Patients on Soliris® Saw Rapid, Clinically Meaningful Improvements in Fatigue1
- Improvements in fatigue began in the induction phase and were maintained over the long term2,3
- Fatigue in PNH is often disproportionate to the nominal hemoglobin level; fatigue is also due to hemolysis independent of hemoglobin level1,4,5
- In the SHEPHERD study, 78% of patients achieved clinically meaningful improvements in fatigue3
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. Hillmen P, Young NS, Schubert J, et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006;355:1233-1243. 2. Socié G, Hillmen P, Muus P, et al. Sustained improvements in transfusion requirements, fatigue and thrombosis with eculizumab treatment in paroxysmal nocturnal hemoglobinuria [ASH abstract]. Blood. 2007;110: Abstract 3672. 3. Brodsky RA, Young NS, Antonioli E, et al. Multicenter phase 3 study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobinuria. Blood. 2008;111:1840-1847. 4. Hill A, Muus P, Dührsen U, et al. Improvement in fatigue with eculizumab treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) occurs independent of changes in anemia [abstract]. Haematologica. 2008;93(suppl 1):359. Abstract 0903. 5. Brodsky RA. Paroxysmal nocturnal hemoglobinuria. In: Hoffman R, Benz EJ Jr, Shattil SJ, et al, eds. Hematology: Basic Principles and Practice. 4th ed. Philadelphia, PA: Elsevier Churchill Livingstone; 2005:419-427. 6. Parker C, Omine M, Richards S, et al; for International PNH Interest Group. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005;106:3699-3709.