Summary Safety Review - Kadcyla (trastuzumab emtansine) - Assessing the Potential Risk of Tumor Lysis Syndrome

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: 2021-06-24

Product

Kadcyla (trastuzumab emtansine)

Potential Safety Issue

Tumor Lysis Syndrome, a condition that occurs when cancer cells are killed rapidly, releasing their contents into the blood, causing blood chemical imbalance and organ damage.

Key Messages

  • Kadcyla (trastuzumab emtansine) is a prescription drug authorized for sale in Canada for the treatment of early or late stage breast cancer.
  • Health Canada reviewed the risk of tumor lysis syndrome with the use of Kadcyla. This review was triggered by summary information received from the manufacturer.
  • Health Canada's review of the available information could not confirm a link between the use of Kadcyla and the risk of tumor lysis syndrome in Canada. At the time of this review, Health Canada found the available information for Kadcyla related to this risk in Canada is too limited to warrant regulatory action.
  • Health Canada has asked the manufacturer for additional information about the risk of tumor lysis syndrome related to the use of Kadcyla in Canada and in other jurisdictions, and will review this information as it becomes available to determine if any measures are needed at that time.
  • Health Canada will continue to monitor the safety of Kadcyla, as it does for all health products on the Canadian market.

Overview

Health Canada reviewed the potential risk of tumor lysis syndrome with the use of Kadcyla. The review was triggered by reports of suspected tumor lysis syndrome in patients using Kadcyla that were provided by the manufacturer.

Tumor lysis syndrome is a potentially life-threatening condition that can occur during cancer treatment. When cancer cells are killed by the cancer treatment, they release their contents (salts and proteins) into the blood. When cancer cells break down faster than the kidneys can remove these substances from the blood, it can cause changes to the chemical balance in the blood, which may result in damage to organs, most commonly the kidneys, heart and brain.

Use in Canada

  • Kadcyla is a prescription drug authorized for sale in Canada for the treatment of early or late stage breast cancer.
  • Kadcyla is administered as an infusion directly into a vein (intravenous), under the supervision of a physician experienced in treating cancer.
  • Kadcyla is available in vials as lyophilized powder containing 100 mg and 160 mg trastuzumab emtansine, respectively.
  • Kadcyla has been marketed in Canada since 2013. Approximately 2,344 Canadian patients have been treated with Kadcyla to date.

Safety Review Findings

  • Health Canada reviewed information received from the manufacturer, as well as information from searches of the Canada Vigilance Databasea, international databases and published literature.
  • Health Canada reviewed 17 cases (10 Canadian and 7 foreign) of tumor lysis syndrome in patients treated with Kadcyla. Of the 17 cases, 4 Canadian cases were found to be unlikely linked to the use of Kadcyla. The remaining 13 cases (6 Canadian and 7 foreign) did not have enough information in the reports for further review. It was difficult to establish a link between tumor lysis syndrome and Kadcyla use due to missing information or the presence of other contributing factors (chemotherapy treatment and underlying medical conditions) in the 17 cases.
  • At the time of the review, Health Canada did not find any reports in the scientific literature to support a link between tumor lysis syndrome and Kadcyla use.

Conclusions and actions

  • Health Canada's review of the available information could not confirm a link between the use of Kadcyla and the risk of tumor lysis syndrome in Canada. At the time of this review, Health Canada found the available information for Kadcyla related to this risk in Canada too limited to warrant regulatory action.
  • Health Canada has asked the manufacturer for additional information about the risk of tumor lysis syndrome related to the use of Kadcyla in Canada and in other jurisdictions, and will review this information to determine if any measures are needed at that time.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of Kadcyla and other health products to the Canada Vigilance Program.
  • Health Canada will continue to monitor safety information involving Kadcyla, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if any 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 Kadcyla both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

Footnotes

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

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