Summary Safety Review - PERJETA (pertuzumab) - Assessing the Potential Risk of Stevens-Johnson Syndrome

April 4, 2016

Product

Perjeta (pertuzumab)

Potential Safety Issue

Stevens-Johnson Syndrome (serious condition of the skin and mucous membranes)

Key Messages

  • Perjeta (pertuzumab), in combination with two other drugs, is used to treat breast cancer that has spread to other parts of the body.
  • This safety review was triggered when Health Canada identified a possible risk of Stevens-Johnson Syndrome with Perjeta treatment, during the routine review of information received from the manufacturer.
  • Health Canada’s review concluded that the evidence was too limited to support a link between the use of Perjeta and the risk of Stevens-Johnson Syndrome. Health Canada has therefore asked the manufacturer to continue monitoring for this risk worldwide and to report new cases of this issue.

Overview

Health Canada carried out a safety review to look into the potential risk of Stevens-Johnson Syndrome with the use of Perjeta. This issue was found during a routine review of information received from the manufacturer.

Stevens-Johnson Syndrome is a rare but serious and potentially life-threatening reaction. It involves blistering or peeling of large areas of skin and mucous linings.

Use in Canada

  • Perjeta, in combination with other treatments, is used to treat patients with breast cancer that has spread to other parts of the body.
  • Perjeta has been sold in Canada since May 2013. It is available by prescription only.
  • Perjeta is sold as an intravenous solution in a 30 mg/mL strength.

Safety Review Findings

  • At the time of the review, there were no Canadian reports of Stevens-Johnson Syndrome with the use of Perjeta.
  • This safety review looked at 2 international reports of Stevens-Johnson Syndrome with the use of Perjeta that were submitted by the manufacturer. The review of these reports was limited by factors such as missing information and the possible role of other medications taken by the patient.
  • A search of the scientific literature did not find any reports of Stevens-Johnson Syndrome with the use of Perjeta.
  • Information regarding the risk of Stevens-Johnson Syndrome is already included in the Canadian prescribing information for one of the two other drugs that are used in combination with Perjeta.

Conclusions and Actions

  • Health Canada’s review concluded that the evidence was too limited to support a link between the use of Perjeta and the risk of Stevens-Johnson Syndrome.
  • Health Canada has asked the manufacturer to continue to actively monitor for this risk worldwide and to report new cases of Stevens-Johnson Syndrome to Health Canada.
  • Health Canada will continue to monitor side effect information involving Perjeta, 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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