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Dupilumab Pregnancy and Breastfeeding Warnings

Dupilumab is also known as: Dupixent

Medically reviewed on May 1, 2017

Dupilumab Pregnancy Warnings

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

US FDA pregnancy category: Not assigned.

Risk Summary: Human IgG antibodies are known to cross the placental barrier; therefore, this drug may be transmitted from the mother to the developing fetus.

Comments:
-The effects in the developing fetus are unknown.

In animal studies, no adverse developmental effects were observed in offspring after maternal subcutaneous administration of a homologous antibody against interleukin-4-receptor alpha during organogenesis through parturition at doses up to 10 times the maximum recommended human dose (MRHD). There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-Human IgG is present in human milk.
-The effects in the nursing infant are unknown.
-Some experts recommend caution if this drug is used during breastfeeding, especially when nursing a newborn or premature infant.

No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.

See references

References for pregnancy information

  1. British Medical Association. Royal Pharmaceutical Society of Great Britain. Joint Formulary Committee "British National Formulary. Available from: URL: http://bnf.org/bnf/"
  2. "Product Information. Dupixent (dupilumab)." sanofi-aventis, Bridgewater, NJ.

References for breastfeeding information

  1. British Medical Association. Royal Pharmaceutical Society of Great Britain. Joint Formulary Committee "British National Formulary. Available from: URL: http://bnf.org/bnf/"
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. "Product Information. Dupixent (dupilumab)." sanofi-aventis, Bridgewater, NJ.

Further information

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

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