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Abelcet (Amphotericin B) - 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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Published Studies Related to Abelcet (Amphotericin B)

Economic evaluation of caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia in Sweden. [2011.07]
OBJECTIVE: To evaluate the cost-effectiveness of caspofungin versus liposomal amphotericin B (L-AmB) for empirical antifungal therapy in patients with persistent fever and neutropenia in Sweden... CONCLUSION: Given the underlying assumptions and data used, caspofungin is expected to be cost-effective with at least comparable outcomes compared to L-AmB for the empirical treatment of patients with suspected fungal infections in Sweden.

Safety and efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial. [2011.06.30]
BACKGROUND: Treatment options for visceral leishmaniasis (VL) in East Africa are far from satisfactory due to cost, toxicity, prolonged treatment duration or emergence of parasite resistance... The design allows repeated testing throughout the trial recruitment period while maintaining good statistical properties (Type I & II error rates) and reducing the expected sample sizes.

Single-dose liposomal amphotericin B (AmBisome(R)) for the treatment of visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial. [2011.03.06]
BACKGROUND: AmBisome(R) is an efficacious, safe anti-leishmanial treatment. There is growing interest in its use, either as a single dose or in combination treatments... Results will inform the design of combination treatment studies.

Intrapulmonary disposition of amphotericin B after aerosolized delivery of amphotericin B lipid complex (Abelcet; ABLC) in lung transplant recipients. [2010.12.15]
BACKGROUND: Inhaled amphotericin preparations have been used for prophylaxis against invasive aspergillosis in lung transplant recipients. However, no published data exist regarding the pharmacokinetic profile of amphotericin B lipid complex in lung transplant recipients... CONCLUSIONS: We conclude that administration through aerosolized nebulization of amphotericin B lipid complex every 24 hr for 4 days in lung transplant recipients achieved amphotericin B concentrations in ELF above minimum inhibitory concentration of the Aspergillus nearly at 168 hr after the last inhaled dose and is well tolerated.

Comparison of 2 doses of liposomal amphotericin B and conventional amphotericin B deoxycholate for treatment of AIDS-associated acute cryptococcal meningitis: a randomized, double-blind clinical trial of efficacy and safety. [2010.07.15]
BACKGROUND. It is generally acknowledged that amphotericin B is the most effective treatment for cryptococcal meningitis... Liposomal amphotericin B at a dosage of 3 mg/kg/day is accompanied by significantly fewer adverse effects.

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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

Phase III, Study of Three Short Course Combination Regimens (Ambisome´┐Ż, Miltefosine, Paromomycin) Compared With AmBisome´┐Ż Alone for the Treatment of Visceral Leishmaniasis in Bangladesh [Recruiting]
This protocol will evaluate the efficacy and safety of various combinations of the three drugs; AmBisome, Paromomycin and Miltefosine at reduced total dosage against the standard treatment with a total dose of 15mg/kg of AmBisome.

Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia [Recruiting]
The aim of this clinical trial is to assess 25-30 patients of both sexes, between the ages of 3 to 18 years, who are receiving intensive chemotherapy treatment for acute myeloblastic or lymphoblastic leukemia (AML, ALL) and will be treated with aerosolised (inhalation) amphotericin B lipid complex (Abelcet«) as a prophylactic for invasive pulmonary aspergillosis during prolonged neutropenia.

The trial will evaluate the overall tolerability of the drug and the efficacy of aerosolised ABLC for primary prophylaxis of invasive pulmonary aspergillosis (IPA). In the event that the working hypothesis is confirmed, aerosolised ABLC treatment would be an effective, safe and reliable prophylactic option for IPA. It would offer an alternative to the systemic administration of antifungal triazoles without affecting the antileukemic treatment in pediatric patients with AL.

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.

To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar [Recruiting]
The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar).

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Reports of Suspected Abelcet (Amphotericin B) Side Effects

Blood Creatinine Increased (4)Blood Bilirubin Increased (3)Chills (3)Pyrexia (3)Renal Failure (3)Body Temperature Increased (2)Multi-Organ Failure (2)Oxygen Saturation Decreased (2)Autonomic Nervous System Imbalance (2)Renal Impairment (2)more >>

Page last updated: 2011-12-09

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