Patients who receive an overdose of chemotherapy drugs will now have access to an emergency treatment called uridine triacetate.
Patients who receive an overdose of chemotherapy drugs will now have access to an emergency treatment called uridine triacetate (Vistogard).
The product is designed to help adults and children who receive an excess of fluorouracil or capecitabine and develop life-threatening toxicities within 4 days of receiving the cancer treatments.
“Treating cancer requires not only selecting which drug may be most effective and well tolerated, but ensuring the correct dose is given at proper intervals,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “While rare, unintentional overdose can occur. Today’s approval is a first-of-its-kind therapy that can potentially save lives following overdose or life-threatening toxicity from these chemotherapy agents.”
Vistogard was studied in a trial of 135 patients who either experienced an overdose or who had early-onset and severe toxicities within 96 hours of taking fluorouracil.
Of the patients who received Vistogard for an overdose, 97% were still alive after 30 days, and 89% of the patients who had experienced early-onset severe or life-threatening toxicity and took Vistogard were still alive at 30 days.
One-third of the patients restarted chemotherapy in less than 1 month.
Vistogard, which is taken orally, works by prohibiting cell damage and cell death caused by fluorouracil.
Diarrhea, vomiting, and nausea are the most common adverse effects reported.