Page 80 - Heart Transplant Protocol

Heart Function Service: Heart Transplant Protocols

Protocols for the Administration of Eculizumab (Soliris®)

Description:
Eculizumab is a recombinant humanized monoclonal antibody that binds to the complement
protein C5 and inhibits the formation of the terminal complement complex C5b-9.

Indication:
Treatment of nocturnal hemoglobinuria (PNH) and off-label treatment of Antibody Mediated
Rejection.

Vaccination prior to treatment:
Patient who have received eculizumab are at increased risk for infections from encapsulated
bacteria. Serious Meningococcal infection has been reported and meningococcal vaccine
(Menactra & Bexsero) should be administered at least 2 weeks prior to eculizumab treatment.
Patient should have Pneumococcal and Haemophilus B influenza vaccine response checked and
revaccinate or prophylaxis accordingly. However in our patient population vaccination is often
not possible and then appropriate antibiotic prophylaxis should be given during eculizumab
treatment and for three months afterwards.

Labs for Vaccine response:
# 0050542 Haemophilus influenza b Antibody, IgG
# 2005779 Streptococcus pneumoniae Antibodies, IgG (23 Serotypes)
# 2001603 Neisseria meningitides Tetravalent Antibodies (Serogroups A, C, W-135 and Y), IgG
Please order all testing as “miscellaneous send out” tests. There is testing for S. pneumoniae
IgG built in EPIC, but it is to measure the immune response against other vaccines, not the 23-
serovalent vaccine

Dose:

Weight Induction Maintenance
5 - <10 kg 300mg weekly x 1 300mg Wk2; 300mg Q3wks
10 - <20 kg 600mg weekly x 1 300mg Wk2; 300mg Q2wks
20 - <30 kg 600mg weekly x 2 600mg Wk3; 600mg Q2wks
30 - <40 kg 600mg weekly x 2 900mg Wk3; 900mg Q2wks
≥40 kg 900mg weekly x 4 1200mg Wk5; 1200mg Q2wks

1. Please contact pharmacy when you are considering Eculizumab to start the insurance
process.
2. Please contact Soliris at 1-888-765-4747 to enroll both the physician and the patient in
the REMS program.
3. A medical staff from Soliris will contact the registered attending to formulate a
treatment plan for the patient. So the drug will be released to the pharmacy.
Infectious Disease Prophylaxis: Pneumococcal, meningococcal and PJP prophylaxis should be initiated
if patient do not have adequate response to vaccine.

Administration:
Infuse over 1-4 hours in pediatric patient; decrease infusion rate or discontinue for infusion
reactions.

Updated November 9, 2017 80