When you see these RED FLAGS

DON'T WAIT TO ACT

Administer Vistogard^® (uridine triacetate) oral granules at the initial signs of early-onset or serious 5-FU toxicity

For signs that appear within 96 hours after the end of 5-FU administration
The first and only treatment for early-onset, severe or serious 5-FU or capecitabine toxicity or overdose

If you suspect signs or symptoms of toxicity, don’t wait to treat^{3, 19}

—Red flags that develop early—

especially during the first or second treatment cycle and appearing within 96 hours of 5-FU administration—may become severe or life-threatening⁴

Red flags require attention

Treat 5-FU overdose immediately with Vistogard®, regardless of the presence of symptoms. Toxicities may begin within hours of starting 5-FU.¹⁹

Assess patient for severe 5-FU toxicity
Stop 5-FU or capecitabine
Administer Vistogard^®
Prior to 96 hours after discontinuation of 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.

Limitations of use

VISTOGARD is not recommended for the non–emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs.
The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established.

Important Safety Information

In clinical studies, adverse reactions occurring in >2% of patients receiving VISTOGARD included vomiting (10%), nausea (5%), and diarrhea (3%).
One person receiving uridine triacetate experienced grade 3 nausea and vomiting.
VISTOGARD was discontinued for adverse reactions in 2 (1.4%) patients.

The efficacy of Vistogard^® was assessed in 2 open- label trials (N=135, 95% with cancer diagnosis, 6 pediatric patients) who had either received an overdose of 5-FU or capecitabine, or presented with severe or life-threatening symptoms of 5-FU toxicity within 96 hours following the end of 5-FU or capecitabine administration. Overdose was defined as administration of 5-FU at a dose or infusion rate greater than the intended dose or maximum tolerated dose for the patient’s intended regimen of 5-FU. Vistogard^® was administered at 10 g orally every 6 hours for 20 doses or at a body surface area–adjusted dosage of 6.2 g/m2/dose for 20 doses for 4 patients between 1 and 7 years of age. The major efficacy outcome was survival at 30 days or until the resumption of chemotherapy if prior to 30 days.⁴