ULORIC Safety Data

Demonstrated safety profile in gout patients including those with CKD through stage 31,2

Over 4000 patients studied, some for over 5 years3

Adverse reactions occurring in ≥1% of ULORIC-treated patients and at least 0.5% greater than seen in patients receiving placebo in phase 3 controlled studies1*

Safety chart

*ULORIC 80 mg and allopurinol were included in the CONFIRMS, APEX, and FACT studies. Placebo was included only in APEX, and ULORIC 40 mg was included only in CONFIRMS.2,4,5
Of the patients who received allopurinol, 10 received 100 mg, 145 received 200 mg, and 1122 received 300 mg, based on level of renal impairment.1

Safety profile evaluated in gout patients with CKD through stage 41-3

  • ULORIC has no boxed warning1
  • No renal dose adjustments required for patients with CKD through stage 31
  • The dose of ULORIC is limited to 40 mg once daily in patients with severe renal impairment1
  • Adverse reaction rates were consistent across the overall study population, including in a subgroup of gout patients with CKD stages 2 and 32,4,5

Kidney function should be a key consideration when selecting a urate-lowering therapy.6

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Dosing for ULORIC

Dosing for ULORIC

Simple dosing for you and your gout patients with CKD through stage 3.1

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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. ULORIC (febuxostat) prescribing information. Takeda Pharmaceuticals.
  2. 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.
  3. Data on file. Takeda Pharmaceuticals.
  4. Schumacher HR, Becker MA, Wortmann RL, et al. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008;59(11):1540-1548.
  5. Becker MA, Schumacher HR Jr, Wortmann RL, et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout [published correction appears in N Engl J Med. 2006;354(14):1533]. N Engl J Med. 2005;353(23):2450-2461.
  6. Khanna D, Fitzgerald JD, Khanna PP, et al. 2012 American College of Rheumatology Guidelines for Management of Gout. Part 1: Systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res. 2012;64(10):1431-1446.

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.