Tacrolimus (topical use)

Immunosuppressive macrolide that inhibits calcineurin, used to prevent rejection of transplanted organs (kidney, liver, heart, etc.) and in the treatment of atopic eczema, psoriasis and other autoimmune diseases (arthritis, lupus, inflammatory bowel disease, etc.). Oral systemic administration and topical dermatological application.

Systemic administration is approved by various scientific societies and experts due to its negligible excretion in breast milk, the absence of side effects in infants of treated mothers and the low or zero plasma levels measured in these infants. For more details, see Tacrolimus (oral use).

Absorption and bioavailability through the skin is even lower than through the oral route, even 30 times lower, even when applied to 50% of the body surface ^{(EMA 2016, Gutfreund 2013, Undre 2009, Draelos 2005)}, so even lower levels in milk are expected than with oral administration.

If it must be applied to the breast, to prevent the infant from ingesting it, it should be applied after a feed and washed off thoroughly with water before the next feed. ^{(Deleuran 2024, Vestergaard 2019)}

It is advisable to avoid applying creams, gels and other topical products containing paraffin (mineral oil) to the nipple so that the infant does not absorb them. ^{(Concin 2008, Noti 2003)}

See below the information of this related product:

• Tacrolimus (oral use) (Safe product and/or breastfeeding is the best option.)