Summary Safety Review - GILENYA (fingolimod) - Assessing the Risk of the Abnormal Tissue Growth (Cancer)

October 19, 2016


Gilenya (fingolimod)

Potential Safety Issue

Abnormal tissue growth (cancer)

Key Messages

  • Gilenya (fingolimod) is used to treat multiple sclerosis, a condition that leads to the damage of the nervous system, causing physical disability. It is specifically used in patients who have had a poor response to, or are unable to tolerate one or more other therapies for multiple sclerosis.
  • Health Canada first carried out a safety review in 2014, to assess the risk of abnormal tissue growth, and requested more information from the manufacturer. This review is a follow-up assessment of the data provided by the manufacturer.
  • The current review concluded that the current product labelling appropriately describes the risks linked with the use of Gilenya and that Health Canada should continue to conduct annual assessments of abnormal tissue growth (cancer), particularly those related to skin as associated with Gilenya (fingolimod).


A safety review was completed to look into a potential link between Gilenya (fingolimod) and abnormal tissue growth (cancer). When a cancer forms a mass, it can commonly be referred to as a tumor. Tumors can be further divided into those that are cancerous (malignant) and those that are non-cancerous (benign).

This follow-up safety review assessed the data provided by the manufacturer in response to Health Canada’s request following the first safety review conducted in 2014.

Use in Canada

  • Gilenya is a medicine used to treat multiple sclerosis to reduce the frequency of signs and symptoms of multiple sclerosis and delay the progression of physical disability.
  • Gilenya is recommended in patients who have had a poor response to, or are unable to tolerate one or more other therapies for multiple sclerosis.
  • Gilenya was first marketed in Canada in March 2011.

Safety Review Findings

  • The updated data reviewed indicated that there has been some additional cases of skin cancer reported but at this point the frequency does not appear to be increased. This has been previously observed and included in the product label.
  • Patients receiving medicines that suppress the immune system, like Gilenya, are known to have increased risk for the development of abnormal tissue growth (cancer). Product information for these drugs typically mentions this risk.
  • Product information for Gilenya includes information about the risk of cancer, especially skin cancers. It also recommends to check for suspicious skin lesions before starting treatment and regularly during treatment with Gilenya, and to promptly evaluate any such lesions. This information can be found in the Warnings and Precautions, Adverse Reactions and Consumer Information sections of the product information for Gilenya.

Conclusions and Actions

  • Health Canada's current safety review concluded that the previous actions including labelling changes and annual assessments of information pertaining to abnormal tissue growth (cancer) associated with the use of Gilenya remains appropriate given the information reviewed.
  • Health Canada will continue to monitor safety information involving Gilenya, 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

There have been a Summary Safety Review Footnote 1 and 2 risk communications related to skin cancer issued by Health Canada: an Information UpdateFootnote 2 and an Info Watch article in the Health product InfowatchFootnote 3.

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