About Soliris®

Discovered, developed and marketed exclusively by Alexion, Soliris® (eculizumab) is the first and only approved medication that blocks complement and reduces hemolysis in patients with PNH.23 Clinical studies have found that Soliris improves the symptoms and reduces the major health problems associated with PNH.18,19,24

In clinical trials submitted to the U.S. Food and Drug Administration and other regulatory agencies worldwide, patients who received Soliris experienced a number of benefits, including:

  • Immediate and sustained reduction in chronic hemolysis in all patients18,19
  • Fewer thrombotic events (blood clots) as compared to the same time period prior to starting Soliris24
  • Significant improvements in fatigue levels and overall quality of life18,19
  • Significant reduction in the need for transfusions19

Alexion researchers and independent physicians continue to learn more about PNH and its treatment through ongoing clinical experience and clinical studies.

Soliris is available in more than a dozen countries, including the United States, Germany, the United Kingdom, France, Italy and Spain. In early 2009, regulatory authorities in Australia and Canada approved Soliris for the treatment of patients with PNH, and Alexion submitted an application for approval of Soliris in Japan. Soliris is designated an orphan drug in the United States, European Union and other territories.

“Soliris directly targets the underlying disease process responsible for debilitating symptoms that may contribute to shortened life spans of PNH patients. Having cared for more than 300 patients with PNH over my career, I believe this is the most important advance that has been made in the treatment of this disease. Treatment with Soliris markedly decreases the hemolysis responsible for anemia, fatigue, poor patient functioning and blood clots in PNH patients.”

Wendell F. Rosse, M.D.
Florence McAlister Professor of Medicine Emeritus
Duke University


Hear more from Dr. Rosse at PNHSource.com.



IMPORTANT SAFETY INFORMATION

Soliris increases the risk of meningococcal infections. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early

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 medical 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 anticoagulant withdrawal during Soliris treatment has not been studied. Therefore, treatment with Soliris should not alter anticoagulant management.

Soliris is generally well tolerated. The most frequent adverse events observed in clinical studies were headache, a runny nose (nasopharyngitis), back pain, nausea, and tiredness (fatigue).