"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
There is no known antidote for overdoses of VALSTAR (valrubicin) . The primary anticipated complications of overdosage associated with intravesical administration would be consistent with irritable bladder symptoms.
Myelosuppression is possible if VALSTAR (valrubicin) 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 VALSTAR (valrubicin) is administered when bladder rupture or perforation is suspected, weekly monitoring of complete blood counts should be performed for 3 weeks.
VALSTAR (valrubicin) is contraindicated in patients with known hypersensitivity to anthracyclines or polyoxyl castor oil.
Patients with concurrent urinary tract infections should not receive VALSTAR (valrubicin) .
VALSTAR (valrubicin) should not be administered to patients with a small bladder capacity, i.e., unable to tolerate a 75 mL instillation.
Last reviewed on RxList: 11/24/2008
This monograph has been modified to include the generic and brand name in many instances.
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