HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ZURAMPIC safely and effectively. See full prescribing information for ZURAMPIC.
ZURAMPIC ® (lesinurad) tablets, for oral use
Initial U.S. Approval: 2015
WARNING: RISK OF ACUTE RENAL FAILURE, MORE COMMON WHEN USED WITHOUT A XANTHINE OXIDASE INHIBITOR SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
•Acute renal failure has occurred with ZURAMPIC and was more common when ZURAMPIC was given alone.
•ZURAMPIC should be used in combination with a xanthine oxidase inhibitor. (1.1, 5.1, 6.1)
INDICATIONS AND USAGE
ZURAMPIC is a URAT1 inhibitor indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone. (1)
Limitations of Use:
•ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia. (1.1)
•ZURAMPIC should not be used as monotherapy. (1.1, 5.1)
DOSAGE AND ADMINISTRATION
•ZURAMPIC is recommended at 200 mg once daily in combination with a xanthine oxidase inhibitor, including allopurinol or febuxostat. The maximum daily dose of ZURAMPIC is 200 mg. (2.1)
•Failure to take ZURAMPIC with a xanthine oxidase inhibitor may increase the risk of renal adverse reactions. (2.1, 5.1)
•ZURAMPIC tablets should be taken in the morning with food and water. (2.1)
•Patients should be instructed to stay well hydrated. (2.1)
•Assess renal function before initiating ZURAMPIC. Do not initiate ZURAMPIC if eCLcr is below 45 mL/min. (2.2)
•Discontinue ZURAMPIC if eCLcr persistently falls below 45 mL/min. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablet: 200 mg. (3)
CONTRAINDICATIONS
•Severe renal impairment, end stage renal disease, kidney transplant recipients, or patients on dialysis. (4, 8.6)
•Tumor lysis syndrome or Lesch-Nyhan syndrome. (4)
WARNINGS AND PRECAUTIONS
•Renal events: Adverse reactions related to renal function have occurred after initiating ZURAMPIC. A higher incidence was observed at the 400 mg dose, with the highest incidence occurring with monotherapy use. Monitor renal function at initiation and during therapy with ZURAMPIC, particularly in patients with eCLcr below 60 mL/min, and eva luate for signs and symptoms of acute uric acid nephropathy. (5.1)
•Cardiovascular events: Major adverse cardiovascular events were observed with ZURAMPIC; a causal relationship has not been established. (5.2)
ADVERSE REACTIONS
Most common adverse reactions in 12-month controlled clinical trials (occurring in greater than or equal to 2% of patients treated with ZURAMPIC in combination with a xanthine oxidase inhibitor and more frequently than on a xanthine oxidase inhibitor alone) were headache, influenza, blood creatinine increased, and gastroesophageal reflux disease. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•Moderate Cytochrome P450 2C9 (CYP2C9) Inhibitors: Use with caution. (7.1)
•Sensitive CYP3A Substrates: Monitor for efficacy of the CYP3A substrate. (7.2)
USE IN SPECIFIC POPULATIONS
•Renal impairment: Not recommended for patients with eCLcr below 45 mL/min. ( 2.2, 5.1, 8.6)
•Hepatic impairment |
