Drugs
Information on Natalizumab (marketed as Tysabri)
Natalizumab is used to prevent episodes of symptoms and slow the worsening of disability in patients with relapsing forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Natalizumab is also used to treat and prevent episodes of symptoms in people who have Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) who have not been helped by other medications or who cannot take other medications. Natalizumab is in a class of medications called immunomodulators. It works by stopping certain cells of the immune system from reaching the brain and spinal cord and causing damage.
To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this sheet.
Related Information
FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
1/20/2012FDA Drug Safety Podcast for Healthcare Professionals: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
1/20/2012FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri
Press Release - 1/20/2012FDA Drug Safety Podcast for Healthcare Professionals: Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
4/26/2011FDA Drug Safety Communication: Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
4/22/2011FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML) with the use of Tysabri (natalizumab)
2/5/2010Tysabri (natalizumab): Update of Healthcare Professional Information
MedWatch 2/5/2010Information for Healthcare Professionals - Natalizumab Injection for Intraveneous Use (marketed as Tysabri) - (8/2008)
Issued 8/25/2008Information For Healthcare Professionals - Natalizumab Injection for Intraveneous Use (marketed as Tysabri) - (2/2006)
Issued 2/2006Risk Risk Minimization Plan: Summary of TOUCH (PDF - 55KB)Tysabri (natalizumab) Medication Guide 2012 (PDF - 63KB)FDA Approves Resumed Marketing of Tysabri Under a Special Distribution Program
Historical Information
FDA Statement On Tysabri Review Time
(3/24/2006)Questions and Answers on Tysabri (natalizumab) Regarding Lifting of the Clinical Hold
(2/15/2006)Natalizumab (marketed as Tysabri) Questions and Answers
(3/1/2005)Public Health Advisory - Suspended Marketing of Tysabri (natalizumab)
(2/28/2005)FDA Issues Public Health Advisory on Tysabri, a New Drug for MS
(2/28/2005)First Monoclonal Antibody Treatment For Multiple Sclerosis Approved
(11/23/2004)Approval Letter - Natalizumab (marketed as Tysabri) (11/23/2004) From Drugs@FDA (11/23/2004) Questions and Answers on Natalizumab
(11/23/2004)
Labeling and Regulatory History from Drugs@FDA
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