XURIDEN- uridine triacetate granule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

uridine triacetate (UNII: 2WP61F175M) (uridine - UNII:WHI7HQ7H85)

Available from:

Wellstat Therapeutics Corporation

INN (International Name):

uridine triacetate

Composition:

uridine triacetate 951 mg in 1 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

XURIDEN® is indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria. None Risk Summary There are no available data on XURIDEN use in pregnant women to inform a drug-associated risk. When administered orally to pregnant rats during the period of organogenesis, uridine triacetate at doses similar to the maximum recommended human dose (MRHD) of 120 mg/kg per day was not teratogenic and did not produce adverse effects on embryo-fetal development [see Data] . The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study, uridine triacetate was administered orally to pregnant rats during the period of organogenesis at doses up to 2000 mg/kg per day (about 2.7 times the maximum recommended human dose (MRHD) of 120

Product summary:

XURIDEN orange-flavored oral granules (95% w/w) are available in single-use packets (NDC 69468-152-02) containing 2 grams of uridine triacetate in cartons of 30 packets each (NDC 69468-152-30). Store at controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Authorization status:

New Drug Application

Summary of Product characteristics

XURIDEN- URIDINE TRIACETATE GRANULE
WELLSTAT THERAPEUTICS CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XURIDEN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XURIDEN.
XURIDEN® (URIDINE TRIACETATE) ORAL GRANULES
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
XURIDEN is a pyrimidine analog for uridine replacement indicated in
adult and pediatric patients for the
treatment of hereditary orotic aciduria. (1)
DOSAGE AND ADMINISTRATION
Recommended Dosage (2.1):
The starting dosage is 60 mg/kg once daily; the dose may be increased
to120 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.
Preparation and Administration (2.2)
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.
DOSAGE FORMS AND STRENGTHS
Oral granules: 2 gram packets. (3)
CONTRAINDICATIONS
None (4)
ADVERSE REACTIONS
No adverse reactions were reported in clinical trials with XURIDEN in
patients with hereditary orotic
aciduria. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WELLSTAT THERAPEUTICS
CORPORATION AT
(1-800-914-0071) OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodyn