Other safety alerts
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| Singapore: New identified risk of hepatotoxicity (including hepatic failure) in patients treated with Imbruvica® |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Johnson & Johnson International (Singapore) Pte Ltd to inform healthcare professionals about a new identified risk of hepatotoxicity, including hepatic failure, which has been reported in patients treated with Imbruvica® (ibrutinib).
This causal association is based on a recent cumulative review of data from clinical trials, post-marketing cases and literature by Johnson & Johnson and the Imbruvica® package insert will be updated accordingly. Healthcare professionals are advised to discuss with patients the risks associated with the use of Imbruvica®, including hepatoxicity and hepatic failure. It is recommended to assess liver function before initiating treatment with Imbruvica® and monitor patients periodically for changes in liver function parameters during treatment.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/new-identified-risk-of-hepatotoxicity-(including-hepatic-failure)-in-patients-treated-with-imbruvica
In Hong Kong, there are 3 registered pharmaceutical products containing ibrutinib, namely Imbruvica Capsules 140mg (HK-65397), Imbruvica Tablets 140mg (HK-67062) and Imbruvica Tablets 280mg (HK-67063). All products are registered by Johnson & Johnson (Hong Kong) Ltd. They are prescription-only medicines. So far, the Department of Health (DH) has received 36 cases of adverse drug reaction with regard to ibrutinib, but these cases were not related to hepatotoxicity, including hepatic failure.
Safety information on the risk of hepatotoxicity and hepatic failure has already been included in the package insert of Hong Kong registered Imbruvica products. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, Oct 2, 2024
Issued at HKT 16:15
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