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Vectibix and Pregnancy

Due to the unknown risks, Vectibix (panitumumab) is considered a pregnancy Category C medicine, meaning it may not be safe for use during pregnancy. Research has shown that this drug may interfere with organ development, increase the risk for miscarriage, or cause other problems. However, there may be times when the benefits of using it outweigh the risks.

Can Pregnant Women Receive Vectibix?

Vectibix® (panitumumab) is a prescription medication used in the treatment of colorectal cancer that has spread to other areas of the body. It belongs to a group of medicines known as monoclonal antibodies. Based on animal studies and the drug's actions in the body, this product may not be safe for use during pregnancy.

What Is Pregnancy Category C?

Vectibix is classified as a pregnancy Category C drug. 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 used during pregnancy. Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Vectibix works by binding to a structure on the surface of cells known as epidermal growth factor receptor (EGFR). Based on animal studies, EGFR is thought to be important for fetal development, including normal organ development. Therefore, it is possible that Vectibix could interfere with fetal development by binding to EGFR.
Vectibix has not been studied in pregnant women. In animal studies, the medication did not appear to cause birth defects when given to pregnant monkeys in doses as high as five times the recommended human dose. However, it did increase the risk for miscarriage.
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child. Because colorectal cancer can be fatal, a healthcare provider may recommend that a pregnant woman use Vectibix when other treatments are not an option.
It should also be noted that Vectibix can cause potentially life-threatening infusion reactions (an allergic-type reaction that may occur during or shortly after the infusion). Some of the symptoms of an infusion reaction, such as low blood pressure, could be harmful to an unborn baby.
It is generally recommended that men and women of childbearing potential use an adequate form of birth control during Vectibix treatment and for at least six months after treatment ends. Talk to your healthcare provider about which birth control options may be right for you.
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Vectibix Medication Information

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