Zolbetuximab
Vyloy · ATC code L01FX31
Also known as: Zolbetuksimab
- Key facts
- Active substance
- Zolbetuximab
- ATC code
- L01FX31
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Vyloy 100 mg powder for concentrate for solution for infusion. / Vyloy 300 mg powder for concentrate for solution for infusion.
- Marketing authorisation holder
- Astellas Pharma Europe B.V.
- Information as of
- 2026-10-28
Key facts
Zolbetuximab (Vyloy) is a monoclonal antibody against Claudin 18.2, given by infusion with chemotherapy for advanced gastric cancer.
What it is used for
- First-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours are Claudin 18.2 positive, with fluoropyrimidine- and platinum-containing chemotherapy.
Dosing
- Single loading dose of 800 mg/m2 intravenously on Cycle 1, Day 1.
- Maintenance: beginning 3 weeks after the loading dose, 600 mg/m2 every 3 weeks, or beginning 2 weeks after, 400 mg/m2 every 2 weeks, with chemotherapy, until progression or unacceptable toxicity.
- Premedication with a combination of antiemetics (e.g. NK-1 and 5-HT3 receptor blockers) before each infusion; corticosteroids may be considered.
- No dose reduction; adverse reactions are managed by slowing, interrupting or stopping the infusion.
- Requires CLDN18.2 positive tumour status (≥75% of tumour cells with moderate to strong staining).
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Hypersensitivity reactions including anaphylaxis: monitor during and for at least 2 hours after infusion; stop immediately and permanently for anaphylaxis or Grade 3/4.
- Infusion-related reactions (e.g. nausea, vomiting, abdominal pain, salivary hypersecretion, pyrexia, chills, hypertension).
- Nausea and vomiting are very frequent, especially in the first cycle; premedication matters, with fluid replacement as needed.
- Patients with gastric outlet syndrome were not studied.
Side effects
- Most common: nausea (77.2%), vomiting (66.9%), decreased appetite (42%), neutropenia (30.7%), weight decreased (21.9%), pyrexia (17.4%), hypoalbuminaemia (17.1%) and peripheral oedema (13.9%).
- Serious adverse reactions occurred in 45% of patients, most commonly vomiting (6.8%) and nausea (4.9%).
Interactions
- No formal interaction studies; no metabolic drug-drug interactions are expected.
Pregnancy and breastfeeding
- Only in pregnancy if the benefit outweighs the risk; women of childbearing potential should use contraception as a precaution.
- Breast-feeding is not recommended during treatment.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- VyloyAstellas Pharma Europe B.V. · EMEA/H/C/005868
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Vyloy
- Liechtenstein
- Vyloy
- Norway
- Vyloy
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Vyloy – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/vyloy-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.