• Vistogard^® is indicated for the emergency treatment of adult and pediatric patients following a 5-FU or capecitabine overdose regardless of the presence of symptoms
• Vistogard^® treatment should be initiated as soon as possible upon recognizing that a patient has been overdosed with 5-FU or capecitabine
• Administer all 20 doses of Vistogard^®, even if the patient feels well

• Overdose was defined, in clinical studies, as administration of 5-FU at ANY dose, or infusion rate, greater than the intended dose or maximum tolerated dose for the patient’s intended regimen. ^{1, 2, 5, 24}
  • If treatment is delayed until symptoms appear, they may be irreversible.
  • Infusion rate overdoses ranged from 1.3 to 720 times the planned rate in clinical studies ¹

• 96% (130/135) survival in patients who received Vistogard^® for 5-FU overdose or severe or serious 5-FU toxicity ^{1, 2}
• 16% survival in historical case reports of 5-FU overdose before Vistogard^® became available ⁴
  • Patients received only supportive care after overdose. All were overdosed by rate (1.9 to 64 times the planned infusion rate) ^{1, 2}
• Of the 135 patients treated with Vistogard^®, there were 5 deaths due to 5-FU or capecitabine toxicity (4%). Of these, 2 were treated >96 hours following the end of 5-FU administration ^{1, 2}

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.