SOLIRIS (eculizumab): The first treatment specifically approved for PNH

For US Healthcare Professionals

Flow Cytometry in PNH Diagnosis

Flow cytometry is more sensitive, specific, and quantitative for PNH than other complement sensitivity measures, including the Ham, sucrose lysis, and complement lysis sensitivity tests.

Flow cytometry is the gold standard for diagnosis of PNH, following full clinical assessment.1

Flow cytometry is the laboratory standard for confirming the diagnosis of PNH.1,2 Performed on peripheral blood, flow cytometry establishes PNH by

  • Quantifying cells that are missing key GPI-anchored surface proteins (GPI-AP)
     
  • Providing information about the size of the PNH clone1,2
    • PNH clone size, which refers to the proportion of GPI-AP deficient cells, may be associated with the severity of clinical symptoms1
  • Both granulocytes and erythrocytes should be tested3
     
  • Granulocytes provide the best estimate of PNH clone size since they are not affected by complement-mediated hemolysis or by red cell transfusions1,3

Considerations for flow cytometry3,5

Flow Cytometry in PNH Diagnosis

Flow cytometry, in conjunction with a full clinical assessment, should be used to confirm suspicion of PNH.

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IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTION

SOLIRIS® increases the risk of meningococcal infections.

Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of SOLIRIS; revaccinate according to current medication 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.

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

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

Please see important safety information (including boxed warning) as well as the complete prescribing information.

References:
1. Rosse WF, Hillmen P, Schrieber AD. Immune-mediated hemolytic anemia. Hematology. (Am Soc Hematol Educ Program) January 2004:48-62.
2. Luzzatto L, Gianfaldoni G. Recent advances in biological and clinical aspects of paroxysmal nocturnal hemoglobinuria. Int J Hematol. 2006;84:104-112.
3. Parker C, Omine M, Richards S, et al. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005;106:3699-3709.
4. Hall SE, Rosse WF. The use of monoclonal antibodies and flow cytometry in the diagnosis of paroxysmal nocturnal hemoglobinuria. Blood. 1996;87:5332-5340.
5. Krauss JS. Laboratory diagnosis of paroxysmal nocturnal hemoglobinuria. Ann Clin Lab Sci. 2003;33:401-406.
6. Richards SJ, Rawstron AC, Hillmen P. Application of flow cytometry to the diagnosis of paroxysmal nocturnal hemoglobinuria. Comm Clin Cytometry. 2000;42:223-233.