What is the dosage for Febuxostat?

Febuxostat Dosing

Start febuxostat at 40 mg once daily, then increase to 80 mg daily after 2-4 weeks if serum uric acid remains ≥6 mg/dL. 1, 2

Initial Dosing Strategy

• Begin with 40 mg once daily regardless of baseline serum uric acid level, even in severe hyperuricemia 1, 2
• The low starting dose minimizes the risk of precipitating acute gout flares during initial urate mobilization 2
• No dosage adjustment is needed for mild to moderate renal impairment (CrCl 30-89 mL/min) 3, 4

Dose Titration Protocol

• Check serum uric acid after 2-4 weeks of treatment 2, 4
• Escalate to 80 mg once daily if serum uric acid is not <6 mg/dL 1, 2
• The maximum FDA-approved dose in the United States is 80 mg daily 2
• In countries where 120 mg is approved (outside the US), this higher dose can be used for refractory cases failing to reach target with 80 mg daily 2

Target Serum Uric Acid Levels

• Primary target: <6 mg/dL (360 µmol/L) for most patients 1, 2
• Lower target: <5 mg/dL (300 µmol/L) for patients with severe disease burden (tophi, chronic arthropathy, frequent attacks) to facilitate faster crystal dissolution 1, 2

Mandatory Flare Prophylaxis

• Provide colchicine 0.5-1 mg daily OR low-dose NSAIDs for at least 6 months when initiating febuxostat 2, 5
• Febuxostat does not reduce gout attacks in the first 6 months and may paradoxically increase flare frequency initially due to urate mobilization 2, 5
• Discontinuing prophylaxis before 8 weeks approximately doubles the rate of acute gout flares 5

Monitoring Schedule

• Monitor serum uric acid every 2-5 weeks during dose titration 1
• Once target achieved, monitor every 6 months 1
• Monitor for liver function abnormalities, as these are among the most common adverse effects 3, 6

Critical Cardiovascular Precaution

• Switch to alternative urate-lowering therapy in patients taking febuxostat who have a history of cardiovascular disease or develop new cardiovascular events, due to increased risk of cardiovascular events 1
• Cardiovascular thromboembolic events occurred more frequently in randomized trials with febuxostat, though causality has not been definitively established 7

If Target Not Achieved at Maximum Dose

• Add a uricosuric agent (probenecid, fenofibrate, or losartan) in combination with febuxostat 80 mg 2
• Switch to allopurinol if not previously tried or contraindicated 2
• Consider pegloticase only for severe refractory disease with tophi and poor quality of life when all oral options have failed 2

Duration of Therapy

• Continue febuxostat indefinitely once initiated for recurrent gout, as this is chronic therapy 5
• Long-term treatment (3-5 years) maintains target serum urate levels and results in near elimination of gout flares and improved tophus resolution 5, 6