Febuxostat (Adenuric, Ipsen) for the management of hyperuricemia in gout patients. NICE guidance

The following is an excerpt of the NICE guidance about: Febuxostat for the management of hyperuricaemia in people with gout.

1 Guidance
1.1 Febuxostat, within its marketing authorisation, is recommended as an option for the management of chronic hyperuricaemia in gout only for people who are intolerant of allopurinol (as defined in section 1.2) or for whom allopurinol is contraindicated.

1.2 For the purposes of this guidance, intolerance of allopurinol is defined as adverse effects that are sufficiently severe to warrant its discontinuation, or to prevent full dose escalation for optimal effectiveness as appropriate within its marketing authorisation.

1.3 People currently receiving febuxostat should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

2 The technology

2.1 Febuxostat (Adenuric, Ipsen) is a non-purine selective inhibitor of xanthine oxidase that achieves its therapeutic effects by decreasing the serum uric acid concentration. Febuxostat has a marketing authorisation for the treatment of chronic hyperuricaemia in conditions where urate/uric acid deposition has already occurred (including a history or the presence of tophi and/or gouty arthritis).

2.2 The most common side effects associated with febuxostat are diarrhoea, nausea, headache, liver function test abnormalities and rash. Uncommon side effects include fatigue, oedema, dizziness, altered sense of taste, increase in blood amylase, decrease in platelet count, increase in blood creatinine, and arthralgia. Rare side effects include nervousness, insomnia, asthenia and renal insufficiency. The summary of product characteristics (SPC) states that treatment with febuxostat is not recommended for people with ischaemic heart disease or congestive heart failure. For full details of side effects and contraindications, see the SPC.

2.3 The recommended dose of febuxostat is 80 mg once daily. If the person’s serum uric acid concentration is above 6 mg/100 ml (360 µmol/litre) after 2–4 weeks of treatment with 80 mg once daily, febuxostat 120 mg once daily may be considered. The price for febuxostat 80 mg and 120 mg is £0.87 per tablet. Annual treatment costs are approximately £318. Costs may vary in different settings because of negotiated procurement discounts.

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