Generic Name and Formulations:
Febuxostat 40mg, 80mg; tabs.

Company:
Takeda Pharmaceuticals North America, Inc.

Indications for ULORIC:
Chronic management of hyperuricemia in patients with gout.

Adult Dose for ULORIC:
≥18yrs: initially 40mg once daily; if serum uric acid is not <6mg/dL after 2 weeks, 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.

Children's Dose for ULORIC:
<18yrs: not established.

Pharmacological Class:
Xanthine oxidase inhibitor.

Contraindications:
Concomitant azathioprine, mercaptopurine.

Warnings/Precautions:
Not recommended for treating asymptomatic hyperuricemia. Cardiovascular events: monitor for signs and symptoms of MI and stroke. Severe renal impairment or ESRD on dialysis. Severe hepatic impairment. Obtain liver test panel at baseline. Measure liver tests promptly if liver injury suspected; interrupt therapy and investigate cause; if ALT>3xULN with serum total bilirubin >2xULN without alternative etiologies, do not restart; for lesser elevations, use with caution. Obtain target serum uric acid levels <6mg/dL after 2 weeks of initiating therapy. Secondary hyperuricemia (eg, Lesch-Nyhan syndrome, malignant disease, or in organ transplant recipients): not recommended. Pregnancy (Cat.C). Nursing mothers.

Interactions:
See Contraindications. Potentiates xanthine oxidase substrate drugs (theophylline).

Adverse Reactions:
Liver function abnormalities, nausea, arthralgia, rash, gout flares.

How Supplied:
Tabs 40mg—30, 90, 500; 80mg—30, 100, 1000