periodically thereafter [see WARNINGS AND PRECAUTIONS (5.1)]. More frequent renal function monitoring is recommended in patients with an eCLcr below 60 mL/min. ZURAMPIC should be discontinued when eCLcr is persistently less than 45 mL/min [seeWARNINGS AND PRECAUTIONS (5.1)and USE IN SPECIFIC POPULATIONS (8.6)].
2.3 Gout Flares
Gout flares may occur after initiation of urate lowering therapy, including ZURAMPIC, due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. Gout flare prophylaxis is recommended when starting ZURAMPIC, according to practice guidelines.
If a gout flare occurs during ZURAMPIC treatment, ZURAMPIC need not be discontinued. The gout flare should be managed concurrently, as appropriate for the individual patient.
3 DOSAGE FORMS AND STRENGTHS
ZURAMPIC 200 mg tablets are blue, oval shaped, film-coated tablets debossed with “LES200”.4 CONTRAINDICATIONS
The use of ZURAMPIC is contraindicated in the following conditions:
•Severe renal impairment (eCLcr less than 30 mL/min), end stage renal disease, kidney transplant recipients, or patients on dialysis [ see USE IN SPECIFIC POPULATIONS (8.6)]
•Tumor lysis syndrome or Lesch-Nyhan syndrome [ see USE IN SPECIFIC POPULATIONS (8.8)].
5 WARNINGS AND PRECAUTIONS
5.1 Renal Events
Treatment with ZURAMPIC 200 mg in combination with a xanthine oxidase inhibitor was associated with an increased incidence of serum creatinine elevations, most of which were reversible [see ADVERSE REACTIONS (6)]. Adverse reactions related to renal function have occurred after initiating ZURAMPIC. A higher incidence of serum creatinine elevations and renal-related adverse reactions, including serious adverse reactions of acute renal failure, was observed with ZURAMPIC 400 mg, with the highest incidence as monotherapy. ZURAMPIC should not be used as monotherapy [see LIMITATION OF USE (1.1)].
ZURAMPIC should not be initiated in patients with an eCLcr less than 45 mL/min. Renal function should be eva luated prior to initiation of ZURAMPIC and periodically thereafter, as clinically indicated. More frequent renal function monitoring is recommended in patients with an eCLcr less than 60 mL/min [see RENAL IMPAIRMENT (8.6)] or with serum creatinine elevations 1.5 to 2 times the pre-treatment value. ZURAMPIC treatment should be interrupted if serum creatinine is elevated to greater than 2 times the pre-treatment value. In patients who report symptoms that may indicate acute uric acid nephropathy including flank pain, nausea or vomiting, interrupt treatment and measure serum creatinine promptly. ZURAMPIC should not be restarted without another explanation for the serum creatinine abnormalities.
5.2 Cardiovascular Events
In clinical trials, major adverse cardiovascular events (defined as cardiovascular deaths, non-fatal myocardial infarctions, or non-fatal strokes) were observed with ZURAMPIC [see ADVERSE REACTIONS (6.1)]. A causal relationship with ZURAMPIC has not been established.
6 ADVERSE REACTIONS
The following adverse reactions are also discussed in other sections:
•Renal Events [ see WARNINGS AND PRECAUTIONS (5.1)]
•Cardiovascular Events [ see WARNINGS AND PRECAUTIONS (5.2)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clini |
