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

Important Safety Information

Is SOLIRIS right for me?

Alexion Pharmaceuticals is committed to patient safety and the appropriate use of SOLIRIS® (eculizumab).


Important Safety InformationBecause SOLIRIS blocks a part of the immune system, you may be at an increased risk for certain infections during SOLIRIS treatment. Your doctor will give you important safety information about SOLIRIS.

As a safety precaution, patients must be vaccinated against meningoccal infection at least 2 weeks before starting SOLIRIS. You will also be closely monitored for meningoccal infection while receiving SOLIRIS therapy.

 


Patient Safety Information Card

Your doctor or healthcare provider will provide you with a Patient Safety Information Card to carry with you at all times. This card will help you to recognize the early signs and symptoms of a potentially serious infection, including bacterial meningitis. You will need to seek medical care in the event that you 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 stiff 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

Call your doctor or seek emergency medical care right away if you have any of the symptoms listed above.

Patient Safety Information Card

Patient Safety Information Card
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Next: Clinical Studies

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.