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	⅛
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§