AMPHOTEC SUMMARY
AMPHOTEC®
Amphotericin B Cholesteryl Sulfate
Complex for Injection
AMPHOTEC® is a sterile, pyrogen-free, lyophilized powder for reconstitution and intravenous (IV) administration. AMPHOTEC consists of a 1:1 (molar ratio) complex of amphotericin B and cholesteryl sulfate. Upon reconstitution, AMPHOTEC forms a colloidal dispersion of microscopic disc-shaped particles. 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. Amphotericin B is an antifungal polyene antibiotic produced by a strain of Streptomyces nodosus. Amphotericin B, which is the established name for [1R (1 R *,3 S *,5 R *,6 R *,9 R *,11 R *, 15 S *,16 R *,17 R *,18 S *,19 E,21 E,23 E,25 E,27 E,29 E,31 E,33 R *,35 S *,36 R *,37 S *)]-33-[(3-Amino-3,6-dideoxy- ß -D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.
AMPHOTEC is indicated for the treatment of invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate in effective doses, and in patients with invasive aspergillosis where prior amphotericin B deoxycholate therapy has failed.
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NEWS HIGHLIGHTS
Published Studies Related to Amphotec (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.
Clinical Trials Related to Amphotec (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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Page last updated: 2009-10-20
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