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

For US Healthcare Professionals

Discontinuation

Discontinuing SOLIRIS therapy

Patients who discontinue SOLIRIS® (eculizumab) should be monitored for signs and symptoms of serious hemolysis1 which may include

  • Greater than 25% absolute decrease in PNH clone size (in the absence of dilution due to transfusion) in 1 week or less
     
  • A hemoglobin level <5gm/dL or a decrease >4 gm/dL in 1 week or less
     
  • Angina
     
  • Change in mental status
     
  • 50% increase in serum creatinine level
     
  • Thrombosis

Patients who discontinue SOLIRIS should be monitored for at least 8 weeks.

  • In clinical studies of 196 patients, 16 patients discontinued treatment with SOLIRIS and serious hemolysis was not observed

Next: Dosing and Administration

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.