Cetuximab

The Basics

What is Cetuximab?

Used to treat a certain type of cancer of the colon or rectum and also used to treat head and neck cancer.

Brand names for Cetuximab

Erbitux

How Cetuximab is classified

Antibodies – Monoclonal, Antineoplastic Agents

Cetuximab During Pregnancy

Cetuximab pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Cetuximab while pregnant

Based on findings from animal studies and its mechanism of action [see CLINICAL PHARMACOLOGY], ERBITUX can cause fetal harm when administered to a pregnant woman. There are no available data for ERBITUX exposure in pregnant women. In an animal reproduction study, intravenous administration of cetuximab once weekly to pregnant cynomolgus monkeys during the period of organogenesis resulted in an increased incidence of embryolethality and abortion. Disruption or depletion of EGFR in animal models results in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development (see Data). Human IgG is known to cross the placental barrier; therefore, cetuximab may be transmitted from the mother to the developing fetus. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. Data

Taking Cetuximab While Breastfeeding

What are recommendations for lactation if you're taking Cetuximab?

No information is available on the clinical use of cetuximab during breastfeeding. Because cetuximab is a large protein molecule with a molecular weight of 145,782, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, cetuximab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during cetuximab therapy and for 2 months after the last dose.

Maternal / infant drug levels

No information is available on the clinical use of cetuximab during breastfeeding. Because cetuximab is a large protein molecule with a molecular weight of 145,782, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, cetuximab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during cetuximab therapy and for 2 months after the last dose.

Possible effects of Cetuximab on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Cetuximab

None listed