Summary Safety Review - GILENYA (fingolimod) - Assessing the Potential Risk of a Rare Brain Infection (Progressive Multifocal Leukoencephalopathy)

August 19, 2016

Product

Gilenya (fingolimod)

Potential Safety Issue

Rare brain infection (progressive multifocal leukoencephalopathy)

Key Messages

  • Gilenya (fingolimod) is used to treat multiple sclerosis, a disease of the nervous system. It is used in adult patients with a specific type of multiple sclerosis (relapsing-remitting) who do not respond well, or are unable to tolerate other (one or more) therapies for multiple sclerosis.
  • Health Canada carried out a safety review as a result of an international report of a rare brain infection (progressive multifocal leukoencephalopathy), in a patient taking Gilenya (fingolimod). This patient had no previous treatment with other multiple sclerosis drugs known to increase the risk of this brain infection.
  • Health Canada’s review concluded that from the available evidence, there was a possible link between progressive multifocal leukoencephalopathy and Gilenya (fingolimod).While this review was being carried out, the product information for Gilenya (fingolimod) was updated by the manufacturer to warn about this potential risk. Health Canada has requested the manufacturer to continue to monitor for this potential risk and provide Health Canada with any new information it becomes aware of on this safety issue.

Overview

Health Canada’s safety review was carried out as a result of an international report of a suspected progressive multifocal leukoencephalopathy (a rare brain infection) in a patient taking Gilenya for multiple sclerosis. This patient had no previous treatment with other multiple sclerosis drugs known to increase the risk of this brain infection. Multiple sclerosis is a potentially disabling disease of the brain and spinal cord (central nervous system).

During Health Canada’s safety review, the manufacturer updated the product information to reflect the risk of progressive multifocal leukoencephalopathy.

Progressive multifocal leukoencephalopathy is a rare brain infection caused by a virus (John Cunningham Virus). This infection can happen as a result of a weakened immune system, and is often fatal.

Use in Canada

  • Gilenya (fingolimod) is used for the treatment of adult patients with a specific type of multiple sclerosis (relapsing-remitting multiple sclerosis) who do not respond well, or are unable tolerate other (one or more) multiple sclerosis therapies.
  • Gilenya (fingolimod) has been marketed in Canada since 2011, but to date it is not widely used in Canada.

Safety Review Findings

  • At the time of the review, there were 4 international case reports of suspected progressive multifocal leukoencephalopathy linked to fingolimod use that happened to patients who had not used other multiple sclerosis drugs known to increase the risk of this brain infection before. There were no Canadian case reports.
  • Health Canada’s review showed a possible link between progressive multifocal leukoencephalopathy and Gilenya (fingolimod). However, some of the patients had other medical conditions or used drugs, which could also be linked with progressive multifocal leukoencephalopathy.
  • A search of the literature found some evidence of a link between progressive multifocal leukoencephalopathy and fingolimod use. However, more evidence was found on the risk of progressive multifocal leukoencephalopathy with other drugs used to treat multiple sclerosis.
  • The product information was updated by the manufacturer on September 15, 2015 to include new warnings of the potential risk of progressive multifocal leukoencephalopathy with Gilenya (fingolimod). Health Canada’s safety review did not identify any new safety concerns.

Conclusions and Actions

  • The safety review did not identify the need for further updates to the product information on the known potential risk of progressive multifocal leukoencephalopathy. The product information for Gilenya already warns of the potential risk of progressive multifocal leukoencephalopathy.
  • Health Canada has already shared information with Canadians on the potential risks of progressive multifocal leukoencephalopathy with Gilenya, and the changes to the product information. Footnote 1Footnote 2
  • Health Canada has requested the manufacturer to continue to provide information on this safety issue.
  • Health Canada will continue to monitor safety information involving Gilenya (fingolimod), 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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