Other safety alerts
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| Australia: Update: Tocilizumab and hepatotoxicity |
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The Therapeutic Goods Administration (TGA) announces that, following the July 2019 Medicines Safety Update article regarding tocilizumab and hepatotoxicity, the Product Information (PI) for tocilizumab has been updated to include more information about this potential safety issue. Tocilizumab is marketed in Australia under the brand name Actemra.
A comprehensive assessment of reports of serious hepatic injury associated with tocilizumab use has been performed across all available clinical and post-marketing data sources. The sponsor of Actemra, Roche, has identified eight cases of tocilizumab-related moderate to severe drug-induced liver injury, including acute liver failure, hepatitis and jaundice. These events occurred between two weeks to more than five years after initiation of tocilizumab, with median latency of 98 days. In these eight cases, two cases of acute liver failure required liver transplantation.
These events are considered rare and the benefit-risk profile of tocilizumab in the approved indications remains favourable.
Health professionals are reminded that tocilizumab is known to cause transient mild to moderate elevation of hepatic transaminases, with increased frequency when used in combination with other potentially hepatotoxic drugs (such as methotrexate).
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.
It is not recommended to initiate tocilizumab treatment in patients with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal (ULN), except in cases of cytokine release syndrome. In patients who develop elevated ALT or AST greater than five times ULN, discontinue tocilizumab.
Health professionals are advised to follow all guidance relating to liver enzyme abnormalities, including dose modification and tocilizumab discontinuation, contained in the updated PI.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/update-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 (Roche), 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 various overseas drug regulatory authorities, and was posted on the Drug Office website since 12 Apr 2019, with the latest update posted on 18 Jul 2019. Letters to inform local healthcare professionals were issued by DH on 12 Apr 2019. In Dec 2019, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and noted that Roche had submitted application to update the package insert with information relevant to hepatotoxicity. DH is working with the company to update the safety information of the local products, and will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, Dec 11, 2019
Issued at HKT 16:00
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