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.

Alternate Drugs to Consider

(Rheumatoid Arthritis) Adalimumab, Certolizumab Pegol, Etanercept, Infliximab, Tocilizumab

References

1.

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 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