Description:

Actemra^® (tocilizumab) is a biological product indicated for rheumatoid arthritis in adults, polyarticular systemic juvenile idiopathic arthritis (pJIA) and systemic juvenile idiopathic arthritis (sJIA) in patients above 2 years old, as well as giant cell arteritis (GCA) in adults.

Serious drug-induced liver injury, including acute liver failure, hepatitis and jaundice, which in some cases required liver transplant, have been observed with the use of Actemra^®.

Several measures should be considered in patients receiving Actemra^®, as follows:

• All healthcare professionals are advised to monitor the ALT and AST levels of their patients every 4 to 8 weeks for the first 6 months of Actemra^® treatment, followed by every 12 weeks thereafter for all approved indications.
• Exercise caution when initiating Actemra^® treatment in patients with ALT or AST >1.5 times the upper limit of normal (ULN). Treatment is not recommended in patients with ALT or AST >5 times ULN.
• Recommended dose modifications of Actemra^® due to the liver enzyme abnormalities remain unchanged. Please refer to the product information for full prescribing details.

NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Roche (Malaysia) Sdn. Bhd. to highlight this safety issue. For further information, please contact your local sales person for a copy of the DHPC.