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Erbitux and Pregnancy

Because of the potential for fetal harm, and based on the results of animal studies, women who are pregnant should use Erbitux (cetuximab) only if the benefits outweigh the risks. Cancer is a potentially fatal illness, so this may very well be the case for some women. If you are not pregnant, you or your partner should use a reliable method of birth control during treatment.

Can Pregnant Women Use Erbitux?

Erbitux® (cetuximab) is a prescription medication approved to treat certain people with head and neck cancer. It is also approved to treat certain types of cancer of the colon and rectum. Based on the results of animal studies, Erbitux may not be safe for use during pregnancy.

What Is Pregnancy Category C?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are given a pregnancy Category C rating automatically.
Erbitux works by blocking the action of a protein in the body known as epidermal growth factor receptor (EGFR). EGFR is thought to be important for fetal development. Therefore, blocking its actions may cause fetal harm.
Erbitux has been reported to cause infusion reactions (an allergic-type reaction that may occur during intravenous administration of the medication). An infusion reaction can cause serious symptoms, including low blood pressure, which could be harmful to an unborn baby.
This medication has not been adequately studied in pregnant women. In animal studies, Erbitux did not appear to cause birth defects, but did increase the risk for miscarriage when given to pregnant monkeys in doses up to four times the usual human dose.
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child. Because head and neck cancers and colorectal cancer can be fatal, a healthcare provider may recommend Erbitux even during pregnancy.
Men and women of childbearing potential should use an adequate form of birth control during treatment, and for at least six months after the last Erbitux dosage. Talk to your healthcare provider about which birth control options may be right for you.
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