WARNINGS
Viadur®, 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 symptoms, including bone pain, neuropathy, hematuria, or ureteral or bladder outlet obstruction (see PRECAUTIONS).
Cases of ureteral obstruction and spinal cord compression, which may contribute to paralysis with or without fatal complications, have been reported with LH-RH agonists.
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).
X-rays do not affect Viadur® functionality. Viadur® is radio-opaque and is well visualized on X-rays.
The titanium alloy reservoir of Viadur® is nonferromagnetic and is not affected by magnetic resonance imaging (MRI). Slight image distortion around Viadur® may occur during MRI procedures.
Information for Patients
An information leaflet for patients is included with the product.
Laboratory tests
Response to Viadur® should be monitored by measuring serum concentrations of testosterone and prostate-specific antigen periodically.
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 in rats and mice. In rats, dose-related increases of benign pituitary hyperplasia and benign pituitary adenomas were noted at 24 months when the drug was administered subcutaneously at high daily doses (4 to 24 mg/m2, 50 to 300 times the daily human exposure based on body surface area). There were significant but not dose-related increases 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 pituitary abnormalities were observed at up to 180 mg/m2 (over 2000 times the daily human exposure based on body surface area) for 2 years.
Mutagenicity studies were performed with leuprolide acetate using bacterial and mammalian systems. These studies provided no evidence of a mutagenic potential.
Pregnancy, Teratogenic Effects
Pregnancy Category X (see CONTRAINDICATIONS).
Pediatric Use
Viadur® is contraindicated in pediatric patients and was not studied in children
(see CONTRAINDICATIONS).
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