Last update: July 21, 2017

Tacrolimus (topical use)

Very Low Risk for breastfeeding


Safe. Compatible.
Not risky for breastfeeding or infant.

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.

Systemic administration is approved by various scientific societies and expert panels, (Constantinescu 2014, Götestam-Skorpen 2016, Flint 2016) due to its negligible excretion into breastmilk, the absence of side effects in infants from treated mothers and a low or absent plasma levels in these infants (for details, see info on Tacrolimus).

Absorption and bioavailability through skin is even lower than that found by mouth, 30 times lower even after application on 50% of body surface (Draelos 2005 Undre 2009, Gutfreund 2013, EMA2016), therefore milk levels would be expected further lower than after oral ingestion.

Do not apply on the breast to prevent ingestion by the infant, otherwise, do it just after a meal and clean the nipple thoroughly with water before the next feed.
Local application on the nipple of creams, gels and other products containing paraffin (mineral oil) should better be avoid to keep the infant off from absorption (Noti 2003, Concin 2008).


See below the information of this related product:

Alternatives

We do not have alternatives for Tacrolimus (topical use) since it is relatively safe.

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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.

Group

Tacrolimus (topical use) belongs to this group or family:

Tradenames

Main tradenames from several countries containing Tacrolimus (topical use) in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. Der: <10 %
Molecular weight 822 daltons
Protein Binding 99 %
Tmax 3 hours
T1/2 11,3 hours
M/P ratio 0,5 -
Theoretical Dose < 0,0001 mg/Kg/d
Relative Dose < 0,06 %
Relat.Ped.Dose < 0,03 %

References

  1. EMA. Protoptic. Ficha técnica. 2016 Full text (in our servers)
  2. EMA. Protoptic. Drug Summary. 2016 Full text (in our servers)
  3. 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)
  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. 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
  6. 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
  7. Constantinescu S, Pai A, Coscia LA, Davison JM, Moritz MJ, Armenti VT. Breast-feeding after transplantation. Best Pract Res Clin Obstet Gynaecol. 2014 Abstract
  8. Gutfreund K, Bienias W, Szewczyk A, Kaszuba A. Topical calcineurin inhibitors in dermatology. Part I: Properties, method and effectiveness of drug use. Postepy Dermatol Alergol. 2013 Abstract
  9. 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. 2012 Abstract
  10. Undre NA, Moloney FJ, Ahmadi S, Stevenson P, Murphy GM. Skin and systemic pharmacokinetics of tacrolimus following topical application of tacrolimus ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol. 2009 Abstract
  11. Concin N, Hofstetter G, Plattner B, Tomovski C, Fiselier K, Gerritzen K, Fessler S, Windbichler G, Zeimet A, Ulmer H, Siegl H, Rieger K, Concin H, Grob K. Mineral oil paraffins in human body fat and milk. Food Chem Toxicol. 2008 Abstract
  12. Draelos Z, Nayak A, Pariser D, Shupack JL, Chon K, Abrams B, Paul CF. Pharmacokinetics of topical calcineurin inhibitors in adult atopic dermatitis: a randomized, investigator-blind comparison. J Am Acad Dermatol. 2005 Abstract
  13. Noti A, Grob K, Biedermann M, Deiss U, Brüschweiler BJ. Exposure of babies to C15-C45 mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003 Abstract

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