Classes
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
Description
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
Indications
Indicated for the treatment of prostate cancer.
Contraindications
Hypersensitivity
Pregnancy
Adverse Effects
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%)
Warnings
May cause fetal harm when administered to pregnant females
Pregnancy and Lactation
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
Maximum Dosage
120 mg/dose subcutaneously every 4 weeks.
120 mg/dose subcutaneously every 4 weeks.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
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)