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.

• Ferring Pharmaceuticals, Inc.

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.

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) 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Bravelle, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Bravelle, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Bravelle or to any of its ingredients
• have been told by a healthcare provider that you are at an increased risk for blood clots (thrombosis)
• have ever had a blood clot (thrombosis), or anyone in your family has ever had a blood clot
• had stomach (abdominal) surgery
• had twisting of your ovaries (ovarian torsion)
• had or have cysts in your ovaries
• have any other medical conditions
• are pregnant or suspect that you might be pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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. 

Use Bravelle exactly as prescribed.

Bravelle 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. Your healthcare provider will tell you where and how to administer Bravelle. 

Bravelle may be mixed with a medication called Menopur into the same syringe when you administer it subcutaneously. Your healthcare provider will show you how to mix and inject Bravelle before you do it for the first time.

Follow your physician's instructions for administration exactly as provided. For additional information about adminstration of Bravelle, see below:

Preparing your Bravelle

1. Wash your hands well with soap and water and dry your hands with a clean towel
2. Open the Q•Cap by peeling back the label. Set aside the blister pouch with the Q•Cap. Do not take the Q•Cap out of the pouch at this time. Do not touch the ends of the Q•Cap
3. Remove the plastic caps from the vials of Bravelle and 0.9% Sodium Chloride, USP. Check the vial of Bravelle to make sure there is powder or a pellet in the vial. Check the 0.9% Sodium Chloride, USP vial to make sure that there are no particles in the liquid and the liquid in the vial is clear. If you do not see powder or see particles or the liquid is discolored, do not use the vial and call your pharmacist or healthcare provider
4. Wipe the tops of the vials with alcohol and allow them to dry. Do not touch the tops of the vials after you have wiped them
5. Place the vial of 0.9% Sodium Chloride, USP on the table. Remove the Q•Cap from the blister pouch by grasping the sides with your fingers. Carefully twist the syringe onto the connector end (luer) of the Q•Cap until you feel a slight resistance. Do not touch the spike at the end of the Q•Cap
6. Pull down on the syringe plunger until you have withdrawn the amount of 0.9% Sodium Chloride, USP from the vial that your healthcare provider told you to use. The usual amount of 0.9% Sodium Chloride, USP used to mix your Bravelle is 1 mL, but you should use the amount that your healthcare provider tells you to use
7. Hold the syringe and place the spike end of the Q•Cap over the top of the 0.9% Sodium Chloride, USP vial. Push the tip of the Q•Cap into the rubber stopper of the vial until it stops. Be careful not to push down on the syringe plunger during this step
8. Slowly push on the syringe plunger down to move the air from the syringe into the vial. Keeping the syringe and Q•Cap together, turn the vial upside down and pull down on the syringe plunger to withdraw the right amount of 0.9% Sodium Chloride, USP from the vial. Your healthcare provider should tell you the right amount of 0.9% Sodium Chloride, USP to use
9. Place the 0.9% Sodium Chloride, USP vial on the table. Remove the Q•Cap and syringe from the vial by pulling up on the syringe barrel. Throw away the 0.9% Sodium Chloride, USP vial in your household trash
10. Hold the vial of Bravelle powder in one hand. Hold the sides of the syringe with your other hand and place the tip of the Q•Cap over the top of the vial. Push the tip of the Q•Cap into the rubber stopper of the vial until it stops. Be very careful not to push down on the syringe plunger during this step
11. Slowly push down on the syringe plunger to push the 0.9% Sodium Chloride, USP into the vial with the Bravelle powder in it. Gently swirl the vial until the Bravelle powder is completely dissolved. Do not shake the vial as this will cause bubbles
12. As soon as the powdered medicine has completely dissolved, turn the vial upside down and pull down on the plunger to withdraw all of the Bravelle into the syringe

If your healthcare provider tells you to use more than 1 vial of Bravelle

1. Mix your first vial of Bravelle powder with 0.9% Sodium Chloride, USP. Do not inject your dose yet
2. Use the liquid in the syringe you have just mixed to mix the next vial of Bravelle 
3. You can use the liquid in the syringe to mix up to 5 more vials of medicine
4. Your healthcare provider will tell you how many vials of Bravelle

Removing the Q•Cap and adding your needle for injection

1. When you have finished mixing the last vial needed for your injection and have withdrawn all the medicine into the syringe, remove the syringe from the Q•Cap
2. Twist the syringe counter-clockwise while holding the Q•Cap steady. Carefully remove the syringe from the Q•Cap. Throw away the Q•Cap with the attached medicine vial into your household trash. Carefully set the syringe with the medicine down on the table, being careful not to touch the tip of the syringe
3. You are now ready to attach the needle to the syringe for your injection. Your healthcare provider will tell you what needle you should use for your injection
4. While holding the syringe tip pointing up, place the needle on top of the syringe. Gently push down on the needle and twist the needle onto the syringe in a clockwise direction until it is tight
5. Hold the syringe with the needle pointing straight up. Pull down slightly on the plunger and tap the barrel of the syringe so that any air bubbles rise to the top. Slowly press the plunger until all the air is out of the syringe and a small drop of liquid is seen at the tip of the needle
6. Tap the syringe to remove the small drop of liquid at the tip of the needle
7. Carefully set the syringe with needle down on the table. Do not let the needle touch anything to keep it sterile. The medicine is now ready for you to inject

Injecting Bravelle

1. Select a site to inject Bravelle on your stomach area (abdomen). Pick a site on your lower abdomen, 1-2 inches below the navel, alternating between left and right sides. Each day, inject in a different site to help reduce soreness and skin problems. For example, on day 1, inject yourself on the right side of your abdomen. The next day, inject yourself on the left side of your abdomen. Changing your injection site every day will help reduce soreness and skin problems
2. Clean your injection site with an alcohol pad. Let the alcohol dry
3. Carefully remove the needle cap from the syringe
4. Hold the syringe in 1 hand. Use your other hand to gently hold a fold of skin where you will insert your needle. Hold the skin between your thumb and index finger
5. Hold your syringe at a right angle to your skin, like a dart. Quickly insert the needle all the way into your skin fold
6. Push the plunger of the syringe with a steady motion. Keep pushing until all the fluid is injected into your skin
7. Let go of your skin fold and pull the needle straight out of your skin

After your injection

• If there is any bleeding at your injection site, place a gauze pad over your injection site. Apply gentle pressure to stop the bleeding. Do not rub the site
• If your injection site becomes sore or red, you may put ice on your injection site for 1 minute and then take it off for 3 minutes. If needed, you may repeat this 3 or 4 times

Disposing of your used needles and syringes

• Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away loose needles and syringes in your household trash

If you miss a dose of Bravelle, call your healthcare provider right away. Do not double the amount of Bravelle you are taking.

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. 

If you administer too much Bravelle, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Bravelle is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Before mixing, store Bravelle powder in the refrigerator or at room temperature between 37ºF to 77ºF (3ºC to 25ºC).
• Protect Bravelle from light.
• Bravelle should be used right after mixing.
• Throw away any unused Bravelle.
• Keep Bravelle and all medicines out of the reach of children.