Tofacitinib Levels and Effects while Breastfeeding
Summary of Use during Lactation
The manufacturer and an expert panel recommend that breastfeeding be discontinued during tofacitinib therapy and for 18 hours after the last dose of the immediate-release product or 36 hours after the last dose of the sustained-release product.[1] Data from one woman seem to support this recommendation.[2]
Drug Levels
Maternal Levels. A woman with treatment-refractory ulcerative proctitis was started on tofacitinib 10 mg twice daily. She was nursing her 30-month-old daughter once daily. She stopped breastfeeding when tofacitinib was started, but collected 37 timed milk samples over 14 hours after a dose 25 days after stopping breastfeeding while she was still producing milk. The highest tofacitinib milk concentration of 54.5 mcg/L occurred 4 h after the dose and the lowest milk concentration of 2 mcg/L occurred 14 hours after the dose. Based on the highest milk concentration, the infant would receive 3.4% of the mother’s weight-adjusted dosage. The author agreed with the manufacturer’s recommendation of not breastfeeding until 18 hours after a dose.[2]
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Mahadevan U, Robinson C, Bernasko N, et al. Inflammatory bowel disease in pregnancy clinical care pathway: A report from the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology 2019;156:1508-24. [PubMed: 30658060]
2.
Julsgaard M, Mahadevan U, Vestergaard T, et al. Tofacitinib concentrations in plasma and breastmilk of a lactating woman with ulcerative colitis. Lancet Gastroenterol Hepatol 2023;8:695-7. [PubMed: 37269871]
Substance Identification
Substance Name
Tofacitinib
CAS Registry Number
477600-75-2
Drug Class
Breast Feeding
Lactation
Milk, Human
Antirheumatic Agents
Enzyme Inhibitors
Janus Kinase Inhibitors
JAK Inhibitors
Signal Transduction Inhibitors
Protein Kinase Inhibitors
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