2020年非布司他最新说明书

The latest instructions for febuxostat in 2020

[Indications] It is suitable for the long-term treatment of hyperuricemia in patients with gout. Not recommended for use in asymptomatic hyperuricemia.

  [Usage and Dosage] The recommended oral dose of febuxostat is 40 mg or 80 mg. Once a day. The recommended starting dose of febuxostat is 40 mg once a day. If the blood uric acid level is still not less than 6 mg/dl (approximately 360 μmol/L) after 2 weeks, the recommended dose is increased to 80 mg once a day. There is no need to consider the effects of food and antacids when administering.

[Precautions] Gout attacks: In the early stages of taking febuxostat, the frequency of gout attacks often increases. This is because blood uric acid concentration decreases, leading to mobilization of urate deposited in tissues. To prevent gout attacks during the initial stages of treatment, it is recommended to take nonsteroidal anti-inflammatory drugs or colchicine at the same time. If gout attacks during febuxostat treatment, there is no need to discontinue febuxostat treatment. Gout should be treated accordingly according to the patient's specific situation. Cardiovascular events In randomized controlled trials, patients treated with febuxostat had a higher rate of cardiovascular thrombotic events (including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) than those treated with allopurinol, with febuxostat at 0.74/100 patient-years (95% CI: 0.36-1.37) and allopurinol at 0.60/100 patient-years. A causal relationship between febuxostat and cardiovascular thrombotic events has not been established. Pay attention to monitor the symptoms and signs of myocardial infarction and stroke when taking the drug.

[Special Population] Patients with hepatic insufficiency: Patients with mild or moderate hepatic insufficiency (Child-Pugh Class A.B) do not need to adjust the dose. The efficacy and safety of febuxostat in patients with severe hepatic insufficiency (Child-Pugh Class C) have not been studied. Therefore, febuxostat should be used with caution in these patients. Renal insufficiency: Patients with mild or moderate renal insufficiency (Clcr30-89ml/min) do not need to adjust the dose. The recommended starting dose of febuxostat is 40mg once a day. If the blood uric acid level is still not less than 6mg/dl after 2 weeks, the recommended dose is increased to 80mg once a day. There is no sufficient research data in patients with severe renal insufficiency (Clu<30ml/min), so these patients should use febuxostat with caution. Uric Acid Levels Two weeks after starting febuxostat treatment, it is possible to assess whether the serum uric acid level has reached the target value (less than 6 mg/dl).