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Contact SupplierSoliris (eculizumab) injection is a sterile, preservative-free solution administered intravenously (IV) that functions as a terminal complement inhibitor. It is primarily used to treat several rare autoimmune and blood disorders in adults and some pediatric patients.
MrMed
MrMed
+3
Active Ingredient and Mechanism
Eculizumab, a humanized monoclonal antibody produced by recombinant DNA technology, is the active ingredient in Soliris. It works by binding to the complement protein C5, preventing the formation of the terminal complement complex and inhibiting the part of the immune system that can damage healthy cells in certain diseases.
European Medicines Agency
European Medicines Agency
+4
Approved Indications
Soliris is FDA-approved to treat:
Paroxysmal Nocturnal Hemoglobinuria (PNH): To reduce the destruction of red blood cells.
Atypical Hemolytic Uremic Syndrome (aHUS): To inhibit complement-mediated damage and protect organs. It is not for Shiga toxin E. coli-related HUS.
Generalized Myasthenia Gravis (gMG): In patients positive for anti-acetylcholine receptor antibodies.
Neuromyelitis Optica Spectrum Disorder (NMOSD): In adult patients positive for anti-aquaporin-4 antibodies with a relapsing course.
MrMed
MrMed
+4
Product Presentation and Administration
Soliris is a sterile, preservative-free solution for IV infusion. It is supplied in single-dose vials containing 300 mg of eculizumab in 30 mL (10 mg/mL). It must be diluted to 5 mg/mL before use and administered by a healthcare professional.
RxList
RxList
+2
Important Safety Information (Boxed Warning)
Soliris carries a Boxed Warning due to an increased risk of serious meningococcal infections. Patients must receive meningococcal vaccinations at least two weeks before starting treatment. If immediate treatment is necessary, Soliris can be started with antibiotic prophylaxis while vaccinations take effect, and patients must be monitored for signs of infection