HIGHLIGHTS OF PRESCRIBING INFORMATION
These HIGHLIGHTS do not include all the information needed to use ULORIC safely and effectively. See full prescribing information for ULORIC.

ULORIC (febuxostat) tablet for oral use
Initial U.S. Approval: 2009

 
INDICATIONS AND USAGE
ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. (1)

ULORIC is not recommended for the treatment of asymptomatic hyperuricemia. (1)

 
DOSAGE AND ADMINISTRATION
ULORIC is recommended at 40 mg or 80 mg once daily. The recommended starting dose of ULORIC is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg per dL after 2 weeks with 40 mg, ULORIC 80 mg is recommended. (2.1)
ULORIC can be administered without regard to food or antacid use. (2.1)
No dose adjustment is necessary when administering ULORIC to patients with mild to moderate renal or hepatic impairment. (2.2)

 
DOSAGE FORMS AND STRENGTHS
Tablet: 40 mg, 80 mg. (3)

CONTRAINDICATIONS
ULORIC is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline. (4)

WARNINGS AND PRECAUTIONS
Gout Flare: 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., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months. (2.4, 5.1)
Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with ULORIC than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke. (5.2)
Liver Enzyme Elevation: Transaminase elevations have been observed in ULORIC-treated patients. Monitor liver function tests periodically. (5.3)

 
ADVERSE REACTIONS
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. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-825-3327 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

 
DRUG INTERACTIONS
Concomitant administration of ULORIC with XO substrate drugs, azathioprine, mercaptopurine, or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity. (7)

 
USE IN SPECIFIC POPULATIONS
There is insufficient data in patients with severe renal impairment. No studies have been conducted in patients with severe hepatic impairment. Caution should be exercised in these patients. (8.6, 8.7)
No studies have been conducted in patients with secondary hyperuricemia (including patients being treated for Lesch-Nyhan syndrome or malignant disease, or in organ transplant recipients); therefore, ULORIC is not recommended for use in these patients. (8.8)

See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide 

Revised: 12/2010
 

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