Although zolbetuximab has demonstrated efficacy in clinical trials, there are several warnings and precautions that require close attention during its use. The relevant information is detailed below.

Precautions for Zolbetuximab

The following points should be noted during the administration of zolbetuximab:

1. Hypersensitivity Reactions and Infusion-Related Reactions

Zolbetuximab can cause hypersensitivity reactions, including severe allergic reactions and infusion-related reactions, which may sometimes be life-threatening.

(1) Clinical Manifestations

These include urticaria, recurrent cough, wheezing, a feeling of tightness in the throat, voice changes, nausea, vomiting, abdominal pain, excessive salivation, fever, chest discomfort, chills, back pain, cough, and hypertension.

(2) Management Measures:

a. Patients should be closely monitored during the infusion and for at least 2 hours after the infusion ends (or longer if clinically necessary).

b. If a Grade 2 reaction occurs, the infusion should be interrupted. Resume the infusion at a reduced rate once the symptoms subside to Grade 1 or below.

c. If a Grade 3 or Grade 4 reaction or an allergic reaction occurs, the infusion should be stopped immediately and the drug should be permanently discontinued.

d. Prophylactic antihistamines should be administered before subsequent infusions.

2. Severe Nausea and Vomiting

Zolbetuximab has a strong emetogenic potential, and nausea and vomiting are more common in the early stages of treatment (especially during the first cycle).

Management Measures

a. Prophylactic antiemetic drugs (such as NK-1 receptor antagonists, 5-HT3 receptor antagonists, etc.) should be administered before each infusion.

b. If persistent or worsening nausea or vomiting occurs, the drug should be interrupted or permanently discontinued in a timely manner. Fluid replacement or supportive treatment should be provided as needed.

Administration of Zolbetuximab in Special Populations

For populations such as pregnant women, lactating women, elderly patients, and pediatric patients, the following points should be noted when using zolbetuximab for treatment:

1. Pregnant Women

Currently, there are no data on the use of zolbetuximab in pregnant women. The drug should only be used when the potential benefits are clearly greater than the risks.

2. Lactating Women

It is unknown whether zolbetuximab is excreted in human milk. It is recommended to discontinue breastfeeding during treatment and for 8 months after the last dose.

3. Elderly Patients

However, for elderly patients aged 65 years and above, there are no significant differences in safety or efficacy compared with younger patients.

4. Pediatric Patients

Sufficient research has not yet been conducted to fully establish the safety and efficacy of zolbetuximab in pediatric patients.

As a novel targeted therapeutic drug for CLDN18.2-positive gastric cancer and gastroesophageal junction cancer, close vigilance should be maintained for adverse reactions such as hypersensitivity reactions, infusion-related reactions, and severe nausea and vomiting during the use of zolbetuximab. Medical staff should fully assess the patient's condition before drug administration, develop an individualized treatment plan, closely monitor the patient during treatment, and promptly manage any potential adverse events that may occur.