Approved February 13, 2009

FEBUXOSTAT
(FDA Category 1S)

ULORIC(R) (Takeda Pharmaceuticals America, Inc) is a xanthine oxidase (XO) inhibitor that decreases serum uric acid.

DOSING INFORMATION: The recommended initial dose of febuxostat for the treatment of hyperuricemia associated with gout is 40 milligrams (mg) orally once daily. A dose increase to 80 mg once daily is recommended for patients who do not achieve a serum uric acid (sUA) less than 6 mg per dL after 2 weeks with 40 mg.

PHARMACOKINETICS: Peak plasma levels of febuxostat occur approximately 1 hour and 1.5 hours after oral administration. The percent decrease in serum uric acid concentration was similar when given under fasting conditions or after a high-fat meal. Febuxostat is approximately 99.2% bound to plasma proteins, primarily to albumin. The apparent mean terminal elimination half-life is 5 to 8 hours.

CAUTIONS: Concurrent use of azathioprine, mercaptopurine, or theophylline is contraindicated. Monitoring is recommended as febuxostat may cause gout flare, cardiovascular thromboembolic events, and liver enzyme elevations. The most common side effects are nausea, arthralgia, and rash.

FDA APPROVED INDICATIONS: Febuxostat is indicated for the chronic management of hyperuricemia in patients with gout.