Recommended Dosing

DUZALLO tablets are for oral use. DUZALLO should be taken once daily by mouth, in the morning with food and water. Patients should be instructed to stay well hydrated (e.g., 2 liters of liquid per day).

One tablet of DUZALLO contains the maximum daily lesinurad dose (200 mg). Do not take more than 1 tablet of DUZALLO per day. Do not combine DUZALLO with ZURAMPIC® (lesinurad).

Use of DUZALLO is not recommended for patients taking daily doses of allopurinol less than 300 mg (or less than 200 mg in patients with estimated creatinine clearance [eCLcr] less than 60 mL/min).

Use one tablet of DUZALLO in place of an equivalent portion of the total daily allopurinol dose. The total daily dose of allopurinol should be maintained at the time of initiating DUZALLO.

• For patients who have not achieved target serum uric acid on a medically appropriate dose of allopurinol > 300 mg, DUZALLO may be initiated by using one tablet of DUZALLO in place of an equivalent portion of the total daily allopurinol dose.
• For patients who have not achieved target serum uric acid on a medically appropriate dose of allopurinol of 300 mg, DUZALLO may be initiated by using one tablet of DUZALLO 200 mg lesinurad /300 mg allopurinol daily in place of 300 mg of allopurinol.
• For patients who have not achieved target serum uric acid on a medically appropriate dose of allopurinol of 200 mg, DUZALLO may be initiated by using one tablet of DUZALLO 200 mg lesinurad /200 mg allopurinol daily in place of 200 mg of allopurinol.

For patients currently on ZURAMPIC (lesinurad) in combination with allopurinol, DUZALLO may be initiated by using one tablet of DUZALLO in place of ZURAMPIC (lesinurad) and an equivalent portion of the daily allopurinol dose.

Patients With Renal Impairment

Patients with decreased renal function require lower doses of allopurinol than those with normal renal function. No dose adjustment is needed for lesinurad in patients with mild or moderate renal impairment (eCLcr of 45 mL/min or greater).

Assessment of renal function is recommended prior to initiation of DUZALLO and periodically thereafter [see Warnings and Precautions (5.1)]. DUZALLO should not be initiated in patients with an eCLcr less than 45 mL/min. DUZALLO should be discontinued when eCLcr is persistently less than 45 mL/min [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6)]. More frequent renal function monitoring is recommended in patients with an eCLcr below 60 mL/min.

Gout Flares

Gout flares may occur after initiation of urate-lowering therapy, including DUZALLO, due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. For patients not currently taking lesinurad, gout flare prophylaxis is recommended when starting DUZALLO, according to practice guidelines.

If a gout flare occurs during DUZALLO treatment, DUZALLO need not be discontinued. The gout flare should be managed concurrently, as appropriate for the individual patient [see Patient Counseling Information (17)].