Summary Safety Review - YERVOY (ipilimumab) - Assessing the Potential Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

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: 2016-04-22

Product

Yervoy (ipilimumab)

Potential Safety Issue

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Key Messages

  • Yervoy is a drug that is used to treat malignant melanoma (a type of skin cancer) that has spread or that cannot be removed by surgery.
  • This safety review was triggered when Health Canada identified a possible risk of DRESS with Yervoy treatment, during the routine review of published case reports.
  • Health Canada's safety review concluded that there is a potential risk of DRESS with Yervoy. Therefore, Health Canada worked with the manufacturer to update the Canadian prescribing information for Yervoy to include more details about this potential safety issue.

Overview

Health Canada carried out a safety review to look into the potential risk of DRESS with the use of Yervoy. This issue was found during the review of published case reports. The review also looked at new safety information that was requested from the manufacturer.

DRESS describes a group of rare but serious and potentially life-threatening adverse reactions to medications, such as fever, severe skin rash with swollen face or peeling of the skin over large areas of the body, etc. These reactions usually occur two weeks to two months after starting a medication.

Use in Canada

  • Yervoy is used to treat adult patients with malignant melanoma that has spread or that cannot be removed by surgery.
  • Yervoy has been sold in Canada since 2012. It is available by prescription only.
  • Yervoy is sold as a liquid in a 5 mg/mL strength and is given intravenously in a hospital or clinic under medical supervision.

Safety Review Findings

  • At the time of the review, there were no Canadian case reports of DRESS with the use of Yervoy.
  • A search in the World Health Organization's Adverse Drug Reaction Database found 3 reports of DRESS with the use of Yervoy.
  • The manufacturer shared a report from the Global Safety Database which contained cases of DRESS that were possibly caused by Yervoy. As the review of these cases was complicated by various factors, a link between Yervoy and DRESS could not be established or ruled out.

Conclusions and actions

  • Based on the information reviewed, Health Canada concluded that there may be a link between Yervoy and DRESS. Yervoy affects the immune system of the patient in a way which may increase the chances for DRESS to develop.
  • The Canadian prescribing information for Yervoy has been updated to include this potential risk.
  • Health Canada continues to monitor side effect information involving Yervoy, 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.

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