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FDA Date: 10/23/2017
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