What Bravelle is used for and how to use it
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Bravelle - Consumer Medicine Information

Manufacture: Ferring Pharmaceuticals
Country: United States
Condition: Female Infertility, Follicle Stimulation
Class: Gonadotropins
Form: Liquid solution, Subcutaneous (SC), Intramuscular (IM)
Ingredients: follicle stimulating hormone (FSH), corresponding, lactose monohydrate, polysorbate 20 (tween 20), sodium phosphate buffer (sodium phosphate dibasic, heptahydrate and phosphoric acid)

(Urofollitropin for Injection, Purified)

For Subcutaneous or Intramuscular Injection

About This Medication

What the Medication is Used For

BRAVELLE (Urofollitropin for Injection, Purified) is a highly purified preparation of Follicle Stimulating Hormone (FSH), collected from the urine of menopausal women.

Follicle stimulating hormone (FSH) is a hormoneproduced by the pituitary gland which helps to develop eggs (follicles) in women´s ovaries. About 40% of female infertility disorders are caused by ovulation abnormalities.

BRAVELLE is used as a treatment of infertility in women who have not been able to become pregnant because of ovulation problems. It is also used by women enrolled in an assisted fertility program that uses procedures such as in vitro fertilization or embryo transfer.

What it Does

In women, FSH is important for the monthly ripening of the follicle, a tiny cyst in the ovary in which the egg cell develops. If the body does not produce enough FSH, infertility may result. In these cases, BRAVELLE can be used to make up for the shortage. To determine the right dosage, a daily check may be necessary. Follicle ripening is determined by means of ultrasound, and the amountof estrogens (female hormones) in blood or urine can be measured. When the follicle is big enough, a hormone preparation with a strong hormonal activity is given (human chorionic gonadotropin, hCG). This causes ovulation (release of the egg).

In spite of careful monitoring, often more than one egg cell is released. This increases the chance of having more than one baby.

BRAVELLE is only available with your physician´s prescription.

When it Should Not be Used:

BRAVELLE should not be used if you have any of the following conditions:

  • Abnormal bleeding of genitals or uterus without known cause
  • Uncontrolled adrenal gland or thyroid disease
  • Tumours: Brain or sex–hormone–dependent
  • Ovarian cyst or enlarged ovaries
  • Primary ovarian failure

And/or

  • If you suspect you may be pregnant
  • If you are breast–feeding

Talk to your physician before taking the medication.

What the Medicinal Ingredient Is

BRAVELLE contains Follicle Stimulating Hormone (FSH), corresponding to 75 international units (IU) per vial.

What Are the Important Nonmedicinal Ingredients

The important nonmedicinal ingredients are: Lactose monohydrate, Polysorbate 20 (Tween 20), Sodium Phosphate buffer (sodium phosphate dibasic, heptahydrate and phosphoric acid).

What Dosage Form it Comes In

BRAVELLE is available in vials as a sterile, lyophilized, white to off–white powder or pellet.

Each vial is available with an accompanying vial of sterile diluent containing 2 mL of 0.9% Sodium Chloride Injection, USP.

Warnings and Precautions

BRAVELLE should only be prescribed by a physician who is thoroughly familiar with fertility problems.

Taking any preparation of Follicle Stimulating Hormone puts a woman at risk of producing multiple eggs, which, if fertilized, may lead to multiple births.

BRAVELLE is a potent gonadotropic (gonadstimulating) compound capable of causing Ovarian Hyperstimulation Syndrome (OHSS), characterized by minor enlargement of ovaries and accumulation of fluid in the abdomen, which can cause distention and pain. In rare severe cases, the ovarian enlargement can be massive and result in loss of fluid from the blood. The fluid accumulates in the abdomen, around the lungs and/or the heart, causing pressure on these critical organs. The main symptoms are pain, difficulty breathing, vomiting and diarrhea. Patients suffering from moderate to severe OHSS may need hospitalization.

Before Using Bravelle

Before treatment with BRAVELLE is considered, the patient has to undergo a thorough gynecological and endocrinological evaluation. This may involve gynecological examination, as well as documentation of ovulation (or lack thereof) by means of daily basal body temperature measurements and other tests.

Proper Use of This Medication

Usual Dose

The dose of BRAVELLE will be different for each patient. Follow your doctor´s directions. Generally, BRAVELLE is taken every day for a period of up to 12 days. Once your physician determines that your response has been sufficient to support ovulation, he/she may administer a single dose of hCG by injection.

How to Use Bravelle

BRAVELLE is administered as an injection. Your physician may ask you to administer BRAVELLE to yourself. BRAVELLE comes in a box containing 2 vials: The active medicine is contained in a vial as a cake of dry powder. The second vial contains a liquid, Sodium Chloride Injection, which is used to dissolve the dry powder. The injections are given slowly under the skin (for instance, the abdominal wall) or into the muscle (for instance, in the buttock near the hip).

In some instances, you or your partner may give the injections. Your doctor will tell you when and how to do this.

If you are using this drug at home:

  • Understand and use the proper method of safety. Prepare the medicine, according to instruction given to you by your physician.
  • Wash your hands with soap and water and use a clean work area to prepare your injection.
  • Make sure you clearly understand and carefully follow your doctor´s instructions on how to give yourself an injection, including the proper needle and syringe.
  • Do not inject more or less of the medicine than your doctor prescribed.
  • Move the site of injection to different areas to prevent skin problems.
  • Throw away needles, syringes, bottles and unused medicine after the injection in a safe manner.>

Tell your doctor when you use the last dose of BRAVELLE. Usually a single dose of another hormone, human chorionic gonadotropin (hCG), is given to women taking BRAVELLE the day after the last dose of BRAVELLE. Your doctor will give you this medicine or arrange for you to get it at the right time.

Side Effects and What to do About Them

Treatment with gonadotropic preparations may lead to unwanted over stimulation of the ovaries. The first symptoms of ovarian stimulation may be noticed as pain in the abdomen, feeling sick or diarrhea. More severe cases may have accumulation of fluid in the abdomen and⁄or chest, weight gain and the occurrence of blood clots. Contact your doctor without delay if you are experiencing any of these symptoms during treatment or within a few days after the last injection.

If severe abdominal pain, nausea, vomiting and rapid weight gain occur, stop taking BRAVELLE and get emergency help immediately

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

Abdominal bloating, diarrhea, flu–like symptoms, such as body aches or pain, coughing, fever, headache, loss of voice, runny nose, unusual tiredness or weakness, nausea, passing of excess gas, vaginal bleeding between menstrual periods, acne, breast pain or tenderness, mood swings, dizziness, painful menstrual periods, redness, pain or swelling at the injection site, sleepiness, vaginal discharge, fainting, light–headedness, migraine headache, nervousness, stomach discomfort, fast, racing heartbeat, itchy skin, loss of appetite, unusual thirst.

Once you stop taking BRAVELLE your body may need time to adjust. The length of time this takes depends on the amount of medicine you had used and how long you have used it for. During this period, check with your doctor immediately if you notice any of the following: Severe abdominal pain, nausea, vomiting, rapid weight gain.

How to Store It

  • This medicine has been prescribed only for your current medical problem. It should not be used for other medical conditions or by other people.
  • Keep BRAVELLE in the original box in a safe place out of the reach of children.
  • Store at 15° - 25°C. Protect from light.
  • The expiry date is printed on the label after “exp:” Do not use after this date.

Reporting Suspected Side Effects

To monitor drug safety, Health Canada collects
information on serious and unexpected effects of
drugs. If you suspect you have had a serious or
unexpected reaction to this drug you may notify
Health Canada by:

Toll-free telephone: 866–234–2345
Toll-free fax 866–678–6789
By email:cadrmp@hc-sc.gc.ca

By regular mail:
National AR Centre
Marketed Health Products Safety and
Effectiveness
Information Division
Marketed Health Products Directorate
Tunney´s Pasture, AL 0701C
Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you
should contact your physician or pharmacist.

More Information

For more information or help, call 1–800–263–4057

Ferring Inc., Toronto, Ontario