Serious Meningococcal Infections

Eculizumab increases the risk of serious and life-threatening infections caused by Neisseria meningitidis.

• Complete or update meningococcal vaccination at least 2 weeks prior to the first dose of eculizumab, unless the risks of delaying eculizumab outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor. (5.1)
• Patients receiving eculizumab are at increased risk for invasive disease caused by N. meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of meningococcal infections, and evaluate immediately if infection is suspected. (5.1)

SOLIRIS is available only through a restricted program called the ULTOMIRIS and SOLIRIS REMS. (5.2) 

BKEMV is available only through a restricted program called BKEMV REMS. (5.2)