Summary Safety Review - YONDELIS (trabectedin) - Assessing the Potential Risk of Fluid Leakage from Small Blood Vessels (capillary leak 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: 2016-08-04
Product
Yondelis (trabectedin)
Potential Safety Issue
Fluid leakage from small blood vessels (capillary leak syndrome)
Overview
Use in Canada
- Yondelis is used alone to treat some advanced cancers, such as those from fat cells (liposarcoma) or from smooth muscles (leiomyosarcoma). It can also be used together with another drug to treat ovarian cancer. Yondelis is usually used when other treatments have not worked.
- Yondelis has been sold in Canada since August 2010. It is not widely used in Canada.
- Yondelis is usually prescribed by cancer specialists. It is given by injection into a large vein once every 3 weeks. The dose is calculated using the patient's height and weight.
Safety Review Findings
- At the time of the review, there were no Canadian cases of capillary leak syndrome reported with the use of Yondelis.
- A search was carried out on published scientific and medical literature. It did not find strong evidence of a link between capillary leak syndrome and the use of Yondelis.
- There were international cases of capillary leak syndrome reported with the use of Yondelis. Health Canada reviewed 26 international case reports. The review showed that Yondelis played a possible role in 20 cases of capillary leak syndrome. It was difficult to determine how much of a role Yondelis played in the reported cases of capillary leak syndrome because other health conditions could have explained some of the reported medical problems.
- The literature review showed that capillary leak syndrome has been reported with other drugs, some of them being used to treat various cancers. Some of these cancer drugs are labelled for capillary leak syndrome in their product information. Capillary leak syndrome is listed in the European product information for Yondelis.
Conclusions and actions
- Health Canada's safety review concluded that there is a potential risk of capillary leak syndrome with the use of Yondelis.
- Health Canada is recommending updates to the Canadian product information to include the potential risk of capillary leak syndrome with the use of Yondelis.
- Health Canada continues to monitor side effect information involving Yondelis, 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 and when any new health risks are identified.
Additional information
The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.
For additional information, contact the Marketed Health Products Directorate.