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Dinutuximab Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on May 17, 2023.

Dinutuximab is also known as: Unituxin

Dinutuximab Pregnancy Warnings

Use is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: Monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. Pregnant women should be advised of the potential risk to a fetus.

-This drug may cause fetal harm based on its mechanism of action.
-Females of reproductive potential should be advised to use effective contraception during treatment and for two months after the last dose of this drug.

This drug has not been studied in pregnant animals or humans.

See references

Dinutuximab Breastfeeding Warnings

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. The manufacturer recommends that breastfeeding be discontinued during therapy.

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

-Human IgG is present in human milk.
-There is no information on the effects of the drug on the breastfed infant.
-There is no information on the effects of the drug on milk production.

See references

References for pregnancy information

  1. "Product Information. Unituxin (dinutuximab)." United Therapeutics Corporation (2015):

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network." (2013):
  2. "Product Information. Unituxin (dinutuximab)." United Therapeutics Corporation (2015):

Further information

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