Drug Monograph
TYSABRI
Natalizumab 300mg/15mL; soln for IV infusion after dilution; preservative-free.
Your search for tysabri returned 17 results
Drugs in the Pipeline
FDA Denies Approval of Tysabri for Subcutaneous Administration
Currently, the FDA-approved route of administration of Tysabri for MS is through intravenous infusion.
Uncategorized
FDA warns of progressive multifocal leukoencephalopathy (PML) risk with Tysabri
The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients treated with Tysabri (natalizumab, from Biogen Idec).
News
Tysabri gains Crohn’s disease indication
The FDA has approved the use of Tysabri (natalizumab, from Biogen Idec) for the treatment of moderate-to-severe Crohn's disease in patients with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies.
Uncategorized
RECALL: Tysabri Labeling Updated with New Progressive Multifocal Leukoencephalopathy Information
The FDA has updated the Tysabri (natalizumab; Biogen Idec) labeling to provide new information about the size of the risk of progressive multifocal leukoencephalopathy (PML) associated with use of Tysabri for the treatment of multiple sclerosis and Crohn's disease.
Drugs in the Pipeline
Phase 3 Study of Tysabri for Secondary-Progressive Multiple Sclerosis
Biogen Idec and Elan announced a global Phase 3b study, ASCEND, that is being conducted to evaluate the effectiveness of Tysabri (natalizumab) as a treatment for secondary-progressive multiple sclerosis (SPMS).
Uncategorized
Tysabri labeling to include safety information on risk of progressive multifocal leukoencephalopathy
The FDA has notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri (natalizumab, from Biogen Idec) infusions received.
News
Tysabri Labeling to Include Anti-JCV Antibody Status as PML Risk Factor; Stratify JCV Antibody ELISA Test Approved
The FDA has approved a labeling change for Tysabri (natalizumab; Biogen Idec) that identifies anti-JCV antibody status as a risk factor for progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri for the treatment of multiple sclerosis (MS) or Crohn's disease.
Uncategorized
FDA issues Tysabri warning
The FDA is warning healthcare providers of reported hepatic injury associated with Tysabri (natalizumab, from Biogen Idec).
Drug Monograph Updates
October 2019 Recap of Drug Updates
The summary below gives an overview of important additions and changes MPR has made to its drug database through the end of October. The chart below provides highlights of key monograph updates made this month (not an inclusive list). Click on the name of the drugs to view the full monographs on eMPR.com. Key: D=Dosing,…
