Full Prescribing Information
Important Safety Information
Patient Site
Vistogard® is being distributed by BTG Pharmaceuticals as of July 1, 2023. For more details please click here.

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

Read More

You are now leaving the patient site.

The section you selected contains information intended for U.S. healthcare professionals only.
Please certify that you are a U.S. healthcare professional by clicking the link below.

Yes, I am a U.S. Healthcare professional No, I am not a U.S. Healthcare professional