Section 07 · Monograph
Eculizumab-aagh
Reviewed Nov 2026FDA label
EpysqliComplement C5 inhibitor (biosimilar)
- Forms
- IV: 300mg/30mL (10mg/mL)
- Dose
- gMG: 900mg IV weekly x4, 1200mg at week 5, then 1200mg every 2 weeks (same as Soliris); REMS
- MOA
- Blocks C5 cleavage, prevents membrane attack complex
Black Box Warning
- Serious meningococcal infections: life-threatening and fatal infections have occurred — complete or update meningococcal vaccination at least 2 weeks before the first dose unless risks of delay outweigh risks; monitor for early signs and evaluate immediately; available only through a restricted REMS program
Indications
- Paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)FDA-labeled
- Generalized myasthenia gravis in adults who are anti-AChR antibody positive (indication added after initial approval)FDA-labeled
Mechanism of Action
- Humanized monoclonal antibody that binds complement protein C5, blocking its cleavage and formation of the terminal complement complex C5b-9
Full Dosing
Adult / usual
- gMG: 900mg IV weekly for 4 weeks, then 1200mg at week 5, then 1200mg every 2 weeks
- Biosimilar to Soliris with the same dosing; supplemental dose may be needed after plasmapheresis or IVIG
- Confirm current approved indications in the label (NMOSD may not be included)
Contraindications
- Unresolved serious Neisseria meningitidis infection
- Patients not currently vaccinated against N. meningitidis unless the risks of delaying outweigh the infection risk
Drug Interactions
- Neonatal Fc receptor blockers may lower eculizumab exposure and reduce effectiveness
- Plasma exchange and IVIG remove drug — supplemental dosing needed
Adverse Effects
- Serious meningococcal and other encapsulated-organism infections
- Headache, nasopharyngitis, back pain
- Infusion reactions
Monitoring Parameters
- Meningococcal signs and symptoms; vaccination status
- Infusion reactions
- Disease manifestations after discontinuation
Pregnancy & Lactation
- Limited data; IgG crosses the placenta — use if benefit justifies risk
- Unknown whether present in human milk