ULORIC® (febuxostat) tablet

Febuxostat is a non-hygroscopic, white crystalline powder that is freely soluble in dimethylformamide; soluble in dimethylsulfoxide; sparingly soluble in ethanol; slightly soluble in methanol and acetonitrile; and practically insoluble in water. The melting range is 205°C to 208°C.

ULORIC tablets for oral use contain the active ingredient, febuxostat, and are available in two dosage strengths, 40 mg and 80 mg. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, silicon dioxide and magnesium stearate. ULORIC tablets are coated with Opadry II, green.

Mechanism of Action
ULORIC, a xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid. ULORIC is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations

ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.

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.

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.

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.
 
Liver Enzyme Elevation: Transaminase elevations have been observed in ULORIC-treated patients. Monitor liver function tests periodically.

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

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

ULORIC can be administered without regard to food or antacid use.

No dose adjustment is necessary when administering ULORIC to patients with mild to moderate renal or hepatic impairment.

Recommended Dose
For treatment of hyperuricemia in patients with gout, 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.

ULORIC can be taken without regard to food or antacid use.

Special Populations
No dose adjustment is necessary when administering ULORIC in patients with mild to moderate renal impairment. The recommended starting dose of ULORIC is 40 mg once daily. For patients who do not achieve a sUA less than 6 mg per dL after 2 weeks with 40 mg, ULORIC 80 mg is recommended.

No dose adjustment is necessary in patients with mild to moderate hepatic impairment.

Uric Acid Level
Testing for the target serum uric acid level of less than 6 mg per dL may be performed as early as 2 weeks after initiating ULORIC therapy.

Gout Flares
Gout flares may occur after initiation of ULORIC due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. Flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended upon initiation of ULORIC. Prophylactic therapy may be beneficial for up to six months.

If a gout flare occurs during ULORIC treatment, ULORIC need not be discontinued. The gout flare should be managed concurrently, as appropriate for the individual patient [see Warnings and Precautions].

ULORIC is a registered trademark of Teijin Pharma Limited registered in the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

All other trademark names are the property of their respective owners.
©2009, 2011 Takeda Pharmaceuticals America, Inc.
ULR015 R2

PRINCIPAL DISPLAY PANEL - 40 mg Blister Carton
UNIT DOSE
Rx Only
10 cards
containing
10 tablets
each

Uloric®
(febuxostat)
tablets
40 mg
FOR INSTITUTIONAL USE ONLY