ABELCET SUMMARY
ABELCET® is a sterile, pyrogen-free suspension for intravenous infusion. ABELCET® consists of amphotericin B complexed with two phospholipids in a 1:1 drug-to-lipid molar ratio. The two phospholipids, L-(alpha)-dimyristoylphosphatidylcholine (DMPC) and L-(alpha)-dimyristoylphosphatidylglycerol (DMPG), are present in a 7:3 molar ratio. ABELCET® is yellow and opaque in appearance, with a pH of 5-7.
ABELCET® indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy. This is based on open-label treatment of patients judged by their physicians to be intolerant to or failing conventional amphotericin B therapy (See DESCRIPTION OF CLINICAL STUDIES).
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NEWS HIGHLIGHTSMedia Articles Related to Abelcet (Amphotericin B)
Breast Cancer Drug May Beat Fungal Infection
Source: MedicineNet Fungal Nails Specialty [2009.07.27]
Title: Breast Cancer Drug May Beat Fungal Infection
Category: Health News
Created: 7/25/2009 7:00:00 AM
Last Editorial Review: 7/27/2009
Published Studies Related to Abelcet (Amphotericin B)
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.
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...
Cost-effectiveness evaluation of voriconazole versus liposomal amphotericin B as empirical therapy for febrile neutropenia in Australia. [2009.01]
OBJECTIVES: A major randomized clinical trial, evaluating voriconazole versus liposomal amphotericin B (LAMB) as empirical therapy in febrile neutropenia, recommended voriconazole as a suitable alternative to LAMB. The current study sought to investigate the health economic impact of using voriconazole and LAMB for febrile neutropenia in Australia... CONCLUSIONS: In this study, which used the current standard five component endpoint to assess the impact of empirical antifungal therapy, LAMB was associated with cost savings relative to voriconazole.
Liposomal amphotericin B: a review of its use as empirical therapy in febrile neutropenia and in the treatment of invasive fungal infections. [2009]
Liposomal amphotericin B (AmBisome) is a lipid-associated formulation of the broad-spectrum polyene antifungal agent amphotericin B... There was no difference in the incidence of these adverse events between the liposomal amphotericin B and micafungin groups in a study in paediatric patients.
A prospective randomized controlled trial comparing PCR-based and empirical treatment with liposomal amphotericin B in patients after Allo-SCT. [2008.12.15]
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...
Clinical Trials Related to Abelcet (Amphotericin B)
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 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.
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]
Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis [Terminated]
The purpose of this study is to evaluate the safety and effectiveness of micafungin in
combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.
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