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

• Soliris Risk Evaluation and Mitigation Strategy (REMS) Site

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.

Diseases for which it is used

• Paroxysmal nocturnal hemoglobinuria (PNH)
• Atypical hemolytic-uremic syndrome (aHUS)

Patient drug information

• Eculizumab (Soliris) package insert pages 7-8
• Brief patient counseling information can be found on page 6 of the package insert
• Eculizumab (Soliris) patient drug information (Chemocare)
• Eculizumab (Soliris) patient drug information (UpToDate)

History of changes in FDA indication

• 3/16/2007: Initial FDA approval for "the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis."
• 9/23/2011: Additional indication for "the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy."