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Drug Evaluation

An overview of micafungin as a treatment option for invasive candidiasis in pediatric patients younger than 4 months old

ORCID Icon, ORCID Icon, &
Pages 1987-1993 | Received 28 Jul 2022, Accepted 11 Nov 2022, Published online: 22 Nov 2022

References

  • Barton M, O’Brien K, Robinson JL, et al. Invasive candidiasis in low birth weight preterm infants: risk factors, clinical course and outcome in a prospective multicenter study of cases and their matched controls. BMC Infect Dis. 2014 Jun 12;14(1):327.
  • Benjamin DK Jr., Stoll BJ, Fanaroff AA, et al. Neonatal candidiasis among extremely low birth weight infants: risk factors, mortality rates, and neurodevelopmental outcomes at 18 to 22 months. Pediatrics. 2006 Jan;117(1):84–92.
  • Pappas PG, Lionakis MS, Arendrup MC, et al. Invasive candidiasis. Nat Rev Dis Primers. 2018 May 11;4(1):18026.
  • Kilpatrick R, Scarrow E, Hornik C, et al. Neonatal invasive candidiasis: updates on clinical management and prevention. Lancet Child Adolesc Health. 2022 Jan;6(1):60–70.
  • Abdel-Haq N, Smith SM, Asmar BI. Micafungin injection for the treatment of invasive candidiasis in pediatric patients under 4 months of age. Expert Rev Anti Infect Ther. 2022 Apr;20(4):493–505.
  • Benjamin DK Jr., Stoll BJ, Gantz MG, et al. Neonatal candidiasis: epidemiology, risk factors, and clinical judgment. Pediatrics. 2010 Oct;126(4):e865–73.
  • Cotten CM, McDonald S, Stoll B, et al. The association of third-generation cephalosporin use and invasive candidiasis in extremely low birth-weight infants. Pediatrics. 2006 Aug;118(2):717–722.
  • Lee JH, Hornik CP, Benjamin DK Jr., et al. Risk factors for invasive candidiasis in infants >1500 g birth weight. Pediatr Infect Dis J. 2013 Mar;32(3):222–226.
  • Aliaga S, Clark RH, Laughon M, et al. Changes in the incidence of candidiasis in neonatal intensive care units. Pediatrics. 2014 Feb;133(2):236–242.
  • Mantadakis E, Pana ZD, Zaoutis T. Candidemia in children: epidemiology, prevention and management. Mycoses. 2018 Sep;61(9):614–622.
  • Pana ZD, Roilides E, Warris A, et al. Epidemiology of invasive fungal disease in children. J Pediatric Infect Dis Soc. 2017 Sep 1;6(suppl_1):S3–S11.
  • Walsh TJ, Katragkou A, Chen T, et al. Invasive candidiasis in infants and children: recent advances in epidemiology, diagnosis, and treatment. J Fungi. 2019 Jan 24;5(1):11.
  • Hashimoto S. Micafungin: a sulfated echinocandin. J Antibiot (Tokyo). 2009 Jan;62(1):27–35.
  • Iwamoto T, Fujie A, Sakamoto K, et al. WF11899A, B and C, novel antifungal lipopeptides. I. Taxonomy, fermentation, isolation and physico-chemical properties. J Antibiot (Tokyo). 1994 Oct;47(10):1084–1091.
  • Nyfeler R, Keller-Schierlein W, Nüesch J. [Stoffwechselprodukte von Mikroorganismen 143. Mitteilung. Echinocandin B, ein neuartiges Polypeptid-Antibioticum aus Aspergillus nidulans var. echinulatus: isolierung und Bausteine]. Helv Chim Acta. 1974;57(8):2459–2477.
  • Schwartz RE, Giacobbe RA, Bland JA, et al. L-671,329, a new antifungal agent. I. Fermentation and isolation. J Antibiot (Tokyo). 1989 Feb;42(2):163–167.
  • Denning DW. Echinocandin antifungal drugs. Lancet. 2003 Oct 4;362(9390):1142–1151.
  • Kurtz MB, Douglas CM. Lipopeptide inhibitors of fungal glucan synthase. J Med Vet Mycol. 1997 Mar-Apr;35(2):79–86.
  • Giacobbe DR, Del Bono V, Viscoli C, et al. Use of 1,3-beta-D-glucan in invasive fungal diseases in hematology patients. Expert Rev Anti Infect Ther. 2017 Dec;15(12):1101–1112.
  • Odabasi Z, Paetznick VL, Rodriguez JR, et al. Differences in beta-glucan levels in culture supernatants of a variety of fungi. Med Mycol. 2006 May;44(3):267–272.
  • Nishiyama Y, Uchida K, Yamaguchi H. Morphological changes of Candida albicans induced by micafungin (FK463), a water-soluble echinocandin-like lipopeptide. J Electron Microsc. 2002;51(4):247–255.
  • European Medicines Agency. Mycamine (R). Summary of product characteristics last accessed 12 Jun 2022]. Available at 2022 Jun 12: https://www.ema.europa.eu/en/documents/product-information/mycamine-epar-product-information_en.pdf.
  • Taormina G, Gopinath R, Moore J, et al. A regulatory review approach for evaluation of micafungin for treatment of neonatal candidiasis. Clin Infect Dis. 2021 Dec 16;73(12):2335–2340.
  • Tezer H, Canpolat FE, Dilmen U. Invasive fungal infections during the neonatal period: diagnosis, treatment and prophylaxis. Expert Opin Pharmacother. 2012 Feb;13(2):193–205.
  • Bersani I, Piersigilli F, Goffredo BM, et al. Antifungal Drugs for Invasive Candida Infections (ICI) in neonates: future perspectives. Front Pediatr. 2019;7:375.
  • Yanni SB, Smith PB, Benjamin DK Jr., et al. Higher clearance of micafungin in neonates compared with adults: role of age-dependent micafungin serum binding. Biopharm Drug Dispos. 2011 May;32(4):222–232.
  • Wasmann RE, Muilwijk EW, Burger DM, et al. Clinical pharmacokinetics and pharmacodynamics of micafungin. Clin Pharmacokinet. 2018 Mar;57(3):267–286.
  • Auriti C, Falcone M, Ronchetti MP, et al. High-dose micafungin for preterm neonates and infants with invasive and central nervous system candidiasis. Antimicrob Agents Chemother. 2016 Dec;60(12):7333–7339.
  • Benjamin DK Jr., Kaufman DA, Hope WW, et al. A phase 3 study of micafungin versus amphotericin b deoxycholate in infants with invasive candidiasis. Pediatr Infect Dis J. 2018 Oct;37(10):992–998.
  • Hope WW, Mickiene D, Petraitis V, et al. The pharmacokinetics and pharmacodynamics of micafungin in experimental hematogenous Candida meningoencephalitis: implications for echinocandin therapy in neonates. J Infect Dis. 2008 Jan 1;197(1):163–171.
  • Leroux S, Jacqz-Aigrain E, Elie V, et al. Pharmacokinetics and safety of fluconazole and micafungin in neonates with systemic candidiasis: a randomized, open-label clinical trial. Br J Clin Pharmacol. 2018 Sep;84(9):1989–1999.
  • Emiroglu M. Micafungin use in children. Expert Rev Anti Infect Ther. 2011 Sep;9(9):821–834.
  • Wiederhold NP, Lewis JS. The echinocandin micafungin: a review of the pharmacology, spectrum of activity, clinical efficacy and safety. Expert Opin Pharmacother. 2007 Jun;8(8):1155–1166.
  • Fromtling RA. Micafungin sodium (FK-463). Drugs Today (Barc). 2002 Apr;38(4):245–257.
  • Heresi GP, Gerstmann DR, Reed MD, et al. The pharmacokinetics and safety of micafungin, a novel echinocandin, in premature infants. Pediatr Infect Dis J. 2006 Dec;25(12):1110–1115.
  • Auriti C, Goffredo BM, Ronchetti MP, et al. High-dose micafungin in neonates and young infants with invasive candidiasis: results of a phase 2 study. Antimicrob Agents Chemother. 2021 Mar 18;65(4):e02494–20.
  • Kuse ER, Chetchotisakd P, da Cunha CA, et al. Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial. Lancet. 2007 May 5;369(9572):1519–1527.
  • Queiroz-Telles F, Berezin E, Leverger G, et al. Micafungin versus liposomal amphotericin B for pediatric patients with invasive candidiasis: substudy of a randomized double-blind trial. Pediatr Infect Dis J. 2008 Sep;27(9):820–826.
  • Viscoli C, Bassetti M, Castagnola E, et al. Micafungin for the treatment of proven and suspected invasive candidiasis in children and adults: findings from a multicenter prospective observational study. BMC Infect Dis. 2014 Dec 31;14(1):725.
  • Schuller SS, Bauer C, Unterasinger L, et al. Safety and efficacy of micafungin in extremely low birth weight infants. Pediatr Infect Dis J. 2018 Jun;37(6):e169–e172.
  • Maede Y, Ibara S, Nagasaki H, et al. Micafungin versus fluconazole for prophylaxis against fungal infections in premature infants. Pediatr Int. 2013 Dec;55(6):727–730.
  • van Burik JA, Ratanatharathorn V, Stepan DE, et al. Micafungin versus fluconazole for prophylaxis against invasive fungal infections during neutropenia in patients undergoing hematopoietic stem cell transplantation. Clin Infect Dis. 2004 Nov 15;39(10):1407–1416.
  • Kim BK, Choi JY, Hong KT, et al. Prospective study on prophylactic micafungin sodium against invasive fungal disease during neutropenia in pediatric & adolescent patients undergoing autologous hematopoietic stem cell transplantation. Children (Basel). 2022 Mar 7;9(3). DOI:10.3390/children9030372
  • El Cheikh J, Ceballos P, Dalle JH, et al. Micafungin prophylaxis in routine medical practice in adult and pediatric patients with hematological malignancy: a prospective, observational study in France. Diagn Microbiol Infect Dis. 2019 Jul;94(3):268–273.
  • Food and Drug Administration. Mycamine (R). Highlights of prescribing information last accessed 1 Jul 2022]. Available at 2022 Jul 1: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021506s023lbl.pdf.
  • Benjamin DK Jr., Poole C, Steinbach WJ, et al. Neonatal candidemia and end-organ damage: a critical appraisal of the literature using meta-analytic techniques. Pediatrics. 2003 Sep;112(3 Pt 1):634–640.
  • Zaoutis TE, Heydon K, Localio R, et al. Outcomes attributable to neonatal candidiasis. Clin Infect Dis. 2007 May 1;44(9):1187–1193.
  • Andes D. Regulatory level of evidence and practicality in antifungal use decisions for less common fungal diseases. Clin Infect Dis. 2021 Dec 16;73(12):2341–2343.
  • Ascher SB, Smith PB, Watt K, et al. Antifungal therapy and outcomes in infants with invasive Candida infections. Pediatr Infect Dis J. 2012 May;31(5):439–443.
  • Driessen M, Ellis JB, Cooper PA, et al. Fluconazole vs. amphotericin B for the treatment of neonatal fungal septicemia: a prospective randomized trial. Pediatr Infect Dis J. 1996 Dec;15(12):1107–1112.
  • Linder N, Klinger G, Shalit I, et al. Treatment of candidaemia in premature infants: comparison of three amphotericin B preparations. J Antimicrob Chemother. 2003 Oct;52(4):663–667.
  • NDA multi-disciplinary review and evaluation NDA 21506/S-023: mycamine (micafungin sodium), 2019 last accessed 1 Jul 2022]. Available at 2022 Jul 1: https://www.fda.gov/media/134936/download.
  • Borman AM, Szekely A, Johnson EM. Isolates of the emerging pathogen Candida auris present in the UK have several geographic origins. Med Mycol. 2017 Jul 1;55(5):563–567.
  • Briano F, Magnasco L, Sepulcri C, et al. Candida auris Candidemia in Critically Ill, Colonized Patients: cumulative Incidence and Risk Factors. Infect Dis Ther. 2022 Jun;11(3):1149–1160.
  • Chakrabarti A, Sood P, Rudramurthy SM, et al. Incidence, characteristics and outcome of ICU-acquired candidemia in India. Intensive Care Med. 2015 Feb;41(2):285–295.
  • Chowdhary A, Anil Kumar V, Sharma C, et al. Multidrug-resistant endemic clonal strain of Candida auris in India. Eur J Clin Microbiol Infect Dis. 2014 Jun;33(6):919–926.
  • Chowdhary A, Sharma C, Meis JF. Candida auris: a rapidly emerging cause of hospital-acquired multidrug-resistant fungal infections globally. PLoS Pathog. 2017 May;13(5):e1006290.
  • Di Pilato V, Codda G, Ball L, et al. Molecular epidemiological investigation of a nosocomial cluster of C. auris: evidence of recent emergence in Italy and ease of transmission during the COVID-19 pandemic. J Fungi. 2021 Feb 15;7(2):140.
  • Lone SA, Ahmad A. Candida auris-the growing menace to global health. Mycoses. 2019 Aug;62(8):620–637.
  • Mesini A, Saffioti C, Mariani M, et al. First case of candida auris colonization in a preterm, extremely low-birth-weight newborn after vaginal delivery. J Fungi. 2021 Aug 10;7(8):649.
  • Osei Sekyere J. Candida auris: a systematic review and meta-analysis of current updates on an emerging multidrug-resistant pathogen. Microbiologyopen. 2018 Aug;7(4):e00578.
  • Perlin DS. Echinocandin Resistance in Candida. Clin Infect Dis. 2015 Dec 1;6(Suppl 6):S612–7.
  • Al-Baqsami ZF, Ahmad S, Khan Z. Antifungal drug susceptibility, molecular basis of resistance to echinocandins and molecular epidemiology of fluconazole resistance among clinical Candida glabrata isolates in Kuwait. Sci Rep. 2020 Apr 10;10(1):6238.
  • Sharma D, Paul RA, Rudramurthy SM, et al. Impact of FKS1 genotype on echinocandin in vitro susceptibility in candida auris and in vivo response in a murine model of infection. Antimicrob Agents Chemother. 2022 Jan 18;66(1):e0165221.
  • Kordalewska M, Lee A, Park S, et al. Understanding echinocandin resistance in the emerging pathogen Candida auris. Antimicrob Agents Chemother. 2018 May 25;62(6):e00238–18.
  • Johnson MD, Lewis RE, Dodds Ashley ES, et al. Core recommendations for antifungal stewardship: a statement of the mycoses study group education and research consortium. J Infect Dis. 2020 Aug 5;222(Suppl 3):S175–S198.

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