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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
A 65-year-old man developed heart block secondary to infusion-related hypersensitivity reaction during treatment with itolizumab and sodium chloride for COVID-19.
The man was a COVID-19 patient and was admitted to ICU due to shortness of breath and cough. His ECG suggested left bundle branch block (LBBB), and supported through non-invasive ventilation and started treatment with remdesivir, dexamethasone, unspecified antibiotics, unspecified low molecular weight heparins, along with other unspecified supportive treatment. He was maintaining on continuous positive airway pressure mode of non-invasive ventilation on third day of ICU admission. Due to increasing severity of COVID-19, a decision was made to initiate infusion of itolizumab [Alzumab-L] injection. Hydrocortisone and pheniramine were given 30 minutes before initiation of itolizumab infusion. Itolizumab 100mg injection was diluted in 250mL of sodium chloride and was started at an infusion rate of 25 mL/hour [exact route not stated]. About 20 minutes after initiation of the infusion, he started developing shivering, sweating and impending doom. He also developed sudden bronchospasm and his oxygen saturation dropped to 90%. A subsequent ECG revealed a second-degree atrioventricular nodal block, secondary to the infusion-related hypersensitivity reaction. Blood pressure was found to be increased. A grade 4 infusion-related hypersensitivity reaction was thus determined.
The man's infusion was immediately withdrawn, and a repeat dose of hydrocortisone and pheniramine were administered along with other supportive measures. He became alert and his respiratory symptoms relieved eventually. However, his second-degree heart block was persistent. He was closely observed and ECG reverted to its previous state after 24 hours. He was weaned from the ventilator and put on face mask on the eighth day of the hospital stay.
Reference
- Kumar N, et al. Second-degree heart block caused by itolizumab-induced infusion reaction in covid-19. Indian Journal of Critical Care Medicine 25: 474-475, No. 4, Apr 2021. Available from: URL: 10.5005/jp-journals-10071-23794 [DOI] [PMC free article] [PubMed]