verage decrease in serum uric acid with ZURAMPIC 200 mg in Study 3 was similar to that seen in Study 1 and Study 2 (see Figure 3 and Figure 4).
Table 6: Proportion of Patients Achieving Target Serum Uric Acid Levels (< 5 mg/dL) in a Study with ZURAMPIC in Combination with Febuxostat in Tophaceous Gout
Timepoint
Patients Achieving Serum Uric Acid Target
Difference of Proportion
(95% C.I.)
Placebo
+ Febuxostat
80 mg
ZURAMPIC 200 mg
+ Febuxostat 80 mg
ZURAMPIC 200 mg vs
Placebo
Month 6
47%
57%
0.10
(-0.03, 0.23)
As shown in Figure 4, reduction in average serum uric acid levels to < 5 mg/dL was noted for ZURAMPIC 200 mg in combination with febuxostat at the Month 1 visit and was maintained throughout the 12-month study.
Figure 4: Mean Serum Uric Acid Levels Over Time in a Study with ZURAMPIC in Combination with Febuxostat in Tophaceous Gout (Study 3)
Figure 4
14.4 Gout Flares and Tophus Outcomes
In each of the three pivotal studies of ZURAMPIC in combination with a xanthine oxidase inhibitor, the rates of gout flare requiring treatment from the end of Month 6 to the end of Month 12 were not statistically different between ZURAMPIC 200 mg in combination with allopurinol or febuxostat compared with allopurinol or febuxostat alone. In Study 3, the proportion of patients who experienced a complete resolution of ≥ 1 target tophus was not statistically different between ZURAMPIC 200 mg in combination with febuxostat compared with febuxostat alone.
14.5 Use in Patients with Renal Impairment
The estimated differences between ZURAMPIC and placebo in the proportions of patients achieving target serum uric levels in the renal impairment subgroups were largely consistent with the results in the overall population in the three studies. However, there were limited data in patients with eCLcr less than 45 mL/min and there was a trend toward decreasing magnitudes of effect with decreasing renal function: in patients with eCLcr less than 45 mL/min, the estimated difference between ZURAMPIC 200 mg and placebo in the proportion achieving serum uric acid < 6.0 mg/dL at Month 6 was 10% (95% CI: -17, 37), as compared with 27% (95% CI: 9, 45) in the 45 to less than 60 mL/min subgroup and 30% (95% CI: 23, 37) in the 60 mL/min or greater subgroup, based on integrated data from Study 1 and Study 2.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
ZURAMPIC Tablets, 200 mg are blue in color, oval shaped, debossed with “LES200” and are supplied as follows:
NDC Number Size
0310-1475-05 Bottle of 5 tablets
0310-1475-30 Bottle of 30 tablets
0310-1475-90 Bottle of 90 tablets
16.2 Storage and Handling
Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Administration
Advise patients:
•To take ZURAMPIC in the morning with food and water at the same time as a xanthine oxidase inhibitor, allopurinol, or febuxostat.
•Not to take ZURAMPIC alone and to discontinue ZURAMPIC if treatment with the xanthine oxidase inhibitor medication is discontinued.
•Not to take a missed dose of ZURAMPIC later in the day, to wait to take ZURAMPIC on the next day, and not to double the dose.
•To stay well hydrated (eg, 2 liters [68 oz] of liquid per day).
Renal Events
Inform patients that renal even |
