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Is it safe? · Pregnancy Smart

Dupixent During Pregnancy: Is It Safe?

Assigned clinical reviewerMatt Stahl· PharmDDraft · pending clinical reviewUpdated

What does the evidence say about dupixent during pregnancy?

  1. MotherToBaby's review of two published studies covering 115 and 2,895 pregnancies exposed to Dupixent did not find an increased chance of major birth defects, though a larger study also noted a higher rate of miscarriage whose cause is unclear, since it is hard to separate the effect of the medication from the effect of the underlying condition and other factors. 1
  2. Because Dupixent is a large protein molecule, only small amounts are expected to pass into breast milk, and any amount an infant swallows is likely to break down in the baby's stomach and intestines before absorption; published reports of Dupixent use during breastfeeding have not found problems in breastfed infants. 1
  3. Dupixent is an IgG4 monoclonal antibody, a molecule type expected to cross the placenta, with transfer described as most pronounced in the second and third trimesters; a systematic review pooling 13 studies and 69 pregnancies found 84.1% ended in live birth, with normal birth weight in 92.3% of cases and no congenital anomalies reported among the babies of mothers using Dupixent for atopic dermatitis. 2
  4. A 2025 propensity-matched cohort study compared 293 pregnancies exposed to Dupixent with 293 unexposed pregnancies and found no increased risk of adverse pregnancy outcomes overall, including no significant difference in rates of spontaneous abortion or gestational diabetes. 3
  5. A published case followed one woman who continued Dupixent through conception, pregnancy, and breastfeeding; her eczema severity score fell to zero during pregnancy and her infant showed no complications through 48 months of follow-up, illustrating how the drug can support disease control for someone with severe eczema who becomes pregnant. 4

Is dupixent safe in each trimester?

  • First trimester. First-trimester exposure is the most common real-world scenario, since many pregnancies aren't confirmed until after a Dupixent dose has already been given, and the picture so far is reassuring but limited. Studies following pregnant women using Dupixent have not shown a clear increase in major birth defects, and this early window is also when placental transfer of large antibody drugs like this one is expected to be lowest. Many people rely on Dupixent to manage significant asthma or eczema, so stopping a biologic that is working, without medical guidance, is not usually advised.
  • Second trimester. By the second trimester, more of the antibody drug is expected to reach the fetus as placental transfer of IgG-type antibodies increases. This is also where some of the better controlled data comes from: a 2025 propensity-matched cohort study following 293 pregnancies exposed to Dupixent alongside 293 matched, unexposed pregnancies found no increased risk of adverse pregnancy outcomes overall.
  • Third trimester. Placental transfer of Dupixent is expected to be greatest in the second and third trimesters, so a baby delivered late in a pregnancy where Dupixent is being used may have measurable drug levels at birth. Published follow-up, including a case report that tracked one infant for 48 months, has not linked this to developmental problems, but the total evidence base remains small compared with medications that have decades of pregnancy safety data behind them.

Frequently asked questions

Can I breastfeed while using Dupixent?

Likely yes, based on the evidence so far. Dupixent is a large protein molecule, so only small amounts are expected to reach breast milk, and anything a baby swallows is likely broken down during digestion before it can be absorbed. Reports that have followed breastfeeding while using Dupixent have not turned up problems in the infants. Confirm this fits your situation with your prescriber.

Does Dupixent cross the placenta?

Yes. Dupixent is a large IgG4 antibody, and this class of molecule is expected to cross into the fetus, with transfer described in the research as most pronounced in the second and third trimesters. That means a baby born later in a pregnancy where Dupixent is being used may have measurable drug levels at birth, though published follow-up has not linked this to developmental problems so far.

Should I stop Dupixent if I find out I'm pregnant?

Do not stop on your own. Dupixent is prescribed for moderate to severe asthma, eczema, and related conditions, and keeping those conditions controlled during pregnancy matters too. In one published case, a woman who continued Dupixent through conception and pregnancy saw her eczema severity drop to zero, with no complications in her infant through 48 months of follow-up. Whether to continue is an individual decision that should be made with your prescriber, weighing your disease severity against the still-limited pregnancy data.

Does Dupixent increase the risk of miscarriage?

The evidence is mixed, not conclusive. MotherToBaby reports that one large study of pregnancies exposed to Dupixent found a higher miscarriage rate, but notes it is hard to know whether the medication, the underlying condition, or other factors explain that difference. A separate 2025 propensity-matched cohort study did not confirm an increased risk of pregnancy loss. This is exactly the kind of open question a prescriber can help you weigh against your own health history.

Is there a pregnancy registry or study for Dupixent I can join?

Not a Dupixent-specific one right now. MotherToBaby's dedicated Dupixent pregnancy study is closed to new enrollment, though the organization runs other active studies, including one on moderate-to-severe eczema and atopic dermatitis, that people using biologic medications during pregnancy may be able to join.

References

  1. Dupilumab (Dupixent): MotherToBaby Fact Sheet

    MotherToBaby · https://mothertobaby.org/fact-sheets/dupilumab-dupixent/

  2. Long-Term Follow-Up of Dupilumab Treatment During Conception, Pregnancy and Lactation

    PMC · https://pmc.ncbi.nlm.nih.gov/articles/PMC11149818/

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.