Active Ingredient: Lesinurad
Lesinurad, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
200 - 200 mg
From 200 To 200 mg once every day
The recommended dose of lesinurad is 200 mg once daily in the morning. This is also the maximum dose.
Lesinurad tablets must be co-administered at the same time as the morning dose of a xanthine oxidase inhibitor, i.e. allopurinol or febuxostat. The recommended minimum dose of allopurinol is 300 mg, or 200 mg for patients with moderate renal impairment (creatinine clearance [CrCL] of 30-59 mL/min). If treatment with the xanthine oxidase inhibitor is interrupted, lesinurad dosing must also be interrupted.
Patients should be informed that failure to follow these instructions may increase the risk of renal events.
Patients should be instructed to stay well hydrated (e.g. 2 litres of liquid per day).
The target serum uric acid level is less than 6 mg/dL (360 µmol/L). In patients with tophi or persistent symptoms, the target is less than 5 mg/dL (300 µmol/L). Testing for the target serum uric acid level may be performed as early as 4 weeks after initiating lesinurad treatment.
Gout flare prophylaxis with colchicine or a nonsteroidal anti-inflammatory drug (NSAID) is recommended for at least 5 months when starting therapy.
No dose adjustment is necessary based on age; however, elderly patients are more likely to have decreased renal function (see dosing recommendations for renal impairment). Experience in very elderly (≥75 years) is limited.
Lesinurad should be taken in the morning with food and water.
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