Liver injury, including serious cases and cases leading to discontinuation of treatment, has been reported in patients treated with Mavenclad.

Before initiating treatment, a detailed patient history of underlying liver disorders or episodes of liver injury with other medicines should be undertaken.

Liver function tests including serum aminotransferase, alkaline phosphatase, and total bilirubin levels should be assessed prior to initiation of therapy in year 1 and year 2.

During treatment, liver function tests should be conducted, and repeated as necessary. In case a patient develops liver injury, treatment with Mavenclad should be interrupted or discontinued, as appropriate.