September 25, 2016
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Crohn's Disease (cont.)

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Natalizumab (Tysabri)

Natalizumab (Tysabri) is a humanized monoclonal antibody to alpha-4 integrin and is effective in treatment of patients with moderate to severe CD and evidence of inflammation who have not responded to aminosalicylates, antibiotics, corticosteroids, immunomodulators, or TNF inhibitors. This medication targets the cellular adhesion molecule alpha-4 integrin, which is expressed on leukocytes or white blood cells which are known to play a role in the pathogenesis of Crohn's disease7. Physicians who are registered through the CD TOUCH prescribing program may prescribe this medication to patients. Natalizumab was approved by the Food and Drug Administration in 2008 for this use, but has been used prior to this time for some forms of multiple sclerosis.

The recommended dose of Tysabri is 300mg IV infusion over 1 hour every four weeks. It should not be used with concomitant immunosuppressants or TNF-alpha inhibitors.

Side Effects of natalizumab (Tysabri)

The most common adverse effects reported have been headache, fatigue, upper respiratory infections, and nausea. The most serious adverse events reported have been hypersensitivity, immunosuppression/infections and progressive multifocal leukoencephalopathy.7

Progressive multifocal leukoencephalopathy (PML) has developed in patients treated with natalizumab. PML is caused by reactivation of a latent virus, the human JV polyoma virus, which can lead to infection of the CNS that is typically fatal. Infectious complications with other organisms may also be increased. This medication usually is well tolerated, but has been associated with acute hypersensitivity infusion reactions. Patients might also develop anti-natalizumab antibodies and liver toxicity.

All patients started on this drug must be monitored through the TOUCH program whose purpose is to monitor patients for signs and symptoms of PML and to assess the incidence of opportunistic infections.

Medically Reviewed by a Doctor on 11/4/2015


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