This sheet is about exposure to tralokinumab 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 tralokinumab?
Tralokinumab (Adbry®) is a medication in the form of a shot (injection) that has been used to treat moderate to severe atopic dermatitis (eczema) that is hard to treat with topical therapies (used on the skin). It has also been used to treat atopic dermatitis in people who cannot use topical therapies. MotherToBaby has a fact sheet on atopic dermatitis here https://mothertobaby.org/fact-sheets/atopic-dermatitis/.
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 tralokinumab. Can it make it harder for me to get pregnant?
Studies have not been done to see if taking tralokinumab can make it harder to get pregnant.
Does taking tralokinumab increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. Studies have not been done to see if tralokinumab can increase the chance of miscarriage.
Does taking tralokinumab 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 tralokinumab, might increase the chance of birth defects in a pregnancy. Human studies have not been done to see if tralokinumab can increase the chance of birth defects. An animal study did not find an increased chance of birth defects when tralokinumab was used in pregnancy.
Does taking tralokinumab in pregnancy increase the chance of other pregnancy-related problems?
Studies have not been done to see if tralokinumab can increase the chance of 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).
Does taking tralokinumab in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if tralokinumab can increase the chance of behavior or learning issues for the child.
Can my baby receive live vaccines before one year of age if I take tralokinumab while pregnant?
Since tralokinumab might 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 might 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 tralokinumab 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 tralokinumab:
Tralokinumab has not been studied for use in humans while breastfeeding. Based on the size of the tralokinumab molecules, it is thought that the chance it enters the breastmilk is low. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a man takes tralokinumab, could it affect fertility or increase the chance of birth defects?
Studies have not been done to see if tralokinumab could affect men’s fertility (ability to get a woman pregnant) or increase the chance of birth defects. 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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