ADR that result in revision of patient information
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| Australia: Tocilizumab and hepatotoxicity |
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Therapeutic Goods Administration (TGA) advises health professionals that serious drug-induced liver injury, including acute liver failure, hepatitis and jaundice, have been observed with the administration of tocilizumab. The frequency of serious hepatotoxicity is considered rare, but in some cases treatment has required liver transplant.
Patients treated with tocilizumab should be closely monitored for liver adverse events and advised to seek immediate medical advice if they have signs or symptoms of hepatotoxicity such as jaundice, dark urine, itch, loss of appetite, nausea or vomiting. Patients presenting with signs or symptoms of hepatotoxicity should be promptly investigated.
The current Product Information (PI) for tocilizumab does not recommend treatment in patients with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above five times the upper limit of normal (ULN). Caution should continue to be exercised when considering initiation of tocilizumab treatment in patients with ALT or AST above 1.5 times ULN. Tocilizumab is known to cause transient or intermittent mild to moderate elevation of hepatic transaminases.
The TGA is currently reviewing the data on the nature and incidence of hepatotoxicity with tocilizumab, and may recommend changes to the PI.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/tocilizumab-and-hepatotoxicity
In Hong Kong, there are 4 registered pharmaceutical products containing tocilizumab, namely Actemra Conc For Soln For Infusion 400mg/20ml (HK-59200), Actemra Conc For Solution For Inf 200mg/10ml (HK-59201), Actemra Conc For Soln For Infusion 80mg/4ml (HK-59202) and Actemra Solution For Injection in Pre-filled Syringe 162mg/0.9ml (HK-63771). All products are registered by Roche Hong Kong Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received 8 cases of adverse drug reaction related to tocilizumab, but these cases are not related to hepatotoxicity. Related news was previously issued by Singapore Health Sciences Authority and Health Canada, and was posted on the Drug Office website on 12 Apr 2019 and 22 May 2019 respectively. Letters to inform local healthcare professionals were issued by the DH on 12 Apr 2019. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Jul 12, 2019
Issued at HKT 15:00
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