Uloric (febuxostat) - What You Need to Know

Uloric Lowers Serum Uric Acid

Taking pills.
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Uloric  (febuxostat) was approved by the U.S. FDA on February 13, 2009. Uloric was the first new treatment option in 40 years for patients who have hyperuricemia and gout, according to Takeda Pharmaceuticals North America, Inc.

Uloric is a drug used for the chronic management of hyperuricemia in gout. Uloric lowers serum uric acid levels by blocking xanthine oxidase -- the enyzme responsible for uric acid production.

Xanthine oxidase breaks down hypoxanthine (a natural-occurring purine derivative) to xanthine, and then to uric acid.

How Is Uloric Administered?

The approved doses of Uloric are 40 mg and 80 mg to be given once daily. Uloric is an oral medication (taken by mouth). The recommended starting dose of Uloric is 40 mg once daily. An increase to 80 mg is recommended for patients who do not achieve a serum uric acid of less than 6 mg/dL after two weeks on the 40 mg dose. Uloric may be taken with or without food and there are no recommendations preventing the use of antacids. No dose adjustment is needed in patients who have mild to moderate renal or hepatic impairment.

How Did Uloric Perform in Clinical Trials?

In clinical trials, high dose Uloric was found to be more effective than placebo or standard dose allopurinol -- the other medication used to treat hyperuricemia. Also, in a 6-month phase III trial -- the percentage of gout patients, who reduced their uric acid levels to desired levels below 6, was much higher for those taking 80 mg than for those taking 40 mg of Uloric.

What Side Effects and Warnings Have Been Associated With Uloric?

Uloric is not recommended for people with asymptomatic hyperuricemia. Uloric should not be used by people already being treated with azathioprine (Imuran), mercaptopurine,and theophylline.

Based on three randomized, controlled clinical studies, liver function abnormalities, nausea, arthralgia, and rash are the most common adverse reactions that occur in at least 1% of patients treated with Uloric and at least 0.5% greater than placebo.

Also, compared to allopurinol, Uloric was associated with a higher rate of cardiovascular thromboembolic events, but no direct causal relationship was identified. Liver function abnormalities were the most common adverse reaction that lead to the discontinuation of Uloric.  

There have been postmarketing reports of hepatic failure, fatal and non-fatal, in patients treated with Uloric. The reports did not contain sufficient data to establish probable cause though.

An increase in gout flares is often experienced when anti-hyperuricemic agents are started. That includes Uloric. If a gout flare that is associated with the initiation of Uloric treatment occurs, the drug does not need to be discontinued. In order to prevent gout flares associated with the initiation of Uloric treatment, an NSAID or colchicine may be taken concurrently. The increase in gout flares has been attributed to the lowering of serum uric acid levels which, in turn, causes movement of urate from tissue deposits.  

There have been no well-controlled studies of Uloric in pregnant women.

In pregnancy, Uloric should only be used if the anticipated benefit outweighs potential risk to the fetus. Also, it is not known if Uloric is excreted in human milk. Nursing women must be cautious. 

The safety and effectiveness of Uloric in children under 18 years old is also not known.

Sources:

Uloric Prescribing Information. Uloric.com. Takeda Pharmaceuticals Inc. Revised March 2013. Accessed 11/23/2015.
http://general.takedapharm.com/content/file.aspx?applicationcode=6C7C39D8-5D09-453B-BF30-696A4AB88E62&FileTypeCode=ULORICPI&cacheRandomizer=4030a556-fbf6-408d-9243-7f4ae0a0ca84

FDA Approves ULORIC® (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout. Takeda Pharmaceuticals. February 13, 2009.
http://www.tpna.com/newsroom/press_release_detail.aspx?year=2009&id=151

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