Palliative treatment of advanced prostatic carcinoma, central precocious puberty, endometriosis.

The drug appears to be as effective as diethylstilbestrol (3 mg daily) in the palliative treatment of metastatic prostate cancer, but with a lower order of toxicity. The effectiveness in the treatment of endometriosis is equivalent to danazol.

Following IM administration of the long-acting injectable suspension or subcutaneous administration of the long-acting injectable suspension, the drug is released slowly and gradually from its biodegradable copolymer-containing vehicle (after an initial, rapid absorption of immediately available drug), thus providing a prolonged duration of action.

Hypersensitivity to leuprolide, GnRH, or GnRH analogs; spinal-cord compression (orchiectomy suggested); pregnancy; undiagnosed abnormal vaginal bleeding; breast-feeding.

X

Because the effects of leuprolide on lactation and nursing infants currently are not known, the drug should not be used in nursing women.

Vasomotor hot flashes, edema, gynecomastia, bone pain, thrombosis, and GI disturbances.

Prostatic cancer: 3.75 mg SC or IM once a month;
endometriosis: 3.75 mg SC or IM once a month, initiate at 1st-5th day after the start of menstrual period;
central precocious puberty: 300ug/kg/dose IM every 28 days (minimum dose: 7.5 mg).

The Leuprorelin vials should be avoided freezing the product and protected from light and stored in the carton until used.. The potency of the reconstituted suspension has been shown to be stable for 24 hours.