Adenuric^©(febuxostat) film coated tablets 80 and 120 mg. Rx. Reimbursed with conditions.

ATC-code: M04AA03

Therapeutic indications: Treatment of chronic hyperuricaemia in conditions in adults where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).

Dosing: The recommended oral dose of ADENURIC is 80 mg once daily without regard to food. If serum uric acid is > 357 µmol/L after 2-4 weeks, ADENURIC 120 mg once daily may be considered. ADENURIC works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 357 μmol/L. Gout flare prophylaxis of at least 6 months is recommended.

Contraindications: Hypersensitivity to the active substance or to any of the excipients.

Warnings and precautions: Treatment with febuxostat in patients with pre-existing major cardiovascular diseases (e.g. myocardial infarction, stroke or unstable angina) should be avoided, unless no other therapy options are appropriate. A numerical greater incidence of investigator-reported cardiovascular APTC events (defined endpoints from the Anti-Platelet Trialists’ Collaboration (APTC) including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) was observed in the febuxostat total group compared to the allopurinol group in the APEX and FACT studies (1.3 vs. 0.3 events per 100 Patient Years (PYs)), but not in the CONFIRMS study (see section 5.1 for detailed characteristics of the studies). The incidence of investigator-reported cardiovascular APTC events in the combined Phase 3 studies (APEX, FACT and CONFIRMS studies) was 0.7 vs. 0.6 events per 100 PYs. In the long-term extension studies the incidences of investigator-reported APTC events were 1.2 and 0.6 events per 100 PYs for febuxostat and allopurinol, respectively. No statistically significant differences were found and no causal relationship with febuxostat was established. Identified risk factors among these patients were a medical history of atherosclerotic disease and/or myocardial infarction, or of congestive heart failure. In the post registrational CARES trial the rate of major adverse cardiovascular events was similar in febuxostat versus allopurinol treated patients (HR 1.03; 95% CI 0.87- 1.23), but a higher rate of cardiovascular deaths was observed (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73).

Storage: Adenuric does not require any special storage conditions.

Pack size:
80 mg: 28 and 84 tabs.
120 mg: 28 tabs.

For full information regarding prescription and SPC (June 2019) please see www.fass.se