AMBISOME

DESCRIPTION OF CLINICAL STUDIES Eleven clinical studies supporting the efficacy and safety of Am B isome were conducted. This clinical program included both controlled and uncontrolled studies. These studies, which involved 2,171 patients, included patients with confirmed systemic mycoses, empirical therapy, and visceral leishmaniasis. Nineteen hundred and forty-six (1946) episodes were evaluable for efficacy, of which 1,280 (302 pediatric and 978 adults) were treated with Am B isome. Three controlled empirical therapy trials compared the efficacy and safety of Am B isome to amphotericin B. On...

ADVERSE REACTIONS The following adverse events are based on the experience of 592 adult patients (295 treated with Am B isome and 297 treated with amphotericin B deoxycholate) and 95 pediatric patients (48 treated with Am B isome and 47 treated with amphotericin B deoxycholate) in Study 94-0-002, a randomized double-blind, multi-center study in febrile, neutropenic patients. Am B isome and amphotericin B were infused over two hours. The incidence of common adverse events (incidence of 10% or gre...

CONTRAINDICATIONS Am B isome is contraindicated in those patients who have demonstrated or have a known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk.

Drug Interactions No formal clinical studies of drug interactions have been conducted with Am B isome; however, the following drugs are known to interact with amphotericin B and may interact with Am B isome: Antineoplastic Agents Concurrent use of antineoplastic agents may enhance the potential for renal toxicity, bronchospasm, and hypotension. Antineoplastic agents should be given concomitantly w...