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Toxicokinetic and mechanistic basis for the safety and tolerability of liposomal amphotericin B.

Expert opinion on drug safety (2013-08-13)
Angela S Loo, Saif A Muhsin, Thomas J Walsh
ABSTRACT

Amphotericin B (AmB) was first approved by the US Food and Drug Administration in 1959 with sodium deoxycholate (DAmB, Fungizone®). Extensive toxicities associated with the drug led to the development of lipid formulations of AmB, including liposomal amphotericin B (L-AmB, AmBisome®). Phase I studies as well as comparative Phase III clinical trials indicate that L-AmB is associated with less nephrotoxicity and reduced infusion-related toxicity. There is, however, no recent comprehensive review of the safety and tolerability of L-AmB. This article reviews the safety, tolerability and the mechanisms of the major toxicities associated with L-AmB, including nephrotoxicity, infusion-related reactions (IRRs), anemia and thrombocytopenia, and hepatic abnormalities. The article further discusses the mechanism of action and pharmacokinetics of L-AmB. L-AmB is a broad-spectrum antifungal agent that has significantly reduced toxicities compared to its predecessor, DAmB.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Amphotericin B from Streptomyces sp., ~80% (HPLC), powder
Sigma-Aldrich
Amphotericin B from Streptomyces sp., BioReagent, suitable for cell culture, ~80% (HPLC)
Supelco
Amphotericin B trihydrate, VETRANAL®, analytical standard
Amphotericin B for peak identification, European Pharmacopoeia (EP) Reference Standard
Amphotericin B, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Amphotericin B solution, 250 μg/mL in deionized water, 0.1 μm filtered, BioReagent, suitable for cell culture
Amphotericin B for microbiological assay, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Amphotericin B solubilized, powder, γ-irradiated, BioXtra, suitable for cell culture