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Tysabri

Tysabri

Tysabri, also known as Natalizumab, is a biological treatment originally approved in 2004 for Multiple Sclerosis (MS).[1] It has since received FDA approval for treatment of moderate to severe Crohn's disease (approved in 2008) for patients that have had inadequate response to typical therapies for Crohn's disease, including TNF-alpha inhibitors.[2][4]

Tysabri, is an integrin receptor antagonist produced by Elan Pharmaceuticals Inc., which is administered by infusion over 1 hour, every 4 weeks.[2]

Persons who receive Tysabri are at increased risk for getting PML - Progressive Multifocal Leukoencephalopathy , for which there is no cure.

Risk Factors for PML Increase With:
- Weakened Immune System (due to disease, genetics, or prior treatment withimmunosuppressant drugs)[2]
- Exposure to John Cunningham Virus (JCV) demonstrated by JCV antibodies[4]
- Long-term administration of Tysabri (especially more than 2 years)[4]

In patients with all 3 risk factors the risk of getting PML is 11 per 1,000 patients (11/1,000)[4]

External Links

- Patient Guide to Important Tysabri Information http://www.tysabri.com/en_US/tysb/si...I-medguide.pdf

- Official Website

References

1. Official Website for Tysabri http://www.tysabri.com

2. Full Prescribing Information.http://www.tysabri.com/en_US/tysb/si...TYSABRI-pi.pdf

3. Patient Information Sheet for Tysabri
http://www.tysabri.com/en_US/tysb/si...I-medguide.pdf

4. FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
http://www.fda.gov/Drugs/DrugSafety/ucm288186.htm

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