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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.

Please see Prescribing Information for AmBisome.

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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 with AmBisome.

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 toxicity.

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, Inc.

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.