Leitura clínica
Comentário
Anticorpo monoclonal IgG4k recombinante humanizado que bloqueia a subunidade alfa-4 da integrina humana dificultando a passagem de linfócitos T através das meninges. Uso aprovado no tratamento de formas graves de esclerose múltipla (EMA 2017) e em doença de Crohn rebelde a outros tratamentos (Yarur 2013, FDA 2012). Administração em perfusão intravenosa a cada 4 semanas. Seu peso molecular muito elevado explica o pequeno ou nulo passo ao leite observado (Callegari 2023, Proschmann 2021, Ciplea 2020, Mahadevan 2019, Matro 2018, Proschmann 2018, Hainke 2015, Baker 2015), já que as moléculas de mais de 800-1.000 Da. têm dificuldades para passar ao leite materno. (Hale, Almas 2016, Anderson 2016). Não foram detectados níveis plasmáticos nos bebês que mamam de mães tratadas (Ciplea 2020) e não se observaram problemas clínicos, nem de desenvolvimento, nem infecciosos, nem complicações vacinais nesses bebês que mamam. (Witt 2026, Carrozzo 2025, Camilli 2025, Ciplea 2020, Mahadevan 2019). Por sua natureza proteica é inativado no trato gastrointestinal, não sendo absorvido, (biodisponibilidade oral praticamente nula), o que dificulta ou impede o passo ao plasma do bebê que mama a partir do leite materno ingerido (Lactmed, Rademaker 2018, Bragnes 2017, Götestam 2016, Witzel 2014, Butler 2014, Mervic 2014, Cree 2013), salvo em prematuros e período neonatal imediato, em que pode haver maior permeabilidade intestinal (Sammaritano 2020). Esperar duas semanas após o parto antes de retomar o tratamento permite que os níveis plasmáticos do recém-nascido desçam dos prévios intrauterinos e também reduz ao mínimo a transmissão ao bebê. (Krysko 2023). Autores especialistas consideram seguro ou muito provavelmente seguro o uso deste e outros anticorpos monoclonais durante a amamentação (Shipley 2025, Mahadevan 2025 e 2017, Sánchez 2023, Gklinos 2023, Ciplea 2020, Freedman 2020, Whittam 2019, Dobsosn 2019, Lamb 2019, Langer 2019, Matro 2018, Anderson 2018 e 2016, Almas 2016, Baker 2015, Briggs 2015, Damas 2015, Witzel 2014, Pistilli 2013, van der Woude 2010). Outros autores preferem alternativas com menor excreção no leite materno. (Hoxha 2025, Alroughani 2016). Pode consultar abaixo a informação destes produtos relacionados: Doença inflamatória intestinal (DII) materna (Bastante seguro. Efeitos adversos leves ou pouco prováveis. Compatível em determinadas circunstâncias. Acompanhamento recomendado. Leia o comentário.) Esclerose múltipla materna (Bastante seguro. Efeitos adversos leves ou pouco prováveis. Compatível em determinadas circunstâncias. Acompanhamento recomendado. Leia o comentário.)
Encontrabilidade
Outros nomes e marcas
Sinônimos e grafias 6
- Anti-alfa4 integrina
- ناتاليزوماب
- Натализумаб
- 那他珠单抗
- ナタリズマブ
- L04AA23
Marcas comerciais na fonte 3
- Tizabri (Тизабри)
- Tyruko
- Tysabri
Dados da fonte
Farmacocinética
| Variável | Valor | Unidade |
|---|---|---|
| Biodisp. oral | 0 | % |
| Peso Molecular | 149.000 | daltons |
| Vd | 0,08 | l/Kg |
| T½ | 264 | horas |
| Índice L/P | 0.001 - 0,003 | - |
| Dosis Teórica | 0.14 (0,07 - 0,43) | mg/Kg/d |
| Dosis Relativa | 1,7 - 5,3 | % |
Rastreabilidade
Bibliografia
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