XURIDEN

XURIDEN- uridine triacetate granule
Wellstat Therapeutics Corporation

1 INDICATIONS AND USAGE

XURIDEN® is indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended starting dosage of oral XURIDEN is 60 mg/kg once daily. Increase the dosage of XURIDEN to 120 mg/kg (not to exceed 8 grams) once daily for insufficient efficacy, such as occurrence of one of the following:

  • Levels of orotic acid in urine remain above normal or increase above the usual or expected range for the patient
  • Laboratory values (e.g., red blood cell or white blood cell indices) affected by hereditary orotic aciduria show evidence of worsening
  • Worsening of other signs or symptoms of the disease

The XURIDEN dose to be administered at the 60 mg/kg and 120 mg/kg dose levels by body-weight is presented in Tables 1 and 2.

A 2 gram packet of XURIDEN contains approximately ¾ teaspoon of XURIDEN. Therefore, in the tables below for patients requiring doses in multiples of 2 grams (¾ teaspoon) an entire packet(s) may be administered without weighing or measuring.

XURIDEN Daily Dose Based on Body Weight (kg)

Patient Weight Table 1: XURIDEN 60 mg/kg * Dose Level
Kilograms Dose to be Administered Using a Scale (grams) Dose in Teaspoons
*
total daily dose by weight category in the tables was rounded to achieve the approximate dose level
may use 1 entire 2 gram packet without weighing or measuring
may use 2 entire 2 gram packets without weighing or measuring
§
may use 3 entire 2 gram packets without weighing or measuring
up to 5 0.4
6-10 0.4 to 0.6 ¼
11-15 0.7 to 0.9 ½
16-20 1 to 1.2
21-25 1.3 to 1.5
26-30 1.6 to 1.8 ¾
31-35 1.9 to 2.1
36-40 2.2 to 2.4 1
41-45 2.5 to 2.7
46-50 2.8 to 3
51-55 3.1 to 3.3 1 ¼
56-60 3.4 to 3.6
61-65 3.7 to 3.9 1 ½
66-70 4 to 4.2
71-75 4.3 to 4.5
Above 75 6§ 2 §
Patient Weight Table 2: XURIDEN 120 mg/kg * Dose Level
Kilograms Dose to be Administered Using a Scale (grams) Dose in Teaspoons
*
total daily dose by weight category in the tables was rounded to achieve the approximate dose level
may use 2 entire 2 gram packets without weighing or measuring
may use 3 entire 2 gram packets without weighing or measuring
§
may use 4 entire 2 gram packets without weighing or measuring
up to 5 0.8 ¼
6-10 0.8 to 1.2 ½
11-15 1.4 to 1.8 ¾
16-20 2 to 2.4 1
21-25 2.6 to 3
26-30 3.2 to 3.6 1 ¼
31-35 3.8 to 4.2 1 ½
36-40 4.4 to 4.8 1 ¾
41-45 5 to 5.4 2
46-50 5.6 to 6
51-55 6.2 to 6.6 2 ¼
56-60 6.8 to 7.2 2 ½
61-65 7.4 to 7.8
66-70 8§ 2 ¾ §
71-75 8§
Above 75 8§
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