Natalizumab 300mg/15mL; soln for IV infusion after dilution; preservative-free.
Drugs in the Pipeline
Currently, the FDA-approved route of administration of Tysabri for MS is through intravenous infusion.
The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients treated with Tysabri (natalizumab, from Biogen Idec).
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.
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
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).
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.
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.
The FDA is warning healthcare providers of reported hepatic injury associated with Tysabri (natalizumab, from Biogen Idec).
Drug Monograph 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,…