SOLIRIS (eculizumab): The first treatment specifically approved for PNH

For US Healthcare Professionals

Safety

SOLIRIS and commitment to your patient's safety

Alexion Pharmaceuticals is committed to your patient's safety and the appropriate use of SOLIRIS® (eculizumab). The SOLIRIS® Guardian Program provides education and support to all healthcare providers and patients during all phases of treatment, with specific emphasis on

Safety
  • The need to vaccinate all patients against Neisseria meningitidis at least 2 weeks prior to initiating SOLIRIS therapy
     
  • Minimizing patient risk for meningococcal infection by ensuring that patients know how to recognize the early signs and symptoms of potentially serious infections during treatment
     
  • Providing guidance on how to safely manage treatment discontinuations

Next: Vaccine Requirement

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTION

SOLIRIS® increases the risk of meningococcal infections.

Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of SOLIRIS; revaccinate according to current medication guidelines for vaccine use.

Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary.

The effect of withdrawal of anticoagulant therapy during SOLIRIS treatment has not been established. Therefore, treatment with SOLIRIS should not alter anticoagulant management.

SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING INCLUDING WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS.

The most frequent adverse events observed in clinical studies were headache, nasopharyngitis, back pain, nausea, fatigue, and cough.

Please see important safety information (including boxed warning) as well as the complete prescribing information.

References:
1. SOLIRIS® prescribing information. Alexion Pharmaceuticals, Inc. 2007.
2. Bilukha OO, Rosenstein N, for the National Center of Infectious Diseases. Centers for Disease Control and Prevention (CDD). Prevention and control of meningococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2005;54:1-21.