Liposomal amphotericin B as an antifungal prophylaxis in bilateral lung transplantation: a safety analysis

Background: Lung transplantation (LT) is the definitive treatment for end-stage chronic respiratory failure. Despite improvements in surgical and perioperative care, fungal infections remain a major complication in LT recipients, and antifungal prophylaxis with liposomal amphotericin B (L-AmB) is commonly used. However, evidence on the safety of L-AmB administration in LT recipients remains limited. This retrospective observational study aimed to assess the profile of renal, hepatic and hematologic safety, and the incidence of hypersensitivity adverse events following prophylactic L-AmB use in LT recipients. Methods: A retrospective, single-center observational study of adult patients (≥ 18 years) who underwent their first bilateral LT at the University Hospital of Padua (Italy), between January 2020 and March 2025. All patients received intravenous L-AmB (3 mg/kg/day for 5 days) as postoperative antifungal prophylaxis. Adverse effects were assessed based on acute kidney injury (AKI), liver toxicity, hematotoxicity, and infusion reactions. Laboratory values were collected at baseline, on days 1, 2, 3, 7, and 14 post-L-AmB initiation. Results: 189 LT recipients were screened and 140 enrolled. Concerning safety profile, AKI occurred in 55 (39%) patients, with serum creatinine peaking at 48 h (p = 0.025), as compared to baseline. Mild transaminase elevations occurred in 86% of patients within the first 48 h, and bilirubin increased in 10%, with no episodes of acute liver failure. Anemia (85%) and transient thrombocytopenia (9%) were observed. Hypokalemia was found in 28%. Renal replacement therapy was needed in 2%. No infusion-related or allergic reactions to L-AmB were observed. According to the institutional fungal surveillance protocol, no proven, probable, or possible invasive fungal infections were documented during the observation period. However, the present study was not designed to assess the prophylactic efficacy of L-AmB. Conclusions: In this cohort of bilateral LT recipients receiving standardized L-AmB prophylaxis, no discontinuation, dose adjustment, infusion reaction, or proven fungal infection was documented. Renal, hepatic, hematologic, and electrolyte abnormalities were frequent; but cannot be specifically attributed to L-AmB in the absence of a comparator group, given the multifactorial pathophysiology of the early post-transplant period. These findings underscore the importance of vigilant monitoring of organ function during L-AmB administration in this vulnerable population.