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
• Medication Guide
• Elements to Assure Safe Use