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
--------------------------------------------------------------------------------
Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
2.2 Special Populations
2.3 Uric Acid Level
2.4 Gout Flares
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Gout Flare
5.2 Cardiovascular Events
5.3 Liver Enzyme Elevations
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Xanthine Oxidase Substrate Drugs
7.2 Cytotoxic Chemotherapy Drugs
7.3 In Vivo Drug Interaction Studies
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
8.8 Secondary Hyperuricemia
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Management of Hyperuricemia in Gout
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 General Information
17.2 FDA-Approved Patient Labeling
--------------------------------------------------------------------------------
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
ULORIC® is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout.
ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.
2 DOSAGE AND ADMINISTRATION
2.1 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 [see Clinical Pharmacology (12.3)].
2.2 Special Populations
No dose adjustment is necessary when administering ULORIC in patients with mild to moderate renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. 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 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
<
