Eculizumab: practical considerations
Eculizumab: Practical Considerations |
Before administration |
Meningococcal vaccination mandatory |
Tetravalent ACWY conjugated vaccine + multicomponent serogroup B vaccine |
Prophylaxis |
Long-term antibiotic prophylaxis recommended |
Administration |
Intravenous infusion |
Maintenance therapy is administered every 14 d |
Monitoring |
CH50 and AH50 <10% |
Eculizumab trough level 100 µg/ml |
Hematologic indicators of TMA |
Patient education |
Vigilance regarding meningococcal infection |
Counseling family members |
Genetic screening |
When to stop? |
Continue during intercurrent illness, unless infection with encapsulated organism, due to high risk of TMA relapse in this context |
Withdrawal |
Systematic investigation in clinical trials is being undertaken |
May be appropriate in some patientsa, with monitoring: liaise with specialist center |
This guidance is based on our practice in the United Kingdom, and the 2015 Kidney Disease: Improving Global Outcomes Controversies Conference consensus recommendations (6). Eculizumab (Soliris; Alexion Pharmaceuticals) is a recombinant humanized mAb that functionally blocks C5, and is approved by the US Food and Drug Administration and the European Medicines Agency for use in atypical hemolytic uremic syndrome. ACWY, meningococcal serotypes; CH50, total complement hemolytic activity; AH50, alternative pathway hemolytic activity; TMA, thrombotic microangiopathy; aHUS, atypical hemolytic uremic syndrome.
↵a For example, if there is no renal recovery after 6 months of treatment.