Alexion Pharmaceuticals

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Soliris®

Soliris® (eculizumab), is a first-in-class terminal complement inhibitor discovered, developed and commercialized by Alexion. Soliris is approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH)1, a progressive and life-threatening disease characterized by the excessive destruction of red blood cells (hemolysis).1,2,3 Soliris is the first and only therapy approved for the treatment of PNH to reduce hemolysis.

In the United States and European Union, Soliris is also approved for the treatment of patients with atypical hemolytic uremic syndrome (aHUS), an ultra-rare, life-threatening, genetic disease that can progressively damage vital organs, leading to stroke, heart attack, kidney failure and death.4,5 Soliris is the first and only therapy approved for the treatment of aHUS. Specifically, Soliris is indicated for the treatment of patients with aHUS to inhibit complement-mediated thrombotic microangiopathy, or TMA. The effectiveness of Soliris in aHUS is based on the effects on TMA and renal function. Prospective clinical trials in additional patients are ongoing to confirm the benefit of Soliris in patients with aHUS. Soliris is not indicated for the treatment of patients with Shiga toxin E coli-related hemolytic uremic syndrome (STEC-HUS).

Soliris works by selectively targeting and blocking the complement cascade—a normal part of the immune system that, when activated inappropriately, plays a role in serious diseases like PNH and aHUS. Soliris has earned some of the pharmaceutical industry’s highest honors for innovation, including the 2008 Prix Galien USA Award for Best Biotechnology Product with broad implications for future biomedical research and the 2009 Prix Galien France Award in the category of Drugs for Rare Diseases.

To learn more about Soliris, visit www.Soliris.net.



IMPORTANT SAFETY INFORMATION

The U.S. product label for Soliris includes a boxed warning:

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

See full prescribing information for complete boxed warning

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early (5.1).


  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with a meningococcal vaccine at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. (See Serious Meningococcal Infections (5.1) for additional guidance on the management of meningococcal infection.)
  • Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program (5.2). Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-soliris (1-888-765-4747).

The most frequently reported adverse reactions in the PNH randomized trial (≥ 10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea.

The most frequently reported adverse reactions in aHUS single arm prospective trials (≥ 15% combined per patient incidence) are: hypertension, upper respiratory tract infection, diarrhea, headache, anemia, vomiting, nausea, urinary tract infection, and leukopenia.

Please see full Prescribing Information and Important Safety Information for Soliris® (eculizumab).