AM B Isome (Amphotericin B) - Summary

AM B ISOME SUMMARY

Am B isome for Injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains 50 mg of amphotericin B, USP, intercalated into a liposomal membrane consisting of approximately 213 mg hydrogenated soy phosphatidylcholine; 52 mg cholesterol, NF; 84 mg distearoylphosphatidylglycerol; 0.64 mg alpha tocopherol, USP; together with 900 mg sucrose, NF; and 27 mg disodium succinate hexahydrate as buffer. Following reconstitution with Sterile Water for Injection, USP, the resulting pH of the suspension is between 5-6.

Am B isome is indicated for the following:

• Empirical therapy for presumed fungal infection in febrile, neutropenic patients.
• Treatment of Cryptococcal Meningitis in HIV infected patients (see DESCRIPTION OF CLINICAL STUDIES).
• Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) 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 Am B isome, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES).

See DOSAGE AND ADMINISTRATION for recommended doses by indication.

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NEWS HIGHLIGHTS

Published Studies Related to AM B Isome (Amphotericin B)

A phase II randomized trial of amphotericin B alone or combined with fluconazole in the treatment of HIV-associated cryptococcal meningitis. [2009.06.15]
BACKGROUND: Cryptococcosis is a life-threatening infection among patients with human immunodeficientcy virus (HIV) infection. Therapeutic options for the treatment of central nervous system cryptococcosis are limited, especially in resource-limited settings... CONCLUSIONS: AmB plus fluconazole administered at a dosage of 800 mg for 14 days, followed by fluconazole administered at a dosage of 800 mg daily for 56 days, is well-tolerated and efficacious among HIV-positive patients with central nervous system cryptococcosis. These results have significant treatment implications and should be validated in a randomized phase III trial.

Economic impact of caspofungin as compared with liposomal amphotericin B for empirical therapy in febrile neutropenia in Australia. [2009.06]
BACKGROUND: In a major clinical trial, caspofungin was as efficacious as liposomal amphotericin B (LAmB) for empirical therapy in febrile neutropenia. The current study sought to evaluate the economic impact of caspofungin as compared with LAmB for febrile neutropenia in Australia... CONCLUSIONS: This is the first economic study to evaluate the place of caspofungin as empirical therapy in Australia. Caspofungin is more cost-beneficial than LAmB, which contradicts the current Australian guidelines of recommending LAmB as the first choice for empirical therapy.

Postoperative application of amphotericin B nasal spray in chronic rhinosinusitis with nasal polyposis, with a review of the antifungal therapy. [2009.06]
Chronic rhinosinusitis (CRS) affects 1-4% of the adult population. The etiology of this multifactorial, chronic disease, which leads to a significant impairment of the quality of life, often accompanied by nasal polyposis, is not fully understood...

A prospective randomized controlled trial comparing PCR-based and empirical treatment with liposomal amphotericin B in patients after allo-SCT. [2009.04]
We compared the efficacy and safety of empirical plus PCR-based vs empirical liposomal amphotericin B treatment after Allo-SCT. Allo-SCT recipients were randomized to receive either PCR-based preemptive therapy (group A; n=198) or empirical antifungal therapy (group B; n=211) with liposomal amphotericin B...

The effect of topical amphotericin B on inflammatory markers in patients with chronic rhinosinusitis: a multicenter randomized controlled study. [2009.02]
BACKGROUND: It has been suggested that an exaggerated immune response to fungi is crucial in the pathogenesis of chronic rhinosinusitis (CRS). Based on this rationale, the use of topical antifungals (amphotericin B) has been advocated. Studies on its clinical effectiveness are, however, contradictory. OBJECTIVES: To examine the effect of nasal antifungal treatment on secreted mediators in samples of nasal lavage fluid from patients with CRS with or without nasal polyps (NP)... CONCLUSIONS: Topical amphotericin B has no significant effect on activation markers of nasal inflammatory cells in chronic rhinosinusitis with or without nasal polyps.

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Clinical Trials Related to AM B Isome (Amphotericin B)

A Study of Caspofungin, Liposomal Amphotericin B or the Combination of Both for Patients After Stem-Cell Transplantation [Completed]
The study compares the safety, efficacy and pharmacokinetics of caspofungin, liposomal amphotericin B or the combination of both in the antifungal treatment of adult patients after allogeneic haematopoietic stem-cell transplantation with granulocytopenia and persistent i. g. recurrent fever under adequate antibacterial therapy.

Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®) [Completed]
The purpose of this study is to determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®) in lung transplant recipients who are positive for invasive aspergillosis (IA) in their lungs. Additionally, the investigators hope to determine the concentrations of amphotericin B achieved in the epithelial lining fluid, and serum with the administration of four days of lipid complex of amphotericin B (Abelcet ®) (QD) via aerosolized nebulization

A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar [Completed]
1. To evaluate the Safety and Efficacy of four different short-course regimens of Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who are either treatment naive or treatment resistant to other antileishmanial drugs except amphotericin B containing preparations.

2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar.

Pharmacokinetic Profile of Inhaled Liposomal Amphotericin B in Lung Transplant Recipients - Ambisome Study [Completed]

A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis [Completed]
To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole.

At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.

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