SOLIRIS
ECULIZUMAB
What it does
Eculizumab is a medicine used to treat certain serious blood disorders by helping the body manage its immune response.
Commonly used for: paroxysmal nocturnal hemoglobinuria (PNH), aHUS (atypical hemolytic uremic syndrome), neuromyelitis optica spectrum disorder (NMOSD)
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Sourcing - Kenya onlyRegistration & product details
Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:30:28 · updated 2026-10-21 04:02:22
About this medicine
Eculizumab is a medicine used to treat certain serious blood disorders by helping the body manage its immune response.
What it treats
- paroxysmal nocturnal hemoglobinuria (PNH)
- aHUS (atypical hemolytic uremic syndrome)
- neuromyelitis optica spectrum disorder (NMOSD)
How it works
It works by blocking a part of the immune system that can cause damage to the blood cells and organs.
Who it's for
This medicine is for people with specific blood conditions that affect their red blood cells and kidneys.
AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.
Clinical monograph: Eculizumab
BNF-referencedEculizumab is a recombinant monoclonal antibody that specifically inhibits terminal complement activation by binding to the C5 protein. This action reduces complement-mediated cell damage and is especially beneficial in conditions characterized by excessive complement activation, such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It is administered via intravenous infusion and is indicated for patients who need to control hemolysis and associated complications.
Indications
- Paroxysmal nocturnal hemoglobinuria
- Atypical hemolytic uremic syndrome
Dosage
Children: Refer to the BNF for Children for specific dosing information as it may vary based on the child's condition and weight.
Adults: For paroxysmal nocturnal hemoglobinuria, the initial dose is 600 mg administered intravenously once a week for the first 4 weeks, followed by a maintenance dose of 900 mg administered once every 2 weeks.
Mechanism of action
Eculizumab binds to the C5 protein in the complement system, inhibiting its cleavage into C5a and C5b. This prevents the formation of the membrane attack complex (MAC), which is responsible for cell lysis. By inhibiting terminal complement activation, eculizumab effectively reduces the inflammatory and hemolytic processes associated with diseases like PNH and aHUS.
Pharmacodynamics
The pharmacodynamic effects of eculizumab are mainly related to its immunosuppressive properties. By inhibiting the complement system, it decreases the levels of hemolysis, reduces the risk of thrombosis, and mitigates organ damage caused by complement-mediated inflammation. Patients may experience a reduction in symptoms associated with these conditions, including fatigue and hemoglobinuria.
Pharmacokinetics
Eculizumab has a half-life of approximately 11 to 15 days, allowing for biweekly or monthly dosing regimens depending on the indication. It is primarily eliminated through the reticuloendothelial system, and its pharmacokinetics may vary in patients with renal impairment or those on concurrent immunosuppressive therapy. The drug's clearance may be affected by the presence of anti-drug antibodies in some patients.
Contra-indications
- Patients unvaccinated against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae
- Unresolved infection caused by encapsulated bacteria
Adverse effects
- Asthenia
- Diarrhoea
- Dizziness
- Epistaxis
- Fever
- Gastrointestinal discomfort
- Headache
- Increased risk of infection
- Myalgia
- Nausea
- Pain
- Sepsis
- Skin reactions
- Thrombocytopenia
Precautions
- Patients must be closely monitored for at least 8 weeks after treatment discontinuation
- Vaccination against serious infection recommended at least 2 weeks prior to treatment
Pregnancy
Avoid-toxicity in animal studies.
Breast-feeding
Avoid-no information available.
Storage
Store in a refrigerator (2–8 °C) and protect from light.
Formulations
- Solution for infusion (Aspaveli 1080mg/20ml)
AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.