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Drug - Uloric tablet (febuxostat) 40 mg, 80 mg [Takeda]

January 2010

Therapeutic area - Diabetes

FDA approved indication

Uloric is indicated for the chronic management of hyperuricemia in adults with gout.

It is not indicated for the treatment of asymptomatic hyperuricemia.


The recommended starting dose is 40 mg once daily. If serum uric acid levels (sUA) <6 mg/dL is not achieved after 2 weeks, febuxostat 80 mg once daily is recommended. Uloric can be given without regard to food or antacid use.


  • Patient has a hypersensitivity reaction to allopurinol OR
  • Patient has had inadequate serum uric acid lowering from allopurinol

Relative costs of drug therapy

Uloric is priced at $5.62/tablet either strength. The recommended dose is once daily.

The allopurinol 300 mg MAC price is $0.07. The average number tabs/Rx is 30.3.

100 mg MAC is $0.06 with an average number of tabs/Rx of 44.3.


Febuxostat, a xanthine oxidase inhibitor effectively lowers serum uric acid to recommended levels of <6 mg/dL. Febuxostat was studied at doses ranging from 40 mg, 80 mg, 120 mg and 240 mg. It appears to have some dose-response effects up to 120 mg. However, it is approved for once daily dosing in the 80 mg and 40 mg strengths only.

In clinical trials where febuxostat was compared to allopurinol, the 40mg strength performed as well as allopurinol. The 80 mg dose of febuxostat did achieve statistical significance over 300 mg of allopurinol. There was not a statistical benefit vs. allopurinol for tophi size and number of incidence of gout flares. Notably, these are secondary outcomes of the febuxostat trials; however, preventing gout flares is a primary goal of gout treatment. While all the data were not presented here, febuxostat was proven safe and effective in mild to moderate renal impairment; however it was not studied in patients with severe renal impairment.


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