EPYSQLI 300mg concentrate for solution for infusion medication leaflet

L04AJ01 eculizumab • Antineoplastic and immunomodulating agents | Immunosuppressants | Complement inhibitors

Eculizumab is a monoclonal antibody used for the treatment of rare conditions such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It works by inhibiting complement C5, preventing the destruction of blood cells and tissues.

The medication is administered intravenously, as directed by a doctor, and requires careful monitoring for adverse effects.

Side effects may include headache, hypertension, respiratory infections, or injection site reactions. In rare cases, severe infections such as meningitis may occur.

Eculizumab is not recommended for patients with hypersensitivity to this medication or without meningococcal vaccination.

General data about EPYSQLI 300mg

Substance: eculizumab

Date of last drug list: 01-12-2025

Commercial code: W71446001

Concentration: 300mg

Pharmaceutical form: concentrate for solution for infusion

Quantity: 1

Product type: generic

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

Manufacturer: SAMSUNG BIOEPIS NL B.V. - OLANDA

Holder: SAMSUNG BIOEPIS NL B.V. - OLANDA

Number: 1735/2023/01

Shelf life: 3 years

Concentrations available for eculizumab

10mg/ml, 300mg