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 nearly 50 countries worldwide, including the United States (US), European Union (EU), and Japan.
PNH is a debilitating blood disorder in which chronic, uncontrolled activation of complement, a component of the normal immune system, results in hemolysis (destruction of red blood cells), leading to blood clots, organ failure and shortened survival.
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 (blockage of a blood vessel by a blood clot) and chronic kidney disease (CKD).
Treating Patients Who Have PNH with Soliris
Data from numerous 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. With the availability of Soliris, the outlook for patients has changed dramatically: In the initial PNH registration trials, 100 percent of patients had an objective response to Soliris, and long-term data published by independent investigators from patients treated with Soliris for up to eight years showed improved survival rates similar to normal healthy individuals matched for their age and gender.
To learn more about PNH, visit www.PNHSource.com. To learn more about treatment with Soliris, visit www.Soliris.net.
Click here to view full prescribing information for Soliris.
IMPORTANT SAFETY INFORMATION
THE U.S. PRODUCT LABEL FOR SOLIRIS INCLUDES A BOXED WARNING
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
See full prescribing information for the 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).
In a randomized, placebo-controlled clinical study of Soliris in patients with PNH, the most frequently reported adverse reactions (≥ 10% overall and greater than placebo) were headache, nasopharyngitis (inflammation of the nasal passages and upper pharynx), back pain, and nausea.
In two prospective, single-arm studies of Soliris in patients with aHUS, the most frequently reported adverse reactions (≥ 15% combined per patient incidence) were hypertension (high blood pressure), upper respiratory tract infection, diarrhea, headache, anemia, vomiting, nausea, urinary tract infection, and leukopenia (abnormally low white blood cell count).