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

For US Healthcare Professionals

Vaccine Requirement

Patients receiving SOLIRIS must be vaccinated against Neisseria meningitidis1,2

  • A meningococcal vaccination must be administered to all patients at least 2 weeks prior to the first dose of SOLIRIS® (eculizumab)1
     
  • Do not initiate SOLIRIS therapy in patients with unresolved Neisseria meningitidis infection or who are not currently vaccinated against Neisseria meningitidis
     
  • Currently available vaccines protect against four serotypes: A, C, Y, and W135. There have been 2 vaccinated patients who have developed meningococcal infections. In both cases, infection was due to Neisseria meningitidis serotypes other than those covered by the available vaccines.

Next: Long-Term Patient Safety

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.