Early Diagnosis Drives Effective PNH Management
If any of these conditions are evident in your patients, they should be screened for PNH1*
- Bone marrow disorders such as aplastic anemia (AA) and myelodysplastic syndromes (MDS). Patients should be screened at diagnosis and annually
- Many patients with AA or MDS go on to develop PNH
- The presence of even very small PNH clones in patients with AA or MDS may be predictive of response to immunosuppressive therapy2,3
- Unexplained venous or arterial thromboses (e.g., transient ischemic attack [TIA]) in typical (e.g., DVT) or atypical sites
- Hemolysis in the presence of anemia, fatigue, smooth muscle dystonia (dysphagia, abdominal pain, dyspnea, erectile dysfunction), unexplained visceral pain, hemoglobinuria, or Coombs-negative hemolysis
- End organ damage with hemolysis4-8
- Renal insufficiency
- Liver disease
PNH is a heterogeneous disease that presents uniquely in each patient. No one sign or symptom provides a diagnosis of PNH
- Appropriate clinical assessment of the patient, along with lab results, provides a more complete diagnostic picture
- Patient assessments are essential to identify the presence or absence of symptoms and establish the burden of disease for an individual patient
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.
*Adapted from Parker, et al.
References: 1. 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.
2. Sugimori C, Chuhjo T, Feng X, et al. Minor population of CD55–CD59– blood cells predicts response to immunosuppressive therapy and prognosis in patients with aplastic anemia. Blood. 2006;107:1308-1314.
3. Wang H, Chuhjo T, Yasue S, Omine M, Nakao S. Clinical significance of a minor population of paroxysmal nocturnal hemoglobinuria–type cells in bone marrow failure syndrome. Blood. 2002;100:3897-3902.
4. Hillmen P, Lewis SM, Bessler M, Luzzatto L, Dacie JV. Natural history of paroxysmal nocturnal hemoglobinuria. N Engl J Med. 1995;333:1253-1258.
5. Socié G, Mary J-Y, de Gramont A, et al, for the French Society of Haematology. Paroxysmal nocturnal haemoglobinuria: long-term follow-up and prognostic factors. Lancet. 1996;348:573-577.
6. Nishimura J-I, Kanakura Y, Ware RE, et al. Clinical course and flow cytometric analysis of paroxysmal nocturnal hemoglobinuria in the United States and Japan. Medicine. 2004;83:193-207.
7. FDA approves first-of-its-kind drug to treat rare blood disorder [press release]. Washington DC: Food and Drug Administration; March 16, 2007.
8. Hill A, Richards SJ, Hillmen P. Recent developments in the understanding and management of paroxysmal nocturnal haemoglobinuria. Br J Haematol. 2007;137:181-192.