Other safety alerts
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| Singapore: Imbruvica® (ibrutinib) package insert updates to dose modifications for adverse reactions and to warnings and precautions |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Johnson & Johnson Pte Ltd to inform healthcare professionals of important updates to the “Dose Modifications” and “Warnings and Precautions” sections of the Singapore package insert for Imbruvica® (ibrutinib).
The updated dose modification recommendations for adverse reactions may reduce the occurrence of additional serious events and are intended to improve tolerability for continued Imbruvica® treatment. In addition, the revised “Warnings and Precautions” section carries additional information on cardiac arrhythmias, cardiac failure, and sudden fatal cardiac events, including a description of risk factors and guidelines for assessment and management to help prescribers better manage patients at risk. Healthcare professionals are advised to review and follow the updates to the Imbruvica® Singapore package insert.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/imbruvica-(ibrutinib)-package-insert-updates-to-dose-modifications-for-adverse-reactions-and-to-warnings-and-precautions
In Hong Kong, there are 4 registered pharmaceutical products containing ibrutinib, namely Imbruvica Capsules 140mg (HK-64088), 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 28 cases of adverse drug reaction related to ibrutinib, of which 6 cases were related to atrial fibrillation and one case was related to heart failure.
Related news on the risk of ventricular tachyarrhythmia associated with the use of ibrutinib was previously issued by the United Kingdom Medicines and Healthcare products Regulatory Agency and Health Canada, and was posted on the Drug Office website on 16 Aug 2017 and 27 Jul 2018. Letters to inform local healthcare professionals were issued by the DH on 16 Aug 2017. In Dec 2017, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided that the package insert of ibrutinib-containing products should include safety information on the risk of ventricular tachyarrhythmia.
Related news on the risk of cardiac arrhythmias and cardiac failure associated with the use of ibrutinib was previously issued by Health Canada and European Medicines Agency, and was posted on the Drug Office website on 30 Aug 2022 and 3 Oct 2022.
The current package insert of the above 4 local ibrutinib-containing products include safety information on the risk of cardiac arrhythmia (including atrial fibrillation, atrial flutter and ventricular tachyarrhythmia) and cardiac failure. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Wednesday, Oct 5, 2022
Issued at HKT 16:00
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