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

The first and only treatment for 5-FU or
capecitabine overdose 1, 2

Don’t wait for overdose symptoms:
Treat immediately 19, 20

  • 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
Dosing Instructions
  • 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

Unprecedented survival in 5-FU overdose or toxicity

  • 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
Clinical Data

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

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.

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