RiteMED Febuxostat Special Precautions

Cardiovascular disorders: Treatment with FEBUXOSTAT in patients with Ischaemic heart disease or congestive heart failure is not recommended.
Acute gouty attacks (gout flare): Febuxostat treatment should not be started until an acute attack of gout has completely subsided. As with other urate lowering medicinal products, gout flares may occur during initiation of treatment due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. At treatment initiation with FEBUXOSTAT flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended. If a gout flare occurs during FEBUXOSTAT treatment, it should not be discontinued. The gout flare should be managed concurrently as appropriate for the individual patient. Continuous treatment with FEBUXOSTAT decreases frequency and intensity of gout flares.
Xanthine deposition: As with other urate lowering medicinal products, in patients in whom the rate of urate formation is greatly increased (e.g. malignant disease and its treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract. As there has been no experience with FEBUXOSTAT, its use in these populations is not recommended.
Mercaptopurine/Azathioprine: FEBUXOSTAT use is not recommended in patients concomitantly treated with mercaptopurine/azathioprine.
Theophylline: FEBUXOSTAT should be used with caution in patients concomitantly treated with theophylline and theophylline levels should be monitored in patients starting FEBUXOSTAT therapy.
Liver disorders: During the phase 3 clinical studies, mild liver function test abnormalities were observed in patients treated with FEBUXOSTAT (3.5%). Liver function test is recommended prior to the initiation of therapy with FEBUXOSTAT and periodically thereafter based on clinical judgement.
Thyroid disorders: Increased TSH values (>5.5 μIU/mL) were observed in patients on long-term treatment with FEBUXOSTAT (5.0%) in the long term open label extension studies. Caution is required when FEBUXOSTAT is used in patients with alteration of thyroid function.