The US Food and Drug Administration (FDA) has approved Vistogard (uridine triacetate) as the first and only antidote for the emergency treatment in adult and pediatric patients following an overdose of certain chemotherapy drugs.
Vistogard is administered to patients receiving the chemotherapy agents 5-Fluororacil (5-FU) or capecitabine, and to treat patients who exhibit early-onset, severe, or life-threatening toxicity within 96 hours after the end of treatment with 5-FU or capecitabine.
The drugs 5-FU (given by intravenous infusion) and capecitabine (given orally) are essential components of combination anticancer regimens to treat solid tumors, including those of the colon, pancreas, breast, and head and neck. Life-threatening or even lethal toxicities can occur if the drug has been administered at a dose or rate greater than intended or when a patient has an increased susceptibility to the toxicities of the drug. Vistogard, given orally, blocks cell damage and cell death caused by these chemotherapeutic agents.
A clinical trial involving 135 adult and pediatric patients (treated in separate trials) who had received an overdose of 5-FU or capecitabine, or had early-onset, unusually severe or life-threatening toxicities within 96 hours after receiving 5-FU, provided data on efficacy and safety of Vistogard. Of those treated with Vistocard for overdose, 97% were still alive at 30 days and those treated for early-onset, severe or life-threatening toxicity, 89% were alive at 30 days. In both studies, 33% of the patients resumed chemotherapy in less than 30 days.
The most common side effects of treatment with Vistogard were diarrhea, vomiting, and nausea. The safety and efficacy of Vistogard initiated more than 96 hours following the end of treatment with 5-FU or capecitabine has not been established. Vistogard is not recommended for treating nonemergency adverse reactions because Vistogard may lessen the efficacy of these drugs.
The approval of Vistogard is important because it represents the first treatment with a demonstrated track record of efficacy and allows some patients to resume chemotherapy sooner following the resolution of the toxicity.