What studies say about Dupixent in pregnancy
Dupixent (dupilumab) has limited human data from pregnancy registries and observational studies. In the Dupixent Pregnancy Registry (ongoing since 2018), over 300 exposed pregnancies showed no clear increased risk of major birth defects, miscarriage, or adverse outcomes compared to the general population—rates aligned with background levels (e.g., 3-5% for major malformations).[1][2] Animal studies at high doses found no direct embryo-fetal harm, but reduced pup survival occurred at maternal exposures far above human levels.[3]
FDA pregnancy category and labeling
Dupixent carries a Pregnancy Category B rating in older classifications (no evidence of risk in animal studies, but inadequate human data). Current FDA labeling states data are insufficient to confirm safety, advising use only if potential benefits outweigh risks. It crosses the placenta, peaking in fetal circulation by third trimester.[1][4]
Recommendations for pregnant patients
Guidelines from the American College of Allergy, Asthma & Immunology (ACAAI) and others suggest continuing Dupixent if benefits (e.g., for severe atopic dermatitis or asthma) exceed risks, especially after first trimester. Discontinuation may worsen maternal disease, indirectly harming the fetus. Consult a specialist; no routine fetal monitoring changes are recommended beyond standard care.[2][5]
What happens to breastfeeding with Dupixent
Dupilumab appears in breast milk at low levels (less than 1% of maternal dose), unlikely to harm infants. Major allergy societies deem it compatible with breastfeeding.[1][6]
Risks patients worry about most
Common concerns include miscarriage (no elevated risk in registries), preterm birth, low birth weight, and eczema flares in newborns. No causal links found, but underlying conditions like asthma increase natural risks. Long-term child effects remain under study.[2][7]
Alternatives during pregnancy
Safer options depend on condition:
- Atopic dermatitis: Topical steroids, emollients; cyclosporine if severe.
- Asthma: Inhaled corticosteroids (e.g., budesonide, preferred).
- Eosinophilic esophagitis: Budesonide slurry.
Avoid biologics like Xolair (omalizumab) in first trimester if possible; data gaps persist for most.[5][8]
Sources
[1]: Dupixent Prescribing Information (FDA)
[2]: MotherToBaby Dupixent Fact Sheet
[3]: Dupixent Clinical Pharmacology Review (FDA)
[4]: Drugs.com Pregnancy Warnings for Dupixent
[5]: AAAAI/ACAAI Biologics in Pregnancy Guidelines
[6]: LactMed Database: Dupilumab
[7]: Dupixent Pregnancy Registry Interim Report
[8]: UpToDate: Management of Atopic Dermatitis in Pregnancy