Label: ULORIC- febuxostat tablet

  • NDC Code(s): 64764-677-11, 64764-677-13, 64764-677-19, 64764-677-30, view more
  • Packager: Takeda Pharmaceuticals America, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 27, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ULORIC safely and effectively. See full prescribing information for ULORIC. ULORIC (febuxostat) tablets, for oral use - Initial U.S ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: CARDIOVASCULAR DEATH

    Gout patients with established cardiovascular (CV) disease treated with ULORIC had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [see Warnings and Precautions (5.1)].

    Consider the risks and benefits of ULORIC when deciding to prescribe or continue patients on ULORIC. ULORIC should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable [see Indications and Usage (1)].

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  • 1 INDICATIONS AND USAGE
    ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage - The recommended ULORIC dosage is 40 mg or 80 mg once daily. The recommended starting dosage of ULORIC is 40 mg once daily. For patients who do not achieve a serum uric ...
  • 3 DOSAGE FORMS AND STRENGTHS
    40 mg tablets, light green to green, round, debossed with "TAP" and "40" 80 mg tablets, light green to green, teardrop shaped, debossed with "TAP" and "80"
  • 4 CONTRAINDICATIONS
    ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions (7)].
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Cardiovascular Death - In a cardiovascular (CV) outcome study, gout patients with established CV disease treated with ULORIC had a higher rate of CV death compared to those treated with ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described elsewhere in the prescribing information: Cardiovascular Death [see Warnings and Precautions (5.1)] Hepatic Effects [see Warnings and ...
  • 7 DRUG INTERACTIONS
    7.1 Xanthine Oxidase Substrate Drugs - ULORIC is an XO inhibitor. Based on a drug interaction study in healthy patients, febuxostat altered the metabolism of theophylline (a substrate of XO) in ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Limited available data with ULORIC use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. No adverse ...
  • 10 OVERDOSAGE
    ULORIC was studied in healthy patients in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities. No overdose of ULORIC was reported in clinical studies. Patients ...
  • 11 DESCRIPTION
    ULORIC (febuxostat) is a xanthine oxidase inhibitor. The active ingredient in ULORIC is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - ULORIC, a xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid. ULORIC is not expected to inhibit other enzymes involved in purine ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Two-year carcinogenicity studies were conducted in F344 rats and B6C3F1 mice. Increased transitional cell papilloma and carcinoma of ...
  • 14 CLINICAL STUDIES
    A serum uric acid level of less than 6 mg/dL is the goal of antihyperuricemic therapy and has been established as appropriate for the treatment of gout. 14.1 Management of Hyperuricemia in ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    ULORIC 40 mg tablets are light green to green in color, round, debossed with "TAP" on one side and "40" on the other side and supplied as: NDC NumberSize - 64764-918-11Hospital Unit Dose ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). CV Death - Inform patients that gout patients with established CV disease treated with ULORIC had a higher rate ...
  • PATIENT PACKAGE INSERT
    This Medication Guide has been approved by the U.S. Food and Drug AdministrationULR015 R10Revised: April 2023       MEDICATION GUIDE - ULORIC (Ū–'lor–ik) (febuxostat) tablets, for oral ...
  • PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Label
    NDC 64764-918-30 - 30 Tablets - Uloric - (febuxostat) tablets - 40 mg - Dispense the accompanying - Medication Guide to each patient.
  • PRINCIPAL DISPLAY PANEL - 80 mg Tablet Bottle Label
    NDC 64764-677-30 - 30 Tablets - Uloric - (febuxostat) tablets - 80 mg - Dispense the accompanying - Medication Guide to each patient.
  • INGREDIENTS AND APPEARANCE
    Product Information