Important Safety Information

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.

Please see Prescribing Information for AmBisome.

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