Full Prescribing Information
Important Safety Information
For Patients

Pre-Clinical

Earlier treatment improved survival in animal studies

After a lethal dose of 5-FU in animal studies 20

Vistogard
when VISTOGARD® dosing
began at 24 hours

Treatment: with uridine triacetate (2 g/kg every 8 hours for 15 doses over 5 days) was initiated at 24, 48, 74, and 96 hours (n=10/group) after a lethal overdose of 5-FU (300 mg/kg) in normal mice and in a model of DPD delivery 20.

The clinical significance of animal studies is unknown.

  • Survival diminished with increasing interval between the 5-FU dose and uridine triacetate treatment, indicating that earlier administration is more beneficial 20
  • In mice given a sub-lethal dose of 5-FU, the administration of oral uridine triacetate diminished but did not completely prevent hematological toxicity as a function of increasing dose

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.

Clinical

The first and only treatment for early-onset, severe or serious 5-FU or capecitabine toxicity

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