非布索坦目前已知获批适应症有什么？

Febuxostat (febuxostat, feburic) is a new type of selective new non-purine xanthine oxidase (XO) inhibitor. The main component is febuxostat. The drug was approved by the U.S. Food and Drug Administration (FDA) for marketing in the United States in February 2009. In 2010, it was launched in France, the United Kingdom, Germany and other countries. What are the currently known approved indications for febuxostat?

Febuxostat is used to treat patients with hyperuricemia who have symptoms of gout.

The dose of febuxostat is 40 mg or 80 mg once daily. The recommended starting dose of this product is 40 mg, and there is no need to consider the effects of food or antacids when administering this product. Febuxostat is rapidly and extensively absorbed after oral administration, with a peak time of approximately 1.0-1.5 hours and 84% absorption. There is no accumulation of febuxostat when therapeutic doses are applied every 24 hours. After oral administration at doses of 80 mg and 120 mg one or more times daily. If administered with a high-fat meal, the peak concentration was reduced by 49% and 38%, and the area under the curve was reduced by 18% and 16%, respectively, at a dose of 80 mg per day or once per day at a dose of 120 mg. However, no clinically significant change in the percentage reduction in serum uric acid concentration was observed.

Patients with mild or moderate renal impairment: No dosage adjustment is necessary while taking this product. The recommended starting dose of this product is 40 mg once daily. After a dose of 40 mg for two weeks, for patients whose serum uric acid level (sUA) is still higher than 6 mg/dl, the recommended dose is 80 mg. No dose adjustment is required for patients with mild to moderate hepatic impairment. There are no studies on the use of this product in patients with severe hepatic impairment, so this product should be administered with caution.

Use in Elderly Patients: After multiple doses of oral administration of this product to elderly patients (≥65 years old), the Cmax and AUC of febuzoxostat and its metabolites are similar to those in younger patients (18-40 years old). In addition, the percentage decrease in serum uric acid concentration was similar in older and younger subjects. No dose adjustment is required for elderly patients.