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Urofollitropin

    Brands

    DEA Class; Rx

    Common Brand Names; Bravelle, Fertinorm HP

    • Gonadotropins; 
    • Ovulation Stimulators

    Human-derived urinary gonadotropin; lower cost than recombinant FSH; primarily contains FSH with negligible (< 0.1 IU) LH activity per 1000 IU of FSH activity; used for infertility protocols for ovulation induction; also used for spermatogenesis induction in men with reproductive failure due to hypothalamic or pituitary dysfunction or hypogonadotropic hypogonadism.

    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

    No specific maximum dosage limit recommendations are available. Dosage regimens of urofollitropin depend upon the patient’s age, sex, weight, condition being treated, the formulation used, and the prescribing clinician’s judgment. Therefore, doses may vary widely and must be carefully individualized.

    Urofollitropin

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