Full Prescribing Information
Important Safety Information
For Patients

The first and only treatment for early-onset,
severe or serious 5-FU or capecitabine toxicity 1, 2

Don’t wait—improve survival

Unprecedented survival with Vistogard® (uridine triacetate) oral granules 1, 2

Vistogard
  • 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 1, 2
    • Patients received only supportive care after overdose. All were overdosed by rate (1.9 to 64 times the planned infusion rate)
  • 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

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.

The efficacy of Vistogard® was assessed in 2 open- label trials (N=135, 95% with cancer diagnosis, 6 pediatric patients) who had either received an overdose of 5-FU or capecitabine, or presented with severe or life-threatening symptoms of 5-FU toxicity within 96 hours following the end of 5-FU or capecitabine administration. Overdose was defined as administration of 5-FU at a dose or infusion rate greater than the intended dose or maximum tolerated dose for the patient’s intended regimen of 5-FU. Vistogard® was administered at 10 g orally every 6 hours for 20 doses or at a body surface area–adjusted dosage of 6.2 g/m2/dose for 20 doses for 4 patients between 1 and 7 years of age. The major efficacy outcome was survival at 30 days or until the resumption of chemotherapy if prior to 30 days.4

Unprecedented survival in 5-FU overdose or toxicity 1, 2

Survival surpassing historical reports

Survival with Vistogard®
(uridine triacetate)
oral granules (N=135) 1, 2

Based on retrospective historical case reports of 25 patients who were overdosed with 5-FU and received supportive care only; all were overdosed by rate with a range 1.9 to 64 times the planned infusion rate and 84% died. 1, 2

33% of patients resumed chemotherapy within 30 days1

Of the 135 patients (95% with cancer diagnosis) enrolled in the 2 studies, 33% (n=45) with a cancer diagnosis who had received an overdose of 5-FU or had rapid onset of severe toxicity resumed chemotherapy in <30 days.5

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.

Pre-Clinical

Earlier treatment improved survival in animal studies

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