Actemra® (tocilizumab) and risk of hepatotoxicity

F. Hoffmann-La Roche would like to inform healthcare professionals on the risk of hepatotoxicity associated with the use of Actemra® (tocilizumab). Serious drug-induced liver injuries, including acute liver failure, hepatitis and jaundice, in some cases requiring liver transplant, have been observed with the administration of Actemra®. The frequency of serious hepatotoxicity is considered rare. The current approved prescribing information does not recommend treatment with Actemra® in patients with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above 5X upper limit of normal (ULN). Caution should be exercised when considering initiation of Acetmra® treatment in patients with ALT or AST above 1.5X ULN. In the letter, it is recommended for patients with Rheumatic Arthritis, Polyarticular Juvenile Idiopathic Arthritis and Systemic Juvenile Idiopathic Arthritis, to be monitored for their ALT and AST every 4 to 8 weeks for the first 6 months of treatment followed by every 12 week thereafter. Recommended dose modifications (reduction, interruption or discontinuation) of Actemra® due to liver enzyme abnormalities remain unchanged in drug label. Please refer to the letter for details.      
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

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.