This sheet is 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/, https://mothertobaby.org/fact-sheets/psoriasis-and-pregnancy/ and https://mothertobaby.org/fact-sheets/inflammatory-bowel-disease-pregnancy/. Tofacitinib is marketed under the brand name Xeljanz® and Xeljanz XR®.
Sometimes when people find out they are pregnant, they think about changing how they take their medication, or stopping their medication altogether. However, it is important to talk with your healthcare providers before making any changes to how you take this medication. Your healthcare providers can talk with you about the benefits of treating your condition and the risks of untreated illness during pregnancy.
I take tofacitinib. Can it make it harder for me to get pregnant?
Studies have not been done to see if taking tofacitinib could make it harder to get pregnant.
Does taking tofacitinib 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 tofacitinib increase the chance of birth defects?
Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Animal studies showed an increase in birth defects with the use of tofacitinib at 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.
Does taking tofacitinib in pregnancy increase the chance of other pregnancy related problems?
Studies have not been done to see if tofacitinib increases the chance for pregnancy-related problems such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces at birth).
Does taking tofacitinib in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if tofacitinib can cause behavior or learning issues for the child.
Breastfeeding 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 male takes tofacitinib, could it affect fertility (ability to get partner pregnant) or increase the chance of birth defects?
Studies have not been done to see if tofacitinib could affect male fertility or increase the chance of birth defects. In general, exposures that fathers or sperm donors have are unlikely to increase the risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.
MotherToBaby is currently conducting a study looking at tofacitinib and other medications used to treat autoimmune diseases in pregnancy. If you are interested in taking part in this study, please call 1-877-311-8972, or visit: https://mothertobaby.org/join-study/.
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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.
