Question

I am a breastfeeding mother and i want to know if it is safe to use Tacrolimus? Is Tacrolimus safe for nursing mother and child? Does Tacrolimus extracts into breast milk? Does Tacrolimus has any long term or short term side effects on infants? Can Tacrolimus influence milk supply or can Tacrolimus decrease milk supply in lactating mothers?

Tacrolimus lactation summary

Tacrolimus is safe in breastfeeding
  • DrLact safety Score for Tacrolimus is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of Tacrolimus is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that Tacrolimus does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of Tacrolimus safe in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About Tacrolimus usage in lactation

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).

Answer by DrLact: About Tacrolimus usage in lactation

Limited data indicate that amounts of systemically administered tacrolimus are low in breastmilk and probably do not adversely affect the breastfed infant. European experts consider tacrolimus to be probably safe to use for inflammatory bowel disease during breastfeeding.[1] U.S. investigators and clinicians from the National Transplantation Pregnancy Registry and other experts consider tacrolimus acceptable to use during breastfeeding following transplant.[2][3][4][5][6][7] Exclusively breastfed infants should be monitored if this drug is used during lactation, possibly including measurement of serum levels to rule out toxicity if there is a concern. Topical tacrolimus presents a low risk to the nursing infant because it is poorly absorbed after topical application and peak blood concentrations are less than 2 mcg/L in most patients. Ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. If the breast is to be treated, an alternate drug is preferred; do not apply to the nipple area while nursing.[8][9][10]

Tacrolimus Side Effects in Breastfeeding

One infant was exclusively breastfed during maternal tacrolimus therapy throughout gestation to at least 2.5 months of age at which time the infant was developing normally physically and neurologically. An ultrasound examination of the infant's thymus was normal.[12] The National Transplantation Pregnancy Registry reported data gathered from 1991 to 2011 on mothers who breastfed their infants following organ transplantation. A total of 68 mothers with transplants (mostly kidney or liver) used tacrolimus while breastfeeding a total of 83 infants. Duration of nursing ranged from 1 week to 1.5 years and follow-up of the children ranged from weeks to 16 years. There were no reports of problems in any of the infants or children.[4] As of December 2013, a total of 92 mothers had breastfed 125 infants for as long as 26 months with no apparent adverse effects in infants.[5] The breastfed infants of six women who took tacrolimus during pregnancy for organ transplantation were breastfed (4 exclusive, 2 partial) for 45 to 180 days and followed for periods of 2 to 30 months. The mothers' mean daily tacrolimus dosage during breastfeeding was 9.6 mg daily (range 4.5 to 15 mg daily). Four mothers were also taking azathioprine 100 to 150 mg daily, one was taking diltiazem, and one was taking prednisolone 15 mg and aspirin 75 mg daily. None of the infants had any clear tacrolimus-related side effects, although one had transient thrombocytosis that resolved despite continued breastfeeding. Developmental milestones were normal and no pattern of infections was noted.[17] Two mothers with systemic lupus erythematosus were reported who took tacrolimus 3 mg daily during pregnancy and lactation as well as prednisolone 30 or 40 mg daily. Three years after birth, both children were healthy. The durations of lactation were not stated.[19]
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. We do not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.