Active Substance: febuxostat
Common Name: febuxostat
ATC Code: M04AA03
Marketing Authorisation Holder: Menarini International Operations Luxembourg S.A. (MIOL)
Active Substance: febuxostat
Authorisation Date: 2008-04-21
Therapeutic Area: Gout
Pharmacotherapeutic Group: Antigout preparations
Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and / or gouty arthritis).
What is Adenuric?
Adenuric is a medicine that contains the active substance febuxostat. It is available as tablets (80 and 120 mg).
What is Adenuric used for?
Adenuric is used to treat adults with long-term hyperuricaemia (high levels of uric acid or â€˜urateâ€™ in the blood). Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys. When this happens in the joints and causes pain, it is known as â€˜goutâ€™. Adenuric is used in patients who already have signs of a build-up of crystals, including arthritis (pain and inflammation in the joints) or tophi (â€˜stonesâ€™, larger deposits of urate crystals that can cause joint and bone damage).
The medicine can only be obtained with a prescription.
How is Adenuric used?
The recommended dose of Adenuric is 80 mg once a day. This usually reduces blood uric-acid levels within two weeks, but the dose can be increased to 120 mg once a day if blood uric-acid levels remain high (above 6 mg per decilitre) after two to four weeks. Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first six months of treatment with Adenuric. Adenuric treatment should not be stopped if an attack of gout occurs.
How does Adenuric work?
The active substance in Adenuric, febuxostat, reduces the formation of uric acid. It works by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body. By reducing the production of uric acid, Adenuric can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up. This can reduce the symptoms of gout. Keeping uric-acid levels low for long enough can also shrink tophi.
How has Adenuric been studied?
Adenuric has been studied in two main studies involving a total of 1,834 patients with hyperuricaemia and gout. The first study, carried out in 1,072 patients, compared three doses of Adenuric (80, 120 and 240 mg once a day) with placebo (a dummy treatment) and allopurinol (another medicine used to treat hyperuricaemia). The study lasted six months. The second study compared two doses of Adenuric (80 and 120 mg once a day) with allopurinol over one year in 762 patients.
In both studies, allopurinol was used at a dose of 300 mg once a day, except in patients with kidney problems, who took 100 mg. The main measure of effectiveness was the number of patients whose final three blood uric-acid levels were below 6 mg/dl. Blood uric-acid levels were measured every month.
What benefit has Adenuric shown during the studies?
Adenuric was more effective than allopurinol and placebo in reducing blood uric-acid levels. In the first study, 48% of the patients taking 80 mg Adenuric once a day (126 out of 262) and 65% of the patients taking 120 mg once a day (175 out of 269) had levels of uric acid below 6 mg/dl in the final three measurements. This was compared with 22% of the patients taking allopurinol (60 out of 268) and none of the 134 patients taking placebo. Similar results were seen in the second study after a year.
What is the risk associated with Adenuric?
The most commonly reported side effects with Adenuric are gout flare-ups, abnormal liver test results, diarrhoea, nausea (feeling sick), headache, rash and oedema (swelling). These side effects were mostly mild or moderate in severity. Rare serious hypersensitivity (allergic) reactions to Adenuric have occurred post-marketing. For the full list of all side effects reported with Adenuric, see the package leaflet.
Adenuric must not be used in people who are hypersensitive to febuxostat or any of the other ingredients.
Why has Adenuric been approved?
The CHMP concluded that Adenuric was more effective than allopurinol at lowering blood uric-acid levels, but that it could carry a greater risk of side effects affecting the heart and blood vessels. The Committee decided that Adenuricâ€™s benefits are greater than its risks and recommended that it be given marketing authorisation.
Other information about Adenuric
The European Commission granted a marketing authorisation valid throughout the European Union for Adenuric on 21 April 2008.
For more information about treatment with Adenuric, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
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