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.
Healthcare professional, Industry member, Therapeutic Products
Published:

Dear Healthcare Professional Letters

18 Feb 2022

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.