Fatigue and Impaired Quality of Life Are Significant Consequences of Hemolysis in PNH Regardless of Transfusion Requirements1

Abdominal pain, fatigue, and other quality-of-life issues are commonly reported in PNH1

  • Severity of fatigue and impact on QoL can be independent of anemia/transfusion requirements1
  • 96% of patients report fatigue1
  • 59% of patients transfusion-free within a year1
  • 76% of patients forced to modify their daily activities due to their PNH 1
  • 17% of patients unemployed due to PNH1

57% of patients report abdominal pain1

  • Abdominal pain is associated with hemolysis2
  • Hemolysis causes nitric oxide consumption leading to vasoconstriction, smooth muscle contraction, and ischemia2,3
  • Severe abdominal pain in PNH can be associated with intestinal ischemia4,5
    • Marked elevation of D-dimers6
    • Electron microscopic findings of ischemia on biopsy4
    • Venous blockage identified by angiography or MRI7




IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

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

  • 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 withdrawal of anticoagulant therapy during Soliris treatment has not been established. Therefore, treatment with Soliris should not alter anticoagulant management.

The most frequent adverse events observed in clinical studies were headache, nasopharyngitis, back pain, nausea, and fatigue.

SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING INCLUDING WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS.

References: 1. Meyers G, Weitz I, Lamy T, et al. Disease-related symptoms reported across a broad population of patients with paroxysmal nocturnal hemoglobinuria [ASH abstract]. Blood. 2007;110: Abstract 3683. 2. Hill A, Rother RP, Hillmen P. Improvement in the symptoms of smooth muscle dystonia during eculizumab therapy in paroxysmal nocturnal hemoglobinuria. Haematologica. 2005;90(online):e111-e113. 3. Rother RP, Bell L, Hillmen P, Gladwin MT. The clinical sequelae of intravascular hemolysis and extracellular plasma hemoglobin: a novel mechanism of human disease. JAMA. 2005;293:1653-1662. 4. Adams T, Fleischer D, Marino G, Rusnock E, Li L. Gastrointestinal involvement in paroxysmal nocturnal hemoglobinuria: first report of electron microscopic findings. Dig Dis Sci. 2002;47:58-64. 5. Quentin V, Dinasquet M, Rioux-Leclercq N, et al. Hémoglobinurie paroxystique nocturne avec ischémie digestive compliquée de perforation de l’intestin grêle [Paroxysmal nocturnal hemoglobinuria associated with intestinal ischemia leading to small bowel perforation]. Gastroenterol Clin Biol. 2003;27:927-931. 6. Weitz IC, Ghods M, Rochanda L, et al. Eculizumab therapy results in rapid and sustained decreases in markers of thrombin generation and inflammation in patients with PNH [ASH abstract]. Blood. 2008;112: Abstract 407. 7. Khoshini R, Garrett B, Sial S, Eysselein VE. The role of radiologic studies in the diagnosis of mesenteric ischemia. Medscape Gen Med. 2004;6(1):23. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1140698. Published January 6, 2004. Accessed July 14, 2009. 8. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L. Discovery and development of the complement inhibitor eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria. Nat Biotechnol. 2007;25:1256-1264.

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