ERAXIS (anidulafungin)

Commentary

Anidulafungin belongs to echinocandins. It is fungicidal against most Candida spp., including azole-resistant candida spp. (C. glabrata and C. krusei), but less active against C. parapsilosis, C. lusitaniae, and C. guilliermondii species. It is fungistatic against Aspergillus spp. Current FDA indications for anidulafungin include candidemia, other Candida infections (intra-abdominal abscess, peritonitis), and esophageal candidiasis.

 

Anidulafungin is neither an inducer/inhibitor nor a substrate of CYP450 enzyme, and no drug interactions were found. In addition, it undergoes no hepatic or renal metabolism, and is biotransformed by self degradation into inactive metabolites. Thus it is safe for use with any degree of hepatic or renal dysfunction. The cost of anidulafungin is lower than caspofungin.

 

Clinical Trials

Invasive fungal infections

Reboli AC, Rotstein C, Pappas PG, Chapman SW, Kett DH, Kumar D, Betts R, Wible M, Goldstein BP, Schranz J, Krause DS, Walsh TJ; Anidulafungin Study Group.

Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med. 2007 Jun 14;356(24):2472-82.

Benjamin DK Jr, Driscoll T, Seibel NL, Gonzalez CE, Roden MM, Kilaru R, Clark K, Dowell JA, Schranz J, Walsh TJ.

Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections. Antimicrob Agents Chemother. 2006 Feb;50(2):632-8.

Pfaller MA, Diekema DJ, Boyken L, Messer SA, Tendolkar S, Hollis RJ, Goldstein BP.

Effectiveness of anidulafungin in eradicating Candida species in invasive candidiasis. Antimicrob Agents Chemother. 2005 Nov;49(11):4795-7.

Krause DS, Simjee AE, van Rensburg C, Viljoen J, Walsh TJ, Goldstein BP, Wible M, Henkel T.

A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis. Clin Infect Dis. 2004 Sep 15;39(6):770-5. Epub 2004 Aug 27.

Krause DS, Reinhardt J, Vazquez JA, Reboli A, Goldstein BP, Wible M, Henkel T; Anidulafungin Invasive Candidiasis Study Group.

Phase 2, randomized, dose-ranging study evaluating the safety and efficacy of anidulafungin in invasive candidiasis and candidemia. Antimicrob Agents Chemother. 2004 Jun;48(6):2021-4.

Drug-drug interactions and drug metabolism

Dowell JA, Stogniew M, Krause D, Damle B.

Anidulafungin does not require dosage adjustment in subjects with varying degrees of hepatic or renal impairment. J Clin Pharmacol. 2007 Apr;47(4):461-70.

Dowell JA, Stogniew M, Krause D, Henkel T, Damle B.

Lack of pharmacokinetic interaction between anidulafungin and tacrolimus. J Clin Pharmacol. 2007 Mar;47(3):305-14.

Dowell JA, Schranz J, Baruch A, Foster G.

Safety and pharmacokinetics of coadministered voriconazole and anidulafungin. J Clin Pharmacol. 2005 Dec;45(12):1373-82.

Dowell JA, Stogniew M, Krause D, Henkel T, Weston IE.

Assessment of the safety and pharmacokinetics of anidulafungin when administered with cyclosporine. J Clin Pharmacol. 2005 Feb;45(2):227-33.

Review Articles

Gumbo T.

Impact of pharmacodynamics and pharmacokinetics on echinocandin dosing strategies. Curr Opin Infect Dis. 2007 Dec;20(6):587-91. Review.

Kim R, Khachikian D, Reboli AC.

A comparative evaluation of properties and clinical efficacy of the echinocandins. Expert Opin Pharmacother. 2007 Jul;8(10):1479-92. Review.

Vehreschild JJ, Kümmerle T, Karthaus M, Cornely OA.

Anidulafungin--state of affairs from a clinical perspective. Mycoses. 2007;50 Suppl 1:38-43. Review. Erratum in: Mycoses. 2008 Mar;51(2):179.

Cappelletty D, Eiselstein-McKitrick K.

The echinocandins. Pharmacotherapy. 2007 Mar;27(3):369-88. Review.

de la Torre P, Reboli AC

Anidulafungin: a new echinocandin for candidal infections. Expert Rev Anti Infect Ther. 2007 Feb;5(1):45-52. Review.

Wagner C, Graninger W, Presterl E, Joukhadar C.

The echinocandins: comparison of their pharmacokinetics, pharmacodynamics and clinical applications. Pharmacology. 2006;78(4):161-77. Epub 2006 Oct 17. Review.

Vazquez JA.

The safety of anidulafungin. Expert Opin Drug Saf. 2006 Nov;5(6):751-8. Review.

Adverse Drug Reactions and Warnings

 

FDA Information

Manufacturer/Distributor Product Information