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. 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.
Random tacrolimus colostrum levels in 10 samples from 6 mothers (dosage not stated) averaged 1.7 mcg/L (range 0.3 to 1.9 mcg/L) which was about 50% of maternal serum levels. Tacrolimus dosages in these mothers were not reported.
One mother taking 3 mg twice daily (0.1 mg/kg per day), had a peak milk level of 0.57 mcg/L one hour after the dose. The half-life in milk was estimated to be 12.85 hours. The authors estimated that her breastfed infant would receive 0.06% of the maternal weight-adjusted dosage or 0.06 mcg/kg daily, which is 0.03 to 0.04% of the oral starting dosage for pediatric patients.
One mother who had been taking tacrolimus for a kidney transplant 5 years earlier was 3 months postpartum and exclusively breastfeeding her infant. She had been taking a dosage of 2 mg orally twice daily (0.05 mg/kg per day) for at least 2 months. She was also taking atenolol 100 mg, azathioprine 100 mg, diltiazem 180 mg, furosemide 20 mg, and prednisone 5 mg daily. Milk samples obtained over a 12-hour dosage interval found little change throughout the day, with the highest levels of 2.1 mcg/L at 4 and 8.5 hours after the dose. The average milk concentration was 1.8 mcg/L. The authors calculated that an exclusively breastfed infant would receive a daily dosage of 0.27 mcg/kg which is about 0.5% of the maternal weight-adjusted dosage and less than 0.2% of the pediatric dosage for organ transplant rejection.
Nine mothers were taking tacrolimus following kidney transplants. Their trough tacrolimus concentrations ranged between 1.3 and 6.8 mcg/L. In random breastmilk samples, 9 samples had concentrations less than 1 mcg/L, and 3 others had concentrations of 1.2, 1.5, and 2.1 mcg/L, respectively.
Blood samples were collected from 3 exclusively breastfed infants whose mothers were taking tacrolimus. Exact maternal dosages and infant ages at the time of the samples were not reported in the abstract. Tacrolimus was undetectable (<1.9 mcg/L) in the serum of all infants.
The serum of 7 infants whose mothers took tacrolimus during pregnancy and postpartum were measured for tacrolimus. Five of the infants were breastfed and 2 were not. The serum tacrolimus concentrations of all infants fell at about the same rate over the first 2 weeks postpartum, regardless of breastfeeding status, indicating that breastfeeding did not prolong infant tacrolimus levels.
Effects in Breastfed Infants:
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.
The National Transplantation Pregnancy Registry reported data gathered from 1991 to 2009 on mothers who breastfed their infants following organ transplantation. Of the 51 mothers who had a kidney transplant, 14 who had a liver transplant, 4 who had a heart transplant and 1 who had a kidney-liver transplant, 36 took tacrolimus. Concurrent drug therapy was not mentioned. The extent of nursing was not reported for all of the mother-infant pairs, but some infants were partially formula fed. There were no reports of problems in any of the infants.
A pharmacovigilance center in France collected information on the outcome of infants whose mothers took tacrolimus during breastfeeding. Four infants were exclusively breastfed for 3 to 6 months and followed up at 8 months to 2.5 years of age. The infants showed no adverse effects such as unusual infections or developmental abnormalities.
Possible Effects on Lactation:
Relevant published information was not found as of the revision date.
1. van der Woude CJ, Kolacek S, Dotan I et al. European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohn's Colitis. 2010;4:493-510. PMID:21122553 2. Strober B, Berger E, Cather J et al. A series of critically challenging case scenarios in moderate to severe psoriasis: a Delphi consensus approach. J Am Acad Dermatol. 2009;61 (Suppl 1):S1-S46. PMID:19527820 3. Jain A, Venkataramanan R et al. Pregnancy after liver transplantation under tacrolimus. Transplantation. 1997;64:559-65. PMID:9293865 4. French AE, Soldin SJ et al. Milk transfer and neonatal safety of tacrolimus. Ann Pharmacother. 2003;37:815-8. PMID:12773068 5. Gardiner SJ, Begg EJ. Breastfeeding during tacrolimus therapy. Obstet Gynecol. 2006;107 (2 pt. 2):453-5. PMID:16449146 6. Chusney GD, Bramham K, Nelson-Piercy C et al. Tacrolimus monitoring during breastfeeding in neonates of transplant recipients. Ther Drug Monit. 2011;33:476. Abstract. 7. Gouraud A, Bernard N, Millaret A, Bruel M, Paret N, Vial T. Serum level of tacrolimus in of breastfeed infant (sic) and long term follow-up. Fundam Clin Pharmacol. 2011;25 (Suppl. 1):515. Abstract. 8. Coscia LA, Constantinescu S, Moritz MJ et al. Report from the National Transplantation Pregnancy Registry (NTPR): outcomes of pregnancy after transplantation. Clin Transplant. 2009;103-22. PMID:20524279
CAS Registry Number:
LactMed Record Number:
Last Revision Date:
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. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.