Leuprolide Acetate (9 brand names, 6 dosage forms, 5 routes)
Available dosage forms: INJECTABLE, POWDER, SOLUTION, IMPLANT, FOR SUSPENSION, INJECTABLE, TABLET.
Routes of administration: INJECTION, SUBCUTANEOUS, INTRAMUSCULAR, IMPLANTATION, INTRAMUSCULAR, ORAL.
Brand Names
- ELIGARD KIT
- FENSOLVI KIT
- LEUPROLIDE ACETATE
- LEUPROLIDE ACETATE FOR DEPOT SUSPENSION
- LUPANETA PACK
- LUPRON
- LUPRON DEPOT
- LUPRON DEPOT-PED KIT
- VIADUR
Indications and Usage
Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.
Dosage and Administration
The recommended dose is 1 mg (0.2 mL or 20 unit mark) administered as a single daily subcutaneous injection. As with other drugs administered chronically by subcutaneous injection, the injection site should be varied periodically. Each 0.2 mL contains 1 mg of leuprolide acetate, sodium chloride for tonicity adjustment, 1.8 mg of benzyl alcohol as preservative and water for injection. The pH may have been adjusted with sodium hydroxide and/or acetic acid. Follow the pictorial directions on this package insert for administration. NOTE: As with all parenteral products, inspect the solution for discoloration and particulate matter before each use.
Contraindications
Leuprolide acetate injection is contraindicated in patients known to be hypersensitive to GnRH, GnRH agonist analogs or any of the excipients in leuprolide acetate injection. Reports of anaphylactic reactions to GnRH agonist analogs have been reported in the medical literature.
Overdosage
In rats subcutaneous administration of 250 to 500 times the recommended human dose, expressed on a per body weight basis, resulted in dyspnea, decreased activity and local irritation at the injection site. There is no evidence at present that there is a clinical counterpart of this phenomenon. In early clinical trials with leuprolide acetate doses as high as 20 mg/day for up to two years caused no adverse effects differing from those observed with the 1 mg/day dose.