ResoundingHealth
Search
  
Basic Drug Info
Drug Name:TYSABRI
Manufacturer:Biogen Idec or Elan
Other Info:

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



Clinical Trials:


Indications and Usage

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-?.
Multiple Sclerosis -- An autoimmune disorder mainly affecting young adults and characterized by destruction of myelin in the central nervous system. Pathologic findings include multiple sharply demarcated areas of demyelination throughout the white matter of the central nervous system. Clinical manifestations include visual loss, extra-ocular movement disorders, paresthesias, loss of sensation, weakness, dysarthria, spasticity, ataxia, and bladder dysfunction. The usual pattern is one of recurrent attacks followed by partial recovery (see MULTIPLE SCLEROSIS, RELAPSING-REMITTING), but acute fulminating and chronic progressive forms (see MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE) also occur. (Adams et al., Principles of Neurology, 6th ed, p903)

Physical disability --

Crohn's disease -- A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients.

Regional enteritis -- Inflammation of the intestines, but usually only of the small intestine. Regional enteritis increases the risk for developing colon cancer. Also called Crohn's disease.

Inflammation -- A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.

Contraindications

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)].
Leukoencephalopathy, Progressive Multifocal -- An opportunistic viral infection of the central nervous system associated with conditions that impair cell-mediated immunity (e.g., ACQUIRED IMMUNODEFICIENCY SYNDROME and other IMMUNOLOGIC DEFICIENCY SYNDROMES; HEMATOLOGIC NEOPLASMS; IMMUNOSUPPRESSION; and COLLAGEN DISEASES). The causative organism is JC Polyomavirus (JC VIRUS) which primarily affects oligodendrocytes, resulting in multiple areas of demyelination. Clinical manifestations include DEMENTIA; ATAXIA; visual disturbances; and other focal neurologic deficits, generally progressing to a vegetative state within 6 months. (From Joynt, Clinical Neurology, 1996, Ch26, pp36-7)

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Urticaria -- A vascular reaction of the skin characterized by erythema and wheal formation due to localized increase of vascular permeability. The causative mechanism may be allergy, infection, or stress.


This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.