Monday, February 23, 2009

Updated Safety Information regarding Progressive Multifocal Leukoencephalopathy (PML) associated with TYSABRI® (natalizumab)

From Health Canada:
Biogen Idec Canada Inc., in consultation with Health Canada, would like to inform you that previously communicated safety information regarding post-marketing reports of PML in patients receiving TYSABRI® (natalizumab) monotherapy is now included in the Canadian Product Monograph. PML is a known risk of TYSABRI therapy.

TYSABRI is a humanized monoclonal antibody and is currently authorized as monotherapy (i.e. single disease-modifying agent) for the treatment of patients with relapsing-remitting multiple sclerosis (MS) to reduce the frequency of clinical exacerbations, to decrease the number and volume of active brain lesions identified on magnetic resonance imaging (MRI) scans and to delay the progression of physical disability.
For health care professionals
For the public

No comments: