Leaflet VYLOY 100mg powder for concentrate for solution for infusion

Indicated for: cancer

Route of administration: infusion

Substance: zolbetuximab (monoclonal antibody)

ATC: L01FX31 (Antineoplastic and immunomodulating agents | Monoclonal antibodies and antibody drug conjugates | Other monoclonal antibodies and antibody drug conjugates)

Precautions:
Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Zolbetuximab is a monoclonal antibody being investigated for the treatment of certain types of cancer, particularly gastric cancer and gastroesophageal junction adenocarcinoma. It works by targeting the Claudin-18.2 (CLDN18.2) protein, which is specifically expressed on the surface of tumor cells in these cancers. By binding to this protein, zolbetuximab activates the body's immune system to destroy cancer cells.

Zolbetuximab is being studied in clinical trials for patients with advanced or metastatic gastric cancer, in combination with standard chemotherapy regimens such as fluoropyrimidine and oxaliplatin. Preliminary results suggest that this drug may improve overall survival and disease progression in patients with high Claudin-18.2 expression.

Commonly reported side effects include nausea, vomiting, diarrhea, fatigue, and loss of appetite. In some cases, infusion-related reactions such as fever, chills, or skin rashes may occur. Careful monitoring of patients is essential during the administration of the drug.

Zolbetuximab is still in the clinical research phase and is not widely available. Its use is limited to clinical trials, and eligible patients must be tested for Claudin-18.2 expression before receiving the treatment.

General data about VYLOY 100mg

  • Substance: zolbetuximab
  • Date of latest medicines list: 01-06-2026
  • Product code: W71231001
  • Concentration: 100mg
  • Pharmaceutical form: powder for concentrate for solution for infusion
  • Quantity: 1
  • Product type: Generic medicine
  • Price: 3289.04 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: ASTELLAS IRELAND CO. LIMITED - IRLANDA
  • Holder: -
  • Number: 1083/2025/01

Concentrations available for zolbetuximab

  • 100mg
  • 300mg