Progressive Multifocal Leukoencephalopathy
JC virus infection resulting in progressive multifocal leukoencephalopathy (PML), which can be
fatal, was observed in patients treated with GAZYVA. Consider the diagnosis of PML in any
patient presenting with new onset or changes to pre-existing neurologic manifestations.
Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI,
and lumbar puncture. Discontinue GAZYVA therapy and consider discontinuation or reduction
of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML