Vyloy 300mg is used in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with:

• Locally advanced, unresectable or metastatic gastric adenocarcinoma that is HER2-negative and CLDN18.2-positive.

• Locally advanced, unresectable or metastatic gastro-oesophageal junction (GEJ) adenocarcinoma that is HER2-negative and CLDN18.2-positive.

CLDN18.2 (claudin 18.2) is a protein found on the surface of some gastric cancer cells. Tumour testing is required to confirm that the cancer is suitable for treatment with Vyloy.

Vyloy 300mg contains Zolbetuximab, a targeted monoclonal antibody that binds to CLDN18.2 on certain cancer cells.

After binding to CLDN18.2, Zolbetuximab helps the immune system recognise and destroy the cancer cells carrying this protein.

Tell your doctor about all prescription medicines, over-the-counter medicines, vitamins and herbal supplements you take.

• Chemotherapy: Vyloy is specifically administered with fluoropyrimidine- and platinum-containing chemotherapy as part of the prescribed treatment regimen.

• Medicines for nausea and vomiting: Vyloy commonly causes nausea and vomiting, so your doctor may prescribe preventive medicines.

• Other medicines: Tell your doctor about all medicines you take so that treatment can be planned safely.

• Store unopened Vyloy 300mg in a refrigerator at 2°C to 8°C.

• Do not freeze.

• Keep the vial in the original package to protect it from light.

• Do not reuse unused portions of a single-dose vial.

• Reconstituted and diluted solutions must be handled and stored according to the preparation instructions provided to the healthcare professional.

Vyloy 300mg is given as an intravenous infusion by a healthcare professional.

The recommended initial dose is 800mg/m², calculated according to body surface area. This is followed by either:

• 600mg/m² every 3 weeks, or

• 400mg/m² every 2 weeks.

It is given together with fluoropyrimidine- and platinum-containing chemotherapy.

The dose and treatment schedule are selected by the treating oncologist according to the chemotherapy regimen and the patient's condition.

Common side effects:

• Nausea

• Vomiting

• Decreased appetite

• Tiredness

• Reduced blood cell counts

• Injection or infusion-related reactions

• Decreased body weight

Serious side effects:

• Severe hypersensitivity or anaphylaxis

• Serious infusion-related reactions

• Severe or persistent vomiting

• Severe dehydration

• Severe low blood cell counts

• Serious complications related to the accompanying chemotherapy

Seek immediate medical attention for breathing difficulty, swelling of the face or throat, severe dizziness, fainting or other symptoms of a serious allergic reaction.

• Vyloy must be used only after appropriate testing confirms that the tumour is CLDN18.2-positive and HER2-negative.

• Follow the anti-nausea medicines prescribed by your oncologist, especially around infusion days.

• Drink adequate fluids if your doctor advises this, particularly if vomiting or diarrhoea occurs.

• Tell your healthcare team immediately if you develop symptoms during or after the infusion.

• Keep all blood tests and oncology appointments as scheduled.

• Do not skip or alter the accompanying chemotherapy schedule without discussing it with your oncologist.