Formulary
Eculizumab: Indications, Dosing, Side Effects and Interactions
Eculizumab is a recombinant monoclonal antibody that inhibits terminal complement activation at the C5 protein and thereby reduces complement-mediated cell...
MedNext Academy | 5 min read
Eculizumab: Indications, Dosing, Side Effects and Interactions
Eculizumab is a recombinant monoclonal antibody that inhibits terminal complement activation at the C5 protein and thereby reduces complement-mediated cell...
Drug action
Eculizumab is a recombinant monoclonal antibody that inhibits terminal complement activation at the C5 protein and thereby reduces complement-mediated cell damage.
Indications and dose
**Paroxysmal nocturnal haemoglobinuria (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 600 mg once weekly for 4 weeks, then increased to 900 mg once weekly for 1 week, followed by maintenance 900 mg every 12-16 days.
**Atypical haemolytic uraemic syndrome (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 900 mg once weekly for 4 weeks, then increased to 1.2 g once weekly for 1 week, followed by maintenance 1.2 g every 12-16 days.
**Myasthenia gravis (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 900 mg once weekly for 4 weeks, then increased to 1.2 g once weekly for 1 week, followed by maintenance 1.2 g every 12-16 days, consider discontinuation if no response within 12 weeks after initial infusion.
**Neuromyelitis optica spectrum disorder (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 900 mg once weekly for 4 weeks, then increased to 1.2 g once weekly for 1 week, followed by maintenance 1.2 g every 12-16 days.
**Paroxysmal nocturnal haemoglobinuria (under expert supervision) for eculizumab**
- **Child (body-weight 5-9 kg)** (By intravenous infusion): Initially 300 mg once weekly for 2 weeks, followed by maintenance 300 mg every 3 weeks.
- **Child (body-weight 10-19 kg)** (By intravenous infusion): Initially 600 mg once weekly for 1 week, then reduced to 300 mg once weekly for 1 week, followed by maintenance 300 mg every 2 weeks.
- **Child (body-weight 20-29 kg)** (By intravenous infusion): Initially 600 mg once weekly for 3 weeks, followed by maintenance 600 mg every 2 weeks.
- **Child (body-weight 30-39 kg)** (By intravenous infusion): Initially 600 mg once weekly for 2 weeks, then increased to 900 mg once weekly for 1 week, followed by maintenance 900 mg every 2 weeks.
- **Child (body-weight 40 kg and above)** (By intravenous infusion): Initially 600 mg once weekly for 4 weeks, then increased to 900 mg once weekly for 1 week, followed by maintenance 900 mg every 12-16 days.
**Atypical haemolytic uraemic syndrome (under expert supervision) for eculizumab**
- **Child (body-weight 5-9 kg)** (By intravenous infusion): Initially 300 mg once weekly for 2 weeks, followed by maintenance 300 mg every 3 weeks.
- **Child (body-weight 10-19 kg)** (By intravenous infusion): Initially 600 mg once weekly for 1 week, then reduced to 300 mg once weekly for 1 week, followed by maintenance 300 mg every 2 weeks.
- **Child (body-weight 20-29 kg)** (By intravenous infusion): Initially 600 mg once weekly for 3 weeks, followed by maintenance 600 mg every 2 weeks.
- **Child (body-weight 30-39 kg)** (By intravenous infusion): Initially 600 mg once weekly for 2 weeks, then increased to 900 mg once weekly for 1 week, followed by maintenance 900 mg every 2 weeks.
- **Child (body-weight 40 kg and above)** (By intravenous infusion): Initially 900 mg once weekly for 4 weeks, then increased to 1.2 g once weekly for 1 week, followed by maintenance 1.2 g every 12-16 days.
Cautions
Active systemic infection Cautions, further information Meningococcal infection Manufacturer advises vaccinate against Neisseria meningitidis at least 2 weeks before treatment (vaccines against serotypes A, C, Y, W135 and B where available, are recommended); revaccinate according to current medical guidelines. Patients receiving eculizumab less than 2 weeks after receiving meningococcal vaccine must be given prophylactic antibiotics until 2 weeks after vaccination. Advise patient to report promptly any signs of meningococcal infection. Other immunisations should also be up to date.
Contraindications
Patients unvaccinated against Neisseria meningitidis ; unresolved Neisseria meningitidis infection
Side effects
Common or very common Alopecia; asthenia; cough; decreased leucocytes; diarrhoea; dizziness; fever; gastrointestinal discomfort; headache; hypertension; increased risk of infection; influenza like illness; joint disorders; muscle complaints; nausea; oropharyngeal pain; skin reactions; sleep disorders; taste altered; vomiting Uncommon Abscess; anxiety; appetite decreased; chest discomfort; chills; constipation; cystitis; depression; dysuria; haemorrhage; hepatosplenic abscess; hot flush; hyperhidrosis; hypersensitivity; hypotension; infusion related reaction; limb abscess; meningitis meningococcal; mood swings; nasal complaints; oedema; pain; palpitations; paraesthesia; renal abscess; sepsis; spontaneous penile erection; throat irritation; tinnitus; tremor; vascular disorders; vertigo; vision blurred Rare or very rare Abnormal clotting factor; conjunctival irritation; feeling hot; gastrooesophageal reflux disease; gingival discomfort; Grave's disease; jaundice; malignant melanoma; menstrual disorder; syncope; urogenital tract gonococcal infection
Interactions
**Other interactions (6):**
- Based on the potential inhibitory effect of eculizumab on complement-dependent cytotoxicity of rituximab, eculizumab may reduce the expected pharmacodynamic effects of rituximab.
- Plasma exchange (PE), plasmapheresis (PP), fresh frozen plasma infusion (PI) and intravenous immunoglobulin (IVIg) have been shown to reduce eculizumab serum levels.
- A supplemental dose of eculizumab is required in these settings.
- Concomitant use of eculizumab with intravenous immunoglobulin (IVIg) may reduce effectiveness of eculizumab.
- Closely monitor for reduced effectiveness of eculizumab.
- Concomitant use of eculizumab with neonatal Fc receptor (FcRn) blockers may lower systemic exposures and reduce effectiveness of eculizumab.
Pregnancy
Manufacturer advises use only if potential benefit outweighs risk-limited information available. Eculizumab is an immunoglobulin G (IgG) monoclonal antibody; human IgG antibodies are known to cross the placenta.
Breast feeding
Manufacturer advises use with caution-limited information available; unlikely to be present in milk.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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