This sheet is about exposure to dupilumab 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 dupilumab?
Dupilumab is a monoclonal antibody. It has been used to treat moderate-to-severe atopic dermatitis (eczema), prurigo nodularis (a skin condition with hard, itchy bumps called nodules), certain types of moderate-to-severe asthma, sinusitis with nasal polyps (swelling/inflammation of the sinuses with growths inside the nose), and eosinophilic esophagitis (ongoing inflammation of the tube that connects the mouth to the stomach). It is sold under the brand name Dupixent®.
MotherToBaby has fact sheets on asthma here https://mothertobaby.org/fact-sheets/asthma-and-pregnancy/ and atopic dermatitis | eczema 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 dupilumab. Can it make it harder for me to get pregnant?
Studies have not been done to see if taking dupilumab can make it harder to get pregnant.
Does taking dupilumab 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 dupilumab can increase the chance of miscarriage. An increased chance of miscarriage has not been reported in case reports of dupilumab use in pregnancy.
Does taking dupilumab 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 dupilumab, might increase the chance of birth defects in a pregnancy. There are case reports and case series looking at the outcomes of over 50 pregnancies that were exposed to dupilumab in the first trimester. These reports did not show an increased chance of birth defects. Experimental animal studies done by the manufacturer did not report an increase in birth defects or problems with the newborns immune system with exposure to dupilumab.
Does taking dupilumab in pregnancy increase the chance of other pregnancy-related problems?
Studies have not been done to see if dupilumab 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 dupilumab in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if dupilumab can increase the chance of behavior or learning issues for the child.
Breastfeeding while taking dupilumab:
There are no studies on the use of dupilumab in breastfeeding. Dupilumab is a very large protein, which means not much of the medication is expected to pass into breast milk. Any that does get into the breast milk is likely to be destroyed in the infant’s gastrointestinal tract (stomach and intestines), especially in infants older than 4-7 days old. There are reports on the use of dupilumab while breastfeeding, and no infant side effects noted. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a man takes dupilumab, could it affect fertility or increase the chance of birth defects?
Experimental animal studies did not report lower fertility when dupilumab was used. Human studies have not been done. One report described two men who used dupilumab during conception and throughout their partner’s pregnancy. No birth defects were reported. 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 dupilumab and other medications used to treat asthma/autoimmune disorders in pregnancy. If you are interested in taking part in this study, please call 1-877-311-8972 or sign up at https://mothertobaby.org/join-study/.
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