Tofacitinib use while Breastfeeding

Summary of Use during Lactation

Data from 2 mothers indicate that the amount in milk is low, and no adverse effects were seen in infants who were exclusively breastfed during maternal tofacitinib use. Until more data become available, tofacitinib should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Expert opinion considers breastfeeding to be unadvisable during tofacitinib use.[1] 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.[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 hours 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.[3]

One nursing mother taking tofacitinib 5 mg twice daily donated 18 prenursing milk samples on days 20 to 22 postpartum. The median level was 7.8 mcg/L (range 1.8 to 32.8 mcg/L). The highest milk concentration of 32.8 mcg/L occurred 3.5 hours after a maternal dose of tofacitinib. The lowest concentration of 1.8 mcg/L occurred 11.3 hours after the previous tofacitinib dose. Based on the highest milk level, the worst-case daily infant dosage was 4.9 mcg/kg, equating to a weight-adjusted relative infant dose of 3.4%.[4]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Two mothers took tofacitinib during pregnancy while breastfeeding exclusively. One infant whose mother was taking a dose of 10 mg twice daily was breastfed for 6 weeks. At 3.5 of age the infant had normal growth and psychomotor development, and no negative safety signals were seen. The infant received the mandatory non-live vaccinations without complications. A second infant, whose mother was taking tofacitinib 5 mg twice daily and vedolizumab 300 mg every 4 weeks for ulcerative colitis postpartum was followed. She breastfed her infant exclusively for the first 6 months postpartum, and continued breastfeeding for at least 16 months. The child demonstrated normal growth and psychomotor development. The infant received 3 doses of a required hexavalent vaccine (tetanus, diphtheria, polio, pertussis, hepatitis B, and Haemophilus influenza type B) as well as optional non-live vaccines (pneumococcal and meningococcal vaccines) on schedule at 3, 5, and 14 months, with no adverse events reported. At 12 months of age, the child contracted chickenpox, which had a mild course. No other infectious complications were noted. A blood sample was collected from the child at 15 months. Laboratory analysis revealed normal levels of immunoglobulin classes, except for a slightly reduced total IgG antibody level and non-significant anemia. The titers of post-vaccination antibodies were within the typical range for a healthy population, indicating a normal response to vaccination. Extended T-cell and B-cell immunophenotyping was normal, except for mild, non-significant deviations in some T-cell and B-cell populations. The neonatal screening for severe combined immunodeficiency (SCID) was negative. No severe or clinically meaningful pathological findings were observed.[4,5]

A woman was taking tofacitinib 10 mg twice daily for ulcerative proctocolitis. She reduced the dose to 5 mg twice daily at week 23 of pregnancy and continued it for the rest of her pregnancy and while breastfeeding (extent not stated). At 12 weeks of age, the infant underwent a thorough immunologic evaluation that was normal. The infant was given two doses of the live rotavirus vaccine (Rotarix, GlaxoSmithKline) at weeks 13 and 20 of age. No adverse events were reported following immunization, including severe vomiting, diarrhea or intussusception, with active and passive surveillance. The infant was healthy at 12 months of age.[6]

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.

Selinger C, Laube R, Limdi JK, et al. Appropriateness of small molecule agents for patients with IBD of childbearing age - a RAND/UCLA appropriateness panel. Therap Adv Gastroenterol 2024;17:17562848241299737. [PMC free article: PMC11558739] [PubMed: 39539488]

2.

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]

3.

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]

4.

Mitrova K, Julsgaard M, Augustijns P, et al. Tofacitinib in pregnancy: Assessing pregnancy and infant outcomes, cord blood and breast milk concentrations. Clin Gastroenterol Hepatol 2025;23:163–65.e3. [PubMed: 38309493]

5.

Mitrova K, Kostrejova M, Zdychyncova K, et al. Effect of tofacitinib exposure in utero and during breastfeeding on the immune status of exposed child. J Crohns Colitis 2025;19:jjaf049. [PubMed: 40127036]

6.

Ernest-Suarez K, Murguía-Favela LE, Novak KL, et al. Normal infant immunologic assessment and uneventful live rotavirus vaccination despite continuous tofacitinib exposure in utero and during breastfeeding. Crohns Colitis 360 2024;6:otae006. [PMC free article: PMC10841763] [PubMed: 38317692]

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