There is no experience of overdosage in clinical trials. In rats, a single subcutaneous dose of 100 mg/kg (approximately 4,000 times the estimated daily human dose based on body surface area), resulted in dyspnea, decreased activity, and excessive scratching. In early clinical trials with daily subcutaneous 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.

1. LUPRON DEPOT is contraindicated in individuals with known hypersensitivity to GnRH agonists or any of the excipients in LUPRON DEPOT. Reports of anaphylactic reactions to GnRH agonist analogs have been reported in the medical literature.
2. LUPRON DEPOT may cause fetal harm when administered to a pregnant woman. Expected hormonal changes that occur with LUPRON DEPOT increase the risk for pregnancy loss and fetal harm when administered to a pregnant woman (see Pregnancy Category X). LUPRON DEPOT is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Last reviewed on RxList: 3/14/2012
This monograph has been modified to include the generic and brand name in many instances.