News item | 04-11-2022 | 12:00
Ibrutinib (Imbruvica) increases the risk of serious arrhythmias and heart failure. The heart problems can be fatal and are more common in certain patient groups. The MEB therefore advises doctors to check patients’ heart function before and during treatment with Imbruvica. There are also new recommendations for adjusting the dose after heart problems.
Ibrutinib is used in adult patients with B-cell lymphomas. Clinical studies show that Ibrutinib increases the risk of serious cardiac arrhythmias and heart failure. The risk of fatal heart problems is greater in older people, patients with an ECOG performance status of 2 or higher, and patients with cardiovascular disease or at risk thereof. New measures should reduce the risk of these heart problems.
Advice to doctors
- Before starting treatment with Imbruvica, check whether the patient has had previous cardiac problems and examine the patient’s cardiac function.
- Consider alternative treatment in patients at increased risk of heart problems.
- Continue to monitor the patient’s cardiac function during treatment. Treat the patient if cardiac function deteriorates.
- Interrupt Imbruvica treatment if a patient develops symptomatic heart failure or severe heart rhythm abnormalities.
- Use the new dose adjustment recommendations when resuming treatment.
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Risk information letter
The company Janssen-Cilag BV has sent a letter on this subject, a so-called Direct Healthcare Professional Communication (DHPC). The letter with this important risk information was sent to haematologists, oncologists, oncology nurses, cardiologists, hospital pharmacists and all healthcare providers in training in consultation with the MEB and the Inspectorate for Healthcare and Youth (IGJ).
We refer to the identification and analysis of side effects of a medicine as pharmacovigilance or pharmacovigilance. This is a core task of the MEB. In case of urgent and/or important safety issues, medical professionals are notified by means of a DHPC.