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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:

  • 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.

 

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Site Last Modified

  • Last Modified: Thursday 10 October 2024, 16:28:58.

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