"Jan. 24, 2013 -- What's in a name? If it's polycystic ovary syndrome, a lot of confusion, says a panel of experts convened by the NIH -- and they're calling for a change.
Polycystic ovary syndrome (PCOS) is one of the most common endocrine "...
- Patient Information:
Details with Side Effects
(urofollitropin) for Injection, Purified for Subcutaneous Use
Read this Patient Information before you start using BRAVELLE® and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is BRAVELLE®?
BRAVELLE® is a prescription medicine that contains follicle stimulating hormone (FSH). BRAVELLE® is used to treat women:
- who need help developing and releasing eggs (ovulating) and have already received a medicine to control their pituitary gland
- with healthy ovaries so they can make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) Cycle
Who should not use BRAVELLE®?
Do not use BRAVELLE® if you:
- are allergic to urofollitropin or any of the ingredients in BRAVELLE®. See the end of this leaflet for a complete list of ingredients in BRAVELLE® .
- 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 or adrenal gland or pituitary gland that are not controlled by taking medicine
- have a tumor in your female organs, including your ovaries, breast, or uterus that may get worse with high levels of estrogen
- have a tumor of your pituitary gland or hypothalamus
- have abnormal bleeding from your uterus or vagina and the cause is not known
- have ovarian cysts or enlarged ovaries, not due to a problem called polycystic ovary syndrome (PCOS)
What should I tell my healthcare provider before using BRAVELLE®?
Before using BRAVELLE®, tell your healthcare provider if you:
- 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 ovary (ovarian torsion)
- had or have a cyst in your ovary
- have any other medical conditions
- are breast feeding or plan to breast feed. It is not known if BRAVELLE® passes into your breast milk. You and your healthcare provider should decide if you will use BRAVELLE® or breastfeed. You should not do both.
Tell your healthcare provider all the medicines you take, including prescription and overthe-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use BRAVELLE®?
- Read the Instructions for Use at the end of this Patient Information about the right way to use BRAVELLE® or BRAVELLE® mixed with MENOPUR® .
- Use BRAVELLE® exactly as your healthcare provider tells you to use it.
- Your healthcare provider will tell you how much BRAVELLE® to use and when to use it.
- Your healthcare provider may change your dose of BRAVELLE® if needed.
- If you miss a dose of BRAVELLE®, call your healthcare provider right away. Do not double the amount of BRAVELLE® you are taking.
- You may need more than 1 vial of BRAVELLE® for your dose.
- BRAVELLE® may be given under your skin (subcutaneously) or into your muscle (intramuscularly). Your healthcare provider will tell you where and how to give your BRAVELLE® .
- Your healthcare provider will give you BRAVELLE® intramuscularly.
- BRAVELLE® may be mixed with MENOPUR® in the same syringe when you give it subcutaneously.
What are possible side effects of BRAVELLE®?
BRAVELLE® may cause serious side effects, including:
- serious allergic reactions. Symptoms of
allergic reactions include:
- swelling or your face and throat
- rapid swelling all over your body
- trouble breathing
If you have a serious allergic reaction, stop using BRAVELLE® and call your healthcare provider or go to the nearest hospital emergency room right away.
- ovaries that are too large. 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). Using BRAVELLE®
may cause OHSS. OHSS is a serious medical condition that can happen when
your ovaries produce too many eggs (overstimulated). OHSS can cause fluid to
suddenly build up in the area of your stomach, chest, and heart, and cause
blood clots to form. OHSS may also happen after you stop using BRAVELLE®.
Stop using BRAVELLE® and call your healthcare provider or go to the
nearest hospital emergency room right away if you have any of the following
symptoms of OHSS:
- severe pelvic or stomach pain
- sudden weight gain
- swollen stomach
- trouble breathing
- 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.
- blood clots. BRAVELLE® may increase your chance of having blood clots in your blood vessels. Blood clots can cause:
- twisted (torsion) of your ovaries. BRAVELLE® may increase the chance of your ovary twisting, if you already have certain conditions such as OHSS, pregnancy and previous abdominal surgery. Twisting of your ovary may lead to blood flow being cut off to your ovary.
- pregnancy with and birth of multiple babies. BRAVELLE® may increase your chance of having a pregnancy with more than 1 baby. Having a pregnancy and giving birth to more than 1 baby at a time increases the health risk for you and your babies. Your healthcare provider should talk to you about your chances of multiple births before you start using BRAVELLE® .
- birth defects in your unborn baby. Babies born after ART may have an increased chance of birth defects. Your age, certain sperm problems, your genetic background and that of your partner, and a pregnancy with more than 1 baby at a time may increase the chance that your baby may have birth defects.
- ectopic pregnancy (pregnancy outside your womb). BRAVELLE® may increase your chance of having a pregnancy that is abnormally outside of your womb. Your chance of having a pregnancy outside of your womb is increased if you also have fallopian tube problems.
- miscarriage. Your chance of loss of an early pregnancy may be increased if you had difficulty becoming pregnant.
- tumors of the ovary. If you have used medicines like BRAVELLE® more than 1 time to get pregnant, you may have an increased chance of having tumors in your ovaries, including cancer.
The most common side effects of BRAVELLE® include:
- stomach cramps
- stomach fullness and bloating
- pelvic pain
- hot flashes
- trouble breathing
- pain after egg removal (retrieval)
These are not all the possible side effects of BRAVELLE®. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
How should I store BRAVELLE®?
- Before mixing, store BRAVELLE® powder in the refrigerator or at room temperature between 37°F to 77°F (3°C to 25°C).
- 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.
General information about the safe and effective use of BRAVELLE® .
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BRAVELLE® for a condition for which it was not prescribed. Do not give BRAVELLE® to other people, even if they have the same condition you have. It may harm them.
This Patient Information summarizes the most important information about BRAVELLE®. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about BRAVELLE® that is written for health professionals.
For more information go to www.bravelle.com, or call 1-888-FERRING (1-888-337-7464).
What are the ingredients in BRAVELLE®?
Active ingredient: urofollitropin
Inactive ingredients: lactose monohydrate, polysorbate, sodium phosphate dibasic, heptahydrate and phosphoric acid
Instructions for Use
(urofollitropin for injection, purified) for subcutaneous use
Your healthcare provider should show you how to mix and inject BRAVELLE® or BRAVELLE® mixed with MENOPUR® before you do it for the first time. Before using BRAVELLE® or BRAVELLE® mixed with MENOPUR® for the first time, read this Instructions for Use carefully. Keep this leaflet in a safe place and read it when you have questions.
Supplies you will need to give your injection of BRAVELLE® or BRAVELLE® mixed with MENOPUR®. See Figure A.
- a clean, flat surface to work on, like a table
- vials of BRAVELLE® powder (and MENOPUR® powder if you are going to mix the 2 medicines)
- vials of 0.9% Sodium Chloride, USP used for mixing the medicine
- alcohol pads
- rubbing alcohol
- gauze pads
- a sterile syringe and needle. Your healthcare provider should tell you which syringe and needle to use.
- the Q•Cap® that comes with your medicine
- a sharps disposal container for throwing away your used needles and syringes. See “Disposing of your used needles and syringes” at the end of these instructions.
Step 1. Preparing your BRAVELLE® or BRAVELLE® mixed with MENOPUR® .
- Wash your hands well with soap and water. Dry your hands with a clean towel.
- Place all the supplies you need on the clean surface you already prepared.
- Open the Q•Cap® by peeling back the label. See Figure B.
- 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® .
- Remove the plastic caps from the vials of BRAVELLE® (and MENOPUR® if needed) and 0.9% Sodium Chloride, USP. See Figure C.
- Check the vial of BRAVELLE® (and MENOPUR® if needed) 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.
- 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. See Figure D.
- 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. See Figure E. 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® . See Figure E.
- 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. See Figure F.
- 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. See Figure G.
- 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. See Figure H.
- 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. See Figure I.
- Hold the vial of BRAVELLE® powder in 1 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. See Figure J.
- 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. See Figure K.
- 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. See Figure L.
If your healthcare provider tells you to use more than 1 vial of BRAVELLE® or tells you to mix your BRAVELLE® with MENOPUR® in the same syringe:
- Mix your first vial of BRAVELLE® powder or MENOPUR® powder with 0.9% Sodium Chloride, USP. Do not inject your dose yet.
- Use the liquid in the syringe you have just mixed to mix the next vial of BRAVELLE® or MENOPUR® . See Figure J through Figure L.
- You can use the liquid in the syringe to mix up to 5 more vials of medicine.
- Your healthcare provider will tell you how many vials of BRAVELLE® and MENOPUR® to use.
Step 2. Removing the Q•Cap® and adding your needle for injection.
- 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® .
- Twist the syringe counter-clockwise while holding the Q•Cap® steady. Carefully remove the syringe from the Q•Cap®. See Figure M. 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.
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.
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. See Figure N.
- 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. See Figure O.
- Tap the syringe to remove the small drop of liquid at the tip of the needle. See Figure P.
- 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. See Figure Q.
Step 3. Injecting BRAVELLE® or BRAVELLE® mixed with MENOPUR® .
- Select a site to inject BRAVELLE® or BRAVELLE® mixed
with MENOPUR® 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 sites every day will help reduce soreness and skin problems. See Figure R.
- Clean your injection site with an alcohol pad. Let the alcohol dry. See Figure S.
- Carefully remove the needle cap from the syringe. See Figure T.
- 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. See Figure U.
- Hold your syringe at a right angle to your skin, like a dart. Quickly insert the needle all the way into your skin fold. See Figure V.
- Push the plunger of the syringe with a steady motion. Keep pushing until all the fluid is injected into your skin. See Figure W.
- Let go of your skin fold and pull the needle straight out of your skin. See Figure X.
Step 4. 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. See Figure Y.
- 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.
Step 5. 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 (dispose of) loose needles and syringes in your household trash.
- If you do not have a
FDA-cleared sharps disposal container, you may use a household container that
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 2/28/2014
This monograph has been modified to include the generic and brand name in many instances.
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