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

For US Healthcare Professionals

Fewer Thrombotic Events

Approximately 40% of PNH patients experience a thrombotic event1

There were fewer thrombotic events with SOLIRIS than prior to treatment

Fewer Thrombotic Events

  • All SOLIRIS® (eculizumab)-treated patients were enrolled in a long-term open label extension study2
     
  • Fewer thrombotic events occurred with SOLIRIS treatment than during the same period of time prior to treatment2
    • Patients served as their own control; thrombotic events were compared to matched time periods pre-treatment vs during the treatment period

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

Next: 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. Hillmen P, Lewis SM, Bessler M, Luzzatto L, Dacie JV. Natural history of paroxysmal nocturnal hemoglobinuria. N Engl J Med. 1995;333:1253-1258.
2. SOLIRIS® prescribing information. Alexion Pharmaceuticals, Inc. 2007.