Uridine triacetate - an antidote in the treatment of 5-fluorouracil or capecitabine poisoning

ABSTRACT

Introduction: In 2015, vistogard was approved both the US FDA and the European Medicines Agency (EMA) as an antidote in the treatment of 5-FU poisoning following an overdose of 5-FU or capecitabine or in patients exhibiting early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g. gastrointestinal toxicity and/or neutropenia) within 96 h following the end of 5-FU or capecitabine administration.

Areas covered: This paper reviews the history of the development of vistogard (uridine triacetate) to its current status in clinical practice. Vistogard is an orally active prodrug of uridine, which has made a more effective uridine administration technique possible to improve the tolerability of intravenous and oral fluoropyrimidines, including capecitabine. In addition to preclinical data, we also reviewed the data on all the published patients who received vistogard secondary to overdosed 5-FU or capecitabine, or exhibited early onset of severe toxicities.

Expert opinion: Vistogard is the first and the only antidote to overdose and early-onset, severe, or life-threatening toxicities from 5-Fluorouracil or capecitabine.

KEYWORDS:

• 5-Fluorouracil
• capecitabine
• fluoropyrimidines
• PN401
• uridine
• DPYD gene
• vistogard

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose

Additional information

Funding

This paper was not funded.