Products
Ravulizumab was approved in the United States in 2018, in the EU in 2019, and in many countries in 2020 as a concentrate for the preparation of an infusion solution (Ultomiris).
Structure and properties
Ravulizumab is an IgG2/4K monoclonal antibody produced by biotechnological methods.
Effects
Ravulizumab (ATC L04AA43) binds to complement protein C5, inhibiting its cleavage. It preserves the early components of complement activation, which are essential for opsonization of microorganisms and elimination of immune complexes.
Indications
For the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).
Dosage
According to the SmPC. The drug is administered as an intravenous infusion.
Contraindications
- Hypersensitivity
- Patients with unresolved infection with Neisseria meningitidis at the start of treatment.
- Patients without current vaccine protection against Neisseria meningitidis, unless they receive appropriate antibiotic prophylaxis for up to two weeks after vaccination.
Full precautions can be found in the drug label.
Interactions
Drug-drug interactions have been described with intravenous human immunoglobulin.
Adverse effects
The most common potential adverse effects include upper respiratory tract infection, nasopharyngitis, and headache.