Risk of meningococcal infection in patients receiving eculizumab

Risk of meningococcal infection in patients receiving eculizumab

All adverse events in patients receiving Eculizumab must be reported both through the Yellow Card scheme, to Alexion Pharma UK Ltd and the National aHUS service.

Details of treatment associated adverse events other than menigococcal disease are available at https://www.medicines.org.uk/EMC/medicine/19966/SPC/Soliris/.

The greatest known risk to patients receiving Eculizumab is meningococcal infection.

Summary of Recommendations

  • 1) All patients receiving eculizumab should be vaccinated with both a tetravalent A, C, W and Y conjugated vaccine and the multi component serogroup B vaccine Bexsero. In addition we recommend that all patients should receive prophylactic antibiotics as soon as they start eculizumab which they should remain on as long as they are on Eculizumab (and for 8 weeks following cessation). We would recommend two weeks of Ciprofloxacin 500mg bd followed by long-term prophylactic penicillin (Pencillin V) or erythromycin (if penicillin allergic).
  • 2) Antibody titres should be tested at 4-6 weeks post-vaccination. A serum sample should be sent to the Manchester Medical Microbiology Partnership for meningococcal A, B*, C, W and Y serum bactericidal antibody. Local microbiology laboratories will be able to organise this. [NB For patients under the shared care of the National aHUS Service, this following form can be used]. Patients with a sub-optimal response should be re-vaccinated.

*Eculizumab interferes with measurement of B titres as it relies on a complement haemolytic assay. As a result, measurement of anti-B titres cannot be interpreted once eculizumab has been commenced. Measurement of B titres in a patient receiving eculizumab is not helpful and is therefore not required. However, in patients not currently on eculizumab such as those patients awaiting eculizumab pre-emptively ahead of renal transplantation, measurement of B titres should be performed as part of the post-vaccination protocol.

  • 3) No further vaccination should be given if a sub-optimal response is seen after 2 doses of vaccine.
  • 4) In responders antibody titres should be measured at yearly intervals following initial vaccination and revaccinated if titres fall.
  • 5) Patients should continue with prophylactic antibiotics whilst on Eculizumab. 6) Patients with aHUS should be vaccinated when they are listed for transplantation and antibody titres checked at 4-6 weeks post-vaccination.

Full guidelines on the prevention of meningococcal disease in aHUS patients receiving eculizumab are available for adult/children