XURIDEN Oral granules (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Wellstat Therapeutics Corporation

Λέξεις κλειδιά

69468-152

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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, ...

3. Dosage Forms and Strengths

Oral granules: 2 grams of orange-flavored oral granules (95% w/w) in single-use packets

4. Contraindications

None.

5. Warnings and Precautions

None.

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions and using a wide range of doses, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates ...

8.1. Pregnancy

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 ...

8.2. Lactation

Risk Summary There are no data on the presence of uridine triacetate in human milk, the effect on the breastfed infant or the effect on milk production. The development and health benefits of breastfeeding ...

8.4. Pediatric Use

The safety and effectiveness of XURIDEN have been established in pediatric patients. Use of XURIDEN is supported by a single open-label clinical trial of uridine triacetate in 4 patients and a retrospective ...

8.5. Geriatric Use

Clinical trials of XURIDEN did not include patients 65 years of age and older.

11. Description

XURIDEN (uridine triacetate) oral granules is a pyrimidine analog indicated for uridine replacement therapy. Uridine triacetate has the chemical designation (2',3',5'-tri-O-acetyl-β-D-ribofuranosyl)-2,4(1H,3H)-pyrimidinedione. ...

12.1. Mechanism of Action

Uridine triacetate is an acetylated form of uridine. Following oral administration, uridine triacetate is deacetylated by nonspecific esterases present throughout the body, yielding uridine in the circulation ...

12.2. Pharmacodynamics

Hereditary orotic aciduria (uridine monophosphate synthase deficiency) is a rare congenital autosomal recessive disorder of pyrimidine metabolism caused by a defect in uridine monophosphate synthase (UMPS). ...

12.3. Pharmacokinetics

Absorption XURIDEN delivers 4- to 6-fold more uridine into the systemic circulation compared to equimolar doses of uridine itself. Maximum concentrations of uridine in plasma following oral XURIDEN are ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of uridine triacetate. Uridine triacetate was not genotoxic in the Ames test, the mouse lymphoma assay and the ...

14. Clinical Studies

The efficacy of XURIDEN was evaluated in a 6-week open-label study in 4 patients with hereditary orotic aciduria (3 male, 1 female; age range from 3 to 19 years). Three patients were previously treated ...

16.1. How Supplied

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).

16.2. Storage and Handling

Store at controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

17. Patient Counseling Information

Advise the patient or caregiver to read the FDA-approved patient labeling (Instructions for Use) Administration Advise the patient or caregiver: To measure the prescribed dose using either a scale accurate ...