Turn to the liposomal amphotericin B agent that can be kinder to the kidneys†
In a clinical study, AmBisome® delivered
significantly less nephrotoxicity than Abelcet®‡
2/3 less nephrotoxicity with AmBisome than Abelcet1,2
- 14.1% of patients treated with AmBisome 3 mg/kg/day
(n=85) and 14.8% of those treated with AmBisome 5 mg/kg/day
(n=81) experienced nephrotoxicity compared with 42.3% of patients treated with Abelcet
5 mg/kg/day (n=78) (p≤0.001)
Significantly fewer infusion-related reactions with AmBisome than Abelcet1,2
- 51.8% of patients treated with AmBisome 3 mg/kg/day
(n=85) and 48.1% of those treated with AmBisome 5 mg/kg/day (n=81)
experienced infusion-related reactions compared with 88.5% of patients treated with
amphotericin B lipid complex (Abelcet®) 5 mg/kg/day (n=78) (p≤0.001)
- The incidence of some common adverse events was greater in patients taking AmBisome compared to patients taking Abelcet in the clinical study noted above including: chest pain, hypocalcemia, hypomagnesemia, confusion, headache, and rash
†Based on results from a randomized, double-blind, multicenter study of 244
febrile neutropenic patients who previously received broad-spectrum antibacterial
therapy, receiving either AmBisome 3
mg/kg/day (n=85) or 5 mg/kg/day (n=81), or Abelcet
5 mg/kg/day (n=78). The primary endpoint was safety.
Abelcet is not indicated for empiric treatment of febrile neutropenic patients.
‡Nephrotoxicity was defined as a serum creatinine value >2 times baseline.
Adobe® Reader® is required to view a PDF. If you do not have it installed, download it free here.
Adobe® Reader® is a registered trademark of Adobe Systems Incorporated.
AmBisome® is indicated for the following:
- Empirical therapy for presumed fungal infection in febrile neutropenic patients
- Treatment of Cryptococcal Meningitis in HIV-infected patients
- Treatment of Aspergillus species, Candida species and/or Cryptococcus
species infections refractory to amphotericin B deoxycholate, or in patients where
renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate
- Treatment of visceral leishmaniasis; in immunocompromised patients with visceral
leishmaniasis treated with AmBisome, relapse rates were
high following initial clearance of parasites
Important Safety Information
Despite significantly less nephrotoxicity observed at a dose range of 1.5–6.0 mg/kg/day
compared to amphotericin B deoxycholate at a dose range of 0.3–1.2 mg/kg/day in
a randomized clinical trial, dose-limiting renal toxicity may still be observed
Dose-limiting renal toxicity may still be observed with AmBisome
even though significantly less nephrotoxicity was observed at dosages of 3 mg/kg/day
and 5 mg/kg/day compared to amphotericin B lipid complex (Abelcet®) at a dosage of 5 mg/kg/day.
The toxicity of AmBisome due to overdose has not been
defined. Repeated daily doses up to 10 mg/kg in pediatric patients and 15 mg/kg
in adult patients have been administered in clinical trials with no reported dose-related
There have been a few reports of flushing, back pain with or without chest tightness,
and chest pain associated with AmBisome administration;
on occasion this has been severe.
Anaphylaxis has been reported with amphotericin B formulations including AmBisome.
Abelcet® is a registered trademark of Sigma-Tau Pharmaceuticals,
References: 1. Wingard JR, White MH, Anaissie E, et al; and the L Amph/ABLC Collaborative Study Group. A randomized, double-blind comparative trial evaluating the safety of liposomal amphotericin B versus amphotericin B lipid complex in the empirical treatment of febrile neutropenia. Clin Infect Dis. 2000;64:1155-1163.
2. AmBisome (amphotericin B) liposome for injection [package insert]. Northbrook, IL: Astellas Pharma US, Inc.