This sheet is about exposure to tocilizumab 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 tocilizumab?
Tocilizumab is a prescription medication that has been used to treat rheumatoid arthritis (RA), giant cell arteritis in adults, and juvenile idiopathic arthritis (JIA) in children. It has also been used to treat symptoms of severe COVID-19 in hospitalized patients. The brand name for tocilizumab is Actemra®.
MotherToBaby has a fact sheet on rheumatoid arthritis here: https://mothertobaby.org/fact-sheets/rheumatoid-arthritis/.
Sometimes when women 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.
I take tocilizumab. Can it make it harder for me to get pregnant?
It is not known if tocilizumab can make it harder to get pregnant.
Does taking tocilizumab increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. It is not known if taking tocilizumab can increase the chance of miscarriage. Some studies have suggested that taking tocilizumab might increase the chance of miscarriage, while other studies have not. In the studies that reported an increased chance of miscarriage, other factors that are known to increase the chance of miscarriage such as age, use of multiple medications, and symptoms of the health condition being treated were reported as well. Because miscarriage can happen for many reasons, it is hard to know whether a medication, the condition being treated, or other factors such as age or health are the cause.
Does taking tocilizumab 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 tocilizumab, might increase the chance of birth defects in a pregnancy.
Tocilizumab use during pregnancy is not expected to increase the chance of birth defects. Tocilizumab is not expected to cross the placenta and reach the pregnancy in large amounts during the first trimester, which is the time when a birth defect is most likely to happen. For more information on periods of development, see the MotherToBaby fact sheet on critical periods of development here: https://mothertobaby.org/fact-sheets/critical-periods-development/.
Does taking tocilizumab in pregnancy increase the chance of other pregnancy related problems?
Tocilizumab might cross the placenta in higher amounts in the second and third trimesters of pregnancy. Some studies have shown an increased chance of pregnancy complications including preterm delivery (birth before week 37) and low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth) when tocilizumab is used throughout pregnancy to treat conditions such as RA. However, since poorly controlled RA can also increase the chance for preterm delivery, low birth weight, babies born smaller than expected, and other pregnancy complications, it is not known if these findings are due to tocilizumab or to the medical condition being treated.
Published reports of tocilizumab use to treat severe COVID-19 during the second or third trimesters of pregnancy have not identified an increased chance of pregnancy problems or problems for newborns related to the medication. The pregnancy-related problems reported in these cases, such as preterm delivery, c-section, or admission to the neonatal intensive care nursery (NICU) were believed to be because of the severe COVID-19 infection or other underlying medical conditions or complications.
Does taking tocilizumab in pregnancy affect future behavior or learning for the child?
There have been limited studies done to see if tocilizumab can increase the chance of behavior or learning issues for the child. In a study that looked at infants who were exposed to tocilizumab for a short time during the second or third trimesters of the pregnancy, there were no reported changes in their development up to 6 months or 1 year of age.
Can my child receive live vaccines if I take tocilizumab during pregnancy?
Since tocilizumab might suppress the immune system of adults 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 might 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. Most babies can get inactivated vaccines in the first year of life. Inactivated vaccines do not contain live virus, so they cannot cause the disease they protect against. Talk to your child’s healthcare provider about your exposure to tocilizumab 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 tocilizumab:
Tocilizumab passes into breast milk in small amounts, but it is expected to be destroyed in a breastfed child’s stomach before it can be absorbed into the child’s body. No adverse effects have been reported in infants exposed to tocilizumab through breast milk. Experts consider tocilizumab acceptable for use in breastfeeding. If you suspect the baby has any symptoms, contact the child’s healthcare provider. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a man takes tocilizumab, could it affect his fertility or increase the chance of birth defects?
Limited studies have been done to see if tocilizumab could affect male fertility (ability to make healthy sperm). There was no increase in birth defects in a report that included 8 infants born to males who used tocilizumab. In general, exposures that men 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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