Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 10/23/17

Soliris (eculizumab) Injection REMS

Goals of the Soliris (eculizumab) Injection REMS Program

The goals of the REMS are:

• To mitigate the occurrence and morbidity associated with meningococcal infections

• To educate Healthcare Professionals (HCPs) and Patients regarding:

      - the increased risk of meningococcal infections with Soliris

      - the early signs of invasive meningococcal infections, and

      - the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections

REMS Elements

• Medication Guide

• Elements to Assure Safe Use

REMS Summary of Terms