Leitura clínica
Comentário
Anticorpo monoclonal humano IgG1 contra o fator de necrose tumoral usado em doenças autoimunes como artrite reumatoide, artrite idiopática juvenil, espondilite anquilosante, artrite psoriásica, psoríase, hidradenite supurativa, doença de Crohn, colite ulcerosa e uveíte. Administração por via subcutânea semanal ou quinzenalmente. Se excreta no leite materno em quantidade clinicamente não significativa (Matro 2018, Fritzsche 2012, Ben-Horin 2010) e não se observaram problemas clínicos, infecciosos ou de desenvolvimento em bebês cujas mães a tomavam. (Palomino 2025, Bendaoud 2024, Membrive 2023, Matro 2018, Lund 2017, Dall'ara 2016, Julsgaard 2013, Fritzsche 2012, Mishkin 2006, Mahadevan 2006, Vesga 2005) Os níveis no plasma desses bebês foram indetectáveis ou muito baixos. (Julsgaard 2013, Fritzsche 2012) Por sua natureza proteica é inativada no trato gastrointestinal, não sendo absorvida, (biodisponibilidade oral praticamente nula), o que dificulta ou impede a passagem para o plasma do bebê que mama a partir do leite materno ingerido (Lactmed, Anderson 2021, Rademaker 2018, Götestam 2016, Witzel 2014, Butler 2014, Mervic 2014), exceto em prematuros e período neonatal imediato, em que pode haver maior permeabilidade intestinal (Sammaritano 2020). Possivelmente convenha evitar seu uso na primeira semana após o parto: pode haver passagem significativa de IgG para o leite até os primeiros 3-4 dias pós-parto. Esperar duas semanas após o parto antes de retomar o tratamento permite que os níveis plasmáticos do recém-nascido desçam dos anteriores intra-útero e também reduz ao mínimo a transmissão ao bebê. (Krysko 2023) Foi publicado um caso de neutropenia congênita precoce em um recém-nascido cuja mãe tomava adalimumab por uma doença de Crohn e isoniazida por uma tuberculose. (van den Broek 2018) Os fármacos anti-TNF reduzem os níveis de fator de necrose tumoral no leite materno (Sepiashvili 2025). Esta redução do TNF, que intervém na produção de leite, poderia aumentar o risco de insuficiência de amamentação. (Yan 2026) O fabricante (Amgen 2017, EMA 2010) considera seguro o uso desta medicação durante a amamentação. Numerosos especialistas e sociedades científicas de Reumatologia, Gastroenterologia e Dermatologia consideram de muito baixo risco e, portanto, compatível seu uso durante a amamentação. (Hale, Mahadevan 2025, Rüegg 2025, Torres 2023, Russell 2023, Owczarek 2020, Yeung 2020, Sammaritano 2020 e 2014, Lamb 2019, Mahadevan 2019 e 2013, Picardo 2019, Amin 2018, Nguyen 2016, Flint 2016, McConnell 2016, Gotestam 2016, Huang 2016 e 2014, Briggs 2015, Grunewald 2015, Damas 2015, van der Woude 2015 e 2010, Nielsen 2014, Witzel 2014, Butler 2014, Schulze 2014, Yarur 2013, Bae 2012, 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.)
Encontrabilidade
Outros nomes e marcas
Sinônimos e grafias 6
- Αδαλιμουμάμπη
- أداليموماب
- Адалимумаб
- 阿达木单抗
- アダリムマブ
- L04AB04
Marcas comerciais na fonte 12
- Abrilada
- Amgevita
- Hadlima
- Hulio
- Humira
- Humira (Хумира)
- Humira (修美乐)
- Hyrimoz
- Idacio
- Imraldi
- Xilbrilada
- Yuflyma
Dados da fonte
Farmacocinética
| Variável | Valor | Unidade |
|---|---|---|
| Biodisp. oral | 0 | % |
| Peso Molecular | 148.000 | daltons |
| Unión proteínas | 0 | % |
| Vd | 0,07 - 0,09 | l/Kg |
| Tmax | 131 | horas |
| T½ | 360 (240 - 480) | horas |
| Índice L/P | 0,01 | - |
| Dosis Teórica | 0,00465 | mg/Kg/d |
| Dosis Relativa | 0,7 | % |
Rastreabilidade
Bibliografia
- LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consultado el 16 de Abril de 2024 Texto completo (enlace a fuente original)
- 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)
- Palomino L, Velasco Rodríguez-Belvís M, Casanova MJ, Leo-Carnerero E, Calviño-Suárez C, Rivero M, Calvo M, Arroyo MT, Fernández-Clotet A, Pérez-Martínez I, Masedo González Á, Hernández V, Ruiz-Cerulla A, López Serrano P, Vega P, Rodríguez-Lago I, Lidón RV, De Jorge MÁ, Guerra I, García LA, Molina Arriero G, Hervías Cruz D, et al. Psychomotor Development in Infants Following Maternal Exposure to Biologics: Results From the DUMBO Registry. Clin Gastroenterol Hepatol. 2026 Jun;24(6):1688-1701. Resumen Texto completo (enlace a fuente original)
- 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
- Sepiashvili L, Brydon A, Koroshegyi C, Gold A, Dalvi P, Ghayoori S, Rahman M, Huang V, Maxwell C, Nguyen GC, Ito S. Reduction of tumor necrosis factor (TNF) in milk of women receiving anti-TNF antibody. Pediatr Res. 2025 May;97(6):1935-1942. Resumen
- Hoxha T, Youssef M, Huang V, Tandon P. Inflammatory Bowel Disease and Breastfeeding: A Narrative Review. Inflamm Bowel Dis. 2025 Jan 6;31(1):210-219. Resumen
- Mahadevan U, Seow CH, Barnes EL, Chaparro M, Flanagan E, Friedman S, Julsgaard M, Kane S, Ng S, Torres J, Watermeyer G, Yamamoto-Furusho J, Robinson C, Fisher S, Anderson P, Gearry R, Duricova D, Dubinsky M, Long M; Global Consensus Group for Pregnancy and IBD. Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2025 Oct;23(11S):S1-S60. 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)
- Bendaoud S, Nahon S, Beaugerie L, Gornet JM, Wils P, Amiot A, Peyrin-Biroulet L, Abitbol V, Hébuterne X, Altwegg R, Rosa I, Amil M, Heluwaert F, Plastaras L, Stefanescu C, Quentin V, Antoni M, Bideau K, Boualit M, Cuillerier E, Locher C, Skinazi F, et al. Risk of anti-TNF therapy on pregnancy, breastfeeding, live vaccines and related information in patients with inflammatory bowel disease: Real-world data from a nationwide study. Dig Liver Dis. 2024 Dec;56(12):2038-2044. Resumen
- 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)
- Torres J, Chaparro M, Julsgaard M, Katsanos K, Zelinkova Z, Agrawal M, Ardizzone S, Campmans-Kuijpers M, Dragoni G, Ferrante M, Fiorino G, Flanagan E, Gomes CF, Hart A, Hedin CR, Juillerat P, Mulders A, Myrelid P, O'Toole A, Rivière P, Scharl M, Selinger CP, et al. European Crohn's and Colitis Guidelines on Sexuality, Fertility, Pregnancy, and Lactation. J Crohns Colitis. 2023 Jan 27;17(1):1-27. 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
- 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)
- Stratigakis A, Paty D, Zou P, Zhao Z, Li Y, Zhang T. A regression approach for assessing large molecular drug concentration in breast milk. Reprod Breed 2023;3:199-207. Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Anderson PO. Monoclonal Antibodies During Breastfeeding. Breastfeed Med. 2021 Aug;16(8):591-593. Resumen
- Owczarek W, Walecka I, Lesiak A, Czajkowski R, Reich A, Zerda I, Narbutt J. The use of biological drugs in psoriasis patients prior to pregnancy, during pregnancy and lactation: a review of current clinical guidelines. Postepy Dermatol Alergol. 2020 Dec;37(6):821-830. Resumen Texto completo (enlace a fuente original)
- Yeung J, Gooderham MJ, Grewal P, Hong CH, Lansang P, Papp KA, Poulin Y, Turchin I, Vender R. Management of Plaque Psoriasis With Biologic Therapies in Women of Child-Bearing Potential Consensus Paper. J Cutan Med Surg. 2020 Jul/Aug;24(1_suppl):3S-14S. 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)
- Lamb CA, Kennedy NA, Raine T, Hendy PA, Smith PJ, Limdi JK, Hayee B, Lomer MCE, Parkes GC, Selinger C, Barrett KJ, Davies RJ, Bennett C, Gittens S, Dunlop MG, Faiz O, Fraser A, Garrick V, Johnston PD, Parkes M, Sanderson J, Terry H; et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut. 2019 Dec;68(Suppl 3):s1-s106. Resumen Texto completo (enlace a fuente original)
- 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
- 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
- Mahadevan U, Robinson C, Bernasko N, Boland B, Chambers C, Dubinsky M, Friedman S, Kane S, Manthey J, Sauberan J, Stone J, Jain R. Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway: A Report From the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. 2019 Apr;156(5):1508-1524. Resumen Texto completo (enlace a fuente original)
- van den Broek L, van der Werff-Ten Bosch J, Cortoos PJ, van Steijn S, van den Akker M. Severe neutropenia in a breastfed infant: a case report and discussion of the differential diagnosis. Int Med Case Rep J. 2018 Nov 15;11:333-337. Resumen
- 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
- Rademaker M, Agnew K, Andrews M, Armour K, Baker C, Foley P, Frew J, Gebauer K, Gupta M, Kennedy D, Marshman G, Sullivan J. Psoriasis in those planning a family, pregnant or breast-feeding. The Australasian Psoriasis Collaboration. Australas J Dermatol. 2018 May;59(2):86-100. Resumen
- Matro R, Martin CF, Wolf D, Shah SA, Mahadevan U. Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development. Gastroenterology. 2018 Sep;155(3):696-704. Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Lund T, Thomsen SF. Use of TNF-inhibitors and ustekinumab for psoriasis during pregnancy: A patient series. Dermatol Ther. 2017 May;30(3). Resumen
- Amgen. Adaiimumab (Amgevita). Ficha técnica. 2017 Texto completo (en nuestros servidores)
- 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)
- 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
- Huang VW, Chang HJ, Kroeker KI, Goodman KJ, Hegadoren KM, Dieleman LA, Fedorak RN. Management of Inflammatory Bowel Disease during Pregnancy and Breastfeeding Varies Widely: A Need for Further Education. Can J Gastroenterol Hepatol. 2016;2016:6193275. Epub 2016 Sep 20. Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Nguyen GC, Seow CH, Maxwell C, Huang V, Leung Y, Jones J, Leontiadis GI, Tse F, Mahadevan U, van der Woude CJ; IBD in Pregnancy Consensus Group. The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy. Gastroenterology. 2016 Mar;150(3):734-757.e1. 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
- McConnell RA, Mahadevan U. Pregnancy and the Patient with Inflammatory Bowel Disease: Fertility, Treatment, Delivery, and Complications. Gastroenterol Clin North Am. 2016 Resumen
- Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
- van der Woude CJ, Ardizzone S, Bengtson MB, Fiorino G, Fraser G, Katsanos K, Kolacek S, Juillerat P, Mulders AG, Pedersen N, Selinger C, Sebastian S, Sturm A, Zelinkova Z, Magro F; European Crohn’s and Colitis Organization. The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease. J Crohns Colitis. 2015 Feb;9(2):107-24. Review. Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- 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)
- Damas OM, Deshpande AR, Avalos DJ, Abreu MT. Treating Inflammatory Bowel Disease in Pregnancy: The Issues We Face Today. J Crohns Colitis. 2015 Oct;9(10):928-36. 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
- 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)
- Schulze H, Esters P, Dignass A. Review article: the management of Crohn's disease and ulcerative colitis during pregnancy and lactation. Aliment Pharmacol Ther. 2014 Nov;40(9):991-1008. Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Huang VW, Habal FM. From conception to delivery: managing the pregnant inflammatory bowel disease patient. World J Gastroenterol. 2014 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
- 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)
- Yarur A, Kane SV. Update on pregnancy and breastfeeding in the era of biologics. Dig Liver Dis. 2013 Oct;45(10):787-94. Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Julsgaard M, Brown S, Gibson P, Bell S. Adalimumab levels in an infant. J Crohns Colitis. 2013 Resumen
- Mahadevan U, Wolf DC, Dubinsky M, Cortot A, Lee SD, Siegel CA, Ullman T, Glover S, Valentine JF, Rubin DT, Miller J, Abreu MT. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013 Mar;11(3):286-92; quiz e24. Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- 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
- Fritzsche J, Pilch A, Mury D, Schaefer C, Weber-Schoendorfer C. Infliximab and adalimumab use during breastfeeding. J Clin Gastroenterol. 2012 Sep;46(8):718-9. Resumen
- 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
- EMA-AbbVie. Adalimumab (Humira). Drug Summary. 2010 Texto completo (en nuestros servidores)
- Fischer-Betz RE, Schneider M. [Biologics during pregnancy and breast--feeding]. Z Rheumatol. 2010 Resumen
- van der Woude CJ, Kolacek S, Dotan I, Oresland T, Vermeire S, Munkholm P, Mahadevan U, Mackillop L, Dignass A; European Crohn's Colitis Organisation (ECCO). European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohns Colitis. 2010 Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Ben-Horin S, Yavzori M, Katz L, Picard O, Fudim E, Chowers Y, Lang A. Adalimumab level in breast milk of a nursing mother. Clin Gastroenterol Hepatol. 2010 Resumen
- Mahadevan U. Pregnancy, Fertility, and Therapies for IBD. Gastroenterol Hepatol (N Y). 2006 Apr;2(4):234-236. No abstract available. Resumen
- Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul;131(1):283-311. Review. Resumen Texto completo (enlace a fuente original) Texto completo (en nuestros servidores)
- Mishkin DS, Van Deinse W, Becker JM, Farraye FA. Successful use of adalimumab (Humira) for Crohn's disease in pregnancy. Inflamm Bowel Dis. 2006 Aug;12(8):827-8. No abstract available. Resumen
- Vesga L, Terdiman JP, Mahadevan U. Adalimumab use in pregnancy. Gut. 2005 Jun;54(6):890. No abstract available. Resumen