Dosage and Administration

• The starting dosage is 60 mg/kg once daily; the dose may be increased to 120 mg/kg (not to exceed 8 grams) once daily for insufficient efficacy
  • See the Full Prescribing Information for 60 mg/kg and 120 mg/kg weight-based dosing tables
• Measure the dose using either a scale accurate to at least 0.1 gram or a graduated teaspoon accurate to the fraction of the dose to be administered
• Administer the dose with food (applesauce, pudding, or yogurt) or in milk or infant formula
  • See Full Prescribing Information for preparation and administration instructions

Important Safety Information

• There are no contraindications for XURIDEN and no adverse reactions were reported with XURIDEN in patients with hereditary orotic aciduria
• The safety and effectiveness of XURIDEN have been established in pediatric patients. There are no data on the presence of XURIDEN in human milk, the effect on the breastfed infant, or the effect on milk production
• There are no available data on XURIDEN use in pregnant women to inform drug-associated risk

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088


Please see Full Prescribing Information.