Approximately 84% of patients who received intravesical ValstarÔ in clinical studies experienced local adverse events, but approximately half of the patients reported irritable bladder symptoms prior to treatment. The local adverse reactions associated with ValstarÔ usually occur during or shortly after instillation and resolve within 1 to 7 days after the instillate is removed from the bladder.

Table 1 displays the frequency of the local adverse experiences at baseline and during treatment among 170 patients who received 800 mg doses of ValstarÔ in a multiple-cycle treatment regimen. Only 7 of 143 patients who were scheduled to receive six doses failed to receive all of the planned doses because of the occurrence of local bladder symptoms.

Most systemic adverse events associated with use of ValstarÔ have been mild in nature and self-limited resolving within 24 hours after drug administration. Table 2 displays the adverse events other than local bladder symptoms that occurred in 1% or more of the 230 patients who received at least one dose of ValstarÔ (200 to 900 mg) in a clinical trial. It can not be determined whether these events are drug-related.

Adverse reactions other than local reactions that occurred in less than 1% of the patients who received ValstarÔ intravesically in clinical trials are listed below. This list includes only adverse reactions that were suspected of being related to treatment.

Digestive System: Tenesmus.

Metabolic and Nutritional: Nonprotein nitrogen increased.

Skin and Appendages: Pruritus.

Special Senses: Taste loss.

Urogenital System: Local skin irritation, p.o. urine flow, and urethritis.

Inadvertent paravenous extravasation of ValstarÔ was not associated with skin ulceration or necrosis.

Because systemic exposure to ValstarÔ is negligible following intravesical administration, the potential for drug interactions is low. No drug interaction studies were conducted.

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