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Cetuximab Pregnancy and Breastfeeding Warnings

Cetuximab is also known as: Erbitux

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. AU TGA pregnancy category: D US FDA pregnancy category: C 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.

Cetuximab 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: -Studies in animals or sufficient data from lactating women are not available. -Women should not breastfeed during treatment with this drug and for 2 months after the last dose. -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. #349603

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