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Bravelle (Urofollitropin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

OVULATION INDUCTION

Bravelle™ administered SC or IM in conjunction with hCG, is indicated for ovulation induction in patients who have previously received pituitary suppression.

MULTIFOLLICULAR DEVELOPMENT DURING ART

Bravelle™ administered SC in conjunction with hCG is indicated for multiple follicular development (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression.

SELECTION OF PATIENTS

  1. Before treatment with Bravelle™ is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. Except for those patients enrolled in an in vitro fertilization program, this should include a hysterosalpingography (to rule out uterine and tubal pathology) and documentation of anovulation by means of basal body temperature, serial vaginal smears, examination of cervical mucus, determination of serum (or urine) progesterone, urinary pregnanediol and endometrial biopsy. Patients with tubal pathology should receive Bravelle™ only if enrolled in an in vitro fertilization program.
  2. Primary ovarian failure should be excluded by the determination of gonadotropin levels.
  3. Careful examination should be made to rule out the presence of an early pregnancy.
  4. Patients in late reproductive life have a greater predilection to endometrial carcinoma as well as a higher incidence of anovulatory disorders. Cervical dilation and curettage should always be done for diagnosis before starting Bravelle™ therapy in such patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities.
  5. Evaluation of the husband's fertility potential should be included in the workup.

DOSAGE AND ADMINISTRATION

DOSAGE:

Infertile patients with oligo-anovulation: The dose of Bravelle™ to stimulate development of ovarian follicles must be individualized for each patient. The lowest dose consistent with achieving good results based on clinical experience and reported clinical data should be used.

The recommended initial dose of Bravelle™ for patients who have received GnRH agonist or antagonist pituitary suppression is 150 IU daily administered SC or IM for the first 5 days of treatment. Based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results) subsequent dosing should be adjusted according to individual patient response. Adjustments in dose should not be made more frequently than once every 2 days and should not exceed more than 75 to 150 IU per adjustment. The maximum daily dose of Bravelle™ should not exceed 450 IU and in most cases dosing beyond 12 days is not recommended.

If patient response to Bravelle™ is appropriate, hCG (5000 to 10,000 USP units) should be given 1 day following the last dose of Bravelle™. The hCG should be withheld if the serum estradiol is greater than 2000 pg/mL, if the ovaries are abnormally enlarged or if abdominal pain occurs, and the patient should be advised to refrain from intercourse. These precautions may reduce the risk of Ovarian Hyperstimulation Syndrome and multiple gestations. Patients should be followed closely for at least 2 weeks after hCG administration. If there is inadequate follicle development or ovulation without subsequent pregnancy, the course of treatment with Bravelle™ may be repeated. The couple should be encouraged to have intercourse daily, beginning on the day prior to the administration of hCG until ovulation becomes apparent from the indices employed for the determination of progestational activity. In the light of the foregoing indices and parameters mentioned, it should become obvious that, unless a physician is willing to devote considerable time to these patients and be familiar with and conduct the necessary laboratory studies, he/she should not use Bravelle™.

Assisted Reproductive Technologies: The recommended initial dose of Bravelle™ for patients undergoing IVF and donor egg patients who have received GnRH agonist or antagonist pituitary suppression is 225 IU daily administered SC for the first 5 days of treatment. Based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results) subsequent dosing should be adjusted according to individual patient response. Adjustments in dose should not be made more frequently than once every 2 days and should not exceed more than 75 to 150 IU per adjustment. The maximum daily dose of Bravelle™ given should not exceed 450 IU and in most cases dosing beyond 12 days is not recommended.

Once adequate follicular development is evident, hCG (5000-10,000 USP units) should be administered to induce final follicular maturation in preparation for oocyte retrieval. The administration of hCG must be withheld in cases where the ovaries are abnormally enlarged on the last day of therapy. This should reduce the chance of developing OHSS.

DIRECTIONS FOR USING BRAVELLE™

  1. Wash hands thoroughly with soap and water.
  2. Before injections, the septum tops of the vials should be wiped with an aseptic solution to prevent contamination of the contents.
  3. To prepare the Bravelle™ solution, inject 1 mL of Sterile Saline for Injection, USP into the vial of Bravelle™. DO NOT SHAKE, but gently swirl until the solution is clear. Generally, the Bravelle™ dissolves immediately. Check the liquid in the container. If it is not clear or has particles in it, DO NOT USE IT.
  4. For patients requiring a single injection from multiple vials of Bravelle™, up to 6 vials can be reconstituted with 1 mL of Sterile Saline for Injection, USP. This can be accomplished by reconstituting a single vial as described above (see step 3). Then draw the entire contents of the first vial into a syringe, and inject the contents into a second vial of lyophilized Bravelle™. Gently swirl the second vial, as described above, once again checking to make sure the solution is clear and free of particles. This step can be repeated with 4 additional vials for a total of up to 6 vials of lyophilized Bravelle™ into 1 mL of diluent.
  5. Immediately ADMINISTER the reconstituted Bravelle™ either SC (for ovulation induction or multifollicular development during ART) or IM (for ovulation induction). Any unused reconstituted material should be discarded.
  6. Draw the reconstituted Bravelle™ into an empty, sterile syringe.
  7. Hold the syringe pointing upwards and gently tap the side to force any air bubbles to the top; then squeeze the plunger gently until all the air has been expelled and only Bravelle™ solution is left in the syringe.
  8. Bravelle™ works if it is injected SC (for ovulation induction or multifollicular development during ART) or IM (for ovulation induction). The recommended sites for SC injection are either side of the lower abdomen in alternating fashion with the actual injection site varied a little with each injection. SC injection of Bravelle™ into the thigh is not recommended unless the lower abdomen is not usable because of scarring, surgical deformity or other medical conditions.
    The best site for IM injection of Bravelle™ is the upper outer quadrant of the buttock muscle near the hip. This area contains few blood vessels and major nerves. Stretching the skin helps the needle to go in more easily and pushes the tissue beneath the skin out of the way. This helps the solution disperse correctly.
  9. The injection site should be swabbed with a disinfectant to remove any surface bacteria. Clean about two inches around the point where the needle will go in and let the disinfectant dry for at least one minute before proceeding.
  10. For SC injection, the needle should be inserted at a 90° angle to the skin surface.
    For IM injection, the needle should be inserted at a 90° angle to the skin surface. Pushing in with a quick thrust causes the least discomfort.
  11. If the needle is correctly positioned, it will be difficult to draw back on the plunger. Any blood drawn into the syringe means the needle tip has penetrated a vein or artery. If this happens, remove the syringe, cover the injection site with a swab containing disinfectant and apply pressure; the site should stop bleeding in a minute or two.
  12. Once the needle is properly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin or muscle tissue is not damaged.
  13. Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant. A gentle massage of the site - while still maintaining pressure - helps disperse the Bravelle™ solution and relieve any discomfort.
  14. Use the disposable syringe only once and dispose of it properly.

HOW SUPPLIED

Bravelle™ (urofollitropin for injection, purified) is supplied in a sterile, lyophilized, single dose vial containing 82.5 IU of FSH, to deliver 75 IU FSH after reconstituting with the diluent.

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

75IU FSH activity, supplied as:

NDC 55566-8505-2: Box of 5 vials + 5 vials diluent.

NDC 55566-8505-3 Box of 100 vials + 100 vials diluent.

Lyophilized powder may be stored refrigerated or at room temperature (3° to 25°C/37° to 77°F). Protect from light. Use immediately after reconstitution. Discard unused material.

Rx only

Vials of sterile diluent of 0.9% Sodium Chloride Injection, USP, manufactured for Ferring Pharmaceuticals Inc.

Manufactured for:

FERRING PHARMACEUTICALS INC.

SUFFERN, NY 10901

By: CARDINAL HEALTH

Albuquerque, New Mexico 87107

6048-03

6-D6048FR-03

12/16/02

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