TYSABRI (natalizumab) - New Safety Information Regarding Progressive Multifocal Leukoencephalopathy (PML) - For Health Professionals

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Contact: Marketed Health Products Directorate

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This is duplicated text of a letter from Biogen Idec Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on TYSABRI (natalizumab)

May 12, 2010

Dear Health Care Professional,

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

Biogen Idec Canada Inc., in consultation with Health Canada, would like to inform you that updated safety information regarding the risk of PML in patients receiving TYSABRI^® (natalizumab) monotherapy is now included in the Canadian Product Monograph.

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.

PML is a rare, progressive, demyelinating disease of the central nervous system. It is caused by reactivation of the JC virus. PML can cause severe disability or death. The JC virus typically causes PML in immune compromised patients. There have been reported cases of PML in HIV-positive patients, immune suppressed cancer patients, transplantation patients and patients with autoimmune diseases.

In patients treated with TYSABRI for up to 3 years, the incidence of PML increases with longer treatment duration. As of December 31, 2009, approximately 64,600 patients were receiving TYSABRI worldwide. As of April 6, 2010, forty six (46) confirmed cases of PML had been reported. In patients treated for greater than 24 months in the post-marketing setting, the incidence rate of PML is 1.59 per 1000 (95% CI 1.11 - 2.21), compared to a rate of approximately 1 per 1000 in clinical trials. There is limited experience beyond 3 years of treatment, therefore the risk of PML in these patients cannot be reliably estimated.

The Product Monograph, Warnings and Precautions as well as the Consumer Information section have been updated to include this additional information regarding PML. Prescribers are reminded to inform patients about the risk of PML, and at 24 months of treatment to discuss again with the patient and/or caregiver that the risk of PML increases with longer treatment duration.

On a monthly basis, healthcare professionals will continue to have access to information regarding the number of cases of PML and PML incidence rates by contacting Biogen Idec Medical Information at 1-866-477-3462.

All patients who are prescribed TYSABRI are to be enrolled in the Tysabri Care Program™ (TCP), which is a registry of patients. The Tysabri Care Program is associated with the prescribing, administration and monitoring of patients who receive TYSABRI treatment. Through the TCP, prescribers and TCP healthcare professionals are provided information regarding the appropriate use of TYSABRI. This information is also being revised to include the information from the Product Monograph.

Managing marketed health product-related adverse reactions depends on healthcare professionals and consumers reporting them. Any case of serious or unexpected adverse reactions in patients receiving TYSABRI should be reported to the Tysabri Care Program™ or Health Canada at the following addresses:

Should you have any questions regarding TYSABRI^® or require a copy of the revised TYSABRI Product Monograph, please contact the Tysabri Care Program™ at 1-888-827-2827.

Sincerely,

original signed by

Len Walt, M.D., MBA
Medical Director