Information Update - MS drug Gilenya (fingolimod): Safety information on the risk of skin cancer and a rare brain infection
Health Canada is informing Canadians that the drug label (product monograph) for the multiple sclerosis drug Gilenya (fingolimod) has been updated with new safety information on the risk of skin cancer, as well as a rare brain infection known as progressive multifocal leukoencephalopathy (PML).
Gilenya is a prescription drug used in the treatment of relapsing-remitting multiple sclerosis (MS) to reduce the frequency of attacks (relapses) and delay the progression of physical disability. It is specifically used when other MS treatments have not been effective or cannot be tolerated.
Gilenya works by modifying the body's immune system and reducing the access of certain immune cells (white blood cells known as lymphocytes) to the brain and spinal cord, which may reduce the damage that happens in these areas in MS and the frequency of MS relapses. A Health Canada safety review found that Gilenya, like other drugs that suppress the immune system, may increase the risk of lymphomas (lymphocyte cancer) and other cancers, particularly of the skin.
Medicines that suppress the immune system are also known to reduce the body's ability to fight infections. Cases of PML, a rare infection caused by the John Cunningham (JC) virus, have been reported with Gilenya use – including in patients who were not currently taking and had not previously taken other medications that suppress or change the immune system. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems. In severe cases, it can lead to disability or death.
Gilenya labelling already contained information on the possible risk of lymphoma, and warnings about how this drug reduces the body's ability to fight infection. It has been updated to include the risk of skin cancer and PML specifically, and to advise that patients and health professionals be vigilant for symptoms.
What you should do:
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SOURCE Health Canada
For further information: Media Inquiries: Health Canada, (613) 957-2983; Public Inquiries: (613) 957-2991, 1-866 225-0709
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