Leitura clínica
Comentário
Anticorpo monoclonal humanizado contra o fator de necrose tumoral alfa (TNFα) usado em doenças autoimunes como artrite reumatoide, espondiloartrite axial, espondilite anquilosante, artrite psoriásica e doença de Crohn com má resposta à terapia convencional. Administração injetada subcutânea a cada 2 semanas durante meses. Não foram encontrados níveis detectáveis ou muito baixos no leite materno (Morita 2018, Matro 2018, EMA 2018, Clowse 2017, Förger 2016, Mahadevan 2013), provavelmente devido ao seu peso molecular elevadíssimo. O polietilenoglicol de sua parte peguilada tampouco é excretado no leite materno. (Clowse 2017) Por sua natureza proteica, é inativado no trato gastrointestinal, não sendo absorvido (biodisponibilidade oral praticamente nula), o que dificulta ou impede a passagem para o plasma do lactente a partir do leite materno ingerido. (Anderson 2018). Não foram observados problemas a curto ou longo prazo de desenvolvimento, nem infecciosos ou imunológicos, nem problemas com a vacinação em lactentes de mães que o tomavam (Sahuquillo 2024, Membrive 2023, Lambiase 2022, Pieto 2021, Matro 2018, Clowse 2017, Mahadevan 2013 y 2012), e não foram detectados níveis, ou foram muito baixos, no plasma desses lactentes. (Mahadevan 2013) Os fármacos anti-TNF reduzem os níveis de fator de necrose tumoral (TNF) no leite materno (Sepiashvili 2025). Convém vigiar a produção de leite, já que essa redução do TNF, que intervém na produção de leite, poderia aumentar o risco de insuficiência de amamentação. (Yan 2026) O fabricante (EMA 2018), autores especialistas e associações médicas o consideram compatível com a amamentação. (Hale, Rüegg 2025, Mahadevan 2025, Hoxha 2025, Torres 2023, Russell 2023, Thatiparthi 2021, Owczarek 2020, Sammaritano 2020, Smith 2020, Yeung 2020, Lamb 2019, Picardo 2019, Mahadevan 2019 y 2017, Amin 2018, Matro 2018, Clowse 2017, Flint 2016, Götestam-EULAR 2016, Briggs 2015, Damas 2015, Chaparro 2015, Nielsen 2014, Witzel 2014, Gisbert 2013 y 2011, Yarur 2013, Mahadevan 2011, van der Woude 2010, Fischer 2010) Pode consultar abaixo a informação destes produtos relacionados: Artrite Reumatoide (AR) Materna (Bastante seguro. Efeitos adversos leves ou pouco prováveis. Compatível em determinadas circunstâncias. Acompanhamento recomendado. Leia o Comentário.) Doença inflamatória intestinal (DII) materna (Bastante seguro. Efeitos adversos leves ou pouco prováveis. Compatível em determinadas circunstâncias. Acompanhamento recomendado. Leia o Comentário.) Polietilenoglicol (PEG) (Produto seguro e/ou a amamentação é a melhor opção.)
Encontrabilidade
Outros nomes e marcas
Sinônimos e grafias 7
- Κερτολιζουμάμπη
- سارتوليزوماب بيغول
- Цертолизумаб Пегол
- 培舍珠单抗
- セルトリズマブ ペゴル
- CDP-870; PHA-738144
- L04AB05
Marcas comerciais na fonte 1
- Cimzia
Dados da fonte
Farmacocinética
| Variável | Valor | Unidade |
|---|---|---|
| Biodisp. oral | ≈ 0 | % |
| Peso Molecular | 91.000 | daltons |
| Vd | 0,11 | l/Kg |
| Tmax | 54 - 171 | horas |
| T½ | 336 | horas |
| Índice L/P | 0,0016 | - |
| Dosis Teórica | 0 - 0,04 | mg/Kg/d |
| Dosis Relativa | 0 - 0,3 | % |
Rastreabilidade
Bibliografia
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