Bravelle

Generic Name: urofollitropin (Intramuscular route, Subcutaneous route, Injection route)

ure-oh-FOL-li-troe-pin

Commonly used brand name(s):

In the U.S.

• Bravelle
• Fertinex

In Canada

• Fertinorm Hp
• Metrodin

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Female Reproductive Agent

Pharmacologic Class: Human Follicle Stimulating Hormone

Uses For Bravelle

Urofollitropin is a fertility drug that is identical to the hormone called follicle-stimulating hormone (FSH) that is produced naturally by the pituitary gland.

FSH is primarily responsible for stimulating growth of the ovarian follicle, which includes the developing egg, the cells surrounding the egg that produce the hormones needed to support a pregnancy, and the fluid around the egg. As the ovarian follicle grows, an increasing amount of the hormone estrogen is produced by the cells in the follicle and released into the bloodstream. Estrogen causes the endometrium (lining of the uterus) to thicken before ovulation occurs. The higher blood levels of estrogen will also provide a cue to the hypothalamus and pituitary gland to slow the production and release of FSH.

Another pituitary hormone, luteinizing hormone (LH), also helps to increase the amount of estrogen produced by the follicle cells. However, the main function of LH is to cause ovulation. The sharp rise in the blood level of LH that triggers ovulation is sometimes called the LH surge. After ovulation, the group of hormone-producing follicle cells become what is called the corpus luteum and will produce estrogen and large amounts of another hormone, progesterone. Progesterone causes the endometrium to mature so that it can support the egg after it is fertilized. If implantation of a fertilized egg does not occur, the levels of estrogen and progesterone decrease, the endometrium sloughs off, and menstruation occurs.

Urofollitropin is usually given in combination with human chorionic gonadotropin (hCG). The actions of hCG are almost identical to those of LH. It is given to simulate the natural LH surge. This results in predictable ovulation.

Urofollitropin is often used in women who have low levels of FSH and too-high levels of LH. Women with polycystic ovary syndrome usually have hormone levels such as this and are treated with urofollitropin to make up for the low amounts of FSH. Many women being treated with urofollitropin have already tried clomiphene (e.g., Serophene) and have not been able to conceive yet. Urofollitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

Urofollitropin is to be given only by or under the supervision of your doctor.

Before Using Bravelle

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cyst on ovary—Urofollitropin can cause further growth of cysts on the ovary

• Unusual vaginal bleeding—Some irregular vaginal bleeding is a sign that the endometrium is growing too rapidly, possibly of endometrial cancer, or some hormone imbalances; the increases in estrogen production caused by urofollitropin can make these problems worse. If a hormonal imbalance is present, it should be treated before beginning menotropins therapy

Proper Use of urofollitropin

This section provides information on the proper use of a number of products that contain urofollitropin. It may not be specific to Bravelle. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For becoming pregnant while having a condition called polycystic ovary syndrome:
    • Adults—75 Units injected under the skin or into a muscle once a day for seven or more days. Usually, another medicine called chorionic gonadotropin (hCG) will be given the day after the last dose. If needed, your doctor may then increase your dose of urofollitropin to 150 Units a day for another seven or more days. Higher doses may be prescribed by your doctor.
  • For becoming pregnant while using other pregnancy-promoting methods (assisted reproductive technology [ART]):
    • Adults—150 Units injected under the skin or into a muscle once a day. Your treatment will probably begin on Day 2 or Day 3 after your menstrual period begins. Usually, another medicine called chorionic gonadotropin (hCG) will be given the day after the last dose.

Precautions While Using Bravelle

It is very important that your doctor check your progress at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will likely want to monitor the development of the ovarian follicle(s) by measuring the amount of estrogen in your bloodstream and by checking the size of the follicle(s) with ultrasound examinations.

If your doctor has asked you to record your basal body temperature (BBT) daily, make sure that you do this every day. It is important that intercourse take place around the time of ovulation to give you the best chance of becoming pregnant.

Bravelle Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

• Abdominal or pelvic pain
• bloating (mild)
• redness, pain, or swelling at the injection site

• Abdominal or stomach pain (severe)
• bloating (moderate to severe)
• decreased amount of urine
• feeling of indigestion
• fever and chills
• nausea, vomiting, or diarrhea (continuing or severe)
• pelvic pain (severe)
• shortness of breath
• skin rash or hives
• swelling of lower legs
• weight gain (rapid)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Breast tenderness
• diarrhea (mild)
• nausea
• vomiting

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Abdominal or stomach pain (severe)
• bloating (moderate to severe)
• decreased amount of urine
• feeling of indigestion
• nausea, vomiting, or diarrhea (continuing or severe)
• pelvic pain (severe)
• shortness of breath
• swelling of lower legs
• weight gain (rapid)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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