Safety and pharmacokinetic profiles of repeated-dose micafungin in children and adolescents treated for invasive candidiasis

Pediatric Infectious Disease Journal

Volumn 32, Issue 11, 2013, Pages

  Benjamin, Daniel K ^a   Deville, Jaime G ^b   Azie, Nkechi ^c   Kovanda, Laura ^c   Roy, Mike ^c   Wu, Chunzhang ^c   Arrieta, Antonio ^d  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

^d CHILDREN S HOSPITAL OF ORANGE COUNTY   (United States)

Author keywords

candidiasis; children; micafungin; pharmacokinetics; safety

Indexed keywords

MICAFUNGIN;

ADOLESCENT; ANTIMICROBIAL THERAPY; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; CHILD; CYANOSIS; DRUG BLOOD LEVEL; DRUG FEVER; DRUG SAFETY; DRUG WITHDRAWAL; FEBRILE CONVULSION; FEMALE; HEART FAILURE; HEART VENTRICLE TACHYCARDIA; HUMAN; HYPERTENSION; HYPOCALCEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; HYPOTENSION; INVASIVE CANDIDIASIS; LIVER FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; PATHOLOGIC FRACTURE; PHASE 1 CLINICAL TRIAL; PRESCHOOL CHILD; PRIORITY JOURNAL; REPEATED DRUG DOSE; SCHOOL CHILD; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING;

ADOLESCENT; ANTIFUNGAL AGENTS; BODY WEIGHT; CANDIDIASIS, INVASIVE; CHILD; CHILD, PRESCHOOL; DRUG ADMINISTRATION SCHEDULE; ECHINOCANDINS; FEMALE; HUMANS; INFANT; KIDNEY FUNCTION TESTS; LIPOPEPTIDES; LIVER FUNCTION TESTS; MALE;

EID: 84886953649     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0b013e31829efd14     Document Type: Article

References (19)

1. Steinbach WJ, Roilides E, Berman D, et al.; International Pediatric Fungal Network. Results from a prospective, international, epidemiologic study of invasive candidiasis in children and neonates. Pediatr Infect Dis J. 2012;31:1252-1257.
2. Zaoutis TE, Coffin SE, Chu JH, et al. Risk factors for mortality in children with candidemia. Pediatr Infect Dis J. 2005;24:736-739.
3. Astellas Pharma US Inc. Mycamine label 2011. Available at: http://www. accessdata.fda.gov/drugsatfda-docs/label/2011/021506s011s012lbl.pdf. Accessed January 17, 2012.
4. European Medicines Agency. Mycamine 50 mg powder for solution for infusion: summary of product characteristics 2011. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/000734/WC500031075.pdf. Accessed January 17, 2012.
5. Pappas PG, Kauffman CA, Andes D, et al. Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis. 2009;48:503-535.
6. Messer SA, Diekema DJ, Boyken L, et al. Activities of micafungin against 315 invasive clinical isolates of fluconazole-resistant Candida spp. J Clin Microbiol. 2006;44:324-326.
7. Pfaller MA, Castanheira M, Lockhart SR, et al. Frequency of decreased susceptibility and resistance to echinocandins among fluconazole-resistant bloodstream isolates of Candida glabrata. J Clin Microbiol. 2012;50:1199-1203.
8. Chong Y, Shimoda S, Yakushiji H, et al. Fatal candidemia caused by azoleresistant Candida tropicalis in patients with hematological malignancies. J Infect Chemother. 2012;18:741-746.
9. Queiroz-Telles F, Berezin E, Leverger G, et al.; Micafungin Invasive Candidiasis Study Group. Micafungin versus liposomal amphotericin B for pediatric patients with invasive candidiasis: substudy of a randomized double-blind trial. Pediatr Infect Dis J. 2008;27:820-826.
10. van Burik JA, Ratanatharathorn V, Stepan DE, et al.; National Institute of Allergy and Infectious Diseases Mycoses Study Group. Micafungin versus fluconazole for prophylaxis against invasive fungal infections during neutropenia in patients undergoing hematopoietic stem cell transplantation. Clin Infect Dis. 2004;39:1407-1416.
11. Arrieta AC, Maddison P, Groll AH. Safety of micafungin in pediatric clinical trials. Pediatr Infect Dis J. 2011;30:e97-e102.
12. Hope WW, Seibel NL, Schwartz CL, et al. Population pharmacokinetics of micafungin in pediatric patients and implications for antifungal dosing. Antimicrob Agents Chemother. 2007;51:3714-3719.
13. Seibel NL, Schwartz C, Arrieta A, et al. Safety, tolerability, and pharmacokinetics of Micafungin (FK463) in febrile neutropenic pediatric patients. Antimicrob Agents Chemother. 2005;49:3317-3324.
14. Cornely OA, Pappas PG, Young JA, et al. Accumulated safety data of micafungin in therapy and prophylaxis in fungal diseases. Expert Opin Drug Saf. 2011;10:171-183.
15. Hebert MF, Smith HE, Marbury TC, et al. Pharmacokinetics of micafungin in healthy volunteers, volunteers with moderate liver disease, and volunteers with renal dysfunction. J Clin Pharmacol. 2005;45: 1145-1152.
16. Hiemenz J, Cagnoni P, Simpson D, et al. Pharmacokinetic and maximum tolerated dose study of micafungin in combination with fluconazole versus fluconazole alone for prophylaxis of fungal infections in adult patients undergoing a bone marrow or peripheral stem cell transplant. Antimicrob Agents Chemother. 2005;49:1331-1336.
17. Undre NA, Stevenson P, Freire A, et al. Pharmacokinetics of micafungin in pediatric patients with invasive candidiasis and candidemia. Pediatr Infect Dis J. 2012;31:630-632.
18. Scott LJ. Micafungin: a review of its use in the prophylaxis and treatment of invasive Candida infections. Drugs. 2012;72:2141-2165.
19. Undre N, Stevenson P, Baraldi E. Pharmacokinetics of micafungin in HIV positive patients with confirmed esophageal candidiasis. Eur J Drug Metab Pharmacokinet. 2012;37:31-38.