Full Prescribing Information
Important Safety Information
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Dosage and administration

Vistogard

Advise the patient or caregiver 1, 2, 19

  • Vistogard® (uridine triacetate) oral granules can be taken mixed in food (such as applesauce, pudding, or yogurt)
  • Chewing the Vistogard® granules is not recommended
  • If the patient vomits within 2 hours of taking a dose of Vistogard®, the patient should take another complete dose as soon as possible after vomiting and the next dose at the regularly scheduled time
  • If the patient misses a dose at the scheduled time, to take that dose of Vistogard® as soon as possible. Then take the next dose at the regularly scheduled time

Administer all 20 doses of Vistogard®, even if the patient feels well 19

  • If treatment is delayed until symptoms appear, they may be irreversible.
  • Median duration of exposure was 4.8 days, with a median of 20 doses (range 1 to 23) in clinical trials including both inpatients and outpatients 1

Special dosing instructions 19

  • Vistogard® may be administered via nasogastric tube (NG tube) or gastrostomy tube (G–tube) when necessary (eg, severe mucositis or coma)
  • The pediatric dose is 6.2 g/m2 of body surface area (not to exceed 10 g/dose) orally every 6 hours for 20 doses, without regard to meals
    • Measure the dose using either a scale accurate to ≤0.1 g or a graduated teaspoon accurate to ¼ teaspoon
    • Discard any unused portion of granules. Do not use granules left in the open packet for subsequent dosing

Vistogard® Pediatric Dose Based on Body Surface Area 4

Patient
Body Surface
Area (m2)		 Vistogard®
6.2 g/m2/dose*
Dose in Grams Dose in Graduated
Teaspoons
0.34 to 0.44 2.1 to 2.7 1
0.45 to 0.55 2.8 to 3.4 1¼
0.56 to 0.66 3.5 to 4.1 1½
0.67 to 0.77 4.2 to 4.8 1¾
0.78 to 0.88 4.9 to 5.4 2
0.89 to 0.99 5.5 to 6.1 2¼
1.00 to 1.10 6.2 to 6.8 2½
1.11 to 1.21 6.9 to 7.5 2¾
1.22 to 1.32 7.6 to 8.1 3
1.33 to 1.43 8.2 to 8.8 3¼
1.44 and above† 10.0 1 full packet†

*Dose by body surface area category in this table was rounded to achieve the approximate dose. Each dose is administered every 6 hours for 20 doses.

†May use 1 entire 10 g packet without weighing or measuring. Do not exceed 10 g/dose.

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.

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.

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