This sheet talks about exposure to tofacitinib in pregnancy and while breastfeeding. This information should not take the place of medical care and advice from your healthcare provider.
What is tofacitinib?
Tofacitinib is a prescription medication used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. More information on these conditions can be found in our fact sheets at https://mothertobaby.org/fact-sheets/rheumatoid-arthritis/pdf/, https://mothertobaby.org/fact-sheets/psoriasis-and-pregnancy/pdf/, and https://mothertobaby.org/fact-sheets/inflammatory-bowel-disease-pregnancy/pdf/. Tofacitinib is marketed under the brand name Xeljanz® and Xeljanz® XR.
I take tofacitinib. Can it make it harder for me to get pregnant?
Studies on women have not been done to see if taking tofacitinib could make it harder to get pregnant.
I just found out I am pregnant. Should I stop taking tofacitinib?
Talk with your healthcare providers before making any changes to this medication. They can go over your options, weighing the risks and benefits of treating or not treating your condition.
Does taking tofactinib increase the chance for miscarriage?
Miscarriage can occur in any pregnancy. While it has not been well studied, there are reports of women exposed to tofacitinib during early pregnancy. No increase chance for pregnancy loss was reported.
Does taking tofactinib in the first trimester increase the chance of birth defects?
In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect. This is called her background risk. Animal studies showed an increase in birth defects with the use of doses much higher than those used in humans. In humans, there are reports of women exposed to tofacitinib during early pregnancy. No increased chance for birth defects was reported. There is not enough information to know if tofacitinib increases the chance of birth defects in humans.
Could taking tofacitinib in the second or third trimester cause other pregnancy complications?
It is not known whether tofacitinib can cause other pregnancy complications.
Does taking tofacitinib in pregnancy cause long-term problems in behavior or learning for the baby?
There have been no studies looking into long-term problems in behavior or learning for babies born to women who were taking tofacitinib while pregnant.
Can I breastfeed while taking tofacitinib?
Tofacitinib has not been well studied for use during breastfeeding. The manufacturer and an expert panel recommend that breastfeeding be stopped while using tofacitinib and for 18 hours after the last dose. For the extended release form (Xeljanz® XR), they recommend waiting 36 hours after the last dose before resuming breastfeeding. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a man takes tofacitinib, could it affect his fertility (ability to get partner pregnant) or increase the chance of birth defects?
While it has not been well studied, there are reports of fathers taking tofacitinib before conception. No increase in pregnancy loss or birth defects was reported. In general, exposures that fathers have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/pdf/.
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Selected References:
- Clowse, M., et al. 2016. Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis. Drug Saf. 39:755-762,
- Mahadevan, U., Dubinsky, M. C., Su, C., Lawendy, N., Jones, T. V., Marren, A., … Baumgart, D. C. (2018). Outcomes of Pregnancies With Maternal/Paternal Exposure in the Tofacitinib Safety Databases for Ulcerative Colitis. Inflammatory Bowel Diseases, 24(12), 2494–2500. doi: 10.1093/ibd/izy160
- Mahadevan, U., Robinson, C., Bernasko, N., Boland, B., Chambers, C., Dubinsky, M., … Jain, R. (2019). Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway: A Report From the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology, 156(5), 1508–1524. doi: 10.1053/j.gastro.2018.12.022
- Merren A, Chen Y, Frazier D, Geier J. 2015. Pregnancy Outcomes in the tofacitinib RA study database through April 2014. Abstract doi 10.1136/annrheumdis-2015-eular.3547.
- Picardo S, Seow CH. A Pharmacological Approach to Managing Inflammatory Bowel Disease During Conception, Pregnancy and Breastfeeding: Biologic and Oral Small Molecule Therapy. Drugs. 2019 Jul;79(10):1053-1063. doi:10.1007/s40265-019-01141-w. Review. PubMed PMID: 31183768.
- Xeljanz accessed Nov. 7th, 2019 at https://accessdata.fda.gov/drugsatfda_docs/label/2018/203214s018lbl.pdf. Last updated 7/2019.
OTIS/MotherToBaby recognizes that not all people identify as “men” or “women.” When using the term “mother,” we mean the source of the egg and/or uterus and by “father,” we mean the source of the sperm, regardless of the person’s gender identity.
