Chinese Journal of Pharmacovigilance ›› 2024, Vol. 21 ›› Issue (10): 1148-1153.
DOI: 10.19803/j.1672-8629.20240261

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Seventy-nine cases of tislelizumab-related adverse reactions

WANG Ying1, HUANG Shan1, SHENG Qinyong1, LIAN Xia1, CHANG Ying1, JIANG Yan1, LIN Bing2#, HUANG Aiwen1,*   

  1. 1Department of Clinical Pharmacy, the 900th Hospital of the Joint Logistic Support Force of Chinese PLA, Fuzhou Fujian 350025, China;
    2Department of Pharmacy, the 900th Hospital of the Joint Logistic Support Force of Chinese PLA, Fuzhou Fujian 350025, China
  • Received:2024-04-24 Online:2024-10-15 Published:2024-10-14

Abstract: Objective To analyze the regularity and clinical characteristics of adverse drug reactions (ADR) induced by tislelizumab in order to provide references for safe and rational drug use. Methods Seventy-nine reports of adverse reactions related to tislelizumab submitted by our hospital to the national ADR Monitoring System from January 1, 2020 to March 31, 2024 were retrospectively analyzed, involving patients' demographics, types of drugs used, times of adverse reactions, clinical presentations, organs and/or systems involved, severity, management and outcomes, causality assessment, and off-label use. Results Among these cases of tislelizumab-related adverse reactions, 88.61% occurred after one to five medication cycles. Affecting multiple organs and systems, the main manifestations included bone marrow suppression, skin toxicity, thyroid dysfunction, and liver function abnormalities. Myasthenic syndrome and anaphylactic shock were serious ADR not specified in drug instructions. After discontinuation of the drug and symptomatic treatment, most of the cases improved. Conclusion A few severe adverse reactions of tislelizumab can lead to life-threatening consequences. Close monitoring during clinical use is recommended, with timely symptomatic treatment to reduce severe adverse reactions.

Key words: tislelizumab, immune checkpoint inhibitors, adverse drug reaction, bone marrow suppression, myasthenic syndrome, anaphylactic shock, safety

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