What premedication should be used with zolbetuximab?

Published

Premedicate patients with a combination of antiemetics (e.g., NK-1 and/or 5-HT3 receptor antagonists, as well as other drugs as indicated).

If Grade 2 hypersensitivity reactions or Grade 2 infusion-related reactions (IRRs) occurred during a previous infusion, administer appropriate premedication before the next infusion.1 Please refer to your local prescribing information for complete guidance on appropriate premedication for hypersensitivity reactions or IRRs that occurred during a previous infusion.

The zolbetuximab prescribing information does not provide any additional guidance.

Recommendations on antiemetic use with zolbetuximab are available using the link below.

Modified Delphi Panel Consensus Guidance recommends considering a histamine subtype H2 receptor (H2) antagonist or proton pump inhibitor (PPI) for patients with an intact stomach to prevent dyspepsia, which can mimic nausea.2 The panel recommends starting these a few days to one week before zolbetuximab treatment for maximal mucosal protection. A complete overview of the Consensus Guidance can be accessed using the link below.

The clinical trial protocols for the Phase 3 trials (SPOTLIGHT and GLOW) recommended prophylactic antiemetics before zolbetuximab infusions.3,4 Additional information on antiemetic use in the Phase 3 trials is available using the link below.

Premedication for hypersensitivity reactions and IRRs was not required.3,4 However, if a patient had a Grade 2 IRR during a previous infusion, appropriate premedication was recommended for the next infusion, and antihistamines could be used at the investigator's discretion.

The clinical trial protocols do not provide any additional recommendations on premedication.

  1. Zolbetuximab prescribing information.

  2. Klempner SJ, Pazo-Cid RA, Lonardi S, et al. Consensus guidance for prevention and management of nausea and vomiting in patients treated with zolbetuximab + chemotherapy: a RAND/UCLA modified Delphi panel study. ESMO Gastrointest. Oncol. 2025;7100131. Available at: https://doi.org/10.1016/j.esmogo.2024.100131.

  3. Shah MA, Shitara K, Ajani JA, et al. Supplement to: Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023;29(8):2133-2141. Available at: https://doi.org/10.1038/s41591-023-02465-7.

  4. Shitara K, Lordick F, Bang YJ, et al. Supplement to: Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023;401(10389):1655-1668. Available at: https://doi.org/10.1016/s0140-6736(23)00620-7.

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