Last update Jan. 24, 2017

Ciclosporin

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

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).

Alternatives

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

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

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.
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Other names

Ciclosporin is also known as


Ciclosporin in other languages or writings:

Group

Ciclosporin belongs to this group or family:

Tradenames

Main tradenames from several countries containing Ciclosporin in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 30 %
Molecular weight 1203 daltons
Protein Binding 93 %
VD 3 - 5 l/Kg
Tmax 1 - 2 hours
T½ 6.3 hours
M/P ratio 0.17 - 0.4 -
Theoretical Dose 0.015 - 0.15 mg/Kg/d
Relative Dose 0.2 - 3 %
Ped.Relat.Dose 0.25 - 5 %

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 Full text (link to original source)
  2. 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. Abstract
  3. Brown SM, Aljefri KA, Waas R, Hampton PJ. Systemic medications used in treatment of common dermatological conditions: Safety profile with respect to pregnancy, breast feeding and content in seminal fluid. J Dermatolog Treat. 2017 Abstract
  4. 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)
  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). 2016 Sep;55(9):1693-7. Abstract Full text (link to original source) Full text (in our servers)
  6. Levy RA, de Jesús GR, de Jesús NR, Klumb EM. Critical review of the current recommendations for the treatment of systemic inflammatory rheumatic diseases during pregnancy and lactation. Autoimmun Rev. 2016 Abstract
  7. Shah S, Verma P. Overview of Pregnancy in Renal Transplant Patients. Int J Nephrol. 2016;2016:4539342. Abstract
  8. McConnell RA, Mahadevan U. Pregnancy and the Patient with Inflammatory Bowel Disease: Fertility, Treatment, Delivery, and Complications. Gastroenterol Clin North Am. 2016 Abstract
  9. 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. Abstract Full text (in our servers)
  10. Constantinescu S, Pai A, Coscia LA, Davison JM, Moritz MJ, Armenti VT. Breast-feeding after transplantation. Best Pract Res Clin Obstet Gynaecol. 2014 Nov;28(8):1163-73. Abstract
  11. Sammaritano LR, Bermas BL. Rheumatoid arthritis medications and lactation. Curr Opin Rheumatol. 2014 Abstract
  12. Mazzuoccolo LD, Andrada R, Pellerano G, Neglia V, Abeldaño A. Levels of cyclosporine in breast milk and passage into the circulation of the infant of a mother with psoriasis. Int J Dermatol. 2014 Abstract
  13. Thiagarajan KM, Arakali SR, Mealey KJ, Cardonick EH, Gaughan WJ, Davison JM, Moritz MJ, Armenti VT. Safety considerations: breastfeeding after transplant. Prog Transplant. 2013 Jun;23(2):137-46. Abstract
  14. Osadchy A, Koren G. Cyclosporine and lactation: when the mother is willing to breastfeed. Ther Drug Monit. 2011 Abstract
  15. Lahiff C, Moss AC. Cyclosporine in the management of severe ulcerative colitis while breast-feeding. Inflamm Bowel Dis. 2011 Abstract
  16. Morton A. Cyclosporine and lactation. Nephrology (Carlton). 2011 Abstract
  17. Gisbert JP. Safety of immunomodulators and biologics for the treatment of inflammatory bowel disease during pregnancy and breast-feeding. Inflamm Bowel Dis. 2010 May;16(5):881-95. Abstract
  18. 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 Abstract Full text (link to original source) Full text (in our servers)
  19. Grimer M; Caring for Australians with Renal Impairment (CARI). The CARI guidelines. Calcineurin inhibitors in renal transplantation: pregnancy, lactation and calcineurin inhibitors. Nephrology (Carlton). 2007 Abstract
  20. Danesi R, Del Tacca M. Teratogenesis and immunosuppressive treatment. Transplant Proc. 2004 Abstract
  21. Moretti ME, Sgro M, Johnson DW, Sauve RS, Woolgar MJ, Taddio A, Verjee Z, Giesbrecht E, Koren G, Ito S. Cyclosporine excretion into breast milk. Transplantation. 2003 Jun 27;75(12):2144-6. Abstract
  22. EBPG Expert Group on Renal Transplantation. European best practice guidelines for renal transplantation. Section IV: Long-term management of the transplant recipient. IV.10. Pregnancy in renal transplant recipients. Nephrol Dial Transplant. 2002 Abstract Full text (link to original source) Full text (in our servers)
  23. Coady NT. Maternal transplantation medications during breastfeeding. J Hum Lact. 2002 Abstract
  24. Muñoz-Flores-Thiagarajan KD, Easterling T, Davis C, Bond EF. Breast-feeding by a cyclosporine-treated mother. Obstet Gynecol. 2001 May;97(5 Pt 2):816-8. Abstract
  25. Moretti ME, Lee A, Ito S. Which drugs are contraindicated during breastfeeding? Practice guidelines. Can Fam Physician. 2000 Sep;46:1753-7. Review. Abstract Full text (link to original source) Full text (in our servers)
  26. Nyberg G, Haljamäe U, Frisenette-Fich C, Wennergren M, Kjellmer I. Breast-feeding during treatment with cyclosporine. Transplantation. 1998 Abstract
  27. Thiru Y, Bateman DN, Coulthard MG. Successful breast feeding while mother was taking cyclosporin. BMJ. 1997 Abstract Full text (link to original source) Full text (in our servers)
  28. Nagai Y, Miyakoshi H, Ohsawa K, Ieki Y, Takamura T, Kobayashi K. Cyclosporine A inhibits the secretion of certain anterior pituitary hormones in patients with nephrotic syndrome. Endocrinol Jpn. 1992 Abstract
  29. Ostensen M. Treatment with immunosuppressive and disease modifying drugs during pregnancy and lactation. Am J Reprod Immunol. 1992 Abstract
  30. Ramirez G, Narvarte J, Bittle PA, Ayers-Chastain C, Dean SE. Cyclosporine-induced alterations in the hypothalamic hypophyseal gonadal axis in transplant patients. Nephron. 1991 Abstract
  31. Behrens O, Kohlhaw K, Günter H, Wonigeit K, Niesert S. [Detection of cyclosporin A in breast milk--is breast feeding contraindicated?]. Geburtshilfe Frauenheilkd. 1989 Abstract
  32. Ziegenhagen DJ, Crombach G, Dieckmann M, Zehnter E, Wienand P, Baldamus CA. [Pregnancy during cyclosporin medication following a kidney transplant]. Dtsch Med Wochenschr. 1988 Abstract
  33. Flechner SM, Katz AR, Rogers AJ, Van Buren C, Kahan BD. The presence of cyclosporine in body tissues and fluids during pregnancy. Am J Kidney Dis. 1985 Abstract
  34. Lewis GJ, Lamont CA, Lee HA, Slapak M. Successful pregnancy in a renal transplant recipient taking cyclosporin A. Br Med J (Clin Res Ed). 1983 Abstract Full text (link to original source) Full text (in our servers)

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