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Inicio Enfermedades Infecciosas y Microbiología Clínica ¿Por qué micafungina puede ser de elección en el paciente pediátrico?
Journal Information
Vol. 29. Issue S2.
Micafungina: nuevos retos y nuevas posibilidades en el tratamiento de la infección fúngica invasora
Pages 23-28 (March 2011)
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Vol. 29. Issue S2.
Micafungina: nuevos retos y nuevas posibilidades en el tratamiento de la infección fúngica invasora
Pages 23-28 (March 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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José Tomás Ramos Amadora,
Corresponding author
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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