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Inicio Enfermedades Infecciosas y Microbiología Clínica ¿Por qué micafungina puede ser de elección en el paciente pediátrico?
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Vol. 29. Núm. S2.
Micafungina: nuevos retos y nuevas posibilidades en el tratamiento de la infección fúngica invasora
Páginas 23-28 (Marzo 2011)
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Vol. 29. Núm. S2.
Micafungina: nuevos retos y nuevas posibilidades en el tratamiento de la infección fúngica invasora
Páginas 23-28 (Marzo 2011)
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¿Por qué micafungina puede ser de elección en el paciente pediátrico?
Why might micafungin be the drug of choice in pediatric patients?
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3008
José Tomás Ramos Amadora,
Autor para correspondencia
jtramos.hugf@salud.madrid.org

Autor para correspondencia.
, Luis Prieto Tatob, Sara Guillén Martínb
a Unidad de Enfermedades Infecciosas, Servicio de Pediatría, Hospital Universitario de Getafe, Madrid, España
b Servicio de Pediatría, Hospital Universitario de Getafe, Madrid, España
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Resumen

La micafungina es una equinocandina aprobada por la European Medicines Agency como tratamiento de la candidiasis invasora en niños, incluidos grandes prematuros, y como profilaxis en niños sometidos a trasplante de progenitores hematopoyéticos (TPH), o en quienes se prevea una duración prolongada de la neutropenia. Tiene buena actividad sobre diferentes especies de Candida spp., incluidas las resistentes a fluconazol. Aunque tiene actividad sobre Aspergillus spp., se ha utilizado sobre todo en terapia de combinación en aspergilosis invasoras. Se dispone de una amplia información del uso de micafungina en niños, incluidos neonatos, siendo la única equinocandina aprobada en menores de 3 meses. Se ha evaluado su eficacia, farmacocinética y seguridad en ensayos en fases II y III en niños, en los que ha demostrado su eficacia y seguridad en estudios comparativos con anfotericina B liposomal y fluconazol. Micafungina tiene un perfil farmacocinético en niños que permite su dosificación intravenosa 1 vez al día, con un aclaramiento aumentado respecto al adulto, por lo que las dosis pediátricas son relativamente más altas. La dosis más apropiada en niños menores de 40 kg es de 2 mg/kg/día como tratamiento de candidiasis invasora y de 1 mg/kg/día como profilaxis en niños sometidos a TPH. En neonatos las dosis deben ser superiores. En prematuros, las dosis más apropiadas para alcanzar valores en parénquima cerebral deberían ser de 7 mg/kg/día y de 10 mg/kg en mayores y menores de 1.000 g, respectivamente. Tiene escasas interacciones medicamentosas y un aceptable perfil de seguridad, siendo rara la retirada de la medicación por efectos adversos, si bien se recomienda la monitorización de las transaminasas durante el tratamiento, y la valoración del riesgo-beneficio en pacientes con hepatopatía o administración conjunta de agentes hepatotóxicos.

Palabras clave:
Niños
Prematuros
Micafungina
Abstract

Micafungin is an echinocandin approved by the European Medicines Evaluation Agency for the treatment of invasive candidiasis in children, including premature infants born before 29 weeks of pregnancy, and as prophylaxis in children undergoing hematopoietic stem-cell transplantation or patients at risk of prolonged neutropenia. This drug has good activity in several Candida spp., including those resistant to fluconazole. Although micafungin is active against Aspergillus spp., it has been used mainly in combination therapy for invasive aspergillosis. There is ample information on the use of micafungin in children, including neonates, and this drug is the only echinocandin approved for use in infants aged less than 3 months. The efficacy, pharmacokinetics and safety of micafungin have been evaluated in phase II and III clinical trials in children, in which its efficacy and safety were demonstrated in comparison with liposomal amphotericin B and fluconazole. The pharmacokinetic profile of micafungin in children allows once daily intravenous administration, with greater clearance than in adults, and consequently pediatric doses are relatively higher. The most appropriate dose in children weighing less than 40 kg is 2 mg/kg/day in the treatment of invasive candidiasis and 1 mg/kg/day as prophylaxis in children undergoing hematopoietic stem-cell transplantation. Doses in neonates should be higher. In premature infants, the most appropriate doses to achieve levels in the brain parenchyma are 7 mg/kg/day and 10 mg/kg/day in those weighing more and less than 1,000 g, respectively. Micafungin has few drug-drug interactions and an acceptable safety profile. Withdrawal of this drug due to adverse effects is rare, although transaminase monitoring is recommended during treatment, as well as evaluation of the risk-benefit balance in patients with liver disease or concomitant administration of hepatotoxic drugs.

Keywords:
Children
Premature infants
Micafungin
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Bibliografía
[1.]
W.J. Steinbach, T.J. Walsh.
Mycosis in pediatric patients.
Infect Dis Clin North Am, 20 (2006), pp. 663-678
[2.]
K.A. Marr, F. Carter, F. Crippa, A. Wald, L. Corey.
Epidemiology and outcome of mould infections in hematopoietic stem cell transplant recipients.
Clin Infect Dis, 34 (2002), pp. 909-917
[3.]
L. Sung.
Invasive fungal infections in children with cancer.
J Pediatr Suppl, 156 (2010), pp. S68-S73
[4.]
D.K. Benjamin, B.J. Stoll, A.A. Fanaroff, S.A. McDonald, W. Oh, R.D. Higgins, et al.
Neonatal candidiasis among extremely low birth weight infants: risk factors, mortality rates, and neurodevelopment outcomes at 18 to 22 months.
Pediatrics, 117 (2006), pp. 84-92
[5.]
D.A. Kauffman.
Neonatal candidiasis: clinical manifestations, management, and prevention strategies.
J Pediatr, 156 (2010), pp. S53-S67
[6.]
L. Saiman, E. Ludington, M. Pfaller, S. Rangel-Frausto, R.T. Wiblin, J. Dawson, et al.
Risk factors for candidemia in neonatal intensive care unit patients. The National Epidemiology of Mycosis Survey study group.
Pediatr Infect Dis J, 19 (2000), pp. 319-324
[7.]
Y. Krupova, D. Sejnova, J. Dzatkova, E. Kaiserova, M. Kiskova, R. Babela, et al.
Prospective study of fungemia in children with cancer: análisis of 35 cases and comparison with 130 fungemias in adults.
Support Care Cancer, 8 (2000), pp. 427-432
[8.]
H.L. Vanderbussche, D.A. Van Loo.
A clinical review of echinocandins in pediatric patients.
Ann Pharmacother, 44 (2010), pp. 166-177
[9.]
M.E. Infante, P. Rojo.
Utilidad clínica de la micafungina en el tratamiento de la candidiasis invasora en el neonato.
Rev Iberoam Micol, 26 (2009), pp. 57-61
[10.]
L. Madero López.
Utilidad clínica de la micafungina en el niño y el adolescente.
Rev Iberoam Micol, 26 (2009), pp. 62-64
[11.]
T. Lehrnbecher, A.H. Groll.
Micafungin: a brief review of pharmacology, safety and antifungal efficacy in pediatric patients.
Pediatr Blood Cancer, 55 (2010), pp. 229-232
[12.]
I. Vescan, A.K. Ketko, J. Sobel.
Spontaneous in vitro resistance to echinocandins among Candida parapsilosis and Candida albicans isolates.
International Conference for Antimicrobial Agents and Chemotherapy (ICAAC),
[13.]
M.A. Pfaller, L. Boyken, R.J. Hollis, J. Kroeger, S.A. Messer, S. Tendolkar, et al.
In vitro susceptibility of invasive isolates of Candida spp. to anidulafungin, caspofungin and micafungin: six years of global surveillance.
J Clin Microbiol, 46 (2008), pp. 150-156
[14.]
N.J. Carter, G.M. Keating.
Micafungin: a review of its use in the prophylaxis and treatment of invasive candidiasis in pediatric patients.
Paediatr Drugs, 11 (2009), pp. 271-291
[15.]
D. Benjamin, P.B. Smith, A. Arrieta, L. Castro, P.J. Sánchez, D. Kaufman, et al.
safety and pharmacokinetics of repeat-dose micafungin in young infants.
Clin Pharm, 87 (2010), pp. 93-99
[16.]
N. Seibel, C. Schwartz, A. Arrieta, P. Flynn, A. Shad, E. Albano, et al.
Safety, tolerability and pharmacokinetics of micafungin (MK 463) in febrile neutropenic pediatric patients.
Antimicrob Agents Chemother, 49 (2005), pp. 3317-3324
[17.]
K. Tabata, M. Katashima, A. Kawamura, Y. Tanigawara, K. Sunagawa.
Linear pharmacokinetics of micafungin and its active metabolite in Japanese pediatric patients with fungal infection.
Biol Pharm Bull, 29 (2006), pp. 1706-1711
[18.]
P.A. Mehta, A.A. Vinks, A. Filipovich, J. Bleesing, S. Jodele, M.B. Jordan, et al.
Alternate-day micafunfin prophylaxis in pediatric patients undergoing hematopoietic stem cell transplantation: a pharmacokinetic study.
Biol Blood Marrow Transplant, 16 (2010), pp. 1458-1462
[19.]
G.P. Heresi, D.R. Gerstmann, M.D. Reed, J.N. Van den Anker, J.L. Blumer, L. Kovanda, et al.
The pharmacokinetics and safety of micafungin, a novel echinocandin, in premature infants.
Pediatr Infect Dis J, 25 (2006), pp. 1110-1115
[20.]
M. Kawada, N. Fukuoka, M. Kondo, K. Okazaki, T. Kusaka, K. Kawada, et al.
Pharmacokinetics of prophylactic micafungin in very-low-birth-weight infants.
Pediatr Infect Dis J, 28 (2009), pp. 840-842
[21.]
P.B. Smith, T.J. Walsh, W. Hope, A. Arrieta, A. Takada, L.L. Kovanda, et al.
Pharmacokinetics of an elevated dosage of micafungin in premature neonates.
Pediatr Infect Dis J, 28 (2009), pp. 412-415
[22.]
W.W. Hope, P.B. Smith, A. Arrieta, D.N. Buell, M. Roy, A. Kaibara, et al.
Population pharmacokinetics of micafungin in neonates and young infants.
Antimicrob Agents Chemother, 54 (2010), pp. 2633-2637
[23.]
O.A. Cornely, P. Maddidon, AJ. Ullman.
Pooled analysis of safety for micafungin.
International Conference for Antimicrobial Agents and Chemotherapy (ICAAC),
[24.]
J.A. Van Burik, V. Ratanatharathorn, D.E. Stepan, C.B. Miller, J.H. Lipton, D.H. Vesole, et al.
Micafungin versus fluconazole for prophylaxis against invasive fungal infections during neutropenia in patients undergoing hematopoietic stem cell transplantation.
Clin Infect Dis, 39 (2004), pp. 1407-1416
[25.]
S.h. Kusuki, Y. Hashii, H. Yoshida, S.h. Takizawa, E. Sato, S. Tokimasa, et al.
Antifungal prophylaxis with micafungin in patients treated for childhood cancer.
Pediatr Blood Cancer, 5 (2009), pp. 605-609
[26.]
E.R. Kuse, P. Chetchotisakd, C.A. Da Cunha, M. Ruhnke, C. Barrios, D. Raghunadharao, et al.
Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial.
Lancet, 369 (2007), pp. 1519-1527
[27.]
F. Queiroz-Telles, E. Berezin, G. Leverger, A. Freire, A. Van der Vyer, T. Chotpitayasunondh, et al.
Micafungin versus liposomal amphotericin B for pediatric patients with invasive candidiasis.
Pediatr Infect Dis J, 27 (2008), pp. 820-827
[28.]
A. Arrieta, F. Queiroz-Telles, E. Berezin, A. Freire, S. Diekmann, S. Koblinger.
Micafungin versus liposomal amphotericinB (AmBisome®) in paediatric patients with invasive candidiasis or candidaemia.
17th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID),
[29.]
P.M. Flynn, N. Seibel, A. Arrieta, D. Facklam, L. Kovanda, W. Lau, et al.
Treatment of invasive aspergillosis (IA) in pediatric patients (Pts) with micafungin (MICA) alone or in combination with other systemic antifungal agents.
46th Interscience Conference for Antimicrobial Agents and Chemotherapy (ICAAC),
[30.]
A. Arrieta, P. Maddison, A.H. Groll.
Micafungin in pediatric patients: assessment of safety in clinical trials.
Interscience Conference for Antimicrobial Agents and Chemotherapy (ICAAC),
[31.]
P.G. Pappas, C.M. Rotstein, R.F. Betts, M. Nucci, D. Talwar, J.J. De Waele, et al.
Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis.
Clin Infect Dis, 45 (2007), pp. 883-893
[32.]
A. Gafter-Gvili, L. Vidal, E. Goldberg, L. Leibovici, M. Paul.
Treatment of invasive candidal infections: systematic review and meta-analysis.
Mayo Clin Proc, 83 (2008), pp. 1011-1021
[33.]
European Medicines Agency Assessment report for mycamine (EMEA/H/C/000734) [consultado 29-9-2010]. Disponible en: http//www.emea.europa.eu/humandocs/PDFs/EPAR/mycamine/H-734-en6.pdf
Copyright © 2011. Elsevier España S.L.. Todos los derechos reservados
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