This page about Febuxostat for gout was last reviewed, or updated, on 13 May 2013.
At long last there's a new gout drug ! For long suffering gout patients, perhaps the best gout news in 45 years is that febuxosat has been approved for marketing in those European countries that are members of the European Union (EU). In the EU it has been given the brand/trade name of Adenuric. EU Marketing authorization was announced in early May 2008.
This is a list of countries that have now approved febuxostat for gout as of mid December 2012 - U.S., Canada, Great Britain, Germany, Italy, Ireland, Greece, Austria, France, South Korea, Japan, Philippines (where its brand name is Atenurix), Taiwan, Hong Kong.
In the immediate future, its developers, Teijin Pharma Ltd., hope to get the following febuxostat approvals - China in 2014; and by 2015 - Thailand, Indonesia, Singapore, Malaysia, Vietnam and India.
They also plan to market febuxostat for gout in Eastern Europe, Russia, Central and South America, the Caribbean and the Middle East/North Africa. (See Febuxostat News below for expected dates - explained generally ).
THE GOOD NEWS ABOUT FEBUXOSTAT FOR GOUT
This new gout drug is good news for gout sufferers, including gout sufferers with mild to moderate kidney disease, because in large trials it has outperformed allopurinol, the most common gout medication for long term treatment.
Like allopurinol, it works to lower uric acid production. In two major studies it reduced uric acid (UA) in more gout sufferers, and more patients reached the target 6.0 mg/dL (0.357 mmol/L) level more quickly, than did those on allopurinol.
At 120 mg dosage it has reduced UA levels to the target of 6.0 mg/dL in over 80% of study patients. At 80 mg the numbers were over 70%. This compares with 40% for allopurinol at a 300 mg dosage in most participants who took allopurinol. (Percentages depend precisely on the trial and the number of measurements).
As with allopurinol, this new gout drug works by inhibiting xanthine oxidase, an enzyme required in uric acid production, but it does it in a different way to allopurinol. Febuxostat is removed from the body by the liver and the kidneys, allopurinol by the kidneys.
NOT A WONDER GOUT DRUG, BUT A STEP FORWARD IN GOUT TREATMENT
How good is febuxostat for gout? In trials, its success rate in reducing uric acid (UA) levels down to the important 6.0 mg/dL (0.357 mmol/L) level was not 100%. About 20%-28% of trial patients did not achieve the target at final visit. And it has been less successful in patients who have UA levels above 10.0 mg/dL, (0.595 mmol/L).
But even when uric acid is above 10.0 mg/dL, it has reduced it down to the target in about 60%-67% of study patients at an 80 mg dosage, and by more at higher dosages. Pretty good going.
It can cause side effects of course (see the bottom of this page). And participants taking it had more of the expected gout flares than those who took allopurinol.
Remember that Febuxostat (Adenuric/Uloric/Feburic) is NOT a treatment for gout pain – so it won't be used instead of NSAIDS, colchicine and corticosteroids such as prednisone. But it's recommended that NSAIDs or colchicine are used along with it, at least in the early weeks of treatment.
In most countries it will only be used in gout patients who have chronic hyperuricemia (high UA levels) AND gout, not merely hyperuricemia. It does not work to improve uric acid excretion, so under-excretors may not benefit from it. Under-excretors are usually treated with urosuric (uricosuric) drugs
If you're a gout sufferer who lives in a European country that's a member of the EU, and not all countries in geographical Europe are members, you can ask your doctor's opinion about whether it is right for you, and find out whether or when s/he will consider prescribing it.
WHO WILL GET FEBUXOSTAT AND WHAT'S THE DOSAGE?
This new gout drug is taken orally as a tablet. The recommended dosage is 40 mg - 80 mg daily. If, after two weeks there is no reduction in UA levels, the dose may be increased to 80 mg - 120 mg daily, in those countries that have approved an increase up to 120 mg - ask your doctor. In trials, as much as 240 mg daily has been taken, but this is not a recommended amount for routine treatment. Patients will need another serum (blood) UA test after two weeks treatment to find out how well it's doing.
It also shares one of the benefits of allopurinol. Because it has to be taken just once daily, it's simpler to take and easier not to forget. The more often a drug has to be taken each day, the more likely it is that patients forget to take it.
Your uric acid levels will have to be high, so if you have gout but normal or slightly raised uric acid levels, it is unlikely to be prescribed. And you must have gout crystals.
The presence of tophi If you have tophi, note it has been shown to have some success against tophi. This will be an additional factor in favour (favor) of a decision to prescribe it.
Diets You will not need to be on a low purine diet, or any diet. Good news too is that it can be prescribed for the elderly.
Kidney disease Many gout patients suffer impaired kidneys. In trials it has performed quite well with patients who have mild kidney disease and much better than allopurinol, which did not reduce UA levels in patients with mild/moderate kidney disease by as much. If you have mild to moderate kidney disease (renal impairment) your doctor can determine whether it is right for you. If your kidneys pass certain tests, you'll almost certainly get it, and you won't need a lowered dose.
Febuxostat is a big new plus for kidney disease patients who have gout because doctors are very wary of prescribing drugs which encourage uric acid excretion by the kidneys.
But if you have severe kidney problems, it will be used with great caution, or it is not recommended. However as of April 2011, a trial in patients with moderate to severe renal (kidney) impairment is taking place.
Severe liver problems (hepatic impairment) Use with great caution or not recommended.
Febuxostat and heart disease Use with great CAUTION and regular monitoring, or it is NOT recommended for people with heart disease. You must consult your doctor if you have heart disease of any kind.
Noted possible side effects Dizziness, drowsiness, diarrhoea, (diarrhea), nausea,(sick feeling), rashes, headaches, gout attacks, joint pain, hypertension and liver function abnormalities – considered mild ones. In trials none of these side effects were reported in more than 3.5% of trial patients. The most common were liver function abnormalities, nausea, gout attacks, joint pain, and rash.
For a majority of people who are on a course of this new gout medicine, there will be an increase in gout flares. In which case you must see the flare through and continue taking it. This is also common in allopurinol treatment. For this problem, your doctor should prescribe a prophylactic (advance preventative) medication. These kinds of meds, including colchicine and NSAIDs can be taken with febuxostat.
If you want to read more detail about this new gout drug, visit the website of the European Medicines Agency where you can download the Public Summary, Public Assessment Report and Product Information for Adenuric.
A complete list of noted side effects is in the Public Assessment report as are detailed summaries of the studies. The shortest and easiest read is the Public Summary which is just a couple of pages. The other reports are about 50 pages.
For possible side effects the easiest way to understand these is to read the package leaflet details which are shown on the Public Assessment Report, pages 45-48. On these pages the contact details of the local representative of the marketing authorisation holder for each EU country is also shown.
Visit the official febuxostat (Uloric) U.S. website, where you can download prescribing information.
April 2012 Plans announced to market febuxostat in 16 Central and South American countries; 8 C.I.S (ex USSR) countries, and Australia and New Zealand. Expect launches in 2014 and after.
It means there are plans now to market febuxostat in all major world markets.
July 2011 Febuxostat will be marketed in South Korea, for the treatment of both hyperuricemia and gout. Its brand name will be Feburic.</b>
April 2011 Italy's Menarini, which markets febuxostat in many European countries, expects to lauch it in 16 Middle East and North African countries in 2012 or later. And in Turkey in 2013 or later. Takeda Pharmaceutical North America expects to market febuxostat in Mexico and Caribbean countries in 2012 or later.
January 2011 Japan approves Febuxostat (TMX-67). Approved doses are 10mg, 20mg, 40mg. Some countries have only approved febuxostat for patients with hyperuricemia AND gout. In Japan's case it has also approved the medication for patients with high uric acid (hyperuricemia) and no gout, as well as for those with hyperuricemia and gout. The doses mentioned are for both hyperuricemia, and hyperuricemia and gout.
October 2010 Canada approves febuxostat at a dosage of 80mg, for patients with hyperuricemia and gout. In Canada, its brand name is Uloric.
February 2009 The U.S. approves febuxostat, where its brand name is also Uloric.Read more about this here.
December 2008 Britain's NICE (National Institute for Health and Clinical Excellence) recommended febuxostat for NHS (National Health Service) use in England and Wales. Scotland and Northern Ireland will probably follow soon. Those British gout patients who will get it from the NHS will have to suffer chronic hyperuricemia (high levels of uric acid), and be intolerant of allopurinol, to be prescribed it. Or they have to be gout patients for whom allopurinol is contraindicated.
The recommended dosage is 80 mg daily, but 120 mg daily may be considered. There are warnings and precautions about its use in people with certain kinds of heart disease, which are already well known.
Essentially what has happened here is that febuxostat has been placed behind allopurinol because NICE was not convinced that it's better than allopurinol, if allopurinol is used at higher doses than 300 mg. 300 mg was the amount of allopurinol that febuxostat was mainly compared against in its trials and not higher amounts.
And febuxostat is 13 times more expensive than allopurinol, at least in Britain. This is a big difference. Hence the recommendation for only the kind of gout patients described in the above paragraph. If you use Britain's private health sector providers, check to see if they can prescribe febuxostat for you.
Click here to find out whether it is true that higher levels of uric acid, above the level at which hyperuricemia is defined, make it harder to reduce uric acid levels to those at which the MSU crystals dissolve. And what you should do about it.
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