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

For US Healthcare Professionals

Long-Term Patient Safety

Help optimize long-term patient safety

As part of the SOLIRIS® Guardian Program, all SOLIRIS® (eculizumab) patients receive a Patient Safety Information Card that should be carried with them at all times. This card helps identify the first signs and symptoms of a serious infection (including bacterial meningitis) and encourages patients to seek medical care in the event that they feel ill and experience any of the following symptoms:

  • Moderate to severe headache with nausea or vomiting
  • Moderate to severe headache and a fever
  • Moderate to severe headache with a stiff neck or back
  • Fever of 103°F (39.4°C) or higher
  • Fever and a rash
  • Confusion
  • Severe muscle aches with flu-like symptoms, and eyes sensitive to light

Patients should contact their healthcare provider if they have questions or experience any of the symptoms noted above.

Next: Discontinuation

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.