Summary Safety Review - Tecentriq (atezolizumab) - Assessing the Potential Risk of Autoimmune Hemolytic Anemia
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: 2021-02-03
Product
Tecentriq (atezolizumab)
Potential Safety Issue
Autoimmune Hemolytic Anemia (AIHA), a condition where the body's immune system attacks and destroys its own red blood cells.
Overview
Use in Canada
- Tecentriq (atezolizumab) is a prescription drug authorized for sale in Canada, to be used alone or in combination with other drugs, for the treatment of certain types of lung and liver cancer. Tecentriq is also authorized, with conditions on the manufacturer, to treat certain types of breast and bladder cancer.
- Tecentriq is administered directly into a vein, under the supervision of a physician experienced in treating cancer.
- Tecentriq is available in Canada as single-use vials containing either 1200 mg atezolizumab/20 mL or 840 mg atezolizumab/14 mL.
- Tecentriq has been marketed in Canada since 2017.
Safety Review Findings
- Health Canada reviewed information received from the manufacturer, as well as information from searches of the Canada Vigilance Dabatasea, international databases, and published literature.
- Health Canada's review focused on 36 case reports (one Canadian, 35 foreign) in order to assess the link between the use of Tecentriq and the risk of AIHA. Of the 36 case reports, 5 reports (none Canadian) met the criteria for further assessment. A link between Tecentriq use and AIHA could not be ruled out for these 5 reports; 3 reports were found to be probably linked to the use of Tecentriq and 2 reports were possibly linked. The remaining 31 reports could not be assessed further due to factors such as limited information in the reports, or patients taking other medications at the same time that could also cause AIHA.
- Health Canada also looked at additional information available from 56 studies in published scientific literature. Health Canada's review of these published studies supported a possible link between the use of Tecentriq and the risk of AIHA.
Conclusions and actions
- Health Canada's review of the available information concluded that there may be a link between the use of Tecentriq and the risk of AIHA.
- Health Canada is working with the manufacturer to update the Canadian product safety information for Tecentriq to include the risk of AIHA.
- Health Canada will continue to monitor safety information involving Tecentriq, 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 should new health risks be 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 Tecentriq both in Canada and internationally.
For additional information, contact the Marketed Health Products Directorate.
Footnotes
- Canadian reports can be accessed through the Canada Vigilance Online Database.