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Cetuximab Pregnancy and Breastfeeding Warnings

Cetuximab is also known as: Erbitux

Medically reviewed by Last updated on May 29, 2020.

Cetuximab Pregnancy Warnings

Animal data revealed no evidence of teratogenicity; however, dependent on the dose, an increased incidence of abortion was observed. Sufficient data from pregnant women are not available.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

Use is not recommended.

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

Risk Summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

Comment: Epidermal growth factor receptor (EGFR) is involved in fetal development. Limited data in animals suggest a placental transfer of this drug, and other IgG1 antibodies have been found to cross the placental barrier.

See references

Cetuximab Breastfeeding Warnings

Use is not recommended.

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

-Due to the potential for serious adverse reactions in breastfed infants, women should not breastfeed during therapy 2 months after.
-Human IgG antibodies can be excreted in human milk.

Because this drug 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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Erbitux (cetuximab)." Bristol-Myers Squibb, Princeton, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  3. "Product Information. Erbitux (cetuximab)." Bristol-Myers Squibb, Princeton, NJ.

Further information

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