Actemra® (tocilizumab): New important identified risk of hepatotoxicity

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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:

 

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.