The first and only treatment for early-onset, severe or serious 5-FU toxicity ^{1, 2, 19}

• No contraindications, warnings, precautions, or cytochrome P450 drug–drug interactions⁴
• May be taken without regard to meals⁴
• Pharmacokinetics were not significantly affected by gender or age (in patients aged 20 to 83 years)⁴
• Geriatric patients: Of the 135 patients in clinical studies with Vistogard®, 30% were ≥65, including 11% ≥75
• One patient receiving Vistogard® had Grade 3 nausea and vomiting⁴
• Vistogard® was discontinued for adverse reactions in 2 (1.4%) patients⁴

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.