*Based on in vitro data, the clinical relevance is unknown.
**Double-blind, randomised trial comparing AmBisome® (initial dose of 3 mg/kg/day) and cAMB (0.6 mg/kg/day) as empiric antifungal therapy in adults and children (2-80 years) with persistent neutropenia (< 500/mm3) and fever despite >5 days empirical antibacterial therapy. The total number of patients was 687, of whom almost half (n=333) had acute leukemia. Treatment success (primary efficacy endpoint), was defined as a composite of five criteria: survival for seven days after initiation of the study drug; resolution of fever during the period of neutropenia; successful treatment of any base-line fungal infection, if present; the absence of breakthrough fungal infections during administration of the study drug or within seven days after the completion of treatment; and the absence of premature discontinuation of the study drug because of toxicity or lack of efficacy.14
†Please refer to the AmBisome® SmPC and the SmPC of concomitant medications for a full list of DDIs prior to prescribing to ensure minimal interaction. No specific interaction studies have been performed with AmBisome®. However, recommendations in the prescribing information are based on the known DDI profile of amphotericin B and interactions that may be of clinical significance.5
§AmBisome® is indicated for empiric therapy in the treatment of suspected IFIs in febrile neutropenic patients where the fever has failed to respond to broad spectrum antibiotics and appropriate investigations have failed to define a bacterial or viral cause5
¶No data are available on which to make a dose recommendation for patients with hepatic impairment.
¥AmBisome® is not recommended for use in children below 1 month old due to lack of data on safety and efficacy.5
¥¥AmBisome® has been administered to a large number of patients with pre-existing renal impairment at starting doses ranging from 1-3 mg/kg/day in clinical trials and no adjustment in dose or frequency of administration was required. AmBisome® has been shown to be substantially less toxic than conventional amphotericin B, particularly with respect to nephrotoxicity, however, renal adverse events may still occur. In particular, caution should be exercised when prolonged therapy is required. Regular laboratory evaluation of serum electrolytes, particularly potassium and magnesium, as well as renal, hepatic and haematopoietic function should be performed, at least once weekly. If clinically significant reduction in renal functioning, or worsening of other parameters occurs, consideration should be given to dose reduction, treatment interruption or discontinuation.5