Tissue Distribution of Anidulafungin in Neonatal Rats

Birth Defects Research Part B - Developmental and Reproductive Toxicology

Volumn 95, Issue 1, 2012, Pages 89-94

  Ripp, Sharon L ^a   Aram, Jalal A ^a   Bowman, Christopher J ^a   Chmielewski, Gary ^a   Conte, Umberto ^a   Cross, David M ^a   Gao, Hongying ^a   Lewis, Elise M ^b   Lin, Jian ^a   Liu, Ping ^a   Schlamm, Haran T ^a  

^a PFIZER INC   (United States)

^b CHARLES RIVER LABORATORIES   (United States)

Author keywords

Anidulafungin; Bone; Brain; Heart; Neonatal rats; Tissue distribution

Indexed keywords

ANIDULAFUNGIN;

ANIMAL EXPERIMENT; ANIMAL TISSUE; AREA UNDER THE CURVE; ARTICLE; BONE; BRAIN; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG TISSUE LEVEL; FEMALE; HEART; LIQUID CHROMATOGRAPHY; MALE; MAXIMUM PLASMA CONCENTRATION; NEWBORN; NONHUMAN; PERINATAL PERIOD; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; RAT; SINGLE DRUG DOSE; TANDEM MASS SPECTROMETRY; TIME TO MAXIMUM PLASMA CONCENTRATION;

ANIDULAFUNGIN; BONE; BRAIN; HEART; NEONATAL RATS; TISSUE DISTRIBUTION;

AGING; ANIMALS; ANIMALS, NEWBORN; DOSE-RESPONSE RELATIONSHIP, DRUG; ECHINOCANDINS; FEMALE; MALE; RATS; RATS, INBRED F344; TIME FACTORS; TISSUE DISTRIBUTION;

ANIMALIA; RATTUS;

EID: 84862826668     PISSN: 15429733     EISSN: 15429741     Source Type: Journal    
DOI: 10.1002/bdrb.20347     Document Type: Article

References (31)

1. Benjamin Jr DK, Poole C, Steinbach WJ, Rowen JL, Walsh TJ. 2003. Neonatal candidemia and end-organ damage: a critical appraisal of the literature using meta-analytic techniques. Pediatrics 112:634-640.
2. Benjamin Jr DK, Driscoll T, Seibel NL, Gonzalez CE, Roden MM, Kilaru R, Clark K, Dowell JA, Schranz J, Walsh TJ. 2006. Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections. Antimicrob Agents Chemother 50:632-638.
3. Bowman CJ, Chmielewski G, Lewis E, Ripp S, Sawaryn CM, Cross DM. 2011. Juvenile toxicity assessment of anidulafungin in rats: an example of navigating case-by-case study design through scientific and regulatory challenges. Birth Defects Res B Dev Reprod Toxicol. 92:333-344.
4. Clark JB, Bates TE, Cullingford T, Land JM. 1993. Development of enzymes of energy metabolism in the neonatal mammalian brain. Dev Neurosci 15:174-180.
5. Cohen-Wolkowiez M, Benjamin Jr DK, Piper L, Cheifetz IM, Moran C, Liu P, Aram J, Kashuba ADM, Capparelli E, Walsh TJ, Hope WW, Smith PB. 2011. Safety and Pharmacokinetics of Multiple-Dose Anidulafungin in Infants and Neonates. Clin Pharmcol Ther 89:702-707.
6. Damle B, Stogniew M, Dowell JA. 2008. Pharmacokinetics and tissue distribution of anidulafungin in rats. Antimicrob Agents Chemother 52:2673-2676.
7. Damle BD, Dowell JA, Walsky RL, Weber GL, Stogniew M, Inskeep PB. 2009. In vitro and in vivo studies to characterize the clearance mechanism and potential cytochrome P450 interactions of anidulafungin. Antimicrob Agents Chemother 53:1149-1156.
8. Dobbing J, Sands J. 1979. Comparative aspects of the brain growth spurt. Early Hum Dev 3:79-83.
9. Dowell JA, Knebel W, Ludden T, Stogniew M, Krause D, Henkel T. 2004. Population pharmacokinetic analysis of anidulafungin, an echinocandin antifungal. J Clin Pharmacol 44:590-598.
10. Dowell JA, Stogniew M, Krause D, Damle B. 2007. Anidulafungin does not require dosage adjustment in subjects with varying degrees of hepatic or renal impairment. J Clin Pharmacol 47:461-470.
11. Groll AH, Mickiene D, Petraitiene R, Petraitis V, Lyman CA, Bacher JS, Piscitelli SC, Walsh TJ. 2001. Pharmacokinetic and pharmacodynamic modeling of anidulafungin (LY303366): reappraisal of its efficacy in neutropenic animal models of opportunistic mycoses using optimal plasma sampling. Antimicrob Agents Chemother 45:2845-2855.
12. Hope WW, Mickiene D, Petraitis V, Petraitiene R, Kelaher AM, Hughes JE, Cotton MP, Bacher J, Keirns JJ, Buell D, Heresi G, Benjamin Jr DK, Groll AH, Drusano GL, Walsh TJ. 2008. The pharmacokinetics and pharmacodynamics of micafungin in experimental hematogenous Candida meningoencephalitis: implications for echinocandin therapy in neonates. J Infect Dis 197:163-171.
13. Ibiwoye MO, Sibbons PD, Howard CV, van Velzen D. 1994. Immunocytochemical study of a vascular barrier antigen in the developing rat brain. J Comp Pathol 111:43-53.
14. Kang CI, Rouse MS, Mandrekar JN, Steckelberg JM, Patel R. 2009. Anidulafungin treatment of candidal central nervous system infection in a murine model. Antimicrob Agents Chemother 53:3576-3578.
15. Krause DS, Reinhardt J, Vazquez JA, Reboli A, Goldstein BP, Wible M, Henkel T. 2004a. Phase 2, randomized, dose-ranging study evaluating the safety and efficacy of anidulafungin in invasive candidiasis and candidemia. Antimicrob Agents Chemother 48:2021-2024.
16. Krause DS, Simjee AE, van Rensburg C, Viljoen J, Walsh TJ, Goldstein BP, Wible M, Henkel T. 2004b. A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis. Clin Infect Dis 39:770-775.
17. Krishnan-Natesan S, Manavathu EK, Cutright JL, Chandrasekar PH. 2010. Efficacy of anidulafungin, caspofungin and fluconazole in the early phase of infection in a neutropenic murine invasive candidiasis model. Int J Antimicrob Agents 36:33-36.
18. Maertens JA, Madero L, Reilly AF, Lehrnbecher T, Groll AH, Jafri HS, Green M, Nania JJ, Bourque MR, Wise BA, Strohmaier KM, Taylor AF, Kartsonis NA, Chow JW, Arndt CA, DePauw BE, Walsh TJ. 2010. A randomized, double-blind, multicenter study of caspofungin versus liposomal amphotericin B for empiric antifungal therapy in pediatric patients with persistent fever and neutropenia. Pediatr Infect Dis J 29:415-420.
19. Mayr A, Aigner M, Lass-Florl C. 2011. Anidulafungin for the treatment of invasive candidiasis. Clin Microbiol Infect 1(Suppl 17):1-12.
20. Morgan J. 2005. Global trends in candidemia: review of reports from 1995-2005. Curr Infect Dis Rep 7:429-439.
21. National Research Council. 1996. Guide for the care and use of laboratory animals, Institute of Laboratory Animal Resources Commission on Life Sciences and the National Research Council. Washington, DC: National Academy Press.
22. Petraitiene R, Petraitis V, Groll AH, Candelario M, Sein T, Bell A, Lyman CA, McMillian CL, Bacher J, Walsh TJ. 1999. Antifungal activity of LY303366, a novel echinocandin B, in experimental disseminated candidiasis in rabbits. Antimicrob Agents Chemother 43:2148-2155.
23. Pfaller M, Boyken I, Hollis RJ, Kroeger J, Messer SA, Tendolkar S, Diekema DJ. 2008. In vitro susceptibility of invasive isolates of Candida spp. to anidulafungin, caspofungin, and micafungin: six years of global surveillance. J Clin Microbiol 46:150-156.
24. Pfaller MA, Diekema DJ, Boyken I, Messer SA, Tendolkar S, Hollis RJ, Goldstein BP. 2005. Effectiveness of anidulafungin in eradicating Candida species in invasive candidiasis. Antimicrob Agents Chemother 49:4795-4797.
25. Queiroz-Telles F, Berezin E, Leverger G, Freire A, van der Vyver A, Chotpitayasunondh T, Konja J, Diekmann-Berndt H, Koblinger S, Groll AH, Arrieta A, Micafungin Invasive Candidiasis Study Group. 2008. Micafungin versus liposomal amphotericin B for pediatric patients with invasive candidiasis: substudy of a randomized double-blind trial. Pediatr Infect Dis J 27:820-826.
26. Reboli AC, Rotstein C, Pappas PG, Chapman SW, Kett DH, Kumar D, Betts R, Wible M, Goldstein BP, Schranz J, Krause DS, Walsh TJ. 2007. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med 356:2472-2482.
27. Stolp HB, Dziegielewska KM, Ek CJ, Habgood MD, Lane MA, Potter AM, Saunders NR. 2005. Breakdown of the blood-brain barrier to proteins in white matter of the developing brain following systemic inflammation. Cell Tissue Res 320:369-378.
28. Vazquez JA, Schranz JA, Clark K, Goldstein BP, Reboli A, Fichtenbaum C. 2008. A phase 2, open-label study of the safety and efficacy of intravenous anidulafungin as a treatment for azole-refractory mucosal candidiasis. J Acquir Immune Defic Syndr 48:304-309.
29. Watson RE, Desesso JM, Hurtt ME, Cappon GD. 2006. Postnatal growth and morphological development of the brain: a species comparison. Birth Defects Res B Dev Reprod Toxicol 77:471-484.
30. Zaoutis T. 2010. Candidemia in children. Curr Med Res Opin 26:1761-1768.
31. Zaoutis TE, Argon J, Chu J, Berlin JA, Walsh TJ, Feudtner C. 2005. The epidemiology and attributable outcomes of candidemia in adults and children hospitalized in the United States: a propensity analysis. Clin Infect Dis 41:1232-1239.