Bravelle

/ Ferring Pharmaceuticals

See prescribing information for full details.

Female infertility in the following clinical situations: Anovulation (including polycystic ovarian disease (PCOD) in women who have been unresponsive to treatment with clomiphene citrate. Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART) (e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)).

Tumors of the pituitary or hypothalamic glands. Ovarian, uterine or mammary carcinoma. Pregnancy and lactation. Gynecological hemorrhage of unknown etiology. Hypersensitivity to the active substance or to any of the excipients. Due to unlikeliness of favorable treatment outcome, treatment should not start in: Primary ovarian failure. Ovarian cysts or enlarged ovaries not due to polycystic ovarian disease. Malformation of sexual organs incompatible with pregnancy. Fibroid tumors of the uterus incompatible with pregnancy.

Should only be used under the supervision of physicians who are thoroughly familiar with infertility problems and their management. Intended for SC injection after reconstitution with the solvent provided. The powder should be reconstituted immediately prior to use. In order to avoid the injection of large volumes up to 6 vials of the powder may be dissolved in the solvent provided. Safe and effective use calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum estradiol levels, on a regular basis. The lowest effective dose in relation to the treatment objective should be used. Repeated exposure has not been investigated in clinical trials. The first injection should be performed under direct medicdbal supervision. Before starting treatment, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumors, and appropriate specific treatment given. Patients undergoing stimulation of follicular growth may experience ovarian enlargement or develop hyperstimulation. Excessive ovarian response to gonadotropin treatment seldom gives rise to Ovarian Hyperstimulation Syndrome (OHSS) unless hCG is administered to trigger ovulation. Therefore in cases of ovarian hyperstimulation it is prudent to withhold hCG and advise the patient to refrain from coitus or to use barrier methods for at least 4 days. OHSS may progress rapidly (within 24 hours to several days) to become a serious medicdbal event, therefore patients should be followed for at least two weeks after the hCG administration. If severe OHSS occurs, gonadotropin treatment should be stopped if still ongoing, the patient hospitalised and specific therapy for OHSS started. This syndrome occurs with higher incidence in patients with polycystic ovarian disease. The incidence of multiple pregnancies is increased compared with natural conception. The majority of multiple conceptions are twins. To minimize the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
See prescribing information for full details.

Very common: Headache, abdominal pain.
Common: Urinary tract infection, nasopharyngitis. Nausea, vomiting, abdominal distension, abdominal discomfort, diarrhea, constipation. Rash, muscle spasms. Vaginal hemorrhage, OHSS, pelvic pain, breast tenderness, vaginal discharge. Pain, injection site pain and reactions (redness, bruising, swelling and/or itching).

No drug interaction studies have been conducted in humans.