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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ABELCET NEWS HIGHLIGHTS Media Articles Related to Abelcet (Amphotericin B)
Minute Antibacterial Particles Destroy Drug-Resistant Germs
Source: Hearing / Deafness News From Medical News Today [2009.06.29]
Doctors may get a new arsenal for meningitis treatment and the war on drug-resistant bacteria and fungal infections with novel peptide nanoparticles developed by scientists at the Institute of Bioengineering and Nanotechnology (IBN) of Singapore and reported in Nature Nanotechnology. The stable bioengineered nanoparticles devised at IBN effectively seek out and destroy bacteria and fungal cells that could cause fatal infections and are highly therapeutic.
Published Studies Related to Abelcet (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 [generic for Abelcet] (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.
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 [generic for Abelcet] 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... At day 100, no difference was observed in the incidence of IFI (primary end point) and survival between the two arms.
Tolerability of prophylactic aerosolized liposomal amphotericin-B and impact on pulmonary function: data from a randomized placebo-controlled trial. [2008.12]
BACKGROUND: Invasive pulmonary aspergillosis (IPA) is a leading cause of mortality in immunocompromised patients, with the highest risk observed in patients with acute leukaemia or lung transplantation. IPA-prophylactic strategies include administration of aerosolized amphotericin-B. Liposomal amphotericin-B (L-AmB) is one of the formulations available, although few data exist on safety and tolerability... CONCLUSIONS: Short-term prophylactic nebulization of L-AmB was well tolerated and not associated with decline in pulmonary function or systemic adverse effects.
New treatment approach in Indian visceral leishmaniasis: single-dose liposomal amphotericin B followed by short-course oral miltefosine. [2008.10.15]
BACKGROUND: In Bihar, India, home to nearly one-half of the world's burden of visceral leishmaniasis, drug resistance has ended the usefulness of pentavalent antimony, which is the traditional first-line treatment. Although monotherapy with other agents is available, the use of 2 drugs with different modes of action might increase efficacy, shorten treatment duration, enhance compliance, and/or reduce the risk of parasite resistance. To test the feasibility of a new approach to combination therapy in visceral leishmaniasis (also known a kala-azar), we treated Indian patients with a single infusion of liposomal amphotericin B [generic for Abelcet] (L-AmB), followed 1 day later by short-course oral miltefosine... CONCLUSIONS: These results suggest that treatment with single-dose L-AmB followed by 7-14 days of miltefosine is active against Indian kala-azar. This short-course, sequential regimen warrants additional testing in India and in those regions of endemicity where visceral leishmaniasis may be more difficult to treat. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00370825 .
Tolerability of prophylactic aerosolized liposomal amphotericin-B and impact on pulmonary function: Data from a randomized placebo-controlled trial. [2008.10.07]
BACKGROUND: Invasive pulmonary aspergillosis (IPA) is a leading cause of mortality in immunocompromised patients, with the highest risk observed in patients with acute leukaemia or lung transplantation. IPA-prophylactic strategies include administration of aerosolized amphotericin-B. Liposomal amphotericin-B (L-AmB) is one of the formulations available, although few data exist on safety and tolerability... CONCLUSIONS: Short-term prophylactic nebulization of L-AmB was well tolerated and not associated with decline in pulmonary function or systemic adverse effects.
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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