The maximum tolerable dose of roxadustat in humans has not yet been established. Single supratherapeutic doses of roxadustat 5 mg/kg (up to 510 mg) was administered in healthy subjects, and up to 400 mg TIW in CKD patients with anemia in clinical studies.
Overdose may result in enhanced pharmacodynamic effects, such as a rapid increase in Hb levels or an elevated heart rate, including tachycardia. In the event of an overdose, symptomatic and supportive treatment should be adopted. If Hb levels become excessively high, treatment with roxadustat should be temporarily discontinued. Roxadustat is not significantly removed by haemodialysis.