Alexion Pharmaceuticals

Soliris^® and PNH

Soliris^® (eculizumab) is the first and only therapy specifically tested and approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare, life-threatening blood disorder. Soliris has been approved for the treatment of patients with PNH in more than 35 countries worldwide.

About PNH

PNH is a debilitating, ultra-rare and life-threatening blood disorder defined by chronic, uncontrolled complement activation which causes the chronic destruction of red blood cells (hemolysis), leading to blood clots, organ failure and shortened survival.^2,3,6,7

Historically, up to 35% of patients with PNH treated with best supportive care have died within five years of diagnosis due to serious clinical outcomes such as thromboembolism (TE) and chronic kidney disease (CKD).³

Treating PNH with Soliris

Extensive clinical trials show that Soliris significantly reduces hemolysis in patients with PNH, leading to an improvement in symptoms and a reduction in major health problems associated with the disease.^9,10 For information on recently Published studies see References.

More Information

To learn more about PNH, visit www.PNHSource.com. To learn more about treatment with 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).