This sheet is about exposure to tildrakizumab in pregnancy and while breastfeeding. This information is based on available published literature. It should not take the place of medical care and advice from your healthcare provider.
What is tildrakizumab?
Tildrakizumab (Ilumya®) is a medication that has been used to treat moderate-to-severe plaque psoriasis. For more information about psoriasis in pregnancy, please see the MotherToBaby fact sheet at https://mothertobaby.org/fact-sheets/psoriasis-and-pregnancy/.
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.
I am taking tildrakizumab, but I would like to stop taking it before getting pregnant. How long does the drug stay in my body?
People eliminate medication at different rates. In healthy adults, it takes up to 138 days (about 5 months), on average, for most of the tildrakizumab to be gone from the body.
I take tildrakizumab. Can it make it harder for me to get pregnant?
Studies have not been done in humans to see if tildrakizumab could make it harder to get pregnant. Animal studies did not report an effect on fertility.
Does taking tildrakizumab increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. A report of 14 human pregnancies exposed to tildrakizumab noted a miscarriage in 2 of those 14 pregnancies. This is similar to the rate of miscarriage in the general population. Animal studies did not report a higher chance of miscarriage.
Does taking tildrakizumab 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. In the same report on 14 human pregnancies exposed to tildrakizumab, birth defects were not found among the infants. Animal studies done by the manufacturer also did not show an increase in birth defects with exposure to tildrakizumab.
Does taking tildrakizumab in pregnancy increase the chance of other pregnancy-related problems?
Studies have not been done to see if tildrakizumab 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 [2500 grams] at birth) in humans. In the report of 14 pregnancies exposed to tildrakizumab, one person gave birth early at 36 weeks.
Does taking tildrakizumab in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if tildrakizumab can cause behavior or learning issues for the child.
Can my baby receive live vaccines before one year of age if I take tildrakizumab later in pregnancy?
Since tildrakizumab may suppress the immune system of the person taking it, there is a theoretical 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. Inactivated vaccines do not contain live virus, so they cannot cause the disease they protect against. In the United States, rotavirus is the only live vaccine routinely given in the first year of life. Most people can get inactivated vaccines in the first year of life.
Talk with your child’s healthcare provider about your exposure to tildrakizumab 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 tildrakizumab:
Tildrakizumab has not been studied for use during breastfeeding. Tildrakizumab is a very large protein, so not much of the medication is likely to pass into breast milk. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a male takes tildrakizumab, could it affect fertility (ability to get partner pregnant) or increase the chance of birth defects?
Studies have not been done in humans to see if tildrakizumab could affect male fertility or increase the chance of birth defects above the background risk. Animal studies did not report an effect on fertility. 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/.
MotherToBaby is currently conducting a study looking at tildrakizumab and other medications in pregnancy. If you are interested in learning more, please call 1-877-311-8972 or visit https://mothertobaby.org/join-study.
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OTIS/MotherToBaby encourages inclusive and person-centered language. While our name still contains a reference to mothers, we are updating our resources with more inclusive terms. Use of the term mother or maternal refers to a person who is pregnant. Use of the term father or paternal refers to a person who contributes sperm.
