*Please refer to the Summary of Product Characteristics
of your chosen treatment prior to prescribing.
**Please refer to the Liposomal Amphotericin B Summary of
Product Characteristics for detailed information on safety profile.
†Data from a retrospective cohort study of 431 patients who received
either amphotericin B deoxycholate (conventional amphotericin B)
liposomal amphotericin B (Liposomal Amphotericin B), or amphotericin B
lipid complex (ABLC).14
‡Data from 687 febrile, neutropenic patients who received a total of
7,025 infusions (Liposomal Amphotericin B n=343, conventional
amphotericin B n=344). The study included a broad range of patients in
terms of age (2–79 years Liposomal Amphotericin B, 2–80 years
conventional amphotericin B), gender, race, risk category, and primary
diagnosis.13
§No mandatory dose or frequency adjustments are required with
Liposomal Amphotericin B in patients with renal impairment.1 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. This is particularly important
in patients receiving concomitant nephrotoxic medications. Renal
function should be closely monitored. Due to the risk of hypokalaemia,
appropriate potassium supplementation may be required during the
course of Liposomal Amphotericin B administration. If clinically
significant reduction in renal function or worsening of other parameters
occurs, consideration should be given to dose reduction, treatment
interruption or discontinuation.1
Double-blind study in 339 immunocompromised adults and children
(>30 days old) with proven or probable IA or other mould infections
(EORTC/MSG criteria) who were randomised (1:1) to receive 1st-line
therapy with Liposomal Amphotericin B either at 3 mg/kg/day (standard dose) or
10 mg/kg/day for 14 days (high-loading dose), followed by 3 mg/kg/day.
The primary objective of the trial was to compare the favourable (i.e.,
complete or partial) response of the high-loading dose with the standard
dose of Liposomal Amphotericin B in the modified intent-to-treat
population. Secondary end points included survival up to 12 weeks and
the safety profiles of the treatment regimens.1 Complete/partial
response rates at EOT among patients with confirmed IA treated with
3 mg/kg/day were: 50% (n=103) of all patients, 39% (n=41) of patients
with microbiologically confirmed IA, 56% (n=62) of patients with probable
IA based solely on the presence of a halo sign, and 43% (n=76) of
patients with neutropenia at baseline (<500 cells/mm3).26
Footnote
*Please refer to the Summary of Product Characteristics of your chosen treatment prior to prescribing.
**Please refer to the Liposomal Amphotericin B Summary of Product Characteristics for detailed information on safety profile.
†Data from a retrospective cohort study of 431 patients who received either amphotericin B deoxycholate (conventional amphotericin B)
liposomal amphotericin B (Liposomal Amphotericin B), or amphotericin B lipid complex (ABLC).14
‡Data from 687 febrile, neutropenic patients who received a total of 7,025 infusions (Liposomal Amphotericin B n=343, conventional amphotericin B n=344).
The study included a broad range of patients in terms of age (2–79 years AmBisome®, 2–80 years conventional amphotericin B), gender, race, risk
category, and primary diagnosis.13
§No mandatory dose or frequency adjustments are required with Liposomal Amphotericin B in patients with renal impairment.1 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. This is particularly important in patients receiving concomitant nephrotoxic medications. Renal function should be closely monitored. Due to the risk
of hypokalaemia, appropriate potassium supplementation may be required during the course of Liposomal Amphotericin B administration. If clinically
significant reduction in renal function or worsening of other parameters occurs, consideration should be given to dose reduction, treatment interruption or
discontinuation.1
Double-blind study in 339 immunocompromised adults and children (>30 days old) with proven or probable IA or other mould infections (EORTC/MSG
criteria) who were randomised (1:1) to receive 1st-line therapy with AmBisome® either at 3 mg/kg/day (standard dose) or 10 mg/kg/day for 14 days
(high-loading dose), followed by 3 mg/kg/day. The primary objective of the trial was to compare the favourable (i.e., complete or partial) response of the
high-loading dose with the standard dose of Liposomal Amphotericin B in the modified intent-to-treat population. Secondary end points included survival up
to 12 weeks and the safety profiles of the treatment regimens.1 Complete/partial response rates at EOT among patients with confirmed IA treated with
3 mg/kg/day were: 50% (n=103) of all patients, 39% (n=41) of patients with microbiologically confirmed IA, 56% (n=62) of patients with probable IA based
solely on the presence of a halo sign, and 43% (n=76) of patients with neutropenia at baseline (<500 cells/mm3).26
Footnote