Adverse effect profile of amphotericin B deoxycholate administered with a standardized infusion protocol in hematologic patients: a prospective study in a resource-limited setting

BACKGROUND: Amphotericin B deoxycholate (AmBD), an effective and inexpensive antifungal agent, has significant adverse effects. Studies demonstrating the use of protective measures to prevent or reduce different adverse effects of AmBD are scarce in patients with hematological disorders. Therefore, we aimed to evaluate the adverse effect profile of AmBD administered with a standardized infusion protocol among hematologic patients. METHODS: This prospective observational study was conducted at a tertiary care center of India among 150 hospitalized patients of all ages with different hematological disorders who had received AmBD administered with standardized infusion protocol consisting of premedication use, intravenous hydration and salt loading, and electrolyte supplementation. The clinical characteristics were recorded. Renal function parameters and serum electrolyte levels were measured at regular interval. AmBD-associated infusion-related adverse events (IRAEs), electrolyte imbalances and nephrotoxicity were assessed. RESULTS: AmBD-associated IRAEs, hypokalemia, hypomagnesemia, and nephrotoxicity were observed in 48 (32%), 90 (60%), 123 (82%), and 42 (28%) patients, respectively. In majority of patients, these adverse effects were reversible. AmBD was stopped due to severe IRAEs in 8 (5.3%), hypokalemia in 4 (2.7%), and nephrotoxicity in 6 (4%) patients. Baseline invasive fungal infection (IFI) and AmBD dose >1 mg/kg were risk factors for developing nephrotoxicity. CONCLUSION: We have demonstrated that the AmBD use in hematologic patients is associated with a relatively lower and the reversible IRAEs and nephrotoxicity along with manageable electrolyte imbalances, if it is administered with standardized infusion protocol. Therefore, AmBD should be considered as an inexpensive antifungal agent for IFIs among hematologic patients in resource-constrained settings.