From the Guidelines
The recommended dose of febuxostat is 40mg daily administered orally once daily, as it is equally effective at decreasing serum urate levels as allopurinol 1.
Key Considerations
- For patients with moderate renal impairment, a dose of 40mg daily is recommended, while those with severe renal impairment should receive a lower dose, although the exact dose is not specified in the provided evidence.
- The duration of treatment with febuxostat is typically long-term, and may be continued indefinitely in patients with gout, as it is used to prevent future gout attacks and reduce serum urate levels 1.
Important Points to Note
- Urate-lowering therapy, including febuxostat, is not necessary in cases where the patient would have no or infrequent recurrences of gout attacks 1.
- Patients who decide not to initiate urate-lowering therapy can revisit their decision if they have multiple recurrences of acute gout 1.
- High-quality evidence showed that prophylactic therapy with low-dose colchicine or low-dose NSAIDs reduces the risk for acute gout attacks in patients initiating urate-lowering therapy, including febuxostat 1.
Adverse Effects
- Febuxostat is associated with adverse effects, including abdominal pain, diarrhea, and musculoskeletal pain 1.
From the FDA Drug Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Febuxostat Tablets, 40 mg – 30's count NDC- 70771-1552-3 Febuxostat Tablets, 80 mg – 30's count NDC- 70771-1553-3 The FDA drug label does not answer the question.
From the Research
Recommended Doses of Febuxostat
- The recommended starting dosage of febuxostat is 40 mg orally once daily 2
- If serum uric acid concentrations are not less than 6 mg/dL after two weeks, the dosage can be increased to 80 mg orally once daily 2
- Dosage adjustments are not needed in elderly patients or patients with mild or moderate renal or hepatic impairment 2
Duration of Febuxostat Therapy
- Febuxostat is administered once daily, with no significant accumulation of the drug during multiple dose administration 3
- The duration of febuxostat therapy can be up to 12 months, as shown in a multicenter, randomized, double-blind, placebo-controlled study 4
- Long-term extension studies have confirmed the efficacy and tolerability of febuxostat for up to 3-5 years 5, 6
Special Considerations
- No dose adjustment is required in mild-to-moderate renal impairment 2, 5, 6
- Febuxostat is extensively metabolized by oxidation and acyl glucuronidation, and its metabolites are cleared by the kidney 3
- Patients should be monitored for signs and symptoms of myocardial infarction and stroke, as more cardiovascular thromboembolic events occurred in randomized trials in patients treated with febuxostat 2