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Bravelle

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Bravelle

Bravelle

INDICATIONS

Induction Of Ovulation In Women Who Have Previously Received Pituitary Suppression

Prior to initiation of treatment with BRAVELLE®:

  • Perform a complete gynecologic and endocrinologic evaluation
  • Exclude a diagnosis of primary ovarian failure
  • Exclude the possibility of pregnancy
  • Demonstrate tubal patency
  • Evaluate the fertility status of the male partner

Development Of Multiple Follicles As Part Of An Assisted Reproductive Technology (ART) Cycle In Ovulatory Women Who Have Previously Received Pituitary Suppression

Prior to initiation of treatment with BRAVELLE®:

  • Perform a complete gynecologic and endocrinologic evaluation, and diagnose the cause of infertility
  • Exclude the possibility of pregnancy
  • Evaluate the fertility status of the male partner
  • Exclude women with primary ovarian failure

DOSAGE AND ADMINISTRATION

General Dosing Information

  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Administer BRAVELLE® subcutaneously in the abdomen or intramuscularly as described in Instructions for Use.
  • A healthcare provider should administer BRAVELLE® intramuscularly.

Recommended Dosing For Induction Of Ovulation

The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies].

  • For women who have received GnRH agonist or antagonist pituitary suppression, a starting dose of 150 International Units per day of BRAVELLE® is administered subcutaneously or intramuscularly for 5 days in the first cycle of treatment.
  • In subsequent cycles of treatment, the starting dose (and dosage adjustments) of BRAVELLE® should be determined based on the history of the ovarian response to BRAVELLE® .
  • The following should be considered when planning the woman's individualized dose of BRAVELLE®:
    • Appropriate BRAVELLE® dose adjustment(s), based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results), should be used to prevent multiple follicular growth and cycle cancellation.
    • Do not make adjustments in dose more frequently than once every 2 days and do not exceed more than 75 to 150 International Units per adjustment.
    • Use the lowest dose of BRAVELLE® that will achieve desired results.
    • The maximum, individualized, daily dose of BRAVELLE® is 450 International Units per day.
    • In general, do not exceed 12 days of treatment.
  • When pre-ovulatory conditions are reached, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation.
  • Withhold hCG in cases where the ovarian monitoring on the last day of BRAVELLE® treatment suggests an increased risk of ovarian hyperstimulation syndrome (OHSS) [see WARNINGS AND PRECAUTIONS].
  • Encourage the woman and her partner to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent.

Discourage intercourse when the risk for OHSS is increased [see WARNINGS AND PRECAUTIONS].

Recommended Dosing For Assisted Reproduction Technology

The recommended dosing scheme for patients undergoing IVF follows a stepwise approach and is individualized for each woman. The recommended initial dose of BRAVELLE® for women who have received a GnRH agonist for pituitary suppression is 225 International Units. BRAVELLE® may be administered together with MENOPUR® (menotropins for injection, USP), and the total initial dose when the products are combined should not exceed 225 International Units (150 International Units of BRAVELLE® and 75 International Units of MENOPUR® or 75 International Units of BRAVELLE® and 150 International Units of MENOPUR®).

  • Beginning on cycle day 2 or 3, a starting dose of 225 International Units of BRAVELLE® is administered subcutaneously daily until sufficient follicular development, as determined by ultrasound in combination with measurement of serum estradiol levels, is attained. In most cases, therapy should not exceed 12 days.
  • Adjust the dose after 5 days based on the woman's ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels.
  • Do not make additional dosage adjustments more frequently than every 2 days or by more than 75 -150 International Units at each adjustment.
  • Continue treatment until adequate follicular development is evident, and then administer hCG.
  • Withhold the administration of hCG in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of BRAVELLE® therapy [see WARNINGS AND PRECAUTIONS].
  • Do not administer daily doses of BRAVELLE® or BRAVELLE® in combination with MENOPUR® that exceed 450 International Units.

HOW SUPPLIED

Dosage Forms And Strengths

Lyophilized powder for Injection containing 82.5 International Units of FSH, to deliver 75 International Units of FSH after reconstituting with the diluent, supplied in sterile vials with diluent vials and Q•Cap® vial adapters.

BRAVELLE® (urofollitropin for injection, purified) is supplied in a sterile, lyophilized, single dose vial containing 82.5 International Units of FSH, to deliver 75 International Units 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.

75 International Units FSH activity, supplied as:

NDC 55566-8505-2: Box of 5 vials + 5 vials diluent.
NDC 55566-8505-6: Box of 5 vials + 5 vials diluent + 5 Q•Cap® vial adaptors.

Storage and Handling

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.

Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054. Revised 02/2014

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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