BRAVELLE urofollitropin

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FOLLITROPIN (UNII: 076WHW89TW) (FOLLITROPIN - UNII:076WHW89TW)

Available from:

Ferring Pharmaceuticals Inc.

INN (International Name):

FOLLITROPIN

Composition:

FOLLITROPIN 75 [iU] in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

BRAVELLE- UROFOLLITROPIN
FERRING PHARMACEUTICALS INC.
REFERENCE LABEL SET ID: 46F7740F-C879-4A77-9A16-2821FD772641
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BRAVELLE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BRAVELLE
BRAVELLE (UROFOLLITROPIN FOR INJECTION, PURIFIED) FOR SUBCUTANEOUS OR
INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
BRAVELLE (urofollitropin for injection, purified) is a gonadotropin
indicated for:
Induction of ovulation in women who have previously received pituitary
suppression – intramuscular and subcutaneous
administration (1.1)
Development of multiple follicles as part of an Assisted Reproductive
Technology (ART) cycle in ovulatory women
who have previously received pituitary suppression (1.2)
DOSAGE AND ADMINISTRATION
_Ovulation Induction (2.2)_
Initial starting 150 International Units per day for 5 days,
administered subcutaneously or intramuscularly
Individualization of dosing after 5 days
Dosage adjustments not to occur more frequently than once every 2 days
and not to exceed 75 to 150 International
Units per adjustment
Do not administer greater than 450 International Units per day
_Assisted Reproductive Technology (ART) (2.3)_
Initial starting dose of the first cycle – 225 International Units
per day for 5 days, administered subcutaneously
Individualization of dosing after 5 days
Dosage adjustments not to occur more frequently than once every 2 days
and not to exceed 75 to 150 International
Units per adjustment
Do not administer greater than 450 International Units per day
DOSAGE FORMS AND STRENGTHS
Lyophilized powder for injection: containing 82.5 International Units
of FSH, to deliver 75 International Units FSH after
reconstituting, supplied as lyophilized powder in sterile vials with
diluent vials. (3)
CONTRAINDICATIONS
BRAVELLE is contraindicated in women who exhibit:
Prior hypersensitivity to BRAVELLE or urofollitropins (4)
High levels of FSH indicating primary o