"Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat"...
Safety of doses higher than 300 mg has not been adequately evaluated. The maximum amount of TYSABRI that can be safely administered has not been determined.
- TYSABRI is contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML) [see WARNINGS AND PRECAUTIONS].
- TYSABRI should not be administered to a patient who has had a hypersensitivity reaction to TYSABRI. Observed reactions range from urticaria to anaphylaxis [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 12/30/2013
This monograph has been modified to include the generic and brand name in many instances.
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