ULORIC (febuxostat) Logo

In 3 head-to-head studies of >3400 patients

ULORIC powerfully lowered serum uric acid (sUA) to target levels <6 mg/dL1,2*

Primary Efficacy table
  • 76% of ULORIC 80 mg patients achieved a reduction in sUA levels to <6 mg/dL by Week 21
  • 83% of these patients maintained average sUA levels ≤6 mg/dL throughout treatment
  • ULORIC 80 mg was proven superior to allopurinol at lowering sUA (p<0.001)1,2
  • The 40-mg starting dose of ULORIC effectively lowered sUA similarly to allopurinol1

Individual results may vary based on factors such as baseline serum uric acid levels.





*Based on results combined across three phase 3 studies; ULORIC 40 mg was included only in one of the studies, and ULORIC 80 mg and allopurinol were included in each of the studies.1

In the APEX trial, allopurinol patients (n=10) with serum creatinine >1.5 mg/dL and ≤2 mg/dL were dosed at 100 mg daily. In CONFIRMS, allopurinol patients (n=145) with estimated creatinine clearance (Clcr) ≥30 mL/min and ≤59 mL/min were dosed at 200 mg daily. All other patients received 300 mg daily.1

p<0.001 vs allopurinol.2

Learn more: Efficacy in Mild-Moderate CKD Patients

In the 6-month CONFIRMS study

ULORIC was superior to allopurinol in a subgroup of gout patients with mild to moderate renal impairment1*

Secondary endpoint bar chart
  • Patients with mild or moderate renal impairment can be treated with either dose of ULORIC.1
  • For patients who do not achieve the sUA target level of <6 mg/dL after 2 weeks with ULORIC 40 mg, ULORIC 80 mg is recommended1

There are insufficient data in patients with severe renal impairment and no data in patients with severe hepatic impairment. Caution should be exercised in these patients.1


sUA=serum uric acid.

*Mild to moderate renal impairment is defined as estimated creatinine clearance (Clcr) 30-89 mL/min.3

Allopurinol patients (n=145) with estimated Clcr ≥30 mL/min and ≤59 mL/min were dosed at 200 mg daily.1

p<0.05 vs allopurinol.3

§p<0.05 vs allopurinol and ULORIC 40 mg.3



Patients with mild or moderate renal impairment achieving sUA <6 mg/dL3*

Secondary endpoint bar chart

||This is a descriptive analysis only.

In the CONFIRMS study, patients with mild renal impairment were on allopurinol 200 mg (n=10) and 300 mg (n=355); patients with moderate renal impairment were on allopurinol 200 mg (n=135) and 300 mg (n=1).2

Learn more: Safety Profile

The safety of ULORIC was extensively studied1

The safety profile of ULORIC has been evaluated in more than 4000 patients, in some for more than 5 years2

  • 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*

Incidence of adverse events1

Adverse events chart

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.

*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.3-5

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

Next: Dosing

Register with GoutRx

Register to gain access to additional resources and clinical information for ULORIC.

Patient resources

Take advantage of downloadable patient resources and helpful links for your patients.

Help your patients save on ULORIC

Two ways for eligible
patients to save.

IMPORTANT SAFETY INFORMATION

  • 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.
  • 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.

References:

  1. ULORIC (febuxostat) prescribing information. Takeda Pharmaceuticals.
  2. Data on file. Takeda Pharmaceuticals.
  3. 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.
  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.

Important Safety Information

Expand

IMPORTANT SAFETY INFORMATION

  • 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.
  • 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.