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A. Menarini Pharma GmbH is an Austrian subsidiary of the Menarini Group/Florence.
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Adenuric® is indicated for the treatment of chronic hyperuricemia in conditions that have already led to urate deposition (including a gouty nodule known from medical history or currently present and/or gouty arthritis).1
The active ingredient febuxostat selectively inhibits xanthine oxidase, resulting in a rapid reduction in serum uric acid levels.1 The therapeutic target of 6 mg/dl is achieved significantly more often with Adenuric® than with allopurinol.2,3 Long-term use resolves tophi and reduces gout attacks.2,4 No dose adjustment is required in patients with mild or moderate renal insufficiency.1
Regulatory Text:5 In chronic hyperuricemia with urate deposition (including a gouty nodule known from medical history or currently present and/or gouty arthritis), if there is intolerance/contraindication to the therapeutic alternatives from the Green Range (M04AA) or uric acid levels cannot be reduced below 6 mg/dl despite adequate dosing.
Check uric acid levels every 3 months. Continuation of therapy only if response is confirmed (reduction of uric acid level below 6 mg/dl). After a permanent reduction of the uric acid level below 6 mg/dl over a period of at least one year, the therapy can be discontinued provided that the uric acid levels are checked every six months.
Since June 1, 2020, febuxostat has been suitable for long-term approval by a chief (control) physician for 6 months (L6).5
References: 1 Drug information Adenuric®; 2 Becker, MA et al., N Engl J Med 2005; 353: 2450-2461; 3 Schumacher, HR et al., Arthritis Rheum 2008; 59: 1540-1548; 4 Schumacher, HR et al., Rheumatology 2009; 48: 188-194; 5 Erstattungskodex Adenuric® is a registered trademark of Teijin Limited, Tokyo, Japan
AT-WEB-14-10-2021