FDA Approves Uridine Triacetate for Emergency Treatment of Fluorouracil or Capecitabine Overdose
The U.S. Food and Drug Administration (FDA) today approved uridine triacetate (Vistogard) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil (5-FU) or capecitabine, or who develop certain severe or life-threatening toxicities within 4 days of receiving these 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. While rare, unintentional overdose can occur,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “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.”
Uridine triacetate, taken orally, blocks cell damage and cell death caused by 5-FU chemotherapy. Patients should take uridine triacetate as soon as possible after the overdose (whether or not they have symptoms) or after early-onset (within 4 days) of severe or life-threatening toxicity. The patient’s health-care provider will determine when he or she should return to the prescribed chemotherapy after treatment with uridine triacetate.
Clinical Trial Results
The approval was based on two single-arm, expanded-access studies of adult and pediatric patients who had either received a 5-FU or capecitabine overdose or who presented with severe or life-threatening toxicities within 96 hours after receiving 5-FU or capecitabine (not due to an overdose). The studies’ primary measure was survival at 30 days or until chemotherapy could resume if prior to 30 days.
Of those who were treated with uridine triacetate for overdose, 97% were still alive at 30 days. Of those treated for early-onset severe or life-threatening toxicity, 89% were alive at 30 days. In both studies, 33% of patients resumed chemotherapy in less than 30 days.
Uridine triacetate is not recommended for treating nonemergency adverse reactions associated with 5-FU or capecitabine because it may lessen the efficacy of these drugs. The safety and efficacy of uridine triacetate initiated more than 96 hours following the end of treatment with 5-FU or capecitabine have not been established.
The most common side effects of treatment with uridine triacetate were diarrhea, vomiting, and nausea.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
