There is no known antidote for overdoses of ValstarÔ. The primary anticipated complications of overdosage associated with intravesical administration would be consistent with irritable bladder symptoms.

Myelosuppression is possible if ValstarÔ is inadvertently administered systemically or if significant systemic exposure occurs following intravesical administration (e.g., in patients with bladder/rupture perforation). The maximum tolerated dose in humans by either intraperitoneal or intravenous administration is 600 mg/m². Dose limiting toxicities are leukopenia and neutropenia, beginning within 1 week of dose administration, with nadirs by the second week, and recovery generally by the third week. If ValstarÔ is administered when bladder rupture or perforation is suspected, weekly monitoring of complete blood counts for should be performed for 3 weeks.

ValstarÔ is contraindicated in patients with known hypersensitivity to anthracyclines or Cremophor^ÒEL (polyoxyethyleneglycol triricinoleate).

Patients with concurrent urinary tract infections should not receive ValstarÔ.

ValstarÔ should not be administered to a patient with a small bladder capacity, i.e., unable to tolerate a 75 mL instillation.

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