Generic Name and Formulations:
Febuxostat 40mg, 80mg; tabs.
Takeda Pharmaceuticals USA, Inc.
Indications for ULORIC:
Chronic management of hyperuricemia in patients with gout.
≥18yrs: initially 40mg once daily. Obtain target serum uric acid levels <6mg/dL after 2 weeks of initiating therapy; if not <6mg/dL, may increase to 80mg once daily. Gout flare prophylaxis, with an NSAID or colchicine, upon initiation of therapy and for up to 6 months, is recommended. Severe renal impairment: max 40mg once daily.
<18yrs: not established.
Concomitant azathioprine, mercaptopurine.
Not for treating asymptomatic hyperuricemia. Cardiovascular events: monitor for signs and symptoms of MI and stroke. Measure LFTs at baseline and if liver injury is suspected; interrupt therapy if ALT>3xULN and investigate cause. Do not restart if ALT>3xULN with serum total bilirubin >2xULN without alternative etiologies; for lesser elevations, use with caution. Severe hepatic impairment. Severe renal impairment (see Adult) or ESRD on dialysis. Secondary hyperuricemia (eg, Lesch-Nyhan syndrome, malignant disease, or in organ transplant recipients): not recommended. Pregnancy. Nursing mothers.
See Contraindications. Potentiates xanthine oxidase substrate drugs (eg, theophylline).
Xanthine oxidase inhibitor.
Abnormal LFTs, nausea, arthralgia, rash; gout flares, hepatic failure.
Tabs 40mg—30, 90, 500; 80mg—30, 100, 1000