Mavenclad® (cladribine) – risk of serious liver injury and recommendations for liver function monitoring

A Dear Healthcare Professional Letter has been issued by Merck Pte Ltd to inform healthcare professionals of adverse events of liver injury following treatment with Mavenclad^® (cladribine) and recommendations for liver function monitoring of patients on Mavenclad^®. Liver injury, including serious cases and cases leading to discontinuation of treatment, has been reported in patients treated with Mavenclad^®. A recent review of available safety data has concluded an increased risk for liver injury following treatment with Mavenclad^®. Healthcare professionals are advised to take a detailed patient history of the underlying liver disorders or episodes of liver injury with other medicines before treatment initiation and to assess the patient’s liver function tests prior to initiation of therapy in year 1 and year 2. If a patient develops clinical signs, including unexplained liver enzyme elevations or symptoms suggestive of hepatic dysfunction, healthcare professionals are advised to promptly measure serum transaminases and total bilirubin and interrupt or discontinue treatment with Mavenclad^® as appropriate. Please refer to the letter for details. Published: 16 Feb 2022

Dear Healthcare Professional Letters