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Eraxis (Anidulafungin) - Summary

 
 



ERAXIS SUMMARY

ERAXIS™ (anidulafungin) FOR INJECTION

ERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. Anidulafungin is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls. ERAXIS (anidulafungin) is 1-[(4R,5R)-4,5-Dihydroxy-N2-[[4"-(pentyloxy)[1,1':4',1"-terphenyl]-4-yl]carbonyl]-L-ornithine]echinocandin B . Anidulafungin is a white to off-white powder that is practically insoluble in water and slightly soluble in ethanol.

ERAXIS is indicated for use in the treatment of the following fungal infections:

Candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis) (see CLINICAL STUDIES and MICROBIOLOGY).

ERAXIS has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida, and has not been studied in sufficient numbers of neutropenic patients to determine efficacy in this group.

Esophageal candidiasis (see CLINICAL STUDIES, Table 7 for higher relapse rates off ERAXIS therapy).

Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.


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NEWS HIGHLIGHTS

Published Studies Related to Eraxis (Anidulafungin)

Anidulafungin compared with fluconazole for treatment of candidemia and other forms of invasive candidiasis caused by Candida albicans: a multivariate analysis of factors associated with improved outcome. [2011]
contributed to the treatment differences... CONCLUSIONS: In patients with C. albicans infection, anidulafungin was more

Bronchopulmonary disposition of intravenous voriconazole and anidulafungin given in combination to healthy adults. [2009.12]
Voriconazole and anidulafungin in combination are being investigated for use for the treatment of pulmonary aspergillosis... In healthy adult volunteers, voriconazole achieved high levels of exposure in both ELF and AM, while anidulafungin predominantly concentrated in AM.

Anidulafungin in the treatment of invasive fungal infections. [2008.02]
More antifungal agents have reached clinical use in the past two decades than at any other time. The echinocandins have been a welcome addition to this group, with the latest being anidulafungin... On the other hand, there is insufficient evidence as of yet to support first-line use of anidulafungin in patients with neutropenia or aspergillosis.

Anidulafungin versus fluconazole for invasive candidiasis. [2007.06.14]
BACKGROUND: Anidulafungin, a new echinocandin, has potent activity against candida species. We compared anidulafungin with fluconazole in a randomized, double-blind, noninferiority trial of treatment for invasive candidiasis... CONCLUSIONS: Anidulafungin was shown to be noninferior to fluconazole in the treatment of invasive candidiasis. (ClinicalTrials.gov number, NCT00056368 [ClinicalTrials.gov]). Copyright 2007 Massachusetts Medical Society.

Safety and pharmacokinetics of coadministered voriconazole and anidulafungin. [2005.12]
There is considerable interest in combining echinocandin and triazole antifungal agents for treatment of invasive fungal infections; however, information is needed regarding the tolerability and potential for pharmacokinetic interactions... The geometric mean ratio (90% confidence interval) of the combination/drug alone for AUC(SS) was 97.4% (94.9-99.9), 97.4% (92.1-103.0), and 94.4% (87.0-102.5) for anidulafungin, voriconazole, and the voriconazole metabolite, respectively.

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Clinical Trials Related to Eraxis (Anidulafungin)

Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom [Not yet recruiting]
The purpose of this study is to describe the real world effectiveness of anidulafungin in clinical practice in a large Liver Unit in the United Kingdom.

Anidulafungin PK in Infants and Toddlers [Recruiting]
This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1. 5 mg/kg every 24 hours on study days 2-5. Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.

The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis. [Completed]
Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis.

Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations [Recruiting]
This study will find how weight affects the dosing of a drug called anidulafungin. Currently, the amount of anidulafungin a patient receives is the same regardless of the patient's weight.

β-D-Glucan Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients [Recruiting]
This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3: 1 fashion to either biweekly surveillance using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.

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Reports of Suspected Eraxis (Anidulafungin) Side Effects

Drug Ineffective (3)Death (3)Blood Bilirubin Increased (2)Coagulopathy (2)Hypokalaemia (2)Abdominal Pain (1)Systemic Candida (1)Heparin-Induced Thrombocytopenia (1)Pyrexia (1)Paraplegia (1)more >>


Page last updated: 2013-02-10

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