The U.S. Food and Drug Administration has approved uridine triacetate (Vistogard) for the treatment of adult and pediatric patients who have overdosed on fluorouracil or capecitabine.1
It is indicated regardless of symptoms, or in patients who exhibit early-onset, severe, or life-threatening toxicity that affects the cardiac or central nervous system and/or for those who exhibit unusually severe reactions within 96 hours of receiving treatment with fluorouracil or capecitabine. The safety and efficacy of uridine after 96 hours are not yet known.
The approval was based on the results of 2 single-arm, open-label expanded access studies of patients who had either overdosed on fluorouracil or capecitabine or presented with severe or life-threatening toxicities within 96 hours of administration of those drugs.
The study’s primary endpoint was survival at 30 days following resumption of chemotherapy. A total of 135 patients were enrolled in both trials; 130 (96%) survived and 5 (4%) died. Of those who died, 2 had been treated after 96 hours of chemotherapy administration.
In regard to safety, the most common adverse effects (greater than 2%) were vomiting (10%), nausea (5%) and diarrhea (3%). One patient experienced grade 3 nausea and vomiting. There were no treatment-related deaths.
Uridine should be administered as soon as possible following an overdose or early onset toxicity within the 96-hour window after administration of fluorouracil or caapecitabine. It should be administered in adults 10 mg orally every 6 hours for 20 doses. In children, it should be administered in 6.2 g/m2 of body surface area every 6 hours for 20 doses.
- Uridine triacetate [news release]. Silver Spring, MD: U.S. Food and Drug Administration; December 11, 2015. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm476930.htm. Accessed December 11, 2015.