Alerts
Natalizumab (Tysabri) Monotherapy and Progressive Multifocal Leukoencephalopathy - UPDATE
September 22, 2009
Thirteen reports of progressive multifocal leukoencephalopathy (PML) have been reported in patients receiving natalizumab monotherapy for multiple sclerosis (MS) worldwide. The data suggests that PML incidence may increase with the number of natalizumab infusions. To date, none of the reported cases of PML have included patients using natalizumab for Crohn disease. PML is a viral infection of the central nervous system, mainly seen in immunosuppressed patients. Symptoms of PML include decreased mental function, speech difficulty, partial blindness, and difficulty walking. Natalizumab injection (Tysabri) is a monoclonal antibody approved for the treatment of relapsing MS and Crohn disease. Natalizumab is only available to patients through the TOUCH Prescribing Program. Risk for PML is considered to be higher in patients receiving concurrent immunomodulators with natalizumab compared to natalizumab monotherapy.
No changes in natalizumab prescribing information regarding PML are required by the FDA at this time. Closely monitor patients for symptoms of PML and discontinue natalizumab if PML is suspected.
Additional information can be found through the following links:
- FDA Medwatch Alert (9/2009):
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182667.htm - Information for Healthcare Providers (9/2009):
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107198.htm - FDA Medwatch Alert (8/2008):
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm110599.htm - Information for Healthcare Providers (8/2008):
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126592.htm
Updated
September 22, 2009; August 25, 2008; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
