Important information and usage of Zolbetuximab package insert

1. Drug Introduction

VYLOY (generic name: Zolbetuximab, Chinese name: zotuximab) is a targeted therapeutic monoclonal antibody mainly used to treat gastric cancer and gastroesophageal junction adenocarcinoma. Its mechanism of action is to target the **Claudin 18.2 (CLDN18.2) ** protein, which is highly expressed on some gastric cancer and gastroesophageal cancer cells. By binding to CLDN18.2, zotuximab can promote the immune system's destruction of tumor cells, thereby inhibiting tumor growth.

2. Indications

Zotuximab is suitable for patients with CLDN18.2-positive advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma. It is usually used in first-line treatment in combination with chemotherapy (such as fluorouracil and platinum drugs). CLDN18.2 testing is required before use to ensure that the patient's tumor tissue expresses the protein to improve the therapeutic effect.

3. Dosage and usage

Zotuximab is an intravenous infusion preparation. The recommended dose is usually calculated based on body weight. The standard dose is 800 mg/m each time², infused over two days:

Day 1: 400 mg/m²

Day 2: 400 mg/m²

Follow up every 3weeks (Q3W).

Infusion methods and precautions:

It needs to be administered through intravenous infusion, and the infusion time is usually 1.5-2 hours.

Pre-dose prophylactic medications (such as antihistamines and corticosteroids) can reduce the risk of infusion reactions.

If serious adverse reactions occur, such as infusion-related reactions (IRR), the infusion rate may need to be slowed down or the dose may need to be suspended.

4. Possible adverse reactions and treatments

Zotuximab may cause the following adverse reactions:

(1) Infusion-related reaction (IRR)

The main symptoms are chills, fever, rash, hypotension or shortness of breath.

Precautions: Use antihistamines and corticosteroids prior to administration.

Treatment method: If severe reaction occurs, the infusion needs to be suspended or the infusion speed needs to be reduced.

(2) Gastrointestinal reactions

Nausea and vomiting: more common and can be relieved by antiemetics (such as ondansetron).

Diarrhea: Pay attention to replenishing water. In severe cases, the dosage may need to be adjusted or the medication may be suspended.

(3) fatigue

Some patients may experience fatigue and fatigue, which usually gradually adapt during treatment.

(4) Abnormal liver function

It may cause an increase in liver enzymes (ALT, AST), and liver function needs to be monitored regularly.

(5) Hematological abnormalities

Leukopenia, anemia, etc. may occur, and routine blood tests should be checked regularly.

5. Contraindications and Precautions

（1) Taboo groups

It is prohibited to be used by patients who are allergic to this product or its ingredients.

People with severe liver and kidney damage should use it with caution and adjust the dosage under the guidance of a doctor.

Pregnant and lactating women are not recommended for use and should take contraceptive measures to avoid pregnancy during treatment and for at least 6 months after stopping the drug.

(2)Drug interactions

There are currently no known drug interactions with zotuximab, but it is recommended to consult a physician when using other anticancer drugs or immunomodulators.

6. Other notes

Before treatment: Carry out CLDN18.2 test to ensure that the patient is suitable for the treatment plan.

During treatment: Monitor liver function and blood routine regularly, and evaluate side effects.

After treatment: If the drug is discontinued, the patient's condition needs to be continued to be monitored and observed for delayed adverse reactions.

Zolbetuximab (Zolbetuximab, VYLOY) is a targeted therapy for CLDN18.2 positive gastric cancer and gastroesophageal junction adenocarcinoma. It is mainly administered through intravenous infusion. Its efficacy is significant, but it may also cause adverse reactions such as infusion reactions, gastrointestinal discomfort, and abnormal liver function. Therefore, patients should use this medicine under the guidance of a doctor and undergo regular examinations to ensure safe and effective treatment.

Reference materials:https://www.astellas.com/en/news/29401