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10/21/10 4:03 PM

#106914 RE: DewDiligence #106913

TYSABRI (natalizumab) injection - Update 11/2009 - http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=15274

WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
See full prescribing information for complete boxed warning
---TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability (5.1)
---Monitor patients, and withhold TYSABRI immediately at the first sign or symptom suggestive of PML (4, 5.1)
---TYSABRI is available only through a special restricted distribution program called the TOUCH® Prescribing Program and must be administered only to patients enrolled in this program (5.1, 5.2)


This is from the Daily Med - http://dailymed.nlm.nih.gov/dailymed/about.cfm

DailyMed provides high quality information about marketed drugs. This information includes FDA labels (package inserts). This Web site provides health information providers and the public with a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling as found in medication package inserts. The National Library of Medicine (NLM) provides this as a public service and does not accept advertisements.