其 他 安 全 警 示
|
| |
| European Union: Imbruvica (ibrutinib): new risk minimisation measures, including dose modifications, due to the increased risk for serious cardiac events (English only) |
| |
European Medicines Agency (EMA) announces that the Pharmacovigilance Risk Assessment Committee (PRAC) discussed a direct healthcare professional communications (DHPC) containing important information for Imbruvica (ibrutinib).
This DHPC aims to inform healthcare professionals about an increased risk of fatal and serious cardiac arrhythmias and cardiac failure with the use of ibrutinib.
Patients with advanced age, Eastern Cooperative Oncology Group (ECOG) performance status ≥2, or cardiac co-morbidities may be at greater risk of cardiac events including sudden fatal cardiac events.
The PRAC advises that a clinical evaluation of cardiac history and function should be performed before starting a treatment with ibrutinib. In patients with risk factors for cardiac events, benefits and risks should be assessed before initiating treatment with the medicine and alternative treatment may be considered. Patients should be carefully monitored during treatment for signs of deterioration of cardiac function and be clinically managed. Ibrutinib should be withheld for any new onset or worsening of grade 2 cardiac failure or grade 3 cardiac arrhythmias. Treatment may be resumed as per new dose modification recommendations.
The DHPC for Imbruvica will be forwarded to EMA’s Committee for Medicinal Products for Human Use (CHMP). Following the CHMP decision, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holder, according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registers in European Union Member States.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-26-29-september-2022
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 was posted on the Drug Office website on 30 Aug 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/Monday, Oct 3, 2022
Issued at HKT 16:00
|
| |
|
