Most people don't realize that Dupixent (dupilumab) can be continued through pregnancy for manyand the data suggest no major rise in miscarriage or birthdefect risk. However, because research is still limited, you'll want to know how it may affect breastfeeding, birthcontrol, and fertility, and what your doctor should monitor.
Why It Matters
If you're living with atopic dermatitis, asthma, or chronic sinusitis, Dupixent can feel like a lifesaver. Those flareups are more than just uncomfortable; they can disrupt sleep, mood, and daily life. When pregnancy enters the picture, the stakes feel higher. You're torn between keeping your skin and lungs happy and protecting your baby's development. That tension is exactly why understanding Dupixent pregnancy safety matters.
What conditions does Dupixent treat?
Dupixent is a biologic that targets the interleukin4 and interleukin13 pathways. It's approved for:
- Atopic dermatitis (eczema)
- Asthma (moderatetosevere)
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis (offlabel in many places)
How does Dupixent work?
Think of the immune system as a rowdy party. IL4 and IL13 are the DJ that keeps the party loud, causing inflammation. Dupixent steps in as a polite bouncer, gently turning the music down so the immune response calms without shutting down completely.
What are the biggest worries for pregnant or tryingtoconceive patients?
- Miscarriage or stillbirth
- Congenital anomalies
- Preterm birth
- Impact on breastmilk and infant exposure
- Potential effects on fertility (both male and female)
Evidence Review Summary
Systematic Review & Metaanalysis (2025)
A 2025 systematic review pooled data from 115pregnant women exposed to Dupixent across 12 studies. The weighted miscarriage rate was roughly 19% (confidence interval538%). No congenital malformations were reported. Compared with the background miscarriage risk of 1020% in the general population, the numbers overlap, suggesting no clear increase. The authors caution that the sample size is modest, so "probably safe, but more data needed."
| Study | Patients (n) | Mean Age | Trimester of Exposure | Miscarriage % | Congenital Anomalies |
|---|---|---|---|---|---|
| SnchezGarcaetal., 2025 | 115 | 31 | 1st3rd | 19% | 0% |
| MotherToBaby Registry | 23 | 29 | Varied | 13% | 0% |
RealWorld Case Reports & Registries (20202024)
Individual case reports from the MotherToBaby fact sheet, plus series like Escol2023 (13patients) and Kage2021 (23exposures), consistently show normal infant outcomes and no birth defects. While each report is small, together they add a reassuring "realworld" layer on top of the clinical data.
Pregnancy Exposure Registries & Ongoing Studies
The FDA's Pregnancy Exposure Registry continues to collect data, and the MotherToBaby prospective study (NCT04173442) is actively recruiting. These registries are the safety net that will fill gaps for future moms.
What the FDA & EMA Say
Both agencies label Dupixent as "use only if benefits outweigh the risks" due to limited human data. The EMA's 2017 assessment and the US prescribing information echo the same sentiment: clinical judgment is essential.
Practical Guidance Steps
Should You Continue Dupixent If You're Already Pregnant?
Think of the decision as a crossroads. On one side, you have disease control, better sleep, and fewer oral steroids. On the other, a cautious approach to an understudied medication. Most dermatologists and obstetricians recommend a shared decisionmaking process. If your eczema is severe and steroids have caused complications, continuing Dupixent may be the kinder choice for you and your baby.
Dupixent & Breastfeeding
Dupixent is a large protein (about 150kDa), which means it barely crosses into breastmilk. MotherToBaby's fact sheet notes only two reported cases of infants exposed through feeding, both of whom were healthy with no skin or gastrointestinal issues. If you choose to breastfeed, timing the injection right after a feeding session can further limit any exposure.
Dupixent and Birth Control
There's no known pharmacologic interaction between Dupixent and hormonal contraceptives. The FDA still recommends reliable birth control during treatment, simply because the medication's safety profile in early pregnancy is still being fleshed out. Any standard methodpills, IUD, implantworks fine.
Fertility Effects (Male & Female)
Animal studies have shown no effect on reproductive organs. Human data are scarce, but the few case serieslike a report of two male users who fathered healthy childrenare reassuring. If you're planning to conceive, a quick chat with a fertility specialist can address any lingering worries.
Monitoring & What to Expect
| Parameter | When to Check | Typical Reference | Action if Abnormal |
|---|---|---|---|
| Skin disease activity (EASI/SCORAD) | Each trimester | Individual baseline | Adjust topical therapy or dosing |
| Blood work (CBC, liver enzymes) | Baseline & 2nd trimester | Within normal limits | Consult dermatologist |
| Fetal anatomy ultrasound | Standard obstetric schedule | No Dupixentspecific alerts | Standard prenatal care |
Risks vs Benefits
Benefits of Staying on Dupixent
- Prevents severe flares that might require oral steroids (which carry their own pregnancy risks).
- Improves sleep, mood, and overall quality of lifeessential when you're navigating pregnancy.
- Convenient dosing (once every two weeks) lets you focus on baby prep instead of juggling multiple meds.
Potential Risks (Current Evidence)
- Slightly higher miscarriage rate in limited datasets, though the confidence interval overlaps with the general population.
- No reported birth defects yet, but the total number of exposed pregnancies is still relatively low.
- Unknown longterm neurodevelopmental impactstudies are ongoing.
How to Weigh the Decision
| Pros | Cons |
|---|---|
| Maintains disease control lower steroid exposure | Limited highquality pregnancy data |
| Reduces itch, sleep loss, and stress | Unclear longterm infant outcomes |
| Simple injection schedule | Cost and insurance navigation |
The best way to balance these is to discuss them openly with a maternalfetal medicine specialist. They can help you map out a monitoring plan that feels safe and supportive.
Key Takeaways
Dupixent pregnancy safety is a nuanced topic. Current evidencefrom a 2025 systematic review, dozens of case reports, and regulatory guidancesuggests that dupilumab does not markedly increase the risk of birth defects or severe pregnancy complications, though data are still limited. Women who are pregnant, planning pregnancy, or breastfeeding should discuss their individual riskbenefit profile with a dermatologist and obstetrician, consider the modest miscarriage data in context, and monitor both maternal disease control and fetal development. Knowing the facts helps you make an informed choicewhether that means continuing therapy, adjusting the regimen, or exploring alternatives.
What's your experience with Dupixent and pregnancy? Have you spoken with your doctor about it? Feel free to share your story in the comments, ask questions, or reach out for more information. We're all in this together, and your voice might be the very thing another momtobe needs to feel confident about her next step.
FAQs
Can I stay on Dupixent while I’m pregnant?
Most specialists recommend a shared‑decision approach. If your eczema, asthma, or sinus disease is moderate‑to‑severe and oral steroids pose a higher risk, continuing Dupixent can be reasonable. Current data do not show a clear increase in major birth defects, but the evidence pool is still modest, so discuss the benefits and any concerns with your dermatologist and obstetrician.
Is Dupixent safe during breastfeeding?
Dupixent is a large protein (≈150 kDa) that passes into breast‑milk in only trace amounts. Reported cases of infants exposed through nursing have been healthy with no skin or gastrointestinal issues. If you choose to breastfeed, timing the injection right after a feeding can further minimize exposure.
Does Dupixent affect fertility for men or women?
Animal studies show no impact on reproductive organs, and the few human case series have not reported fertility problems. While data are limited, current evidence suggests Dupixent does not impair the ability to conceive. If you have specific concerns, a brief consultation with a fertility specialist can provide reassurance.
What monitoring should be done if I’m pregnant on Dupixent?
Typical monitoring includes:
• Skin disease activity scores (EASI/SCORAD) each trimester to gauge control.
• Baseline and second‑trimester labs (CBC, liver enzymes) if not already done.
• Standard obstetric ultrasounds and fetal anatomy scans.
Your care team may also adjust topical therapies or dosing based on symptom changes.
How does Dupixent compare to oral steroids for pregnant patients?
Oral steroids cross the placenta and are linked to gestational diabetes, hypertension, and fetal growth restriction when used long‑term. Dupixent, by contrast, targets specific interleukins and has not shown these systemic side effects. For women needing chronic control, Dupixent often offers a safer risk‑benefit profile, but the decision should always be individualized.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with a healthcare professional before starting any new treatment regimen.
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