ZURAMPIC Film-coated tablet Ref.[7621] Active ingredients: Lesinurad

Posology

The recommended dose of Zurampic is 200 mg once daily in the morning. This is also the maximum dose (see section 4.4).

Zurampic 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, Zurampic dosing must also be interrupted.

Patients should be informed that failure to follow these instructions may increase the risk of renal events (see section 4.4).

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 Zurampic treatment.

Gout flare prophylaxis with colchicine or a nonsteroidal anti-inflammatory drug (NSAID) is recommended for at least 5 months when starting therapy (see section 4.4).

Special populations

Elderly (≥65 years)

No dose adjustment is necessary based on age (see section 5.2); 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 (see section 4.4).

Renal impairment

Zurampic must not be initiated in patients with severe renal impairment (CrCL less than 30 mL/min), with end-stage renal disease or in patients on dialysis (see sections 4.3 and 4.4). Based on its mechanism of action, lesinurad may not be effective in these patients (see section 5.1). Zurampic should not be initiated in kidney transplant recipients.

No dose adjustment is necessary in patients with mild or moderate renal impairment (CrCL of 30-89 mL/min) (see sections 4.8, 5.1 and 5.2). Zurampic should be used with caution in patients with a CrCL of 30 to less than 45 mL/min (see section 4.4).

Hepatic impairment

No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B) (see section 5.2). Zurampic has not been studied in patients with severe hepatic impairment; therefore, dose recommendations cannot be given.

Paediatric population

The safety and efficacy of Zurampic in children under 18 years of age have not yet been established. No data are available.

Method of administration

Oral use.

Zurampic should be taken in the morning with food and water.

There is no specific treatment in the event of an overdose, and symptoms of overdose are not established. In case of overdose, patients should be managed by symptomatic and supportive care including adequate hydration.

Shelf life: 3 years.

This medicinal product does not require any special storage conditions.

Clear (PVC/PVDC/Aluminium) blister of 10 or 14 (calendar blister) tablets.

Pack sizes of 10, 28, 30, 98 in non-perforated blisters.

Pack size of 100 × 1 film-coated tablet in perforated unit dose blisters.

Not all pack sizes may be marketed.

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.