Goserelin (1 brand name, 1 dosage form, 1 route)
Available dosage forms: IMPLANT.
Routes of administration: IMPLANTATION.
Brand Names
- ZOLADEX
Dosage and Administration
ZOLADEX, at a dose of 3.6 mg, should be administered subcutaneously every 28 days into the anterior abdominal wall below the navel line using an aseptic technique under the supervision of a physician [see Dosage and Administration (2.7)]. While a delay of a few days is permissible, every effort should be made to adhere to the 28-day schedule.
Drug Interactions
No formal drug-drug interaction studies have been performed. No confirmed interactions have been reported between ZOLADEX and other drugs.
Mechanism of Action
ZOLADEX is a synthetic decapeptide analogue of GnRH. ZOLADEX acts as an inhibitor of pituitary gonadotropin secretion when administered in the biodegradable formulation. In animal and in vitro studies, administration of goserelin resulted in the regression or inhibition of growth of the hormonally sensitive dimethylbenzanthracene (DMBA)-induced rat mammary tumor and Dunning R3327 prostate tumor.
Overdosage
The pharmacologic properties of ZOLADEX and its mode of administration make accidental or intentional overdosage unlikely. There is no experience of overdosage from clinical trials. Animal studies indicate that no increased pharmacologic effect occurred at higher doses or more frequent administration. Subcutaneous doses of the drug as high as 1 mg/kg/day in rats and dogs did not produce any nonendocrine related sequelae; this dose is up to 250 times the estimated human daily dose based on the body surface area. If overdosage occurs, it should be managed symptomatically.