Eculizumab (Soliris)

General information

Class/mechanism: Complement inhibitor; monoclonal antibody that binds to complement protein C5, preventing its cleavage to C5a and C5b and the formation of the terminal complement complex C5b-9. Eculizumab is used in diseases involving abnormal complement-mediated activity, such as paroxysmal nocturnal hemoglobinuria (PNH) and complement-mediated thrombotic microangiopathy (TMA) in patients with atypical hemolytic uremic syndrome (aHUS).
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.

Toxicity management

• Soliris Risk Evaluation and Mitigation Strategy (REMS) Site

Diseases for which it is established (work in progress)

• Atypical hemolytic uremic syndrome
• Paroxysmal nocturnal hemoglobinuria

Diseases for which it is used

• Cold agglutinin disease

Patient drug information

• Eculizumab (Soliris) package insert
• Eculizumab (Soliris) patient drug information (Chemocare)
• Eculizumab (Soliris) patient drug information (UpToDate)

History of changes in FDA indication

• 2007-03-16: Initial approval for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. (Based on SHEPHERD & TRIUMPH)
• 2011-09-23: Additional indication for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. (Based on C08-002, C08-003, C10-004)

History of changes in EMA indication

• 2007-06-20: Initial authorization

History of changes in PMDA indication

• 2013-09-13: New additional indication and a new dosage for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Also known as

• Brand name: Soliris