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

About SOLIRIS

How do I know if SOLIRIS is right for me?

SOLIRIS® (eculizumab) is the first and only medication that is FDA approved specifically to treat PNH.

SOLIRIS treats the underlying cause of the signs and symptoms of PNH (chronic hemolysis). In clinical trials, patients who were treated with SOLIRIS experienced the following benefits:

  • Significant reduction in red blood cell destruction (chronic hemolysis). This reduction in hemolysis began in the first week and was sustained over the long term
     
  • Significant improvements in anemia, including the complete elimination of the need for transfusions or a significant reduction in the number of transfusions required
     
  • Marked improvements in fatigue
     
  • Significant impact on overall quality of life
     
  • Fewer blood clots with SOLIRIS treatment as compared to the same period of time prior to treatment
SOLIRIS is generally well tolerated.

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

Because SOLIRIS blocks part of your immune system, you may be at an increased risk for certain infections during SOLIRIS treatment. You will need to have all recommended immunizations and vaccines before you start treatment with SOLIRIS. Your doctor will give you important safety information about SOLIRIS.

SOLIRIS is generally well tolerated. The most common side effects are headache, runny nose, back pain, and nausea.

Next: How does SOLIRIS work?


IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTION

SOLIRIS® increases the risk of meningococcal infections.

Patients should be vaccinated with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of SOLIRIS. Revaccinate according to current medical guidelines for vaccine use.

Patients should be monitored closely for early signs of meningococcal infections and evaluated immediately if infection is suspected, and treated 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.