Rare reports of serious allergic/hypersensitivity reactions, including life-threatening SJS, TEN & acute anaphylactic reaction/shock. Immediately stop treatment if serious allergic/hypersensitivity reactions, including SJS, occur. Regularly monitor patients w/ pre-existing major CV diseases (eg, MI, stroke or unstable angina). Do not start treatment until an acute attack of gout has completely subsided. Gout flares may occur during treatment initiation. Gout flare prophylaxis of at least 6 mth is recommended. LFT is recommended prior to treatment initiation & periodically thereafter. Not recommended in patients w/ greatly increased rate of urate formation (eg, malignant disease & its treatment, Lesch-Nyhan syndrome); in patients concomitantly treated w/ mercaptopurine/azathioprine; in organ transplant patients. Caution in patients w/ altered thyroid function. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. May impair ability to drive or operate machinery. Efficacy & safety have not been fully evaluated in patients w/ severe renal impairment (CrCl <30 mL/min) & have not been studied in patients w/ severe hepatic impairment (Child-Pugh class C). Limited information is available in patients w/ moderate hepatic impairment. Do not use during pregnancy & while breastfeeding. Safety & efficacy in childn <18 yr have not been established.
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