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Febuxostat

    Brands

    DEA Class; Rx

    Common Brand Names; Uloric

    • Xanthine Oxidase Inhibitors; 
    • Antigout Agents

    Oral, non-purine selective xanthine oxidase inhibitor (XOI)
    Used for the chronic management of gout, usually in patients with inadequate response or who are not candidates for allopurinol treatment
    Carries a boxed warning for a potential increase in cardiovascular death vs. allopurinol

    Indicated for chronic management of hyperuricemia in patients who:

    • Responded inadequately to optimal allopurinol therapy
    • Are intolerant to allopurinol
    • Treatment with allopurinol not advisable

    Coadministration with azathioprine or mercaptopurine

    Liver function abnormalities (4.6-6.6%)

    Rash (0.5-1.6%)

    Nausea (1.1-1.3%)

    Arthralgia (0.7-1.1%)

    Blood and lymphatic system disorders: Anemia, idiopathic thrombocytopenic purpura, leukocytosis/leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia

    Cardiac disorders: Angina pectoris, atrial fibrillation/flutter, cardiac murmur, ECG abnormal, palpitations, sinus bradycardia, tachycardia

    Ear and labyrinth disorders: Deafness, tinnitus, vertigo

    Eye disorders: Vision blurred

    Gastrointestinal disorders: Abdominal distention, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, frequent stools, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gingival pain, hematemesis, hyperchlorhydria, hematochezia, mouth ulceration, pancreatitis, peptic ulcer, vomiting

    General disorders and administration site conditions: Asthenia, chest pain/discomfort, edema, fatigue, feeling abnormal, gait disturbance, influenza-like symptoms, mass, pain, thirst

    Hepatobiliary disorders: Cholelithiasis/cholecystitis, hepatic steatosis, hepatitis, hepatomegaly

    Immune system disorder: Hypersensitivity

    Infections and infestations: Herpes zoster

    Procedural complications: Contusion

    After initiation, an increase in gout flares is frequently observed; increase is due to reduction in serum uric acid levels, resulting in mobilization of urate from tissue deposits

    Not tested for secondary hyperuricemia; not recommended in patients whose rate of urate formation is greatly increased (eg, malignant disease and its treatment, Lesch-Nyhan syndrome)

    Postmarketing reports of serious skin and hypersensitivity reactions reported; discontinue if serious skin reactions are suspected; caution in patients who reported previous similar skin reactions to allopurinol

    Postmarketing reports of fatal and nonfatal hepatic failure; may increase liver enzyme activity; obtain LFTs at baseline, and do not initiate if alanine aminotransferase is 3x ULN with total bilirubin >2x ULN

    Serious skin and hypersensitivity reactions, including Stevens-Johnson Syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) and toxic epidermal necrolysis (TEN) reported; discontinue therapy if serious skin reactions suspected; many patients reported previous similar skin reactions to allopurinol; use caution in these patients

    Limited available data in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes

    There are no data on presence of febuxostat in human milk, effects on breastfed infant, or on milk production

    Adults

    Doses of up to 120 mg/day PO have been used in clinical trials.

    Geriatric

    Doses of up to 120 mg/day PO have been used in clinical trials.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    febuxostat 

    tablet

    • 40mg
    • 80mg