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Recommendations made
pediatrician - Dr. Victоr Аbdоw
Rоckville, МD, USА.


woomen

Is it allowed to take Tacrolimus during lactation?
Is it safe for a nursing mother and a child?

Macrolide immunosuppressant drug that inhibits calcineurin which is used to prevent rejection of transplanted organs (kidney, liver, heart ...) and for treatment of atopic eczema, psoriasis and other autoimmune illnesses (e.g. Arthritis, Lupus, Inflammatory Bowel Disease ...) .Routes of administration: oral for systemic purposes and topical for dermatologic conditions. A high molecular weight and high protein-binding capacity explain that it is was found in clinically insignificant amounts into colostrum and breast milk (Jain 1997, 2003 French, Gardiner 2006, 2013 Zheng, Bramham 2013).No problems were observed on short or long term of developmental or immunological outcomes in more than 150 infants whose mothers were treated (French 2003, Gouraud 2012, Thiagarajan 2013, Constantinescu 2014, Izumi 2014), except a mild and self-limited case of transient thrombocytosis (Gouraud 2012).The plasma levels of drug in these infants were either undetectable or very low (Gomez-Lobo 2012, Gouraud 2012, Bramham 2013, Izumi 2014).A low oral bioavailability that may further be decreased by ingestion of food, especially if it is fat food, would hamper the passage of drug from ingested milk toward the infant plasma. Infants who have been exposed to calcineurin inhibitors during pregnancy may be immunological deficients within the first year of life (Grimer 2007), therefore, it is most important to avoid any lack of breastfeeding without a sound reason. Several medical societies and consensus by experts have considered safe the use of Tacrolimus while breastfeeding (Østensen 2006, van der Houde 2010, Thiagarajan 2013, Armenti 2013, Constantinescu 2014, Schulze 2014, Durst 2015, Götestam-Skorpen 2016, Flint 2016).

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woomen

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Types of risk

VERY LOW RISK
It is allowed while breastfeeding. It is not dangerous for a baby. It is moderately safe. more...

LOW RISK PROBABLE
Possible presence in breast milk is allowed. Follow the doctor's recommendation. more...

HIGH RISK PROBABLE
An unsafe drug, it is necessary to assess the risks while taking. Use safer analogs. more...

VERY HIGH RISK
It is not recommended. You need to stop breastfeeding or choose a safe analog. more...

Scientific literature

The level of risk for breastfeeding is confirmed in these scientific publications:
  1. http://www.ncbi.nlm.nih.gov/pubmed/26750124
  2. http://rheumatology.oxfordjournals.org/content/early/2016/01/12/rheumatology.kev404.full.pdf
  3. http://www.ncbi.nlm.nih.gov/pubmed/26888948
  4. http://ard.bmj.com/content/early/2016/02/17/annrheumdis-2015-208840.full.pdf
  5. http://www.ncbi.nlm.nih.gov/pubmed/27490204
  6. http://www.ncbi.nlm.nih.gov/pubmed/25602023
  7. http://ecco-jcc.oxfordjournals.org/content/eccojc/9/2/107.full.pdf
  8. http://www.ncbi.nlm.nih.gov/pubmed/26115649
  9. http://www.ncbi.nlm.nih.gov/pubmed/26329939
  10. http://www.ncbi.nlm.nih.gov/pubmed/24528912
  11. http://www.ncbi.nlm.nih.gov/pubmed/25200000
  12. http://onlinelibrary.wiley.com/doi/10.1111/apt.12949/epdf
  13. http://www.ncbi.nlm.nih.gov/pubmed/25271063
  14. http://www.ncbi.nlm.nih.gov/pubmed/25175032
  15. https://www.jstage.jst.go.jp/article/tjem/234/1/234_51/_pdf
  16. http://www.ncbi.nlm.nih.gov/pubmed/25420815
  17. http://www.ncbi.nlm.nih.gov/pubmed/23474350
  18. http://www.dldjournalonline.com/article/S1590-8658(13)00050-9/pdf
  19. http://www.ncbi.nlm.nih.gov/pubmed/23749699
  20. http://medwiekurozwoj.pl/articles/2013-1-10.pdf
  21. http://www.ncbi.nlm.nih.gov/pubmed/23274970
  22. http://www.ncbi.nlm.nih.gov/pubmed/23349333
  23. http://www.ncbi.nlm.nih.gov/pubmed/23528073
  24. http://www.ncbi.nlm.nih.gov/pubmed/23782661
  25. http://www.ncbi.nlm.nih.gov/pubmed/23899232
  26. http://www.ncbi.nlm.nih.gov/pubmed/22772888
  27. http://www.ncbi.nlm.nih.gov/pubmed/22387837
  28. http://pdf.medrang.co.kr/Kjg/059/Kjg059-02-05.pdf
  29. http://www.ncbi.nlm.nih.gov/pubmed/22825278
  30. http://www.ncbi.nlm.nih.gov/pubmed/22996303
  31. http://www.ncbi.nlm.nih.gov/pubmed/21122553
  32. http://ecco-jcc.oxfordjournals.org/content/eccojc/4/5/493.full.pdf
  33. http://www.ncbi.nlm.nih.gov/pubmed/18799245
  34. http://www.ncbi.nlm.nih.gov/pubmed/18799245
  35. http://www.ncbi.nlm.nih.gov/pubmed/17661756
  36. http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2036.2007.03397.x/epdf
  37. http://www.ncbi.nlm.nih.gov/pubmed/17316288
  38. http://www.ncbi.nlm.nih.gov/pubmed/16831611
  39. http://www.gastrojournal.org/article/S0016-5085(06)00865-1/pdf
  40. http://www.ncbi.nlm.nih.gov/pubmed/16449146
  41. http://www.ncbi.nlm.nih.gov/pubmed/16712713
  42. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1526635/pdf/ar1957.pdf
  43. http://www.ncbi.nlm.nih.gov/pubmed/12773068
  44. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3636979/pdf/nihms459225.pdf
  45. http://www.ncbi.nlm.nih.gov/pubmed/12091650
  46. http://ndt.oxfordjournals.org/content/17/suppl_4/50.full.pdf
  47. http://www.ncbi.nlm.nih.gov/pubmed/9539100
  48. http://www.ncbi.nlm.nih.gov/pubmed/9293865
  49. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2975612/pdf/nihms244536.pdf

Comments  

+3 #1 Reviewer: 55-64 Male on Treatment for 5 to less than 10 years (Patient) 2018-05-24 10:59
I have had no problems what so ever.

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