Fingolimod - Progressive Multifocal Leukoencephalopathy Cases Added to Product Labeling
August 5, 2015
One probable case of progressive multifocal leukoencephalopathy (PML), a rare brain infection, and one definite case of PML were reported in patients taking fingolimod (Gilenya™) for multiple sclerosis. These are the first two reports of PML following fingolimod therapy in patients not previously treated with any immunosuppressant agent. These cases are now described in the fingolimod product labeling and medication guide.
Progressive multifocal leukoencephalopathy is caused by the John Cunningham (JC) virus, and results in myelin damage in brain tissue. The disease may be fatal or cause disability. Patients with compromised immune function or who are taking immune compromising drugs are at increased risk for PML.
Patients are advised not to make any changes in therapy without first consulting their healthcare professionals. Patients are asked to contact their healthcare provider if they experience changes in balance, eyesight, strength, or thinking, or if they have increased issues with moving appendages. Evaluate a patient with these symptoms for PML, and instruct the patient to stop taking fingolimod.
Additional information is available at the following links:
- MedWatch Alert – August 2015
- FDA Drug Safety Communication – August 2015
- MedWatch Alert – August 2013
- FDA Drug Safety Communication – August 2013
August 5, 2015; September 4, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.