Eculizumab

Products

Eculizumab is commercially available as a concentrate for the preparation of an infusion solution (Soliris). It was approved in many countries in January 2010.

Structure and Properties

Eculizumab is a monoclonal antibody produced by recombinant DNA technology in NSO cell lines. It is composed of two heavy and two light chains of amino acids and has a molecular weight of approximately 148 kDa.

Effects

Eculizumab (ATC L04AA25) binds to complement protein C5, inhibiting terminal activation of the complement system. It thus prevents red blood cell dissolution by complement.

Indications

For the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). Experimental off-label treatment with eculizumab (Soliris) has been reported in severe cases of hemolytic uremic syndrome secondary to EHEC infection (e.g., Lapeyraque et al., 2011; Gruppo et al., 2009). However, there is no official regulatory approval for this indication.

Dosage

According to the SmPC. Eculizumab is administered as an infusion.

Contraindications

  • Hypersensitivity
  • Patients with an infection that has not healed with
  • Patients without current vaccination protection against
  • Hereditary complement defects

Full precautions can be found in the drug label.

Interactions

Drug-drug interactions are not known.

Adverse effects

The most common possible adverse effects include headache, dizziness, nausea, and fever.