Leitura clínica
Comentário
É proteína fusão que inibe fator necrose tumoral alfa (TNFα); usado em doenças autoimunes como artrite reumatoide, artrite psoriásica, psoríase espondilite anquilosante. Administração subcutânea uma ou duas vezes por semana durante 12 a 24 semanas. Possivelmente devido seu elevadíssimo peso molecular alta fixação a proteínas plasmáticas, excreta-se no leite materno em quantidade clinicamente insignificante (Bertrand 2023, Butler 2014, Berthelsen 2010, Keeling 2010, Murashima 2009, Østensen 2007, 2006 y 2004). Níveis plasmáticos bebês que mamam de mães a que se administra Etanercept são indetectáveis ou muito baixos (Berthelsen 2010, Keeling 2010, Murashima 2009). Não foram observados problemas curto ou longo prazo desenvolvimento nem infecciosos ou imunológicos, nem problemas vacinação bebês que mamam de mães que tomam Etanercept (Bertrand 2023, Membrive 2023, Dall'ara 2016, Calligaro 2015, Butler 2014, Keeling 2010), salvo um caso bebê 3 meses que apresentou sonolência, dificuldades alimentar-se e hipotonía uma semana que sua mãe, afetada espondilite anquilosante, começasse tratamento com etanercept. Amamentação persistiu até 5 meses (Eskiyurt 2026). Sua nula biodisponibilidade oral dificultaria passe a plasma bebê que mama a partir leite materno ingerido (Amin 2018, Grunewald 2015, Mervic 2014, Butler 2014, Hyrich 2013, Bae 2012, Keeling 2010), salvo em prematuros e período neonatal imediato, em que pode haver maior permeabilidade intestinal. Esperar duas semanas após parto antes retomar tratamento permite que níveis plasmáticos recém-nascido desçam dos prévios intraútero e também reduz ao mínimo transmissão ao bebê (Krysko 2023). TNF alfa intervém produção leite, que poderia explicar que vários fármacos anti-TNF como adalimumab, infliximab, golimumab, certolizumab e etanercept, possam aumentar risco insuficiência amamentação (Yan 2026). Numerosos especialistas e sociedades científicas Reumatologia Dermatologia consideram muito baixo risco e, portanto compatível, seu uso durante amamentação (Rüegg 2025, Russell 2023, Sammaritano 2020, Amin 2018, Flint 2016, Götestam 2016, Dall'ara 2016, Grunewald 2015, Witzel 2014, Nielsen 2014, Mervic 2014, Butler 2014, Hyrich 2013, Habal 2012, Berthelsen 2010, Keeling 2010, Fischer 2010, Murashima 2009). Pode consultar abaixo informação deste produto relacionado: Artrite Reumatoide (AR) 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 7
- TNR-001; rhu-TNFR:Fc
- Ετανερσέπτη
- إيتانيرسابت
- Этанерцепт
- 依那西普
- エタネルセプト
- L04AB01
Marcas comerciais na fonte 10
- Benepali
- Brenzys
- Enbrel
- Enbrel (Энбрел)
- Enbrel (恩利)
- Enerceptan
- Erelzi
- Eticovo
- Nepexto
- Yisaipu (益赛普)
Dados da fonte
Farmacocinética
| Variável | Valor | Unidade |
|---|---|---|
| Biodisp. oral | ≈ 0 | % |
| Peso Molecular | 150.000 | daltons |
| Vd | 0,24 | l/Kg |
| Tmax | 72 | horas |
| T½ | 70 - 115 | horas |
| Índice L/P | 0,0001 | - |
| Dosis Teórica | <0,011 | mg/Kg/d |
| Dosis Relativa | 0,07 - 1,9 | % |
| Dosis Rel. Ped. | <2,8 | % |
Rastreabilidade
Bibliografia
- Eskiyurt B, Horoz E, Bakırlı DC, Gungor M, Karadas B, Kaplan YC. Possible Association Between Etanercept Use During Breastfeeding and Infant Somnolence, Hypotonia, and Feeding Difficulties: A Case Report and Literature Review. Breastfeed Med. 2026 May 6:15568253261446227. Resumen
- Yan Z, Chen H, Sun J, Chen T, Zhang W, He Y, He J, Zhang C. Divergent safety profiles of TNF inhibitors in pregnancy: a comprehensive pharmacovigilance analysis of the FAERS database. J Autoimmun. 2026 May;160:103553. Resumen
- Rüegg L, Pluma A, Hamroun S, Cecchi I, Perez-Garcia LF, Anderson PO, Andreoli L, Wirström SB, Boyadhzieva V, Chambers C, Costedoat-Chalumeau N, Dolhain RJEM, Fischer-Betz R, Giles I, Gøtestam-Skorpen C, Hoeltzenbein M, Marchiori F, Mayer-Pickel K, Molto A, Nelson-Piercy C, Nielsen OH, Tincani A, et al. EULAR recommendations for use of antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. Ann Rheum Dis. 2025 Jun;84(6):910-926. Resumen Texto completo (enlace a fuente original)
- Pluma A, Hamroun S, Rüegg L, Cecchi I, Kramer M, Perez-Garcia LF, Rivero T, Finckh A, Meissner Y, Förger F. Antirheumatic drugs in reproduction, pregnancy, and lactation: a systematic literature review informing the 2024 update of the EULAR recommendations. Ann Rheum Dis. 2025 Sep;84(9):1561-1590. Resumen Texto completo (enlace a fuente original)
- Russell MD, Dey M, Flint J, Davie P, Allen A, Crossley A, Frishman M, Gayed M, Hodson K, Khamashta M, Moore L, Panchal S, Piper M, Reid C, Saxby K, Schreiber K, Senvar N, Tosounidou S, van de Venne M, Warburton L, Williams D, Yee CS, et al. British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2023 Apr 3;62(4):e48-e88. Resumen Texto completo (enlace a fuente original)
- Membrive-Jiménez C, Sánchez-Piedra C, Martínez-González O, García-González J, Expósito-Pérez L, Bohórquez-Heras C, Campos-Fernández C, Sanchez-Alonso F, Cáliz-Cáliz R, Castrejón-Fernández I. Safety and effectiveness of bDMARDs during pregnancy in patients with rheumatic diseases: Real-world data from the BIOBADASER registry. Reumatol Clin (Engl Ed). 2023 Nov;19(9):500-506. Resumen Texto completo (enlace a fuente original)
- Bertrand K, Rossi S, Wells A, Best B, Chambers CD. The Concentration of Etanercept in Human Milk and Infant Outcomes. J Rheumatol. 2023 May;50(5):712-714. Resumen Texto completo (enlace a fuente original)
- Krysko KM, Dobson R, Alroughani R, Amato MP, Bove R, Ciplea AI, Fragoso Y, Houtchens M, Jokubaitis VG, Magyari M, Abdelnasser A, Padma V, Thiel S, Tintore M, Vukusic S, Hellwig K. Family planning considerations in people with multiple sclerosis. Lancet Neurol. 2023 Apr;22(4):350-366. Resumen
- Sammaritano LR, Bermas BL, Chakravarty EE, Chambers C, Clowse MEB, Lockshin MD, Marder W, Guyatt G, Branch DW, Buyon J, Christopher-Stine L, Crow-Hercher R, Cush J, Druzin M, Kavanaugh A, Laskin CA, Plante L, Salmon J, Simard J, Somers EC, Steen V, Tedeschi SK, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 2020 Apr;72(4):529-556. Resumen Texto completo (enlace a fuente original)
- EMA. Etanercept. Drug Summary. 2018 Texto completo (en nuestros servidores)
- Amin M, No DJ, Egeberg A, Wu JJ. Choosing First-Line Biologic Treatment for Moderate-to-Severe Psoriasis: What Does the Evidence Say? Am J Clin Dermatol. 2018 Feb;19(1):1-13. Resumen
- EMA. Etanercept. Ficha técnica. 2018 Texto completo (en nuestros servidores)
- Flint J, Panchal S, Hurrell A, van de Venne M, Gayed M, Schreiber K, Arthanari S, Cunningham J, Flanders L, Moore L, Crossley A, Purushotham N, Desai A, Piper M, Nisar M, Khamashta M, Williams D, Gordon C, Giles I; BSR and BHPR Standards, Guidelines and Audit Working Group. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016 Sep;55(9):1693-7. Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Dall'ara F, Reggia R, Bazzani C, Andreoli L, Agosti M, Mazza G, Lazzaroni MG, Lojacono A, Motta M, Tincani A. Safety of anti-TNF alfa agents during pregancy and breastfeeding: longterm follow up of exposed children in a case-series of mothers with chronic arthritides. Ann Rheum Dis 2016;75 (Suppl 2):493. Abstract Resumen
- Götestam Skorpen C, Hoeltzenbein M, Tincani A, Fischer-Betz R, Elefant E, Chambers C, da Silva J, Nelson-Piercy C, Cetin I, Costedoat-Chalumeau N, Dolhain R, Förger F, Khamashta M, Ruiz-Irastorza G, Zink A, Vencovsky J, Cutolo M, Caeyers N, Zumbühl C, Østensen M. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016 May;75(5):795-810. Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Calligaro A, Hoxha A, Ruffatti A, Punzi L. Are biological drugs safe in pregnancy? Reumatismo. 2015 Resumen Texto completo (enlace a fuente original)
- Grunewald S, Jank A. New systemic agents in dermatology with respect to fertility, pregnancy, and lactation. J Dtsch Dermatol Ges. 2015 Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- 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
- Witzel SJ. Lactation and the use of biologic immunosuppressive medications. Breastfeed Med. 2014 Dec;9(10):543-6. Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Hyrich KL, Verstappen SM. Biologic therapies and pregnancy: the story so far. Rheumatology (Oxford). 2014 Aug;53(8):1377-85. Resumen Texto completo (en nuestros servidores)
- 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)
- Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014 Feb;11(2):116-27. Resumen
- Habal FM, Huang VW. Review article: a decision-making algorithm for the management of pregnancy in the inflammatory bowel disease patient. Aliment Pharmacol Ther. 2012 Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Bae YS, Van Voorhees AS, Hsu S, Korman NJ, Lebwohl MG, Young M, Bebo B Jr, Kimball AB; National Psoriasis Foundation. Review of treatment options for psoriasis in pregnant or lactating women: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2012 Resumen
- Keeling S, Wolbink GJ. Measuring multiple etanercept levels in the breast milk of a nursing mother with rheumatoid arthritis. J Rheumatol. 2010 Jul;37(7):1551. Resumen
- Berthelsen BG, Fjeldsøe-Nielsen H, Nielsen CT, Hellmuth E. Etanercept concentrations in maternal serum, umbilical cord serum, breast milk and child serum during breastfeeding. Rheumatology (Oxford). 2010 Nov;49(11):2225-7. Resumen
- Fischer-Betz RE, Schneider M. [Biologics during pregnancy and breast--feeding]. Z Rheumatol. 2010 Resumen
- Murashima A, Watanabe N, Ozawa N, Saito H, Yamaguchi K. Etanercept during pregnancy and lactation in a patient with rheumatoid arthritis: drug levels in maternal serum, cord blood, breast milk and the infant's serum. Ann Rheum Dis. 2009 Nov;68(11):1793-4. Resumen
- Østensen M, Motta M. Therapy insight: the use of antirheumatic drugs during nursing. Nat Clin Pract Rheumatol. 2007 Resumen
- Østensen M, Khamashta M, Lockshin M, Parke A, Brucato A, Carp H, Doria A, Rai R, Meroni P, Cetin I, Derksen R, Branch W, Motta M, Gordon C, Ruiz-Irastorza G, Spinillo A, Friedman D, Cimaz R, Czeizel A, Piette JC, Cervera R, Levy RA, et al. Anti-inflammatory and immunosuppressive drugs and reproduction. Arthritis Res Ther. 2006 Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Ostensen M, Eigenmann GO. Etanercept in breast milk. J Rheumatol. 2004 May;31(5):1017-8. No abstract available. Resumen