Patients should be informed that ValstarÔ has been shown to induce complete responses in only about 1 in 5 patients, and that delaying cystectomy could lead to development of metastatic bladder cancer, which is lethal. They should discuss with their physician the relative risk of cystectomy versus the risk of metastatic bladder cancer (see CLINICAL PHARMACOLOGY, CLINICAL TRIALS) and be aware that the risk increases the longer cystectomy is delayed in the presence of persisting CIS.

Patients should be informed that the major acute toxicities from ValstarÔ are related to irritable bladder symptoms that may occur during instillation and retention of ValstarÔ and for a limited period following voiding. For the first 24 hours following administration, red tinged urine is typical. Patients should report prolonged irritable bladder symptoms or prolonged passage of red-colored urine immediately to their physician.

Women of child-bearing potential should be advised not to become pregnant during treatment. Men should be advised to refrain from engaging in procreative activities while receiving therapy with ValstarÔ. All patients of reproductive age should be advised to use an effective contraception method during the treatment period.

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