Usual Adult Dose for Fluorouracil/Capecitabine Overdose

10 grams (1 packet) orally every 6 hours for 20 doses

Comments:

• This drug 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 initiating treatment more than 96 hours following the end of a fluorouracil or capecitabine administration have not been established.

• For the emergency treatment of a fluorouracil or capecitabine overdose regardless of the presence of symptoms
• For use in patients 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.

Usual Adult Dose for Orotic Aciduria

Initial Dose: 60 mg/kg orally once a day

• Dose should be titrated for efficacy (i.e., orotic acid levels in urine); laboratory values (e.g., red blood cell or white blood cell indices) affected by hereditary orotic aciduria show evidence of worsening; or worsening of other signs or symptoms of the disease

Usual Pediatric Dose for Fluorouracil/Capecitabine Overdose

6.2 grams/m2 of body surface area (BSA) orally every 6 hours for 20 doses
Maximum Dose: 10 grams per dose

Comments:

• This drug 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 initiating treatment more than 96 hours following the end of a fluorouracil or capecitabine administration have not been established.

• For the emergency treatment of a fluorouracil or capecitabine overdose regardless of the presence of symptoms
• For use in patients 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.

Usual Pediatric Dose for Orotic Aciduria

Initial Dose: 60 mg/kg orally once a day

• Dose should be titrated for efficacy (i.e., orotic acid levels in urine); laboratory values (e.g., red blood cell or white blood cell indices) affected by hereditary orotic aciduria show evidence of worsening; or worsening of other signs or symptoms of the disease

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: None

Safety and effectiveness have been established in pediatric patients; however, data are limited.

Dialysis

Data not available

Other Comments

Administration Advice:
Uridine triacetate 10 g oral granules (Vistogard):

• Take orally with or without food following preparation instructions below; do not chew granules
• Begin administration as soon as possible after an overdose or early-onset toxicity; complete full course (20 doses)
• If a patient vomits within 2 hours of a dose, give another complete dose as soon as possible after the vomiting episode; administer next dose at the regularly scheduled time
• If a dose is missed, administer dose as soon as possible; administer next dose at the regularly scheduled time

• Take orally mixed with soft food or in milk or infant formula following preparation instructions below; do not chew granules

• Measure dose using a scale accurate to at least 0.1 g OR a graduated teaspoon accurate to one-fourth teaspoon; discard any unused portion of granules; do not use granules left in the open packet for subsequent dosing
• To administer with soft food: Mix the prescribed dose into 3 to 4 ounces of applesauce, pudding, or yogurt; consume immediately; do not store for later
• To administer in milk or infant formula (for doses up to 2 g): Using an oral syringe, draw up 5 mL of milk/infant formula, add prescribed dose, swirl to mix, administer; refill syringe with another 5 mL of milk or infant formula and administer; may follow with a bottle of milk or infant formula
• To administer via nasogastric tube or gastrostomy tube: Prepare approximately 100 mL of a food starch-based thickening product in water; stir briskly until thickener has dissolved; crush 10 g packet of granules to a fine powder and add crushed granules to thickening product; for pediatric patients requiring less than 10 g dose, prepare mixture at a ratio of no greater than 1 g/10 mL; after administration, flush tube with water

• Uridine triacetate 2 g oral granules (Xuriden): A 2 g packet contains approximately three-quarters of a teaspoon of uridine triacetate; manufacturer's product labeling displays a table with weight-based dosing in teaspoons and in grams
• Uridine triacetate 10 g oral granules (Vistogard): Manufacturer's product labeling displays a table with pediatric doses based on BSA and doses in teaspoons and grams

• Two uridine triacetate products are available; the 2 g packets (Xuriden) are indicated for the treatment of hereditary orotic aciduria and the 10 g packets (Vistogard) for the emergency treatment of fluorouracil or capecitabine overdose or for those exhibiting early-onset, severe or life-threatening toxicity within 96 hours following administration.
• Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger subjects.

• Urine levels of orotic acid to assess efficacy in the treatment of hereditary orotic aciduria
• To monitor for worsening disease, follow laboratory values (e.g., red blood cell or white blood cell indices) affected by hereditary orotic aciduria

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Patients/caregivers should be advised on the preparation and administration of this drug and what to do in the event the patient vomits or misses a dose.