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Cetuximab Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Jan 24, 2023.

Cetuximab is also known as: Erbitux

Cetuximab Pregnancy Warnings

Animal data in cynomolgus monkeys revealed no evidence of teratogenicity at exposures up to 16 times those expected clinically, however, a dose-dependent increased incidence of abortion was observed at exposures expected clinically. Disruption or depletion of EGFR (epidermal growth factor receptor) in animal models has been shown to impair embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development. Human IgG is known to cross the placental barrier and transfer of this drug to the fetus may be expected. There are no controlled data in human pregnancy.

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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus

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

Risk Summary: There are no data available in pregnant women. Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

-Pregnant women should be advised of the potential risk to a fetus.
-Some authorities advise adequate contraception be maintained in women of child-bearing potential during treatment and for 2 months after the last dose.

See references

Cetuximab Breastfeeding Warnings

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 and for 2 months after.

Because this drug is a large protein molecule, the amount in milk is likely to be very low. It is also likely that absorption would be minimal because it is probably partially destroyed in the infant GI tract. No information is available on maternal or infant drug levels, effects in breastfed infants, or effects on lactation or breastmilk.

See references

References for pregnancy information

  1. "Product Information. Erbitux (cetuximab)." Bristol-Myers Squibb (2004):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Erbitux (cetuximab)." Bristol-Myers Squibb (2004):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network." (2013):

Further information

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