This sheet is about exposure to etanercept in pregnancy and while breastfeeding. This information is based on published research studies. It should not take the place of medical care and advice from your healthcare provider.
What is etanercept?
Etanercept (Enbrel®) is a medication that has been used to treat some autoimmune diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and juvenile rheumatoid arthritis. Etanercept is called a tumor necrosis factor (TNF) inhibitor because it binds and blocks TNF. TNF is a substance in the body that causes inflammation in the joints, spine, and skin.
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 your medication. Your healthcare providers can talk with you about the benefits of treating your condition and the risks of untreated illness during pregnancy.
For more information, please see the MotherToBaby fact sheets on rheumatoid arthritis at https://mothertobaby.org/fact-sheets/rheumatoid-arthritis/, ankylosing spondylitis at https://mothertobaby.org/fact-sheets/ankylosing-spondylitis/, and psoriasis/psoriatic arthritis at https://mothertobaby.org/fact-sheets/psoriasis-and-pregnancy/.
I am taking etanercept, but I would like to stop taking it before getting pregnant. How long does the drug stay in my body?
The time it takes the body to metabolize (to process) medication is not the same for everyone. In healthy non-pregnant adults, it takes about 3 to 4 weeks, on average, for most of the etanercept to be gone from the body.
I take etanercept. Can it make it harder for me to get pregnant?
Studies have not been done to see if etanercept can make it harder to get pregnant. Etanercept is being studied to see if it might help to improve the success rates of certain fertility treatments.
Does taking etanercept increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. One study found that 337 people treated with etanercept during their pregnancy did not have a higher chance of miscarriage compared to similar groups of people who were not treated with etanercept in pregnancy. Another study found no increase in miscarriage was reported in 417 people exposed to etanercept or another TNF inhibitor during pregnancy.
Does taking etanercept increase the chance of birth defects?
Birth defects can happen in any pregnancy for different reasons. Out of all babies born each year, about 3 out of 100 (3%) will have a birth defect. We look at research studies to try to understand if an exposure, like etanercept, might increase the chance of birth defects in a pregnancy.
Most studies do not show an increased risk of birth defects from using etanercept during pregnancy. Several small studies and one larger study of over 2,000 pregnancies found no increased risk. A few studies did find a higher rate of birth defects, but no specific pattern of birth defects was noted. Also, it is unclear if the defects were due to the medication or the underlying disease. One study found a small increase in risk with TNF inhibitors overall, but it did not compare to similar people not using the medication, so the cause of the increase reported is not clear.
Does taking etanercept in pregnancy increase the chance of other pregnancy-related problems?
A study looking at 495 pregnancies exposed to TNF inhibitors (140 exposed to etanercept) found a small increased chance of preterm delivery (birth before week 37) when looking at all the TNF inhibitor medications. However, the study did not compare these pregnancy outcomes to those who had similar medical conditions but were not taking TNF inhibitors. This study cannot determine if the problems reported were due to the medications or the diseases being treated. Another study including 2,116 people who reported using etanercept during pregnancy did not find an increased chance of pregnancy complications.
Three studies found that people with rheumatoid arthritis, chronic inflammatory arthritis, or psoriasis were more likely to have preterm delivery and have babies with lower birth weight than people who did not have these medical conditions. This was true for the people with medical conditions who used etanercept and those who did not. This makes it hard to know if the autoimmune conditions themselves or use of another medication besides etanercept increased the chance for these issues.
More etanercept is thought to cross the placenta during the second and third trimesters than in the first trimester of pregnancy. Limited information looking at the use of etanercept in the third trimester has not shown increased risks to the fetus.
Does taking etanercept in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if etanercept can affect future behavior or learning for a child exposed during pregnancy.
Can my baby receive vaccines before one year of age if I take etanercept later in pregnancy?
Since etanercept might suppress the immune system of the person taking it, there is a theoretical (not proven) concern that the same thing could happen to the baby if they are exposed during pregnancy. If someone has a weakened immune system, they may be more likely to develop an infection from a “live” vaccine. Live vaccines contain a small amount of live virus. In the United States, rotavirus is the only live vaccine routinely given in the first year of life. Inactivated vaccines do not contain live virus, so they cannot cause the disease they protect against. Most people can get inactivated vaccines in the first year of life.
Talk with your child’s healthcare provider about your exposure to etanercept during pregnancy. They can talk with you about the vaccines your child should receive and the best time for your child to receive them.
Breastfeeding while taking etanercept:
Etanercept is not well-absorbed from the gut. It is expected that any etanercept that gets into breast milk would most likely pass through the baby’s body without getting into their bloodstream. Information on 10 people taking etanercept while breastfeeding suggests that the levels of etanercept in breast milk are very low. Two of these reports looked at the amount of etanercept in the baby’s blood from breast milk and the lab test could not measure any etanercept in their blood. One of the infants was followed to 3 years of age and no harmful effects were reported.
A small study looked at 5 infants exposed to etanercept through breastmilk and compared them to breastfeeding infants of people who had the same medical conditions but were not taking a TNF inhibitor medication. The study found no differences in the infants’ growth, development, response to vaccinations, or illnesses in the first year of life.
A national registry of patients with rheumatic disease treated with drugs like etanercept was conducted in Spain. Three infants whose mothers were taking etanercept were breastfed (extent not stated) with no mild or severe adverse events reported in the infants. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a man takes etanercept, could it affect his fertility or increase the chance of birth defects?
Two small studies reported that men taking etanercept for spondylarthritis (SpA) had the same sperm quality as men with SpA who were not taking a TNF inhibitor. This suggests that etanercept would not affect men’s fertility (ability to get a partner pregnant). In general, exposures that fathers or sperm donors 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/.
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