Zurampic

Posology The recommended dose of Zurampic is 200 mg once daily in the morning. 4). 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. 4). 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).

4). 2); however, elderly patients are more likely to have decreased renal function (see dosing recommendations for renal impairment). 4). 4). 1). Zurampic should not be initiated in kidney transplant recipients. 2). 4). 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.

Summary of the safety profile The safety of Zurampic 200 mg was evaluated in the Phase 3 combination therapy clinical trials (including extension studies). The most commonly reported adverse reactions during treatment with Zurampic 200 mg are influenza, gastro-oesophageal reflux disease, headache and blood creatinine increased.

The serious adverse reactions renal failure, renal impairment and nephrolithiasis have occurred uncommonly (less than 1 case per 100 patients) (see Table 1). In clinical trials, most adverse reactions were mild or moderate in intensity and resolved while continuing Zurampic therapy.

8%). Tabulated list of adverse reactions Adverse reactions are classified according to frequency and System Organ Class. Frequency categories are defined according to the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000) and very rare (<1/10,000).

Table 1 lists adverse reactions identified in clinical studies with patients receiving Zurampic 200 mg once daily in combination with a xanthine oxidase inhibitor, allopurinol or febuxostat. Table 1 Adverse reactions by System Organ Class and frequency System Organ Classification Common Uncommon Rare Infections and infestations Influenza Immune system disorders Hypersensitivity* Metabolism and nutrition disorders Dehydration Nervous system disorders Headache Gastrointestinal disorders Gastro-oesophageal reflux disease Renal and urinary disorders Renal failure** Renal impairment Nephrolithiasis Investigations Blood creatinine increased *Photodermatosis, photosensitivity reaction, dermatitis allergic, pruritus and urticaria.

**Includes the preferred terms: renal failure, renal failure chronic and renal failure acute. Description of selected adverse reactions Renal events Zurampic causes an increase in renal uric acid excretion, which may lead to transient increases in serum creatinine, renal-related adverse reactions and kidney stones.

Renal events Treatment with lesinurad 200 mg in combination with a xanthine oxidase inhibitor was associated with an increased incidence of serum creatinine elevations, which are related to increased renal uric acid excretion. 8). A higher incidence of serum creatinine elevations and renal-related adverse reactions including serious adverse reactions was observed with Zurampic 400 mg when given alone or in combination with a xanthine oxidase inhibitor, with the highest incidence when Zurampic was given as monotherapy.

Medicinal product no longer authorised 4 Experience with Zurampic in patients with an estimated CrCL (eCrCL) less than 45 mL/min is limited; therefore, Zurampic should be used with caution in patients with a CrCL from 30 mL/min to less than 45 mL/min.

g. 4 times per year, based on clinical considerations, such as baseline renal function, volume depletion, concurrent illness or concomitant medications. 5 times the pre-treatment value should be closely monitored. 0 mg/dL. Treatment should be interrupted in patients who report symptoms that may indicate acute uric acid nephropathy including flank pain, nausea or vomiting, and measure serum creatinine promptly.

Zurampic should not be restarted without another explanation for the serum creatinine abnormalities. Pre-existing cardiovascular disease Zurampic is not recommended in patients with unstable angina, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled hypertension or with a recent event of myocardial infarction, stroke, or deep venous thrombosis within the last 12 months, due to insufficient data.

8). Acute gouty attacks (gout flares) Gout flares may occur after initiation of therapy with Zurampic. This is due to reduction in serum uric acid levels resulting in mobilisation of urate from tissue deposits. 2). Zurampic does not need to be discontinued because of a gout flare.

The gout flare should be managed concurrently as appropriate for the individual patient. Continuous treatment with Zurampic decreases the frequency of gout flares. 2). 5). An induction effect of lesinurad should be anticipated after 2 to 3 weeks of continuous co-administration of Zurampic.

1. Patients with tumour lysis syndrome or Lesch-Nyhan syndrome. 2).