Eculizumab — Drug Monograph

Brand names: Soliris

Drug class: Monoclonal Antibody

Mechanism of Action

Humanized monoclonal antibody that binds complement protein C5, preventing its cleavage into C5a and C5b and thereby blocking generation of the terminal complement membrane attack complex (C5b-9). In complement-mediated disorders such as atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH), this halts complement-driven endothelial injury, thrombotic microangiopathy, and intravascular hemolysis.

FDA Indications

• Atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy
• Paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis
• Generalized myasthenia gravis (anti-AChR antibody positive)
• Neuromyelitis optica spectrum disorder (anti-AQP4 antibody positive)

Common Side Effects

• Headache
• Hypertension
• Upper respiratory infection
• Nausea / diarrhea
• Fatigue
• Peripheral edema

Clinical Pearl

Eculizumab was the first terminal complement (C5) inhibitor and transformed the treatment of complement-mediated aHUS and PNH from supportive care to targeted disease control. The defining safety issue is a markedly increased risk of meningococcal disease — meningococcal vaccination (and often prophylactic antibiotics) is mandatory, and the drug is dispensed through a REMS program. It requires every-2-week IV dosing; ravulizumab is the longer-acting successor.

Related Therapies & Mechanisms

• Ravulizumab (Ultomiris) — Monoclonal Antibody · PNH
• Caplacizumab (Cablivi) — Monoclonal Antibody · Supportive Care
• Crovalimab (Piasky) — Monoclonal Antibody · PNH
• Pozelimab (Veopoz) — Monoclonal Antibody · Supportive Care