The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY especially when combined with methotrexate during pregnancy.

What is tofacitinib?

Tofacitinib is a medication known as a disease-modifying antirheumatic drug. It is part of a class of drugs known as Janus kinase inhibitors.

What is tofacitinib used to treat?

Tofacitinib is a prescription medication used for moderate to severe rheumatoid arthritis that is not responsive or intolerant to treatment with methotrexate.

How does tofacitinib work?

Tofacitinib prevents activity of certain chemicals in the body that stimulate the immune response associated with inflammatory diseases such as rheumatoid arthritis.

If I am taking tofacitinib, can it harm my baby?

Evidence is limited as to whether tofacitinib crosses the human placenta. Animal studies suggest that doses of tofacitinib higher than doses used in humans can cause birth defects or spontaneous abortions (miscarriages). As of 2016, data on 47 women exposed to tofacitinib during pregnancy have been collected. There have been 12 pregnancy losses reported.

If I am taking tofacitinib and become pregnant, what should I do?

It is important to weigh the risks versus benefits of tofacitinib therapy for the mother and baby while pregnant. Women on tofacitinib therapy during pregnancy are encouraged to enroll in the Xeljanz XR registry. The manufacturer of tofacitinib recommends that women of reproductive age use a reliable type of birth control during therapy and for at least 1 month following discontinuation of tofacitinib.

If I am taking tofacitinib, can I safely breastfeed my baby?

Tofacitinib is expected to cross into breast milk. Breastfeeding should be avoided while on this medication. The risks and benefits of tofacitinib therapy should be weighed before using during breastfeeding. It is generally recommended to either not breastfeed while on tofacitinib therapy or discontinue tofacitinib if you are breastfeeding.

If I am taking tofacitinib, will it be more difficult to get pregnant?

Animal studies suggest that tofacitinib does not impact male fertility or sperm. Female infertility and post-implantation loss occurred in female animals receiving a dose of tofacitinib 17 times greater than the standard human dose.

If I am taking tofacitinib, what should I know?

Although there is limited human data, animal studies suggest a potential risk during pregnancy. It is important to speak with your doctor if you are on tofacitinib and you become pregnant. You and your doctor can weigh the risks versus benefits of tofacitinib therapy during pregnancy. It is generally recommended to avoid breastfeeding if you are on this medication.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of tofacitinib during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert report about rheumatoid arthritis here, reports about autoimmune diseases here,  and reports about the individual medications used to treat immune disorders here. Additional information can also be found in the resources below. 

For more information about tofacitinib during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Pfizer: Xeljanz Prescribing Information

Read the whole report
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.