Roxadustat-Associated Cholestatic Jaundice in Haemodialysis Patients with Positive Rechallenge

Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is widely used for anaemia in chronic kidney disease. While pivotal trials reported low risks of transaminase elevations, detailed clinical case reports substantiating a causal link with cholestatic jaundice remain scarce. We report a series of four haemodialysis patients who developed cholestatic jaundice after roxadustat initiation, characterized by predominant elevations of direct bilirubin and bile acids with persistently normal transaminases. Notably, two patients had positive rechallenges. Common causes of cholestasis were excluded, and biochemical recovery occurred after drug discontinuation. This case report suggests a causal association between roxadustat and cholestatic jaundice in haemodialysis patients and highlights the value of monitoring cholestatic parameters during therapy.

This case series provides clinical evidence supporting a causal association between roxadustat and cholestatic jaundice in haemodialysis patients, warranting clinical awareness of this potential adverse effect.