Ustequinumabe

Nome original: Ustekinumab

Compatibilidade

Compatível

Seguro, melhor opção

Produto seguro e/ou a amamentação é a melhor opção.

Leia o comentário completo: o nível resume o risco, mas não substitui contexto clínico, dose, idade do bebê ou orientação profissional.

Outros nomes
Inmunoglobulina G1 CNTO-1275, أوستيكينوماب, Устекинумаб, 乌司奴单抗, ウステキヌマブ, L04AC05
Marcas comerciais
Stelara, Stelara (Стелара)
Procedência
Dados editoriais
Tradução
Pendente de revisão
Grupo ATC
L04
Fonte
Abrir original

Comentário

Anticorpo monoclonal humano IgG1 que se une às interleucinas 12 e 23. É utilizado no tratamento da psoríase em placas grave, da artrite psoriásica e da doença de Crohn e colite ulcerativa. Administração intravenosa e subcutânea a cada 12 semanas. Seus dados farmacocinéticos (peso molecular muito elevado e amplo volume de distribuição) explicam a passagem ínfima para o leite materno observada. (Saito 2022, Bar-Gil 2021, Klenske 2019, Matro 2018) Não foram observados problemas clínicos nem maior taxa de infecções nem problemas com as vacinações rotineiras em lactentes de mães em tratamento com este fármaco. (Saito 2022, Bar-Gil 2021, Klenske 2019, Mugheddu 2019, Matro 2018) 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 (Lactmed, Rademaker 2018, Bragnes 2017, Götestam 2016, Mervic 2014, Witzel 2014, Butler 2014) , exceto em prematuros e no período neonatal imediato, nos quais pode haver maior absorção intestinal. (Sammaritano 2020) Não foram detectados problemas em lactentes cujas mães recebiam outros anticorpos monoclonais similares, como belimumab, bevacizumab, infliximab, ituximab, tocilizumab ou ustekinumab. (Bar-Gil 2021, LaHue 2020, Saito 2020, 2019 and 2018, Klenske 2019, Mugheddu 2019, Krysko 2019, Matro 2018, Bragnes 2017, Hyrich 2014, Danve 2014) Diversas sociedades médicas, autores especialistas e consensos de especialistas consideram compatível ou provavelmente compatível o uso desta medicação durante a amamentação. (Lactmed, Hale, Bar-Gil 2021, Laube 2021, Gisbert 2020, Sammaritano 2020, Lamb 2019, Picardo 2019, Mahadevan 2019, Amin 2018, Götestam 2016, McConnell 2016) Dada a forte evidência existente sobre os benefícios da amamentação materna para o desenvolvimento dos bebês e a saúde das mães, convém avaliar o risco-benefício de qualquer tratamento materno, assessorando individualmente cada mãe que deseje seguir com a amamentação. (Koren 2013)

Outros nomes e marcas

Sinônimos e grafias 6
  • Inmunoglobulina G1 CNTO-1275
  • أوستيكينوماب
  • Устекинумаб
  • 乌司奴单抗
  • ウステキヌマブ
  • L04AC05
Marcas comerciais na fonte 2
  • Stelara
  • Stelara (Стелара)

Farmacocinética

VariávelValorUnidade
Biodisp. oral0%
Peso Molecular148.600daltons
Vd0,06 - 0,16l/Kg
Tmax168 - 324horas
480 (360 - 768)horas
Índice L/P0,001 - 0,027-
Dosis Teórica0,0005 - 0,24mg/Kg/d

Bibliografia

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  2. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consultado el 10 de Abril de 2024 Texto completo (enlace a fuente original)
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  15. Saito J, Yakuwa N, Kaneko K, Takai C, Goto M, Nakajima K, Yamatani A, Murashima A. Tocilizumab during pregnancy and lactation: drug levels in maternal serum, cord blood, breast milk and infant serum. Rheumatology (Oxford). 2019 Aug 1;58(8):1505-1507. Resumen
  16. Mugheddu C, Atzori L, Lappi A, Murgia S, Rongioletti F. Biologics exposure during pregnancy and breastfeeding in a psoriasis patient. Dermatol Ther. 2019 May;32(3):e12895. Resumen
  17. Klenske E, Osaba L, Nagore D, Rath T, Neurath MF, Atreya R. Drug Levels in the Maternal Serum, Cord Blood and Breast Milk of a Ustekinumab-Treated Patient with Crohn's Disease. J Crohns Colitis. 2019 Feb 1;13(2):267-269. Resumen
  18. Picardo S, Seow CH. A Pharmacological Approach to Managing Inflammatory Bowel Disease During Conception, Pregnancy and Breastfeeding: Biologic and Oral Small Molecule Therapy. Drugs. 2019 Jul;79(10):1053-1063. Resumen
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  32. Mervic L. Management of moderate to severe plaque psoriasis in pregnancy and lactation in the era of biologics. Acta Dermatovenerol Alp Pannonica Adriat. 2014;23(2):27-31. Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
  33. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014 Mar;70(3):417.e1-10; quiz 427. Resumen
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  35. Ross E, Robinson SE, Amato C, McMillan C, Westcott J, Wolf T, Robinson WA. Therapeutic monoclonal antibodies in human breast milk: a case study. Melanoma Res. 2014 Apr;24(2):177-80. Resumen
  36. Pistilli B, Bellettini G, Giovannetti E, Codacci-Pisanelli G, Azim HA Jr, Benedetti G, Sarno MA, Peccatori FA. Chemotherapy, targeted agents, antiemetics and growth-factors in human milk: how should we counsel cancer patients about breastfeeding? Cancer Treat Rev. 2013 May;39(3):207-11. Resumen
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  38. Ustekinumab. Ficha técnica. 2013 Texto completo (en nuestros servidores)
  39. Weber J, Keam SJ. Ustekinumab. BioDrugs. 2009 Resumen

Como ler os níveis

  1. CompatívelSeguro, melhor opção
  2. Compatibilidade provávelBastante seguro
  3. Compatibilidade limitadaPouco seguro
  4. IncompatívelMuito inseguro

A cor ajuda a localizar o nível; o símbolo, o rótulo e o texto trazem a mesma informação.