AmBisome is an antifungal agent consisting of a liposomal preparation of amphotericin B that is administered by intravenous injection.

AmBisome is a true single bilayer liposomal drug delivery system, consisting of unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Details of the physical and chemical properties of AmBisome are presented in the Overview.

Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products.

AmBisome is indicated for (see Efficacy for complete details):

• Empirical therapy for presumed fungal infection in febrile, neutropenic patients.
• Treatment of cryptococcal meningitis in HIV-infected patients.
• Treatment of patients with 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 (see Pivotal Trials).

For clinically supported details regarding the safety profile of AmBisome, see the Safety and Tolerability section.

AmBisome should be administered by intravenous infusion using a controlled infusion device, over a period of approximately 120 Minutes. Specific administration instructions, as well as dosage details for each indication, are presented in the Dosage and Administration section.

No formal clinical studies of drug interactions have been conducted with AmBisome. However, a list of drugs that are known to interact with amphotericin B and may interact with AmBisome is shown in the Drug Interactions section.

Amphotericin B, the active ingredient of AmBisome, acts by binding to the sterol component of a cell membrane, leading to alterations in cell permeability and cell death.

Frequently asked questions about AmBisome and its use, as well as answers to these questions, can be found in the FAQs section.

Clinical study evidence supporting the efficacy and safety of AmBisome can be found in the Pivotal Trials section.

A guide to reimbursement for AmBisome can be found in the Reimbursement section.

A chronological bibliography containing clinical references to AmBisome, as well as a query tool for these references, can be found in the Bibliography section.