What is the observation period after zolbetuximab administration?

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Monitor patients during and after infusion with zolbetuximab (at least two hours, or longer if clinically indicated) for hypersensitivity reactions

  • Monitor for hypersensitivity reactions with symptoms and signs that are highly suggestive of anaphylaxis (e.g., urticaria, repetitive cough, wheeze and throat tightness/change in voice).1
  • Monitoring is also recommended for patients for signs and symptoms of infusion related reactions including nausea, vomiting, abdominal pain, salivary hypersecretion, pyrexia, chest discomfort, chills, back pain, cough, and hypertension.1

  • In the Phase 3 clinical trials SPOTLIGHT and GLOW, patients were observed for two hours following the first zolbetuximab/placebo infusion (Cycle 1 Day1).2,3
    • If Grade ≥ 2 adverse events occurred during the infusion or during the post-infusion observation period, it was recommended to extend subsequent zolbetuximab/placebo infusion times and to continue observing the patient for two hours post zolbetuximab/placebo infusion.2,3
    • If no Grade ≥ 2 adverse events occurred, it was recommended to observe the patient for one hour post-infusion for their subsequent zolbetuximab/placebo infusions.2,3
  • In Phase 3 clinical trials SPOTLIGHT and GLOW, mFOLFOX6 and CAPOX could be given during the post-infusion observation period.2,3

  1. Data on File.

  2. 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.

  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.

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