Full Prescribing Information
Important Safety Information
For Patients

DON'T WAIT
TO ACT

Vistogard®* (uridine triacetate) oral granules is the first and only antidote for 5-FU overdose and early-onset, severe or serious 5-FU toxicity

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.
*A pyrimidine analog

Don't Wait

Stay alert for early, severe 5-FU or capecitabine toxicity

Vistogard

Don't Wait to Act

These RED FLAGS require immediate attention

Unusually severe side effects 3, 8, 9, 12

Digestive
  • Mucositis (mouth pain, pain on swallowing)
  • Vomiting not well controlled by antiemetics
  • Diarrhea
Blood
  • Leukopenia (WBC ‹3500 or falling rapidly)
  • Neutropenia (ANC ‹1000 cells/µL or falling rapidly)9
  • Thrombocytopenia (‹100,000 platelets/µ or falling rapidly)

CNS and cardiac side
effects 4, 10, 15-18

CNS
  • Altered mental status
  • Cerebellar ataxia
  • Changes in cognition or consciousness
Cardiac
  • Acute cardiomyopathy
  • Chest pain
  • Heart failure
  • Heart attack
  • Irregular heart beat

Red flags developing early (especially during the first or second treatment cycle and appearing within 96 hours of 5-FU or capecitabine administration) should be addressed promptly. 1-3

Vistogard

Dosing

Vistogard

Treating ASAP

Vistogard

Clinical Data

Mechanism of Action

(MOA)

Vistogard

Documented Safety Profile

Vistogard