Is Etanercept compatible with breastfeeding? Do we have alternatives for Etanercept?

Etanercept

August 30, 2018 (Very Low Risk)

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.

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Synonyms

  • rhu-TNFR:Fc
  • TNR-001

Writings

  • Ετανερσέπτη (Greek)
  • إيتانيرسابت (Arabic)
  • Этанерцепт (Cyrillic)
  • 依那西普 (Chinese)
  • エタネルセプト (Japanese)
  • C2224 H3475 N621 O698 S36 (Molecular formula)
  • A dimer of 1-235 tumour necrosis factor receptor (human) fusion protein with 236-467-immunoglobulin G1 (human γ1-chain Fc fragment) (Chemical name)
  • L04AB01 (ATC Code/s)

Drug trade names

References

  1. EMA. Etanercept. Drug Summary. 2018 Full text (in our servers)
  2. EMA. Etanercept. Ficha técnica. 2018 Full text (in our servers)
  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. 2018Abstract
  4. Dall'ara F, Reggia R, Bazzani C et al. 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 FRI0176. 2016 Full text (link to original source) Full text (in our servers)
  5. 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). 2016Abstract Full text (link to original source) Full text (in our servers)
  6. 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. 2016Abstract Full text (link to original source) Full text (in our servers)
  7. Calligaro A, Hoxha A, Ruffatti A, Punzi L. Are biological drugs safe in pregnancy? Reumatismo. 2015Abstract Full text (link to original source) Full text (in our servers)
  8. Grunewald S, Jank A. New systemic agents in dermatology with respect to fertility, pregnancy, and lactation. J Dtsch Dermatol Ges. 2015Abstract Full text (link to original source) Full text (in our servers)
  9. Mervic L. Management of moderate to severe plaque psoriasis in pregnancy and lactation in the era of biologics. Acta Dermatovenerol Alp Pannonica Adriat. 2014Abstract Full text (link to original source) Full text (in our servers)
  10. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014Abstract
  11. Hyrich KL, Verstappen SM. Biologic therapies and pregnancy: the story so far. Rheumatology (Oxford). 2014Abstract Full text (in our servers)
  12. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014Abstract
  13. Habal FM, Huang VW. Review article: a decision-making algorithm for the management of pregnancy in the inflammatory bowel disease patient. Aliment Pharmacol Ther. 2012Abstract Full text (link to original source) Full text (in our servers)
  14. 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. 2012Abstract
  15. Fischer-Betz RE, Schneider M. [Biologics during pregnancy and breast--feeding]. Z Rheumatol. 2010Abstract
  16. Østensen M, Motta M. Therapy insight: the use of antirheumatic drugs during nursing. Nat Clin Pract Rheumatol. 2007Abstract
  17. 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. 2006Abstract Full text (link to original source) Full text (in our servers)