Last update: Aug. 30, 2018

Etanercept

Very Low Risk for breastfeeding


Safe. Compatible.
Minimal risk for breastfeeding and infant.

An IgG1 monoclonal antibody against the tumor necrosis factor alpha (TNFα) used in autoimmune diseases, rheumatoid arthritis, psoriatic arthritis, psoriasis and ankylosing spondylitis.
Subcutaneous administration once or twice a week for 12 to 24 weeks.

Possibly due to its high molecular weight and its high plasma protein binding, it is excreted in breastmilk in clinically insignificant amounts (Butler 2014, Berthelsen 2010, Keeling 2010, Murashima 2009, Østensen 2007, 2006 and 2004).

The plasma levels of infants breastfed by mothers who are administered etanercept are undetectable or very low (Berthelsen 2010, Murashima 2009).

No short-term or long-term developmental, infection or immunological problems or problems with vaccination have been observed in infants whose mothers take etanercept (Dall'ara 2016, Calligaro 2015, Butler 2014, Keeling 2010).

Its zero oral bioavailability would hinder transfer from breastmilk to the infant’s plasma (Amin 2018, Grunewald 2015, Mervic 2014, Butler 2014, Hyrich 2013, Bae 2012, Keeling 2010), except in premature infants and the immediate neonatal period, when there can be greater intestinal permeability.

Numerous experts and scientific associations of rheumatology and dermatology consider its use very low risk and, therefore, compatible during breastfeeding (Amin 2018, Flint 2016, Götestam 2016, Dall'ara 2016, Grunewald 2015, Nielsen 2014, Mervic 2014, Butler 2014, Hyrich 2013, Habal 2012, Berthelsen 2010, Keeling 2010, Fischer 2010, Murashima 2009).

Alternatives

We do not have alternatives for Etanercept since it is relatively safe.

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Etanercept is also known as


Etanercept in other languages or writings:

Group

Etanercept belongs to this group or family:

Tradenames

Main tradenames from several countries containing Etanercept in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≈ 0 %
Molecular weight 150.000 daltons
VD 0,24 l/Kg
Tmax 72 hours
T1/2 70 - 115 hours
M/P ratio 0,0001 -
Theoretical Dose <0,011 mg/Kg/d
Relative Dose 0,07 - 0.2 %
Relat.Ped.Dose <2,8 %

References

  1. 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. Abstract
  2. 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. Abstract
  3. 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 Abstract
  4. EMA. Etanercept. Ficha técnica. 2018 Full text (in our servers)
  5. EMA. Etanercept. Drug Summary. 2018 Full text (in our servers)
  6. 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. Abstract Full text (link to original source) Full text (in our servers)
  7. 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. Abstract Full text (link to original source) Full text (in our servers)
  8. 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 Abstract
  9. Calligaro A, Hoxha A, Ruffatti A, Punzi L. Are biological drugs safe in pregnancy? Reumatismo. 2015 Abstract Full text (link to original source)
  10. Grunewald S, Jank A. New systemic agents in dermatology with respect to fertility, pregnancy, and lactation. J Dtsch Dermatol Ges. 2015 Abstract Full text (link to original source) Full text (in our servers)
  11. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014 Feb;11(2):116-27. Abstract
  12. Mervic L. Management of moderate to severe plaque psoriasis in pregnancy and lactation in the era of biologics. Acta Dermatovenerol Alp Pannonica Adriat. 2014 Abstract Full text (link to original source) Full text (in our servers)
  13. 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. Abstract
  14. Hyrich KL, Verstappen SM. Biologic therapies and pregnancy: the story so far. Rheumatology (Oxford). 2014 Abstract Full text (in our servers)
  15. Witzel SJ. Lactation and the use of biologic immunosuppressive medications. Breastfeed Med. 2014 Dec;9(10):543-6. Abstract Full text (link to original source) Full text (in our servers)
  16. 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 Abstract Full text (link to original source) Full text (in our servers)
  17. 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 Abstract
  18. Fischer-Betz RE, Schneider M. [Biologics during pregnancy and breast--feeding]. Z Rheumatol. 2010 Abstract
  19. Østensen M, Motta M. Therapy insight: the use of antirheumatic drugs during nursing. Nat Clin Pract Rheumatol. 2007 Abstract
  20. 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 Abstract Full text (link to original source) Full text (in our servers)

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