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Dupilumab Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Dec 27, 2022.

Dupilumab is also known as: Dupixent

Dupilumab Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk summary: Available data on use of this drug in pregnant women have not identified a drug-related risk.

-A pregnancy exposure registry is available.
-Human immunoglobulin G (IgG) antibodies cross the placenta; therefore, this drug may be transmitted from the mother to the developing fetus.
-There are risks to the mother and fetus associated with asthma in pregnancy.

Animal studies have failed to reveal evidence of embryofetal toxicity or teratogenicity. From the start of organogenesis to parturition, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of homologous antibody against interleukin-4-receptor alpha up to 10 times the maximum recommended human dose (on a mg/kg basis of 100 mg/kg/week); no treatment-related adverse effects on embryofetal toxicity or malformations were observed. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Health care providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972 or by visiting

In women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and therapy should be adjusted as needed to maintain optimal control.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Dupilumab Breastfeeding Warnings

Based on preliminary evidence and according to some experts, this drug may be safe during breastfeeding. Until more data are available, caution is recommended, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
---The effects of local gastrointestinal exposure and limited systemic exposure to this drug on the nursing infant are unknown.
-Maternal immunoglobulin G (IgG) is excreted into human milk.

Since this drug is a large protein molecule (molecular weight about 147 kilodaltons), the amount in milk is likely to be very low; absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract.

A woman with atopic eczema received 300 mg subcutaneously every 2 weeks during pregnancy and postpartum. She breastfed her infant (extent not provided) for at least 4 months; no complications were reported during this period. The patient became pregnant again 7 months after delivery and continued this drug at the same dose throughout the pregnancy and lactation; no complications were observed during breastfeeding.

See references

References for pregnancy information

  1. "Product Information. Dupixent Pre-filled Syringe (dupilumab)." sanofi-aventis (2022):
  2. "Product Information. Dupixent (dupilumab)." Sanofi-Aventis Australia Pty Ltd (2022):
  3. "Product Information. Dupixent (dupilumab)." Sanofi Genzyme (2023):

References for breastfeeding information

  1. National Library of Medicine (US), National Center for Biotechnology Information "Dupilumab - Drugs and Lactation Database (LactMed)" (2023):
  2. "Product Information. Dupixent Pre-filled Syringe (dupilumab)." sanofi-aventis (2022):
  3. "Product Information. Dupixent (dupilumab)." Sanofi-Aventis Australia Pty Ltd (2022):
  4. "Product Information. Dupixent (dupilumab)." Sanofi Genzyme (2023):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.