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
FDA Accepts TOPICA'S Luliconazole IND To Begin Clinical Trials In Onychomycosis
Source: Infectious Diseases / Bacteria / Viruses News From Medical News Today [2010.02.02]
TOPICA Pharmaceuticals, a privately-held biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for the use of luliconazole, its lead product candidate, in patients with onychomycosis (nail and nail bed fungal infections). The company plans to initiate a Phase 1/2 trial in the first quarter...
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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