy outside of your womb is increased if you also have fallopian tube problems.
• Miscarriage. Your risk of loss of an early pregnancy may be increased if you had difficulty becoming pregnant.
• Tumors of the ovary. If you have used medications like Bravelle more than once to become pregnant, you may have an increased risk of developing tumors in your ovaries.
• Blood clots. Bravelle may increase your risk of having blood clots in your blood vessels. Blood clots can cause blood vessel problems (thrombophlebitis), stroke, loss of limbs, and/or blood clots in your lungs (pulmonary embolus).

Do not use Bravelle if you:

• are allergic to Bravelle or any of its ingredients
• have ovaries that no longer make eggs (primary ovarian failure)
• are pregnant or think you may be pregnant. If Bravelle is taken while you are pregnant, it may harm your baby
• have problems with your thyroid gland, adrenal gland, and/or pituitary gland that are not controlled by taking medications
• have a tumor in your reproductive organs including your ovaries, breasts, or uterus, that may get worse with high levels of estrogen
• have a tumor in your pituitary gland and/or hypothalamus
• have abnormal bleeding from your uterus or vagina and the cause is not yet known
• have ovarian cysts or enlarged ovaries, not due to a problem called polycystic ovary syndrome (PCOS) 

Serious side effects have been reported with Bravelle. See the “Bravelle Precautions” section.

Common side effects of Bravelle include the following:

• stomach cramps
• constipation
• stomach fullness and bloating
• headache
• nausea
• pain
• pelvic pain
• hot flashes
• trouble breathing
• pain after egg removal (retrieval) 

This is not a complete list of Bravelle side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Bravelle falls into category X. It has been shown that women taking Bravelle during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. Pregnant women should not take Bravelle. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Bravelle crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, you and your healthcare provider should decide if you will use Bravelle or breastfeed. You should not do both.