URIDINE TRIACETATE HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VISTOGARD safely and effectively. See full prescribing information for VISTOGARD.
VISTOGARD � (uridine triacetate) oral granules
Initial U.S. Approval: 2015
INDICATIONS AND USAGE
VISTOGARD� is a pyrimidine analog 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. (1)
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. (1)
The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established. (1)
DOSAGE AND ADMINISTRATION
Recommended Dosage
Adults: 10 grams (1 packet) orally every 6 hours for 20 doses, without regard to meals. (2.1)
Pediatric: 6.2 grams/m2 of body surface area (not to exceed 10 grams per dose) orally every 6 hours for 20 doses, without regard to meals. See the full prescribing information for body surface area-based dosing. (2.1)
Preparation and Administration
Pediatric: Measure the dose using either a scale accurate to at least 0.1 gram, or a graduated teaspoon accurate to � teaspoon. (2.1)
Mix each VISTOGARD dose with 3 to 4 ounces of soft foods such as applesauce, pudding or yogurt and ingest within 30 minutes of mixing. Do not chew the VISTOGARD granules. Drink at least 4 ounces of water. (2.2)
If a patient vomits within 2 hours of taking a dose of VISTOGARD, initiate another complete dose as soon as possible after the vomiting episode. Administer the next dose at the regularly scheduled time. (2.2)
If a patient misses a dose at the scheduled time, administer that dose of VISTOGARD as soon as possible. Administer the next dose at the regularly scheduled time. (2.2)
Administer VISTOGARD via a nasogastric tube (NG tube) or gastrostomy tube (G-Tube) when necessary (e.g., severe mucositis or coma). (2.2)
DOSAGE FORMS AND STRENGTHS
Oral granules: 10 gram packets (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
None. (5)
ADVERSE REACTIONS
Adverse reactions occurring in >2% of patients receiving VISTOGARD included vomiting, nausea, and diarrhea. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Wellstat Therapeutics Corporation at (1-800-914-0071) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 2/2017
