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Tysabri (Natalizumab) injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNINGS AND PRECAUTIONS
5.1 Progressive Multifocal Leukoencephalopathy (PML)
- .....PML has been reported following discontinuation of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation. Patients should continue to be monitored for any new signs or symptoms that may be suggestive of PML for approximately six months following discontinuation of TYSABRI.
5.2 Distribution Program for TYSABRI
- bullet added ..... Complete an “Initial Discontinuation Questionnaire” when TYSABRI is discontinued and a “6-Month Discontinuation Questionnaire following discontinuation of TYSABRI.
17 PATIENT COUNSELING INFORMATION
17.2 Progressive Multifocal Leukoencephalopathy
- Instruct patients to continue to look for new signs and symptoms suggestive of PML for approximately 6 months following discontinuation of TYSABRI [see Warnings and Precautions (5.1)].
What is the most important information I should know about TYSABRI?
- If you take TYSABRI, and for 6 months after you stop taking TYSABRI, it is important that you call your doctor right away if you get any new or worsening medical problems.....