Bravelle (urofollitropin for injection, purified)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Ovulation induction / infertility
General Information
Bravelle, approved in May 2002 for the treatment of infertility,
is a highly purified, human-derived follicle-stimulating hormone
(hFSH) indicated for ovulation induction following pituitary
suppression. It is used in conjuction with human chorionic
gonadotropin.
Bravelle is available for both subcutaneous and intramuscular
injection.
Clinical Results
Brevelle was evaluated in a prospective, parallel group,
multicenter trial involving 111 oligo-anovulatory subjects
undergoing ovulation induction. The trial compared Bravelle to
follitropin beta, a recombinant FSH. Subjects first underwent
pituitary suppression with a GnRH agonist and were then randomized
into three treatment groups: Bravelle subcutaneous (SC), Bravelle
intramuscular (IM), and follitropin beta SC. Results of this
clinical trial showed no significant differences in safety and
efficacy between the treatment groups.
Side Effects
Adverse reactions included ovarian hyperstimulation syndrome
(OHSS), with or without pulmonary or vascular complications, which
occurred in 8.2% of subjects receiving Brevelle.
Additional Information
For more information about Bravelle, please visit the Ferring
Pharmaceuticals web site at:
www.ferringusa.com.
