Generic Name and Formulations:
Urofollitropin (follicle-stimulating hormone) 75 IU; per vial; lyophilized pwd for SC or IM inj after reconstitution.
Ferring Pharmaceuticals, Inc.
Indications for BRAVELLE:
Induction of ovulation in patients with functional anovulatory infertility that is not due to ovarian failure, or stimulation of multiple follicles in ovulatory patients undergoing Assisted Reproductive Technologies (ART) who have previously received pituitary suppression.
Individualize. Use lowest effective dose. Ovulation induction: Initially 150 IU SC or IM inj daily for 5 days in the 1st cycle; for subsequent cycles: base initial dose on ovarian response. ART: Initially 225 IU SC inj daily for 5 days starting on Day 2 or 3 of cycle; or may be given in combination with Menopur (total initial dose: max 225 IU [Bravelle 150 IU + Menopur 75 IU; or Bravelle 75 IU + Menopur 150 IU]). Ovulation induction or ART: adjust dose based on response in increments of 75-150 IU at intervals of at least 2 days; max 450 IU daily; usual max 12 days. Induce final maturation/ovulation of follicles with hCG (see Precautions).
Primary ovarian failure. Uncontrolled non-gonadal endocrinopathies (eg, thyroid, adrenal, pituitary). Undiagnosed abnormal uterine bleeding. Ovarian cysts or enlargement. Tumor of pituitary, hypothalamus, breast, ovary, or uterus. Pregnancy (Cat.X).
Do complete gynecological and endocrinological exam first. Risk of ovarian hyperstimulation syndrome (OHSS); monitor for at least 2 weeks after hCG administration. Discontinue if severe OHSS occurs; consider hospitalization (see full labeling). Abnormal ovarian enlargement; monitor ovarian response and/or measure serum estradiol levels. Do not give hCG if abnormally enlarged ovaries on last day of Bravelle therapy to reduce OHSS development. Increased risk of thromboembolic events in severe obesity, thrombophilia, pregnancy, personal or family history of thrombosis. Nursing mothers: not recommended.
Headache, hot flashes, respiratory disorder, abdominal cramps/fullness/enlargement, nausea, pain, pelvic pain; ovarian enlargement or cysts, OHSS, thromboembolic events, ovarian torsion, multi-fetal gestation and birth, ectopic pregnancy, spontaneous abortion, ovarian neoplasms, risk of congenital malformations, hypersensitivity reactions.
Single-dose vials—5 (w. diluent)