Tysabri

Product manufactured by Biogen Inc.

Application Nr Approved Date Route Status External Links
BLA125104 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tysabri Is An Integrin Receptor Antagonist Indicated For Treatment Of: Multiple Sclerosis (Ms) Tysabri Is Indicated As Monotherapy For The Treatment Of Relapsing Forms Of Multiple Sclerosis, To Include Clinically Isolated Syndrome, Relapsing-Remitting Disease, And Active Secondary Progressive Disease, In Adults. Tysabri Increases The Risk Of Pml [See Warnings And Precautions ( 5.1 ) ]. When Initiating And Continuing Treatment With Tysabri, Physicians Should Consider Whether The Expected Benefit Of Tysabri Is Sufficient To Offset This Risk. ( 1.1 ) Crohn's Disease (Cd) Tysabri Is Indicated For 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-Α. ( 1.2 ) Important Limitations: In Cd, Tysabri Should Not Be Used In Combination With Immunosuppressants Or Inhibitors Of Tnf-Α. ( 1.2 ) 1.1 Multiple Sclerosis (Ms) Tysabri Is Indicated As Monotherapy For The Treatment Of Relapsing Forms Of Multiple Sclerosis, To Include Clinically Isolated Syndrome, Relapsing-Remitting Disease, And Active Secondary Progressive Disease, In Adults. Tysabri Increases The Risk Of Pml [ See Warnings And Precautions ( 5.1 ) ]. When Initiating And Continuing Treatment With Tysabri, Physicians Should Consider Whether The Expected Benefit Of Tysabri Is Sufficient To Offset This Risk. 1.2 Crohn's Disease (Cd) Tysabri Is Indicated For 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-Α. Tysabri Should Not Be Used In Combination With Immunosuppressants (E.g., 6-Mercaptopurine, Azathioprine, Cyclosporine, Or Methotrexate) Or Inhibitors Of Tnf-Α [ See Warnings And Precautions ( 5.1 ) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Natalizumab

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