Now FDA-approved for treatment of overdoses of fluorouracil or capecitabine.
On December 11, 2015, the FDA approved Vistogard (uridine triacetate) for the emergency treatment of an overdose of fluorouracil or capecitabine. It was approved for use in both children and adults and also is approved for patients who develop severe or life-threatening drug-induced toxicities within 4 days of receiving fluorouracil or capecitabine. Uridine acetate is a pro-drug of uridine, which competitively inhibits cell damage and cell death caused by fluorouracil or capecitabine. Overdoses of fluorouracil or capecitabine are rare occurrences; however, when they occur, they may be fatal or cause severe drug-related toxicities. Most inadvertent overdoses of fluorouracil have occurred with continuous infusions of the drug or overdoses related to unclear orders, such as confusing the total dose with the daily dose, have occurred.
Inadvertent overdoses of capecitabine have occurred when an incorrect dose of the drug has been prescribed or when patients self-administer an incorrect dose (eg, taking several days of the drug at one time).
Vistogard is provided in packets containing granules of uridine triacetate and is mixed with water or soft foods and taken orally. It may be administered via nasogastric tube when necessary. Adult dosing is 10 grams (one packet) orally every 6 hours for 20 doses. Pediatric dosing is body-surface area based. Full prescribing information can be found at https://www.vistogard.com.