Liposomal amphotericin‐B (AmBisome)® treatment in solid organ and bone marrow transplant recipients. Efficacy and safety evaluation

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Abstract
Eight patients, 4 organ and 4 bone marrow transplant recipients, were treated with a liposomal amphotericin‐B formulation (AmBisome) in a compassionate basis program. Time of treatment ranged from 9–48 days (median 15) with a cumulative AmBisome dose ranging from 450–6480 mg (median 963). Maximum dose ranged from 0.9–2.5 mg/kg (median 1.75). Six of the 8 patients with proven or probable deep fungal infection have been discharged from hospital and are well. Two bone marrow‐transplanted patients died during treatment, I was negative for disseminated fungi at autopsy after 8 days of treatment with a total dose of 906 mg AmBisome. Amphotericin B concentrations in tissue samples taken at autopsy ranged from 25 to 281 μg/g tissue in bone marrow, liver and spleen and from 0.6 to 8 in lung, heart, muscle and kidney. In the other patient, who died after 14 d of treatment with a total dose of 1020 mg AmBisome, autopsy was denied. Two patients developed high alkaline phosphatases during treatment. Otherwise, AmBisome was well‐tolerated in all patients without acute side effects.