Urofollitropin

DEA Class; Rx

Common Brand Names; Bravelle, Fertinorm HP

Indicated for the treatment of infertility in females.

For the treatment of infertility in males (for the stimulation of spermatogenesis in males with primary or secondary hypogonadotropic hypogonadism and resultant oligospermia).

Pregnancy; may cause fetal harm

Hypersensitivity

High levels of FSH indicating primary ovarian failure

Presence of uncontrolled nongonadal endocrinopathies (eg, thyroid, adrenal, or pituitary disorders)

Sex hormone dependent tumors of the reproductive tract and accessory organ

Tumors of pituitary gland or hypothalamus

Abnormal uterine bleeding of undetermined origin

Ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome

Headache (11.1%)

OHSS (11.1%; severe pelvic pain, N/V, weight gain)

Hypertension

Ovarian enlargement

Abdominal cramps

Depression

Emotional lability

Fever

Pain

Breast tenderness

Hot flashes

Ovarian disorder (cyst, pain)

Abdomen enlarged

Abdominal pain

Nausea/vomiting

Weight gain

Uterine spasms

Vaginal discharge/hemorrhage/spotting

Injection site reaction

Postretrieval pain

Should be administered only by physicians thoroughly experienced in fertility disorders

Hypersensitivity/anaphylactic reactions reported

Ovarian hyperstimulation syndrome (OHSS) reported; OHSS is a medical event distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event; characterized by dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium

Use lowest effect dose to minimize abnormal ovarian enlargement; if ovaries are enlarged on last day of therapy, do not administer hCG because of risk for OHSS

May cause pulmonary and vascular complications (eg, atelectasis, ARDS)

Ovarian torsion has been reported after treatment with gonadotropins

Multi-fetal gestation and births have been reported with all gonadotropin therapy

Incidence of congenital malformations after some ART (specifically IVF or ICSI) may be slightly higher than after spontaneous conception (likely due to parental characteristics)

Since infertile women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased

Increased incidence of spontaneous abortion and ovarian neoplasms observed (without causality)

Pregnancy Category: X

Lactation: Not known if excreted in breast milk, avoid using in breast-feeding women

Urofollitropin

Bravelle Intramuscular Inj Pwd F/Sol: 75IU
Bravelle Subcutaneous Inj Pwd F/Sol: 75IU