CLINICAL DATA

7 out of 10 patients achieved sUA goal on ULORIC 80 mg1,2

In 3 head-to-head studies of patients with or without CKD through stage 3

Overall efficacy
  • 76% of patients taking ULORIC 80 mg achieved a reduction in sUA levels to <6 mg/dL by Week 2
  • 83% of these patients maintained average sUA levels ≤6 mg/dL throughout treatment

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

Limit the dose of ULORIC to 40 mg once daily in patients with severe renal impairment1

Individual results may vary based on factors such as baseline sUA levels

CKD=chronic kidney disease; CKD3=CKD stage 3;
Clcr=creatinine clearance; sUA=serum uric acid.
*p<0.001 vs allopurinol and ULORIC 40 mg.3
p≤0.05 vs allopurinol.4
p<0.001 vs allopurinol.5
§
In CONFIRMS, allopurinol patients (n=145) with estimated Clcr≥30 mL/min and Clcr≤59 mL/min were dosed at 200 mg daily. All other patients received 300 mg daily.3
||
In APEX, allopurinol patients (n=10) with serum creatinine >1.5 mg/dL and ≤2 mg/dL were dosed at 100 mg daily.4

ULORIC in gout patients with CKD stages 2 and 31,3¶

In the CONFIRMS study, in a subgroup of
gout patients with CKD stages 2 and 3

Efficacy chart
  • 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 recommended

No dose adjustment is necessary in patients with mild to moderate renal impairment1

In patients with severe renal impairment, limit the dose of ULORIC to 40 mg once daily1

Clcr 30-89 mL/min.3
#
p<0.05 vs allopurinol and ULORIC 40 mg.3
**p<0.05 vs allopurinol.3
††
Allopurinol patients (n=145) with estimate Clcr≥30 mL/min and Clcr≤59 mL/min were dosed at 200 mg daily.1

71% of gout + CKD stage 3 patients achieved sUA <6 mg/dL with ULORIC 80 mg3

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)

No dose adjustment is necessary in patients with mild to moderate renal impairment1

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 exercised in these patients

‡‡This is a descriptive analysis only.
§§Moderate renal impairment is defined as estimated Clcr 30-59 mL/min.3
|| ||
Patients with moderate renal impairment were on allopurinol 200 mg (n=135) and 300 mg (n=1).2

IMPORTANT SAFETY INFORMATION FOR ULORIC (febuxostat)

READ MORE CLOSE

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.

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.

  • ULORIC is contraindicated in patients being treated with azathioprine or mercaptopurine.
  • Cardiovascular Death: In a CV outcomes study, there was a higher rate of CV death in patients treated with ULORIC compared to allopurinol; in the same study ULORIC was non-inferior to allopurinol for the primary endpoint of major adverse cardiovascular events (MACE). Consider the risks and benefits of ULORIC when deciding to prescribe or continue patients on ULORIC.
  • Gout Flares: 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.
  • 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. 

INDICATION

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 allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.

Please see the complete Prescribing Information, including Medication Guide, for ULORIC.

SHOW REFERENCES HIDE 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.