Eraxis (Anidulafungin) - Summary

ERAXIS SUMMARY

These highlights do not include all the information needed to use ERAXIS safely and effectively. See full prescribing information for ERAXIS.

ERAXIS™ (anidulafungin)
For injection, for intravenous use
Initial U.S. Approval: 2006

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)

Study To Assess The Safety, Pharmacokinetics, And Evaluate The Response To Anidulafungin When Treating Children With Invasive Candidiasis [Recruiting]
Anidulafungin (an antifungal drug) is relatively safe and the benefits outweigh the potential adverse effects when used in children diagnosed with invasive candidiasis, including candidemia.

Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom [Completed]
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.

Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations [Completed]
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.

Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis [Completed]
This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis.

Anidulafungin Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ADOPT) [Completed]
Because anidulafungin is generally well tolerated and appears to have limited interaction with other drugs, it is a potential important agent in the treatment of invasive fungal infections. Although anidulafungin is approved for the treatment of invasive candidiasis in adult non-neutropenic patients, dosing guidelines for anidulafungin in (morbidly) obese patients are not available. Subsequently, the pharmacokinetic profile of anidulafungin (as well as other echinocandins) in this specific patient population is still largely unknown. During endoscopic gastric bypass surgery, patients are more prone to various kinds of infection, justifying the prophylactic use of anidulafungin in this specific cohort of patients. To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic gastric bypass surgery will receive a single dose of 100 mg anidulafungin (besides standard anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then be compared to the pharmacokinetics in a normal-weight group.

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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 >>