In all treatment groups, fewer subjects with higher baseline serum urate levels (≥ 10 mg per dL) and/or tophi achieved the goal of lowering serum uric acid to less than 6 mg per dL at the final visit; however, a higher proportion achieved a serum uric acid less than 6 mg per dL with ULORIC 80 mg than with ULORIC 40 mg or allopurinol.

Study 1 eva luated efficacy in patients with mild to moderate renal impairment (i.e., baseline estimated Clcr less than 90 mL per minute). The results in this sub-group of patients are shown in Table 4.

Table 4: Proportion of Patients with Serum Uric Acid Levels Less Than 6 mg per dL in Patients with Mild or Moderate Renal Impairment at Final Visit 
   Difference in Proportion
(95% CI)
ULORIC
40 mg daily
(N=479) ULORIC
80 mg daily
(N=503) allopurinol*
300 mg daily
(N=501) ULORIC 40 mg vs allopurinol ULORIC 80 mg vs allopurinol
*
Allopurinol patients (n=145) with estimated Clcr ≥ 30 mL per min and Clcr ≤ 59 mL per min were dosed at 200 mg daily.
50% 72% 42% 7%
(1%, 14%) 29%
(23%, 35%)

16 HOW SUPPLIED/STORAGE AND HANDLING
ULORIC 40 mg tablets are light green to green in color, round shaped, debossed with "TAP" on one side and "40" on the other side and supplied as:

NDC Number Size
64764-918-11 Hospital Unit Dose Pack of 100 Tablets
64764-918-30 Bottle of 30 Tablets
64764-918-90 Bottle of 90 Tablets
64764-918-18 Bottle of 500 Tablets

ULORIC 80 mg tablets are light green to green in color, teardrop shaped, debossed with "TAP" on one side and "80" on the other side and supplied as:

NDC Number Size
64764-677-11 Hospital Unit Dose Pack of 100 Tablets
64764-677-30 Bottle of 30 Tablets
64764-677-13 Bottle of 100 Tablets
64764-677-19 Bottle of 1000 Tablets

Protect from light. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (Patient Information)

17.1 General Information
Patients should be advised of the potential benefits and risks of ULORIC. Patients should be informed about the potential for gout flares, elevated liver enzymes and adverse cardiovascular events after initiation of ULORIC therapy.

Concomitant prophylaxis with an NSAID or colchicine for gout flares should be considered.

Patients should be instructed to inform their healthcare professional if they develop a rash, chest pain, shortness of breath or neurologic symptoms suggesting a stroke. Patients should be instructed to inform their healthcare professional of any other medications they are currently taking with ULORIC, including over-the-counter medications.

Patient Information
ULORIC (Ū – 'lor – ik)
(febuxostat) tablets

Read the Patient Information that comes with ULORIC before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is ULORIC?

ULORIC is a prescription medicine called a xanthine oxidase (XO) inhibitor, used to lower blood uric acid levels in adults with gout.

It is not