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General: Patients should be advised of the potential benefits and risks of febuxostat.
Patients should be informed about the potential for gout flares, elevated liver enzymes and adverse cardiovascular events after initiation of Febuxostat tablets therapy.
Concomitant prophylaxis with a non steroidal anti-inflammatory drug (NSAID) or colchicine for gout flares should be considered.
Patients should be instructed to inform their healthcare professional if they develop a rash, chest pain, shortness of breath or neurologic symptoms suggesting stroke. Patients should be instructed to inform their healthcare professional of any other medications they are currently taking with Febuxostat Tablets, including over-the-counter medications.
Gout Flare: After initiation of febuxostat, an increase in gout flares is frequently observed. This increase is due to reduction in the sUA levels, resulting in mobilization of urate from tissue deposits.
In order to prevent gout flares when therapy with Febuxostat tablets is initiated, concurrent prophylactic treatment with an NSAID or colchicine is recommended.
Cardiovascular Events: In randomized controlled studies, there was a higher rate of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions and non-fatal strokes) in patients treated with febuxostat [0.74/100 P-Y (95% CI 0.36-1.37)] than allopurinol [0.60/100 P-Y (95% CI 0.16-1.53)]. A causal relationship with febuxostat has not been established. Monitor for signs and symptoms of myocardial infarction (MI) and stroke.
Secondary Hyperuricaemia: No studies have been conducted in patients with secondary hyperuricaemia (including organ transplant recipients); Febuxostat tablets are not recommended for use in patients in whom the rate of urate formation is greatly increased (e.g.; malignant disease and its treatment, Lesch-Nyhan syndrome). The concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.
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