Summary Safety Review - YONDELIS (trabectedin) - Assessing the Potential Risk of Fluid Leakage from Small Blood Vessels (capillary leak syndrome)

August 4, 2016

Product

Yondelis (trabectedin)

Potential Safety Issue

Fluid leakage from small blood vessels (capillary leak syndrome)

Key Messages

  • Yondelis is used alone to treat some advanced soft tissue cancers, or together with another drug to treat ovarian cancer, when other treatments did not work.
  • This safety review was triggered by international reports of fluid leakage from small blood vessels (a rare but serious condition called capillary leak syndrome) in patients who used Yondelis. Health Canada carried out the review to look at the possible link between Yondelis and capillary leak syndrome, and to determine whether steps need to be taken to minimize the risk.
  • Health Canada’s safety review concluded that there is a potential risk of capillary leak syndrome with the use of Yondelis. Health Canada is therefore recommending updates to the Canadian product information for Yondelis to include this risk.

Overview

Health Canada carried out a safety review to look into the potential risk of capillary leak syndrome with the use of Yondelis. During routine monitoring, Health Canada became aware of international reports of capillary leak syndrome in patients who were treated with Yondelis.

Capillary leak syndrome is a rare but potentially life-threatening condition which involves the leakage of fluid from the small blood vessels into various parts of the body. This can cause sudden swelling, shortness of breath, passing less urine, and a drop in blood pressure. Patients with capillary leak syndrome require timely treatment to replace fluid in the body with saline based fluids through the veins, and manage their symptoms in order to improve their condition.

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.

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