General Information 

Vistogard (uridine triacetate) is a pyrimidine analog.

Vistogard is specifically 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.

Mechanism of Action

Vistogard (uridine triacetate) is a pyrimidine analog. Following oral administration, uridine triacetate is deacetylated by nonspecific esterases present throughout the body, yielding uridine in the circulation. Uridine competitively inhibits cell damage and cell death caused by fluorouracil.

Side Effects

Adverse effects associated with the use of Vistogard may include, but are not limited to, the following:

• Vomiting
• Nausea
• Diarrhea

Dosing/Administration

Vistogard is supplied as oral granules for oral administration. Mix each Vistogard dose with 3 to 4 ounces of soft foods such as applesauce, pudding or yogurt and ingest within 30 minutes. Do not chew the granules. Drink at least 4 ounces of water. The recommended dose for adults is 10 grams (one packet) orally every six hours for 20 doses, without regard to meals. The recommended dose for pediatrics is 6.2 grams/m2 of body surface area (not to exceed 10 grams per dose) orally every six hours for 20 doses, without regard to meals. Please see drug label for specific doses based on body surface area.

Clinical Trial Results

FDA Approval

The FDA approval of Vistogard was based on data from a development program in 135 patients designed to demonstrate the efficacy and safety of a single course of 10 grams given orally every six hours for a total of 20 doses. Patients in the studies had either received an overdose of 5-FU or capecitabine, or presented with severe or life-threatening toxicities within 96 hours following the end of 5-FU or capecitabine administration. The overall survival of patients with 5-FU toxicity receiving Vistogard was 96 percent, compared with 16 percent in historical cases employing standard supportive care measures. Vistogard also helped patients resume chemotherapy sooner, with 33 percent resuming their cancer treatment within 30 days.