ArticleBritish journal of clinical pharmacology2013
Tacrolimus placental transfer at delivery and neonatal exposure through breast milk.
Article in British journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 81 citations in OpenAlex.
- British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids.Rheumatology (Oxford, England) · 2023Guideline
- ACG Clinical Guideline: Liver Disease and Pregnancy.The American journal of gastroenterology · 2016Guideline
- Pregnancy-induced changes in the pharmacokinetics of caffeine and its metabolites.Journal of clinical pharmacology · 2016Trial
- Systemic lupus erythematosus and pregnancy: a comprehensive clinical review of maternal, fetal, and treatment considerations.Advances in rheumatology (London, England) · 2026Review
- Safety of Drugs in Breastfeeding Women With CKD.Kidney international reports · 2025Article
- Transporters and drug secretion into human breast milk.Expert opinion on drug metabolism & toxicology · 2025Review
- Compatibility of Post-Kidney Transplant Immunosuppression Therapy with Lactation.Journal of clinical medicine · 2025Review
- Pregnancy after orthotopic liver transplantation: a comprehensive review.Frontiers in transplantation · 2025Review
- An Immune-Independent Mode of Action of Tacrolimus in Promoting Human Extravillous Trophoblast Migration Involves Intracellular Calcium Release and F-Actin Cytoskeletal Reorganization.International journal of molecular sciences · 2024Article
- A literature review of drug transport mechanisms during lactation.CPT: pharmacometrics & systems pharmacology · 2024Review
- A retrospective analysis of the safety of tacrolimus use and its optimal cut-off concentration during pregnancy in women with systemic lupus erythematosus: study from two Japanese tertiary referral centers.Arthritis research & therapy · 2024Article
- Article
- Design Considerations for Pharmacokinetic Studies During Pregnancy.Journal of clinical pharmacology · 2023Article
- Expert consensus on vaccination in patients with inflammatory bowel disease in Japan.Journal of gastroenterology · 2023Article
- Opportunities and challenges of pharmacovigilance in special populations: a narrative review of the literature.Therapeutic advances in drug safety · 2023Review
- Outcomes of Children with Fetal and Lactation Immunosuppression Exposure Born to Female Transplant Recipients.Paediatric drugs · 2022Review
- The impact of gender and sex in psoriasis: What to be aware of when treating women with psoriasis.International journal of women's dermatology · 2022Review
- Pharmacokinetic data in pregnancy: A review of available literature data and important considerations in collecting clinical data.Frontiers in medicine · 2022Review
- State-of-the-Art Review of Pregnancy-Related Psoriasis.Medicina (Kaunas, Lithuania) · 2021Review
- Maternal, foetal and child consequences of immunosuppressive drugs during pregnancy in women with organ transplant: a review.Clinical kidney journal · 2021Review
Corrections and comments
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Authors and funding
11 authors at 4 institutions in 1 country.
Funding
Abstract
AIM(S): The current investigation aims to provide new insights into fetal exposure to tacrolimus in utero by evaluating maternal and umbilical cord blood (venous and arterial), plasma and unbound concentrations at delivery. This study also presents a case report of tacrolimus excretion via breast milk.
methodsMaternal and umbilical cord (venous and arterial) samples were obtained at delivery from eight solid organ allograft recipients to measure tacrolimus and metabolite bound and unbound concentrations in blood and plasma. Tacrolimus pharmacokinetics in breast milk were assessed in one subject.
resultsMean (±SD) tacrolimus concentrations at the time of delivery in umbilical cord venous blood (6.6 ± 1.8 ng ml(-1)) were 71 ± 18% (range 45-99%) of maternal concentrations (9.0 ± 3.4 ng ml(-1)). The mean umbilical cord venous plasma (0.09 ± 0.04 ng ml(-1)) and unbound drug concentrations (0.003 ± 0.001 ng ml(-1)) were approximately one fifth of the respective maternal concentrations. Arterial umbilical cord blood concentrations of tacrolimus were 100 ± 12% of umbilical venous concentrations. In addition, infant exposure to tacrolimus through the breast milk was less than 0.3% of the mother's weight-adjusted dose.
conclusionsDifferences between maternal and umbilical cord tacrolimus concentrations may be explained in part by placental P-gp function, greater red blood cell partitioning and higher haematocrit levels in venous cord blood. The neonatal drug exposure to tacrolimus via breast milk is very low and likely does not represent a health risk to the breastfeeding infant.
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Registered trials
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