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.