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Leuprolide

    Brands

    DEA Class; Rx

    Common Brand Names; Lupron, Lupron Depot, Lupron Depot 3 Month, Lupron Depot 4 Month, Lupron Depot 6 Month, Lupron Depot-Ped, Eligard, Fensolvi, Camcevi

    • Antineoplastics, GNRH Agonist

    Synthetic nonpeptide analog of gonadotropin-releasing hormone (GnRH)
    Used for endometriosis, precocious puberty, prostate cancer, and uterine fibroids
    May cause an increase in symptoms during the first weeks of therapy; monitor patients closely

    Indicated for the treatment of prostate cancer.

    For the management of endometriosis including pain relief and reduction of endometriotic lesions.
    For the treatment of central precocious puberty (idiopathic or neurogenic) in children.
    For the treatment of anemia due to uterine leiomyomata (fibroids) in combination with iron therapy preoperatively in persons for whom 3 months of hormonal suppression is deemed necessary.
    For the treatment of benign prostatic hyperplasia (BPH).
    For the adjuvant treatment of premenopausal women with hormone receptor-positive breast cancer.
    For the treatment of nonspecific symptoms associated with premenstrual syndrome (PMS).

    Hypersensitivity

    Pregnancy

    Fensolvi

    • Injection site pain (31%)

    • Nasopharyngitis (22%)

    • Pyrexia (17%)

    • Headache (16%)

    • Cough (13%)

    Lupron Depot-Ped (monthly)

    • Injection site reactions including abscess (37%)

    • Emotional lability (19%)

    • Acne/seborrhea (13%)

    • Vaginitis/vaginal bleeding or discharge (13%)

    • Rash including erythema multiforme (12%)

    • General pain (12%)

    • Headache (11%)

    Lupron Depot-Ped (q3months)

    • Injection site pain (19-21%)

    Lupron Depot (22.5 mg q3months)

    • Hot flashes/sweats (58.5%)

    • General pain (26.6%)

    • Testicular atrophy (20.2%)

    • Gastrointestinal disorders (16%)

    • Urinary disorders (14.9%)

    • Injection site reaction (13.8%)

    • Joint disorders (11.7%)

    May cause fetal harm when administered to pregnant females

    Contraindicated

    Based on animal data and mechanism of action, fetal harm may occur

    Insufficient data available to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

    Exclude pregnancy in females of reproductive potential prior to initiation

    No data available on presence of leuprolide acetate in either animal or human milk, effects on breastfed infants, or effects on milk production

    Adults

    120 mg/dose subcutaneously every 4 weeks.

    Geriatric

    120 mg/dose subcutaneously every 4 weeks.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Leuprolide Acetate

    injection, powder for reconstitution (Eligard)

    • 7.5mg (monthly)

    • 22.5mg (3 months)

    • 30mg (4 months)

    • 45mg (6 months)

    injection, powder for reconstitution (Fensolvi)

    • 45mg/syringe in kit

    injection, suspension (Lupron Depot)

    • 3.75mg (monthly)

    • 7.5mg (monthly)

    • 11.25mg (3 months)

    • 22.5mg (3 months)

    • 30mg (4 months)

    • 45mg (6 months)

    injection, emulsion (Camcevi)

    • 42mg/prefilled syringe (6 months)

    injection, solution (generic leuprolide acetate)

    • 5mg/mL vial (daily)