Imbruvica: new safety signal for use with rituximab and ACE inhibitors

6 September 2021

As part of its advice on safety-related aspects to other European Medicines Agency committees, the Pharmacovigilance Risk Assessment Committee (PRAC) last week discussed a direct healthcare professional communication (DHPC) containing important safety information for Imbruvica (ibrutinib).

This DHPC aims to inform healthcare professionals about a new safety signal of sudden or cardiac death with Imbruvica when used in combination with rituximab and angiotensin-converting enzyme (ACE) inhibitors. The signal was recognized following a review of the findings of a clinical trial.

Imbruvica is a medicine for treating the blood cancers mantle cell lymphoma, chronic lymphocytic leukemia (CLL) and Waldenström’s macroglobulinemia (also known as lymphoplasmacytic lymphoma), which is marketed by Johnson & Johnson (NYSE: JNJ) unit Janssen and AbbVie (NYSE: ABBV). J&J’s second quarter of 2021 sales of Imbruvica came in at $1.12 billion, up 18% year-on-year.

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