zolbetuximab at a glance
Medicine class
CLDN18.2-targeted monoclonal antibody
Who it is for
Adults with locally advanced, unresectable or metastatic HER2-negative, CLDN18.2-positive gastric or gastro-oesophageal junction adenocarcinoma
How it is given
Slow intravenous infusion in a hospital or clinic, with anti-sickness treatment beforehand
Tumour testing
A validated test must confirm sufficient CLDN18.2 expression before treatment
What is zolbetuximab used for?
The UK licence covers one defined cancer setting.
First-line treatment, with fluoropyrimidine- and platinum-containing chemotherapy, of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma whose tumours are CLDN18.2 positive.
How does zolbetuximab work?
Zolbetuximab binds CLDN18.2, a tight-junction protein exposed on the surface of some cancer cells. The attached antibody recruits immune cells and complement proteins to damage those cells through antibody-dependent and complement-dependent cytotoxicity.
How to take zolbetuximab
Zolbetuximab is prepared and given by an oncology team as a slow infusion into a vein. Anti-sickness medicines are given beforehand. When chemotherapy is given on the same day, zolbetuximab is infused first. It must not be given as a rapid injection or mixed with other medicines through the same infusion line.
Tell the team before treatment if you already feel sick or have been vomiting.
Report new symptoms immediately during or after the infusion.
Do not stop treatment without discussing it with the oncology team.
zolbetuximab side effects
Common or expected effects
- Nausea or vomiting
- Upper abdominal pain
- Reduced appetite and weight loss
- Low blood albumin
- Swelling of the hands, legs or feet
- Excess saliva or general malaise
- Infusion-related or hypersensitivity reactions
Get urgent medical advice
- Anaphylaxis, with hives, wheezing, throat tightness, voice change or breathing difficulty
- A severe infusion reaction, which may include chest discomfort, fever, shaking, back pain, cough, high blood pressure or marked nausea and vomiting
- Severe or persistent vomiting requiring prompt clinical assessment
zolbetuximab in pregnancy
There are no human pregnancy data. Zolbetuximab should be considered during pregnancy only when the expected benefit outweighs the potential risk, so pregnancy or plans to conceive should be discussed promptly with the oncology specialist.
zolbetuximab while breastfeeding
Breastfeeding is not recommended during treatment because it is unknown whether zolbetuximab enters human milk and serious effects in a breastfed child cannot be excluded.
zolbetuximab interactions
Formal medicine-interaction studies have not been performed. Zolbetuximab is not expected to affect cytochrome P450 enzymes or drug transporters through its known mechanism, but the oncology team should review all medicines and supplements.
Other intravenous medicines
They must not be administered through the same infusion line as zolbetuximab.
Fluoropyrimidine- and platinum-containing chemotherapy
These medicines form part of the licensed combination and may contribute to overlapping adverse effects, particularly nausea and vomiting.
Common questions about zolbetuximab
Answers are fully visible for fast scanning and source review.
Is zolbetuximab chemotherapy?
No. It is a targeted monoclonal antibody, but its UK licence requires it to be used with specified chemotherapy.
Who can receive zolbetuximab?
It is licensed for eligible adults with advanced or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma that tests positive for CLDN18.2.
Why is a CLDN18.2 test needed before zolbetuximab?
Zolbetuximab can attach only when its CLDN18.2 target is sufficiently present on tumour cells, so eligibility must be confirmed with a validated tumour test.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.