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Eligard (Leuprolide Acetate) - Warnings and Precautions

 
 



WARNINGS

ELIGARD® 7.5 mg, like other LH-RH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, or bladder outlet obstruction. Isolated cases of ureteral obstruction and/or spinal cord compression, which may contribute to paralysis with or without fatal complications, have been observed in the palliative treatment of advanced prostate cancer using LH-RH agonists. (see PRECAUTIONS).

If spinal cord compression or renal impairment develops, standard treatment of these complications should be instituted.

PRECAUTIONS

General:    Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy (see WARNINGS section).

Laboratory tests:    Response to ELIGARD® 7.5 mg should be monitored by measuring serum concentrations of testosterone and prostate-specific antigen periodically.

In the majority of patients, testosterone levels increased above Baseline during the first week, declining thereafter to Baseline levels or below by the end of the second week. Castrate levels were generally reached within two to four weeks and once achieved were maintained for the duration of treatment. No increases to above the castrate level occurred in any of the patients.

Results of testosterone determinations are dependent on assay methodology. It is advisable to be aware of the type and precision of the assay methodology to make appropriate clinical and therapeutic decisions.

Drug Interactions:    See PHARMACOKINETICS

Drug/Laboratory Test Interactions:    Therapy with leuprolide results in suppression of the pituitary-gonadal system. Results of diagnostic tests of pituitary gonadotropic and gonadal functions conducted during and after leuprolide therapy may be affected.

Carcinogenesis, Mutagenesis, Impairment of Fertility:    Two-year carcinogenicity studies were conducted with leuprolide acetate in rats and mice. In rats, a dose-related increase of benign pituitary hyperplasia and benign pituitary adenomas was noted at 24 months when the drug was administered subcutaneously at high daily doses (0.6 to 4 mg/kg). There was a significant but not dose-related increase of pancreatic islet-cell adenomas in females and of testicular interstitial cell adenomas in males (highest incidence in the low dose group). In mice, no leuprolide acetate-induced tumors or pituitary abnormalities were observed at a dose as high as 60 mg/kg for two years. Patients have been treated with leuprolide acetate for up to three years with doses as high as 10 mg/day and for two years with doses as high as 20 mg/day without demonstrable pituitary abnormalities. No carcinogenicity studies have been conducted with ELIGARD® 7.5 mg.

Mutagenicity studies have been performed with leuprolide acetate using bacterial and mammalian systems and with ELIGARD® 7.5 mg in bacterial systems. These studies provided no evidence of a mutagenic potential.

Pregnancy, Teratogenic Effects:    Pregnancy category X. (See CONTRAINDICATIONS).

Pediatric Use:    ELIGARD® 7.5 mg is contraindicated in pediatric patients and was not studied in children (see CONTRAINDICATIONS).

Page last updated: 2006-01-05

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