Last update May 16, 2018



Safe substance and/or breastfeeding is the best option.

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).

See below the information of this related product:


We do not have alternatives for L04AD02 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.


L04AD02 belongs to this group or family:


Main tradenames from several countries containing L04AD02 in its composition:


Variable Value Unit
Oral Bioavail. 20 - 25 %
Molecular weight 822 daltons
Protein Binding 99 %
VD 2.6 l/Kg
Tmax 1.6 - 3 hours
34 - 43 hours
M/P ratio 0.5 -
Theoretical Dose 0.00006 mg/Kg/d
Relative Dose 0.06 %
Ped.Relat.Dose 0.03 %


  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. Kociszewska-Najman B, Mazanowska N, Pietrzak B, Paczek L, Szpotanska-Sikorska M, Schreiber-Zamora J, Hryniewiecka E, Zochowska D, Samborowska E, Dadlez M, Wielgos M. Low Transfer of Tacrolimus and Its Metabolites into Colostrum of Graft Recipient Mothers. Nutrients. 2018 Abstract Full text (link to original source) Full text (in our servers)
  3. Shah S, Verma P. Overview of Pregnancy in Renal Transplant Patients. Int J Nephrol. 2016;2016:4539342. Abstract
  4. 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
  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. 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)
  7. van der Woude CJ, Ardizzone S, Bengtson MB, Fiorino G, Fraser G, Katsanos K, Kolacek S, Juillerat P, Mulders AG, Pedersen N, Selinger C, Sebastian S, Sturm A, Zelinkova Z, Magro F; European Crohn’s and Colitis Organization. The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease. J Crohns Colitis. 2015 Feb;9(2):107-24. Review. Abstract Full text (link to original source) Full text (in our servers)
  8. EMA. Tacrolimus. Drug Summary. 2015 Full text (in our servers)
  9. EMA. Tacrolimus. Ficha técnica. 2015 Full text (in our servers)
  10. Durst JK, Rampersad RM. Pregnancy in Women With Solid-Organ Transplants: A Review. Obstet Gynecol Surv. 2015 Abstract
  11. Rahman MF, Nandi AK, Kabir S, Kamal M, Basher MS, Banu LA. Topical Tacrolimus versus Hydrocortisone on Atopic Dermatitis in Paediatric Patients: A Randomized Controlled Trial. Mymensingh Med J. 2015 Abstract
  12. Schulze H, Esters P, Dignass A. Review article: the management of Crohn's disease and ulcerative colitis during pregnancy and lactation. Aliment Pharmacol Ther. 2014 Nov;40(9):991-1008. Abstract Full text (link to original source) Full text (in our servers)
  13. Izumi Y, Miyashita T, Migita K. Safety of tacrolimus treatment during pregnancy and lactation in systemic lupus erythematosus: a report of two patients. Tohoku J Exp Med. 2014 Sep;234(1):51-6. Abstract Full text (link to original source) Full text (in our servers)
  14. 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
  15. López LF, Martínez CJ, Castañeda DA, Hernández AC, Pérez HC, Lozano E. Pregnancy and kidney transplantation, triple hazard? Current concepts and algorithm for approach of preconception and perinatal care of the patient with kidney transplantation. Transplant Proc. 2014 Abstract
  16. 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
  17. Bramham K, Chusney G, Lee J, Lightstone L, Nelson-Piercy C. Breastfeeding and tacrolimus: serial monitoring in breast-fed and bottle-fed infants. Clin J Am Soc Nephrol. 2013 Abstract
  18. 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
  19. Yarur A, Kane SV. Update on pregnancy and breastfeeding in the era of biologics. Dig Liver Dis. 2013 Oct;45(10):787-94. Abstract Full text (link to original source) Full text (in our servers)
  20. Armenti VT, Moritz MJ, Davison JM. Breastfeeding and tacrolimus: is it a reasonable approach? Expert Rev Clin Immunol. 2013 Abstract
  21. Hebert MF, Zheng S, Hays K, Shen DD, Davis CL, Umans JG, Miodovnik M, Thummel KE, Easterling TR. Interpreting tacrolimus concentrations during pregnancy and postpartum. Transplantation. 2013 Abstract
  22. Zheng S, Easterling TR, Hays K, Umans JG, Miodovnik M, Clark S, Calamia JC, Thummel KE, Shen DD, Davis CL, Hebert MF. Tacrolimus placental transfer at delivery and neonatal exposure through breast milk. Br J Clin Pharmacol. 2013 Abstract
  23. Gomez-Lobo V, Landy HJ, Matsumoto C, Fishbein TM. Pregnancy in an intestinal transplant recipient. Obstet Gynecol. 2012 Abstract
  24. Gouraud A, Bernard N, Millaret A, Bruel M, Paret N, Descotes J, Vial T. Follow-up of tacrolimus breastfed babies. Transplantation. 2012 Abstract
  25. Grundmann M, Kacirova I, Duricova J, Perinova I. Metoprolol and alfa-hydroxymetoprolol concentrations during lactation - a case report. 12th International Congress of Therapeutic Drug Monitoring and Clinical Toxicology Stuttgart, Germany · October 2-6, 2011. Poster 088. Ther Drug Monit. 2011;33:504. P088. 2011
  26. 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)
  27. Weber JC, Kuhnert C. Traitements de fond des affections inflammatoires systémiques au cours de l’allaitement. [Breastfeeding and drug management in connective tissue and rheumatic diseases]. Rev Med Interne. 2008 Dec;29(12):1017-23. Abstract
  28. Heetun ZS, Byrnes C, Neary P, O'Morain C. Review article: Reproduction in the patient with inflammatory bowel disease. Aliment Pharmacol Ther. 2007 Abstract Full text (link to original source) Full text (in our servers)
  29. 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
  30. Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul;131(1):283-311. Review. Abstract Full text (link to original source) Full text (in our servers)
  31. 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)
  32. Gardiner SJ, Begg EJ. Breastfeeding during tacrolimus therapy. Obstet Gynecol. 2006 Feb;107(2 Pt 2):453-5. Abstract
  33. French AE, Soldin SJ, Soldin OP, Koren G. Milk transfer and neonatal safety of tacrolimus. Ann Pharmacother. 2003 Abstract Full text (link to original source) Full text (in our servers)
  34. 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)
  35. Anderson PO. Tacrolimus and breastfeeding. Transplantation. 1998 Abstract
  36. Jain A, Venkataramanan R, Fung JJ, Gartner JC, Lever J, Balan V, Warty V, Starzl TE. Pregnancy after liver transplantation under tacrolimus. Transplantation. 1997 Abstract Full text (link to original source) Full text (in our servers)

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