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The use of quantitative clinical pharmacology approaches to support moxidectin dosing recommendations in lactation.
Wood, Nolan D; Smith, Danelle; Kinrade, Sally A; Sullivan, Mark T; Rayner, Craig R; Wesche, David; Patel, Kashyap; Rowland-Yeo, Karen.
Afiliación
  • Wood ND; Certara, Princeton, New Jersey, United States of America.
  • Smith D; Medicines Development for Global Health, Southbank, Victoria, Australia.
  • Kinrade SA; Medicines Development for Global Health, Southbank, Victoria, Australia.
  • Sullivan MT; Medicines Development for Global Health, Southbank, Victoria, Australia.
  • Rayner CR; Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia.
  • Wesche D; Certara, Princeton, New Jersey, United States of America.
  • Patel K; Certara, Princeton, New Jersey, United States of America.
  • Rowland-Yeo K; Certara, Princeton, New Jersey, United States of America.
PLoS Negl Trop Dis ; 18(8): e0012351, 2024 Aug.
Article en En | MEDLINE | ID: mdl-39102440
ABSTRACT
Moxidectin is approved by the US Food and Drug Administration (US FDA) for the treatment of onchocerciasis (river-blindness) due to Onchocerca volvulus in patients aged 12 years and older. In onchocerciasis-endemic areas, mass drug administration (MDA) programs with ivermectin, with or without vector control, aim to control the disease, reduce morbidity, interrupt transmission, and more recently, achieve elimination. Moxidectin has the potential to be used in MDA programs. In countries where onchocerciasis is endemic, infants are often breastfed up to the age of 2 years, suggesting that some women are likely to be lactating during such periodic MDA programs. Quantitative analyses of non-clinical and clinical data using non-compartmental analysis and population based pharmacokinetic (popPK) modeling as well as physiologically based pharmacokinetic modeling (PBPK) were performed to determine the amount of moxidectin excreted in breast milk and subsequent exposures in the infant. The results of the analyses were similar. Concentrations of moxidectin in breast milk followed a similar pattern to those in plasma, with maximum concentrations occurring approximately 4 hours after dosing followed by a rapid decline in both breast milk and plasma. As early as two days after dosing, concentrations of moxidectin in breast milk were below the threshold for acceptable daily intake levels established by the European Medicines Agency (EMA) and FDA for secondary exposures from veterinary use, and below the WHO recommended relative infant dose (RID) safety threshold. The analyses were conducted to support prescribers and policy makers on dosing recommendations for moxidectin in lactation.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Lactancia / Macrólidos Límite: Adult / Female / Humans / Infant Idioma: En Revista: PLoS Negl Trop Dis Asunto de la revista: MEDICINA TROPICAL Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Lactancia / Macrólidos Límite: Adult / Female / Humans / Infant Idioma: En Revista: PLoS Negl Trop Dis Asunto de la revista: MEDICINA TROPICAL Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos