Is Tacrolimus (topical use) compatible with breastfeeding? Do we have alternatives for Tacrolimus (topical use)?

Tacrolimus (topical use)

July 21, 2017 (Very Low Risk)

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.

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Drug trade names

References

  1. 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). 2016Abstract Full text (link to original source) Full text (in our servers)
  2. 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. 2016Abstract Full text (link to original source) Full text (in our servers)
  3. EMA. Protoptic. Ficha técnica. 2016 Full text (in our servers)
  4. EMA. Protoptic. Drug Summary. 2016 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. 2015Abstract
  6. Constantinescu S, Pai A, Coscia LA, Davison JM, Moritz MJ, Armenti VT. Breast-feeding after transplantation. Best Pract Res Clin Obstet Gynaecol. 2014Abstract
  7. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014Abstract
  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. 2013Abstract
  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. 2012Abstract
  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. 2009Abstract
  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. 2008Abstract
  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. 2005Abstract
  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. 2003Abstract