Therapy Expectations

In US clinical trials, Soliris® reduced chronic hemolysis in every treated patient, including those with bone marrow disorders such as aplastic anemia (AA) or myelodysplastic syndromes (MDS). Other benefits occurred in the following time frames:

Important things to consider

Soliris is an ongoing therapy. Since PNH is a chronic disease, patients who start Soliris should continue receiving Soliris, even if they feel better.2 If for some reason you and your doctor determine to stop Soliris therapy, only your doctor can safely manage taking you off the drug.

You may have other conditions besides PNH. People with PNH may have other medical conditions that affect the function of their bone marrow such as aplastic anemia (AA) or myelodysplastic syndromes (MDS). These diseases may reduce the production of blood cells and further complicate PNH.5 If you have PNH in combination with AA or MDS, talk to your doctor — it’s important to effectively treat all the conditions you may have.

Considerations while on Soliris

It is important to understand that some medications you are taking, specifically blood thinners, should not be changed without consulting your doctor. Please make sure your doctor knows about all the medications you are taking.





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 anticoagulant withdrawal during Soliris treatment has not been studied. Therefore, treatment with Soliris should not alter anticoagulant management.

Soliris is generally well tolerated. The most frequent adverse events observed in clinical studies were headache, a runny nose (nasopharyngitis), back pain, nausea, and tiredness (fatigue).

Please see full prescribing information for SOLIRIS, including boxed WARNING regarding serious meningitis.


References: 1. 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. 2. Soliris® [package insert]. Cheshire, CT: Alexion Pharmaceuticals Inc; 2008. 3. Hillmen P, Young NS, Schubert J, et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006;355:1233-1243. 4. 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. 5. Parker C, Omine M, Richards S, et al, for the International PNH Interest Group. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005;106:3699-3709.