其 他 安 全 警 示
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| Canada: Imbruvica (ibrutinib): Risk of serious and fatal cardiac arrhythmias or cardiac failure (English only) |
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Health Canada announces that serious and fatal events of cardiac arrhythmia or cardiac failure have occurred in patients treated with Imbruvica. Patients with significant cardiac co-morbidities may be at greater risk for developing these events, including sudden fatal cardiac events. Related warnings have been in the Canadian Product Monograph (CPM) since authorization.
Responding to data from new clinical trials and ongoing monitoring of product safety, the CPM for Imbruvica has been updated to include stronger warnings on these cardiac-related events and new dose modification guidelines.
Among the 4,896 patients who received Imbruvica in clinical trials, which included patients who received Imbruvica in unapproved monotherapy or combination regimens, cardiac-related deaths or sudden deaths were reported in 1% of patients. Of the 4,896 patients, 0.2% reported Grade ≥3 ventricular tachyarrhythmias, 3.7% reported Grade ≥3 atrial fibrillation and atrial flutter, and 1.3% reported Grade ≥3 cardiac failure. These events occurred particularly in patients with acute infections or cardiac risk factors including hypertension, diabetes mellitus and a previous history of cardiac arrhythmia.
New guidelines for Imbruvica dose modification or treatment discontinuation due to cardiac arrhythmia or cardiac failure have been added to the Imbruvica CPM. These dose modification guidelines are intended to improve tolerability for continued Imbruvica treatment and may reduce the occurrence of additional serious events.
Healthcare professionals are advised to:
- Clinically evaluate patients’ cardiac function and consider cardiac history prior to initiating Imbruvica therapy.
- Closely monitor patients for clinical signs of cardiac function deterioration during treatment, and manage appropriately. Consider further evaluation (e.g., electrocardiogram, echocardiogram) for patients who develop arrhythmic symptoms (e.g., palpitations, light-headedness) or new onset of dyspnea.
- Follow the new dose modification guidelines for patients with new onset or worsening cardiac arrhythmia or cardiac failure.
Janssen Inc., in collaboration with Health Canada, has updated the CPM for Imbruvica to include new warnings regarding serious and fatal events of cardiac arrhythmia or cardiac failure, including new dose modification guidelines.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/imbruvica-ibrutinib-risk-serious-and-fatal-cardiac-arrhythmias-or-cardiac-failure
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 27 cases of adverse drug reaction related to ibrutinib, of which 5 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.
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/Tuesday, Aug 30, 2022
Issued at HKT 15:00
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