Genentech has updated the labeling of Rituxan (rituximab) to report a fatal case of progressive multifocal leukoencephalopathy (PML) in a rheumatoid arthritis (RA) patient. While reports of PML in patients with hematologic malignancies and autoimmune diseases appear in Rituxan’s prescribing information, this is the first reported case of PML in an RA patient. Healthcare providers should consider PML in any Rituxan-treated patient presenting with new onset neurologic manifestations and Rituxan should be discontinued if PML is confirmed.
Rituxan is indicated for the treatment of Non-Hodgkin’s Lymphoma (NHL) and in combination with methotrexate for moderate-to-severe RA in adults.
For more information call (800) 821-8590 or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm094994.htm.