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Friday, 09/30/2022 4:02:26 PM

Friday, September 30, 2022 4:02:26 PM

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Impetus for ABBV selloff today:

https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-26-29-september-2022

Imbruvica (ibrutinib): new risk minimisation measures, including dose modifications, due to the increased risk for serious cardiac events

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 human medicines committee (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 EU Member States.

Emphasis added.

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