Wellstat Therapeutics announced that FDA has approved Vistogard (uridine triacetate) as the first and only antidote for emergency treatment of adult and pediatric patients following an overdose of the chemotherapy agents 5-fluorouracil (5-FU) or capecitabine regardless of the presence of symptoms, or to treat patients who exhibit early-onset, severe or life-threatening toxicity affecting cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions within 96 hours after the end of treatment with 5-FU or capecitabine.

Indication: Vistogard is indicated for the emergency treatment of adult and pediatric patients: following a fluorouracil or capecitabine overdose regardless of the presence of symptoms; or, who exhibit 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 hours following the end of fluorouracil or capecitabine administration.

Adverse Events: Occurring in greater than 2% of patients were vomiting (10%), nausea (5%) and diarrhea (3%).

Citation: Wellstat Announces FDA Approval of VISTOGARD (Uridine Triacetate), the First Antidote to Treat Overdoses and Early-Onset Severe Toxicities Due to 5-Fluorouracil (5-FU) and Capecitabine Chemotherapies. [news release]. Gaithersburg, MD: Wellstat Therapeutics; December 11, 2015. http://www.wellstattherapeutics.com/therapeutics/VPR.pdf. Accessed December 16, 2015.