ULORIC
These highlights do not include all the information needed to use ULORIC safely and effectively. See full prescribing information for ULORIC. ULORIC (febuxostat) tablets, for oral useInitial U.S. Approval: 2009
54de10ef-fe5f-4930-b91d-6bbb04c664bd
HUMAN PRESCRIPTION DRUG LABEL
Apr 27, 2023
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
febuxostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (14)
febuxostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 80 mg Tablet Bottle Label
NDC 64764-677-30
30 Tablets
Uloric
(febuxostat)
tablets
80 mg
Dispense the accompanying
Medication Guide to each patient.
DOSAGE & ADMINISTRATION SECTION
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended ULORIC dosage is 40 mg or 80 mg once daily.
The recommended starting dosage of ULORIC is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after two weeks, the recommended ULORIC dosage is 80 mg once daily.
ULORIC can be taken without regard to food or antacid use [see Clinical Pharmacology (12.3)].
Concurrent prophylactic treatment with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].
2.2 Dosage Recommendations in Patients with Renal Impairment and Hepatic
Impairment
The recommended dosage of ULORIC is limited to 40 mg once daily in patients with severe renal impairment. No dose modification is necessary when administering ULORIC in patients with mild or moderate renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
No dosage modification is necessary in patients with mild to moderate hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
2.3 Serum Uric Acid Level Monitoring
Testing for the target serum uric acid level of less than 6 mg/dL may be performed as early as two weeks after initiating ULORIC therapy.
2.4 Recommended Prophylaxis for 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 [see Clinical Studies (14.1)].
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 (5.2)].
- Recommended dosage is 40 mg or 80 mg once daily. The recommended starting dosage is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks, the recommended dosage is 80 mg once daily. (2.1)
- Patients with severe renal impairment: Limit the dosage to 40 mg once daily. (2.2, 8.6)
- Flare prophylaxis is recommended upon initiation of ULORIC. (2.4)
- Can be administered without regard to food or antacid use. (2.1)
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
ULORIC 40 mg tablets are light green to green in color, round, 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].
INFORMATION FOR PATIENTS SECTION
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
CV Death
Inform patients that gout patients with established CV disease treated with ULORIC had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study. Inform all patients of the higher rate of CV death with ULORIC compared to allopurinol. Alert all patients (those with and without CV disease) for the development of signs and symptoms of CV events and to seek medical care promptly should they occur [see Warnings and Precautions (5.1)].
Gout Flares
Inform patients that after initiation of ULORIC an increase in gout flares can occur and that is not reason to stop taking the medication. Instruct patients that it is recommended to initiate and continue gout prophylaxis therapy for six months while taking ULORIC [see Warnings and Precautions (5.2)].
Hepatic Effects
Inform patients that hepatic effects, including fatal ones, have occurred in patients treated with ULORIC. Instruct them to inform their healthcare provider if they experience liver injury symptoms [see Warnings and Precautions (5.3)].
Serious Skin Reactions
Inform patients that serious skin and hypersensitivity reactions have occurred in patients treated with ULORIC. Instruct patients to discontinue ULORIC if they develop symptoms of these reactions [see Warnings and Precautions (5.4)].