USYMRO 45mg 45mg / 0.5ml solution for injection medication leaflet

L04AC05 ustekinumab • Antineoplastic and immunomodulating agents | Immunosuppressants | Interleukin inhibitors

Ustekinumab is a human monoclonal antibody used to treat autoimmune inflammatory diseases such as moderate-to-severe plaque psoriasis, psoriatic arthritis, and inflammatory bowel diseases like Crohn's disease and ulcerative colitis. It works by blocking interleukins IL-12 and IL-23, cytokines involved in inflammatory and autoimmune processes.

By inhibiting these cytokines, ustekinumab reduces inflammation and symptoms associated with these conditions, such as skin lesions, joint pain, diarrhea, and abdominal pain. It is administered as a subcutaneous injection or intravenous infusion, depending on the indication, according to a schedule determined by a healthcare provider.

Common side effects include upper respiratory tract infections, headaches, fatigue, and injection site reactions. Rarely, severe infections, allergic reactions, or an increased risk of certain cancers may occur.

Patients should inform their doctor about any other medical conditions or medications before starting ustekinumab. Regular monitoring is essential to assess the treatment's effectiveness and safety.

General data about USYMRO 45mg 45mg / 0.5ml

Substance: ustekinumab

Date of last drug list: 01-12-2025

Commercial code: W71510001

Concentration: 45mg / 0.5ml

Pharmaceutical form: solution for injection

Quantity: 1

Product type: generic

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

Marketing authorisation

Manufacturer: CILATUS MANUFACTURING SERVICES LIMITED - IRLANDA

Holder: GEDEON RICHTER PLC. - UNGARIA

Number: 1058/2025/01

Shelf life: 2 years

Concentrations available for ustekinumab

130mg, 45mg/0.5ml, 90mg/ml