BRAVELLE- urofollitropin
Ferring Pharmaceuticals Inc.
1.1 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
Recommended Dosing for Induction of Ovulation
The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1)].
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 (5.2, 5.3, 5.11)].
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 (5.2, 5.3)].
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.
DESCRIPTION
BRAVELLE� is a product containing a highly purified preparation of human follicle stimulating hormone (hFSH) extracted from the urine of postmenopausal women. Human FSH is a gonadotropin and consists of two non-covalently linked glycoproteins designated as the α and β subunits. The α subunit has 92 amino acids of which two are modified by attachment of carbohydrates. The β subunit has 111 amino acids of which two are modified by attachment of carbohydrates.
BRAVELLE� is a sterile, lyophilized powder intended for subcutaneous or intramuscular injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of BRAVELLE� contains 82.5 International Units (IU) of Follicle Stimulating Hormone (FSH) activity, 23 mg Lactose Monohydrate, 0.005 mg Polysorbate 20, and Sodium Phosphate buffer (Sodium Phosphate dibasic, Heptahydrate and Phosphoric acid) for pH adjustments, which, when reconstituted with diluent, will deliver 75 International Units of FSH. BRAVELLE� contains up to 2% luteinizing hormone (LH) activity based on bioassay. Human Chorionic Gonadotropin (hCG) is not detected in BRAVELLE�. When stored at 3� to 25�C, up to 40% of the α-subunits may be oxidized.
The in vivo biological activity of urofollitropin for injection, purified is determined by using reference standards calibrated against the First International Standard for follicle-stimulating hormone, (FSH, Urofollitropin), Urinary, Human for Bioassay, National Institute for Biological Standards and Control (NIBSC) at its 46th meeting in 1995.
FSH is a glycoprotein that is acidic and water-soluble.
BRAVELLE� has been mixed in vitro with MENOPUR� with no evidence of aggregation.
Therapeutic class: Infertility
How Supplied
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.
16.2 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.
BRAVELLE� is a prescription medicine that contains follicle stimulating hormone (FSH). BRAVELLE� is used to treat women:
who need help developing and releasing eggs (ovulating) and have already received a medicine to control their pituitary gland
with healthy ovaries so they can make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) Cycle
