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


woomen

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

Immunosuppressant which is an inhibitor of calcineurin and used in the prevention of transplanted organ rejection (kidney, liver, heart ...) and in the treatment of severe forms of autoimmune diseases: Atopic Eczema, Psoriasis, Rheumatoid Arthritis, Ulcerative Colitis, Aplastic Anemia, Asthma, Behçet's Syndrome, Chronic Active Hepatitis, Multiple Sclerosis, Myasthenia Gravis, Sarcoidosis, Scleritis or Uveitis and Scleroderma, among others.Orally administrated for systemic use in one or two daily doses, parenteral injection, eye drops and inhalation. Its high molecular weight and high protein-binding capacity explain the low excretion (<0.36 mg / L) obtained in colostrum and mature breastmilk (Lewis 1983, Flechner 1985, Ziegenhagen 1988, Behrens 1989, Thiru 1997, Nyberg 1998, Munoz-Flores 2001, Moretti 2003, Osadchy 2011, Mazzuoccolo 2014).No short or long term issues on developmental or immunological response have been observed in infants whose mothers were taking this drug (Nyberg 1998, Munoz-Flores2001, Moretti 2003, Lahiff 2011, Morton2011).Plasma levels in most of these infants were undetectable or very low (Ziegenhagen 1988, Nyberg 1998, Munoz-Flores 2001, Moretti 2003, Osadchy 2011, Lahiff 2011, Morton2011). Only one exception has been reported who presented therapeutic levels (Moretti 2003). Its low oral bioavailability, even lower when taken along with food, mostly fatty food, would decrease the passage to infant's plasma from the ingested breastmilk. Although thought to be high, the total amount of alcohol contained in each dose of drug is considered not enough to contraindicate this medication during breastfeeding.There are isolated reports which indicate that cyclosporine may decrease prolactin levels (Ramirez 1991, Nagar 1992).Infants who have been exposed to calcineurin inhibitors during pregnancy may have immunized deficiency in the first year of life (Grimer 2007), hence the importance of not being deprived of breastfeeding for no proven reason. Several medical societies and experts agree that the use of this medication during breastfeeding is safe (van der Houde 2010, Thiagarajan 2013, Constantinescu 2014, Götestam-Skorpen 2016, Flint 2016).

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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/28092212
  2. http://www.ncbi.nlm.nih.gov/pubmed/26750124
  3. http://rheumatology.oxfordjournals.org/content/early/2016/01/12/rheumatology.kev404.full.pdf
  4. http://www.ncbi.nlm.nih.gov/pubmed/26888948
  5. http://ard.bmj.com/content/early/2016/02/17/annrheumdis-2015-208840.full.pdf
  6. http://www.ncbi.nlm.nih.gov/pubmed/27490204
  7. http://www.ncbi.nlm.nih.gov/pubmed/25424052
  8. http://www.tandfonline.com/doi/full/10.3109/09546634.2014.991673
  9. http://www.ncbi.nlm.nih.gov/pubmed/26129693
  10. http://www.ncbi.nlm.nih.gov/pubmed/24614280
  11. http://www.ncbi.nlm.nih.gov/pubmed/25271063
  12. http://www.ncbi.nlm.nih.gov/pubmed/23336105
  13. http://www.ncbi.nlm.nih.gov/pubmed/23782661
  14. http://www.ncbi.nlm.nih.gov/pubmed/21240055
  15. http://www.ncbi.nlm.nih.gov/pubmed/21272141
  16. http://www.ncbi.nlm.nih.gov/pubmed/21538721
  17. http://www.ncbi.nlm.nih.gov/pubmed/19885906
  18. http://www.ncbi.nlm.nih.gov/pubmed/21122553
  19. http://ecco-jcc.oxfordjournals.org/content/eccojc/4/5/493.full.pdf
  20. http://www.ncbi.nlm.nih.gov/pubmed/17316288
  21. http://www.ncbi.nlm.nih.gov/pubmed/16194696
  22. http://www.ncbi.nlm.nih.gov/pubmed/15110638
  23. http://www.ncbi.nlm.nih.gov/pubmed/15759552
  24. http://www.ncbi.nlm.nih.gov/pubmed/12829927
  25. http://www.ncbi.nlm.nih.gov/pubmed/12091650
  26. http://ndt.oxfordjournals.org/content/17/suppl_4/50.full.pdf
  27. http://www.ncbi.nlm.nih.gov/pubmed/11845741
  28. http://www.ncbi.nlm.nih.gov/pubmed/11336764
  29. http://www.ncbi.nlm.nih.gov/pubmed/11013791
  30. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2145042/pdf/canfamphys00031-0055.pdf
  31. http://www.ncbi.nlm.nih.gov/pubmed/9458024
  32. http://www.ncbi.nlm.nih.gov/pubmed/9284666
  33. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2127307/pdf/9284666.pdf
  34. http://www.ncbi.nlm.nih.gov/pubmed/1285866
  35. http://www.ncbi.nlm.nih.gov/pubmed/1606914
  36. http://www.ncbi.nlm.nih.gov/pubmed/1906995
  37. http://www.ncbi.nlm.nih.gov/pubmed/2649410
  38. http://www.ncbi.nlm.nih.gov/pubmed/3277831
  39. http://www.ncbi.nlm.nih.gov/pubmed/3155592
  40. http://www.ncbi.nlm.nih.gov/pubmed/6402165
  41. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1546816/pdf/bmjcred00541-0027a.pdf

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