Bravelle (Urofollitropin) belongs to the class of medications called gonadotropins. It is used to treat infertility in women, when follicle stimulating hormone (FSH) levels are low or as part of assisted reproductive technology procedures such as in-vitro fertilization (IVF). Bravelle (Urofollitropin) works by stimulating the ovaries and mimicking the action of FSH, which stimulates eggs to become mature and ready for release by the ovary.

Bravelle (Urofollitropin) is usually given in combination with a medication called human chorionic gonadotropin (hCG). Bravelle (Urofollitropin) causes ovulation to occur by mimicking a natural hormone called luteinizing hormone (LH). Together these medications help women with infertility problems to become pregnant.

Your doctor may have suggested Bravelle (Urofollitropin) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given Bravelle (Urofollitropin), speak to your doctor. Do not stop using Bravelle (Urofollitropin) without consulting your doctor.

Do not give Bravelle (Urofollitropin) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use Bravelle (Urofollitropin) if their doctor has not prescribed it.

The dose of Bravelle (Urofollitropin) depends on what it is being used for and must be individualized.

For infertility treatment (other than IVF), the usual starting dose is 150 IU daily for the first 5 days of treatment.

For patients undergoing IVF treatment, the usual starting dose is 225 IU daily for the first 5 days of treatment.

In both cases, the response to the medication is determined by blood tests and ultrasound readings. If needed, the dose may be increased to a maximum of 450 IU daily.

The medication should not be used for longer than 12 days in a row.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are receiving the medication without consulting your doctor.

Bravelle (Urofollitropin) should only be prescribed by doctors who are experienced in treating fertility problems.

The medication is injected under the skin or into a muscle. Your doctor or other health professional will show you exactly how to mix and draw up the medication into the needles and how to inject it. It is extremely important to understand your treatment and to follow instructions closely. Be sure to ask your doctor any questions you might have.

If you need to use hCG (as determined by lab tests), your doctor will have you inject a dose of hCG one day after your last day of Bravelle (Urofollitropin).

Once the dose of medication has been prepared by adding the diluting solution to the powder, it should be used immediately. Discard any unused material after use.

Do not use your injectable solution if it appears cloudy, lumpy, or discoloured.

It is important to use Bravelle (Urofollitropin) exactly as prescribed and you must visit your doctor on a regular basis to make sure the medication is working properly and that there are no side effects. You will be asked to have blood tests and ultrasounds to test the amount of estrogen in the bloodstream and to determine the size of the follicles.

The unmixed medication should be stored at room temperature, protected from light, and kept out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Bravelle (Urofollitropin). If you are concerned about side effects, discuss the risks and benefits of Bravelle (Urofollitropin) with your doctor.

The following side effects have been reported by at least 1% of people taking Bravelle (Urofollitropin). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal cramps
• abdominal swelling
• back pain
• breast tenderness
• Constipation
• Diarrhea (mild)
• headache
• hot flashes
• nausea (mild)
• redness, pain, or swelling at the site of injection
• vaginal discharge
• vomiting (not continuing or severe)

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• fast heartbeat
• Fever, chills, or flu-like symptoms
• mood changes
• signs of a urinary tract infection (e.g., pain during urination, fever, cloudy urine)
• vaginal bleeding between menstrual periods

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a blood clot in blood vessels (e.g., difficulty breathing, chest pain, pain and swelling in one leg muscle)
• signs of Stroke (e.g., sudden trouble with vision, dizziness, sudden severe and unusual headache, weakness, difficulty speaking)
• symptoms of a Anaphylaxis (severe allergic reaction) (shortness of breath, swelling of the face or throat, Hives)
• symptoms of ovarian hyperstimulation syndrome (difficulty breathing, abdominal or pelvic pain or discomfort, bloating, nausea, vomiting, diarrhea, decreased amount of urine, rapid weight gain)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Bravelle (Urofollitropin).

Each vial of lyophilized, white to off-white powder or pellet, contains 75 IU of follicle stimulating hormone (FSH), plus 20 mg of lactose as the monohydrate and 0.005 mg tween in a sterile, lyophilized form, for subcutaneous or intramuscular injection. The final product contains sodium phosphate buffer (sodium phosphate dibasic and phosphoric acid). Bravelle contains 1% to 2% luteinizing hormone (LH) activity based on bioassay. Human chorionic gonadotropin (hCG) is not detected in Bravelle. Each vial is available with an accompanying vial of sterile diluent containing 2 mL of 0.9% sodium chloride injection, USP.

Do not use Bravelle (Urofollitropin) if you:

• are allergic to Bravelle (Urofollitropin) or any ingredients of Bravelle (Urofollitropin)
• are infertile for any other cause than lack of follicular development or ovulation (unless you are a candidate for IVF)
• are pregnant or breast-feeding
• have abnormal uterine bleeding of unknown cause
• have an ovarian cyst or enlargement not due to Polycystic Ovary Syndrome
• have certain brain lesions (such as a pituitary tumour)
• have high levels of FSH
• have tumours of the reproductive tract that depend on sex hormones
• have uncontrolled Thyroid or adrenal dysfunction

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Bravelle (Urofollitropin).

Allergic reactions: Bravelle (Urofollitropin) may cause a serious allergic reaction in some people. If you develop hives, difficulty breathing, or swelling of the face or throat, stop using the medication and seek medical attention immediately.

Blood Clots: Bravelle (Urofollitropin) may increase the chance of blood clot formation, causing a reduction of blood flow to organs or the extremities. Talk to your doctor about the risks and benefits of using Bravelle (Urofollitropin). If you experience symptoms of a blood clot (e.g., sharp pain in the muscle of one leg, swelling and warmth of that leg) or a stroke (e.g., confusion, blurred vision, difficulty speaking or moving), seek medical attention immediately.

Kidney problems: If you have reduced kidney function or Kidney Disease, discuss with your doctor how Bravelle (Urofollitropin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bravelle (Urofollitropin), and whether any special monitoring is needed.

Lung problems: Rarely, lung problems have been reported by people using Bravelle (Urofollitropin). Talk to your doctor about the risks and benefits of using Bravelle (Urofollitropin). If you experience any shortness of breath or difficulty breathing, contact your doctor as soon as possible.

Multiple births: Using Bravelle (Urofollitropin) may result in multiple births (e.g., twins). Talk to your doctor about the risks of multiple births before beginning treatment.

Ovarian enlargement: Some women using Bravelle (Urofollitropin) may experience ovarian enlargement associated with abdominal bloating or pain. Most cases do not require treatment, and the condition goes away within 2 to 3 weeks. If you experience these symptoms, contact your doctor.

Ovarian hyperstimulation syndrome (OHSS): Treatment with Bravelle (Urofollitropin) can cause a condition called ovarian hyperstimulation syndrome (OHSS). It most often develops after treatment has stopped. With OHSS, too many follicles grow and cause abdominal or pelvic discomfort or pain, nausea, vomiting, and weight gain. Some women may experience difficulty breathing, diarrhea, and decreased urination. OHSS can progress rapidly and may become serious. If you experience these symptoms while using Bravelle (Urofollitropin) or shortly after stopping, contact your doctor immediately.

Pregnancy: Women should not use Bravelle (Urofollitropin) once they have become pregnant.

Breast-feeding: It is not known if Bravelle (Urofollitropin) passes into breast milk. If you are a breast-feeding mother and are taking Bravelle (Urofollitropin), it may affect your baby. Bravelle (Urofollitropin) should not be used by breast-feeding women.

Children: Bravelle (Urofollitropin) is intended for use by women of child-bearing age. Its safety and effectiveness have not been established for children.

Seniors: Bravelle (Urofollitropin) is intended for use by women of child-bearing age. Its safety and effectiveness have not been established for seniors.