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 providers.
What is dupilumab?
Dupilumab is a monoclonal antibody that 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), eosinophilic esophagitis (ongoing inflammation of the tube that connects the mouth to the stomach), and chronic obstructive pulmonary disease (COPD). 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 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. In animal studies (monkeys and mice), there were no effects on fertility (ability to get pregnant) when animals were given 10 times more dupilumab than would be given to humans.
Does taking dupilumab increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. In two studies, including over 400 pregnancies exposed to dupilumab, no increased chance of miscarriage was reported. Another study, including 2,895 pregnancies exposed to dupilumab, reported an increased chance of miscarriage. As there can be many causes of miscarriage, it is hard to know if medication, the medical condition, or other factors are the cause of miscarriage.
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.
It is not known if dupilumab can increase the chance of birth defects. Two studies, including 115 and 2,895 pregnancies exposed to dupilumab, did not report an increased chance of birth defects.
Does taking dupilumab in pregnancy increase the chance of other pregnancy-related problems?
In a large study including 2,895 women exposed to dupilumab during pregnancy, there was no increase in the chance of pregnancy-related problems such as preterm delivery (birth before week 37 of pregnancy) or low birth weight (weighing less than 5 pounds, 8 ounces [2,500 grams] at birth). Another study looking at 115 women exposed to dupilumab in pregnancy did not report increased chances of high blood pressure or gestational diabetes.
Does taking dupilumab in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if dupilumab can affect a child’s future behavior or learning.
Breastfeeding while taking dupilumab:
Information on using dupilumab while breastfeeding is limited. Because dupilumab is a large protein, only small amounts are expected to pass into breast milk, and any amount that is swallowed is likely to break down in the baby’s stomach and intestines. Reports of dupilumab use during breastfeeding have not found problems in breastfed infants.
If a man takes dupilumab, could it affect fertility or increase the chance of birth defects?
Studies have not been done in humans to see if dupilumab could affect male fertility (ability to make healthy sperm) or increase the chance of birth defects. Animal studies did not find that dupilumab affects fertility. One report of two men who used dupilumab at the time of conception and during their partner’s pregnancies found no birth defects. In general, exposures that fathers and sperm donors have are less likely 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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