Summary Safety Review - IMBRUVICA (ibrutinib) - Assessing the potential risk of a serious and life-threatening abnormal heart rhythm (ventricular tachyarrhythmia)

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2018-07-26

Product

Imbruvica (ibrutinib)

Potential Safety Issue

Abnormal heart rhythm (ventricular tachyarrhythmia)

Key Messages

  • Ibrutinib is a drug authorized for sale in Canada to treat bone marrow and white blood cell cancers. It is also used for the treatment of patients who suffer from refractory chronic graft versus host disease after receiving transplanted tissue from a donor.
  • Health Canada reviewed the potential risk of a type of abnormal heart rhythm called ventricular tachyarrhythmia with the use of ibrutinib following the publication of an article1 describing a potential link.
  • Health Canada's review of the available information found that there may be a link between ibrutinib and ventricular tachyarrhythmia. Health Canada has worked with the manufacturer of ibrutinib to update the product safety information to include ventricular tachyarrhythmia.

Overview

Ibrutinib belongs to a class of cancer drugs called protein kinase inhibitors. It is used for the treatment of adult patients who have a cancer of the bone marrow called chronic lymphocytic leukemia, or have other types of cancer of the blood affecting white blood cells such as Mantle cell lymphoma and Waldenström's macroglobulinemia. It is also used in patients who suffer from a medical complication after receiving transplanted tissue from a donor. This medical complication is called refractory chronic graft versus host disease.

Ventricular tachyarrhythmia is a particular type of serious, life-threatening irregular heart rate that could lead to light-headedness, palpitations, chest pain or eventually sudden death.

Use in Canada

  • Ibrutinib has been marketed in Canada since 2014 under the brand name Imbruvica. It is available as capsules taken by mouth.
  • There have been 22,917 prescriptions of ibrutinib in Canada since its approval in 2014.

Safety Review Findings

  • At the time of the review, Health Canada had received 5 Canadian reportsa of ventricular tachyarrhythmia suspected to be linked to ibrutinib. Of these reports, 1 was further assessed as it met the criteria for this review. This Canadian report showed a likely link between ibrutinib and ventricular tachyarrhythmia.
  • The review also looked at 150 international reports of ventricular tachyarrhythmia suspected to be linked to ibrutinib. Of these reports, 23 were further assessed as they met the criteria for this review. Of the 23 reports, 3 showed a likely link and 20, with one reporting death, were found to have a possible link between ibrutinib and ventricular tachyarrhythmia.
  • In 9 of the 24 cases that were looked at (1 Canadian and 23 international), other factors could have played a role in the ventricular tachyarrhythmia such as the patient's medical history and other medications used.
  • Product safety information of ibrutinib in the United States, Europe and New Zealand has been updated to include ventricular tachyarrhythmia. In addition, the United Kingdom published a safety communication on the risk of ventricular tachyarrhythmia with ibrutinib.

Conclusions and actions

  • Health Canada's review of the available information found that there may be a link between ibrutinib and ventricular tachyarrhythmia.
  • Health Canada has worked with the manufacturer of ibrutinib to update the product safety information to include ventricular tachyarrhythmia. Health Canada will post an InfoWatch PM Update for Imbruvica to inform healthcare professionals and patients about this risk.
  • Health Canada will continue to monitor safety information involving ibrutinib to identify and assess potential harms, as it does for all health products on the Canadian market. Health Canada will take appropriate and timely action if and when new health risks are identified.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information, and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

References

  1. Lampson B, Yu L, Glynn R et al; Ventricular arrhythmias and sudden death in patients taking ibrutinib. Blood, 4 May 2017, Vol 129. No. 18, pp. e2581-2584

Footnotes

  1. Canadian reports can be accessed through the Canada Vigilance Online Database.

Report a problem or mistake on this page
Please select all that apply:
Date modified: