|Manufacturer:||Biogen Idec or Elan|
Inform patients that TYSABRI may cause liver injury.
Instruct the patient to contact their doctor if they develop symptoms of hepatoxicity [see Warnings and Precautions (5.5)].I61061-5 TYSABRI (natalizumab)Manufactured by:Biogen Idec Inc.14 Cambridge Center Cambridge, MA 02142 USA1-800-456-2255Distributed by:Elan Pharmaceuticals, Inc.
South San Francisco, CA 94080© 2008 Biogen Idec Inc.
All rights reserved.TYSABRI® is a registered trademark of Elan Pharmaceuticals, Inc.AVONEX® is a registered trademark of Biogen Idec TOUCH™ is a trademark of Elan Pharmaceuticals, Inc.U.S.Patent Numbers: 5,840,299, 6,033,665, 6,602,503, 5,168,062, 5,385,839, 5,730,978
TYSABRI is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) (1.1)As monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations.TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate MS therapy.Crohn's Disease (CD) (1.2)Inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate conventional CD therapies and inhibitors of TNF-?.Important Limitations:In CD, TYSABRI should not be used in combination with immunosuppressants or inhibitors of TNF-?.
TYSABRI is contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML) [see Boxed Warning, Warnings and Precautions (5.1)].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 (5.3)].