Reported Adverse Drug Reaction Cases
- Lampson BL, et al. Ventricular arrhythmias and sudden death in patients taking ibrutinib(link is external). Blood 2017 129: 2581–84.
Ibrutinib - ventricular tachyarrhythmia, hepatitis B reactivation and infection
Ibrutinib, which is marketed in Australia as Imbruvica, is a selective and covalent inhibitor of Bruton's tyrosine kinase. It is used for the treatment of certain types of blood cancers, including mantle cell lymphoma and Waldenstrom's macroglobulinaemia chronic lymphocytic leukaemia (including small lymphocytic lymphoma).
Updates to the Precautions and Post Marketing Data sections of the Product Information (PI) are being made following TGA evaluation of new data on the safety of ibrutinib.
Ibrutinib continues to have a favourable risk-benefit profile for treating patients with indications specified in the Australian PI.
Cases of ventricular tachyarrhythmia have been reported with the use of ibrutinib.
In a 2017 study of relevant case reports from post-marketing sources and clinical trial data, 11 cases of ventricular tachycardia/ventricular fibrillation and six additional cases of sudden cardiac death in patients exposed to ibrutinib were identified. In 12 of these 17 cases, the events occurred without any evidence of prior cardiac history.
There were 52 cases of ventricular tachyarrhythmia reported in post-marketing settings.
Based on current evidence, the role of ibrutinib in causing ventricular arrhythmia, cardiac arrest and sudden cardiac death is currently unknown.
However, due to the potential severity of these events, ibrutinib should be temporarily discontinued in patients who develop signs and/or symptoms of ventricular tachyarrhythmia, including palpitations, chest pain, dyspnea, dizziness or fainting.
A thorough assessment of risk-benefit should be made before making any decision to restart therapy.
TGA Medicines Safety Update, Volume 8, Number 5, October-November 2017