Eculizumab is considered to be present in a therapeutic level in aHUS if the trough serum concentration is >99 µg/mL (Legendre CM et al, NEJM 2013), and in PNH if the serum concentration is >35 µg/mL (Hillmen P et al, NEJM 2004).
Interpretive Data
The eculizumab level (free anti-C5) is a measurement of the serum level of eculizumab (Soliris®, Alexion Pharmaceuticals), a humanized IgG4 monoclonal antibody directed against the complement protein C5. By binding to C5, eculizumab prevents cleavage of C5 to its active fragments C5a and C5b, thereby preventing formation of C5b-9 and halting the process of complement-mediated cell destruction.
Adequate dosage and dosing interval of eculizumab results in a complete blockade of activation of the terminal complement pathway. If a patient is not being adequately dosed with eculizumab, breakthrough activation of the complement system and subsequently disease reactivation may occur. Along with clinical markers of disease activity and other laboratory measures of terminal complement pathway activity (such as CH50, C5a, and sC5b-9), the eculizumab level may be used to guide therapeutic decision making as to adequate dosage and dosing interval.
CPT Codes
80299
Collection
Collect
2.0 mL Red No Gel
Minimum Collection Volume
1 mL blood or 0.5 mL serum
Unacceptable Conditions
Non-frozen samples
Storage/Transport Temperature
Serum sample should be kept frozen. Transport on dry ice.
Critical Frozen
Serum must be frozen at -70 degrees
Specimen Preparation
For trough level, please collect sample 30 minutes prior to next dose
Eculizumab is considered to be present in a therapeutic level in aHUS if the trough serum concentration is >99 µg/mL (Legendre CM et al, NEJM 2013), and in PNH if the serum concentration is >35 µg/mL (Hillmen P et al, NEJM 2004).
Interpretive Data
The eculizumab level (free anti-C5) is a measurement of the serum level of eculizumab (Soliris®, Alexion Pharmaceuticals), a humanized IgG4 monoclonal antibody directed against the complement protein C5. By binding to C5, eculizumab prevents cleavage of C5 to its active fragments C5a and C5b, thereby preventing formation of C5b-9 and halting the process of complement-mediated cell destruction.
Adequate dosage and dosing interval of eculizumab results in a complete blockade of activation of the terminal complement pathway. If a patient is not being adequately dosed with eculizumab, breakthrough activation of the complement system and subsequently disease reactivation may occur. Along with clinical markers of disease activity and other laboratory measures of terminal complement pathway activity (such as CH50, C5a, and sC5b-9), the eculizumab level may be used to guide therapeutic decision making as to adequate dosage and dosing interval.
