Serious Meningococcal Infections
Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. The use of Soliris increases a patient's susceptibility to serious meningococcal infections (septicemia and/or meningitis).Soliris is associated with an approximate 2,000-fold increased risk of meningococcal disease in comparison to the general U.S. population annual rate (0.14 per 100,000 population in 2015).
- Vaccinate for meningococcal disease according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations for patients with complementdeficiencies. Revaccinate patients in accordance with ACIP recommendations, considering the duration of Soliris therapy.
- Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If urgent Soliris therapy is indicated in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide patients with two weeks of antibacterial drug prophylaxis.
- Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.
Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS1-888-SOLIRIS (1-888-765-47471-888-765-4747 FREE) or at solirisrems.com.
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information