ULORIC Clinical Data

71% of gout + CKD stage 3 patients achieved sUA <6 mg/dL with ULORIC (febuxostat) 80 mg1

In the CONFIRMS study, in a subgroup of gout patients with CKD stage 3

Efficacy chart

  • In patients with CKD stage 2:
    • - 72% taking ULORIC 80 mg achieved sUA goal (N=367)

      - 52% taking ULORIC 40 mg achieved sUA goal (N=349)

      - 46% taking allopurinol achieved sUA goal (N=365)

    *This is a descriptive analysis only.

    Moderate renal impairment is defined as estimated Clcr 30-59 mL/min.1
    Patients with moderate renal impairment were on allopurinol 200 mg (n=135) and 300 mg (n=1).3

    No dose adjustment is necessary in patients with mild to moderate renal impairment.2

    The dose of ULORIC is limited to 40 mg once daily in patients with severe renal impairment. There are no data in patients with severe hepatic impairment. Caution should be used in these patients.2

    CKD=chronic kidney disease; Clcr=creatinine clearance; sUA=serum uric acid.

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Important Safety Information

  • ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine.
  • ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine.
  • An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including ULORIC. If a gout flare occurs during treatment, ULORIC need not be discontinued. Prophylactic therapy (i.e., NSAIDs or colchicine) upon initiation of treatment may be beneficial for up to six months.
  • Cardiovascular Events: In randomized controlled studies, there was a higher rate of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) in patients treated with ULORIC [0.74 per 100 P-Y (95% CI 0.36-1.37)] than allopurinol [0.60 per 100 P-Y (95% CI 0.16-1.53)]. A causal relationship with ULORIC has not been established. Monitor for signs and symptoms of MI and stroke.
  • Hepatic Effects: Postmarketing reports of hepatic failure, sometimes fatal, have been received. Causality cannot be excluded. During randomized controlled studies, transaminase elevations greater than three times the upper limit of normal (ULN) were observed (AST: 2%, 2%, and ALT: 3%, 2% in ULORIC and allopurinol-treated patients, respectively). No dose-effect relationship for these transaminase elevations was noted.
    Obtain liver tests before starting treatment with ULORIC. Use caution in patients with liver disease. If liver injury is detected, promptly interrupt ULORIC and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart treatment if liver injury is confirmed and no alternate etiology can be found.
  • Serious Skin Reactions: Postmarketing reports of serious skin and hypersensitivity reactions, including Stevens-Johnson Syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) and toxic epidermal necrolysis (TEN) have been reported in patients taking ULORIC. Discontinue ULORIC if serious skin reactions are suspected.
  • Adverse reactions occurring in at least 1% of ULORIC-treated patients, and at least 0.5% greater than placebo, are liver function abnormalities, nausea, arthralgia, and rash. Patients should be instructed to inform their healthcare professional if they develop a rash or have any side effect that bothers them or does not go away.

Indication

ULORIC (febuxostat) is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.

Please see the complete Prescribing Information.

  1. Becker MA, Schumacher HR, Espinoza LR, et al. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther. 2010;12(2):R63.
  2. ULORIC (febuxostat) prescribing information. Takeda Pharmaceuticals.
  3. Data on file. Takeda Pharmaceuticals.

Important Safety Information

  • ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine.
  • ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine.
  • An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including ULORIC. If a gout flare occurs during treatment, ULORIC need not be discontinued. Prophylactic therapy (i.e., NSAIDs or colchicine) upon initiation of treatment may be beneficial for up to six months.
  • Cardiovascular Events: In randomized controlled studies, there was a higher rate of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) in patients treated with ULORIC [0.74 per 100 P-Y (95% CI 0.36-1.37)] than allopurinol [0.60 per 100 P-Y (95% CI 0.16-1.53)]. A causal relationship with ULORIC has not been established. Monitor for signs and symptoms of MI and stroke.
  • Hepatic Effects: Postmarketing reports of hepatic failure, sometimes fatal, have been received. Causality cannot be excluded. During randomized controlled studies, transaminase elevations greater than three times the upper limit of normal (ULN) were observed (AST: 2%, 2%, and ALT: 3%, 2% in ULORIC and allopurinol-treated patients, respectively). No dose-effect relationship for these transaminase elevations was noted.
    Obtain liver tests before starting treatment with ULORIC. Use caution in patients with liver disease. If liver injury is detected, promptly interrupt ULORIC and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart treatment if liver injury is confirmed and no alternate etiology can be found.
  • Serious Skin Reactions: Postmarketing reports of serious skin and hypersensitivity reactions, including Stevens-Johnson Syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) and toxic epidermal necrolysis (TEN) have been reported in patients taking ULORIC. Discontinue ULORIC if serious skin reactions are suspected.
  • Adverse reactions occurring in at least 1% of ULORIC-treated patients, and at least 0.5% greater than placebo, are liver function abnormalities, nausea, arthralgia, and rash. Patients should be instructed to inform their healthcare professional if they develop a rash or have any side effect that bothers them or does not go away.

Indication

ULORIC (febuxostat) is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.

Please see the complete Prescribing Information.