Febuxostat Tablets 80 Mg

1 INDICATIONS & USAGE Febuxostat is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Limitations of Use: Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat tablets is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the prescribing information: • Cardiovascular Death [see Warnings and Precautions ( 5.1 )] • Hepatic Effects [see Warnings and Precautions ( 5.3 )] • Serious Skin Reactions [see Warnings and Precautions ( 5.4 )] Adverse reactions in > 1% of patients treated with febuxostat, and at least 0.5% greater than placebo, are liver function abnormalities, nausea, arthralgia, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary Limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. No adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (MRHD).

BOXED WARNING WARNING : CARDIOVASCULAR DEATH Gout patients with established cardiovascular (CV) disease treated with febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [ see Warnings and Precautions ( 5.1 )]. Consider the risks and benefits of febuxostat when deciding to prescribe or continue patients on febuxostat. 5 WARNINGS AND PRECAUTIONS •Gout Flares: An increase in gout flares is frequently observed after initiation of including febuxostat. If a gout flare occurs during treatment, febuxostat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug or colchicine) upon initiation of treatment) may be beneficial for up to six months. ( 2.4 , 5.2 ) •Hepatic Effects: Cases of hepatic failure, some fatal, have been reported.. If liver injury is detected, promptly interrupt febuxostat and then treat cause, if possible, to resolution or stabilization. Permanently discontinue febuxostat if liver injury is confirmed, and no alternate etiology can be found. 4 CONTRAINDICATIONS Febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions ( 7 )]. Febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine. ( 4 )