Cetuximab Pregnancy and Breastfeeding Warnings

Cetuximab is also known as: Erbitux

Cetuximab Pregnancy Warnings

Cetuximab is a recombinant, human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR). EGFR has been implicated in the control of prenatal development and may be essential for normal organogenesis, proliferation, and differentiation in the developing embryo. Human IgG1 is known to cross the placental barrier. Therefore, cetuximab has the potential to be transmitted from the mother to the developing fetus.

Cetuximab has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been conducted. However, animal fertility studies have revealed a tendency for impairment of menstrual cycling including increased incidences of irregularity or absence of cycles. There are no controlled data in human pregnancy. It is not known whether cetuximab can cause fetal harm when administered to a pregnant women or whether cetuximab can affect reproductive capacity. Cetuximab should only be given during pregnancy when benefits outweigh risks.

Cetuximab Breastfeeding Warnings

There are no data on the excretion of cetuximab into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cetuximab, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

If nursing is interrupted, based on the mean half-life of cetuximab nursing should not be resumed earlier than 60 days following the last dose of cetuximab. Because human IgG1 is secreted in human milk, the potential for absorption and harm to the infant after ingestion is unknown.

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