Risk Evaluation and Mitigation Strategies (REMS) Summary

Goals of the Tysabri (natalizumab) Intravenous Injection REMS Program

The goals of the TYSABRI REMS are:

1. To inform prescribers, infusion center healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy (PML) associated with TYSABRI including the increased risk of PML with longer treatment duration, prior immunosuppressant use and the presence of anti-JCV antibodies.

2. To warn against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents, and in patients who are immunocompromised.

3. To promote early diagnosis of PML and timely discontinuation of TYSABRI in the event of suspected PML.

REMS Elements

• Medication Guide

• Elements to Assure Safe Use

• Implementation System

Open the Full REMS Notification

REMS Summary of Terms