Lung Cancer Home > Tarceva and Pregnancy

The cancer drug Tarceva (erlotinib) has been given a pregnancy Category D rating by the FDA. This means that it is generally not recommended for use during pregnancy. In animal studies, the drug was shown to increase the risk of miscarriage. However, sometimes the benefits will significantly outweigh the risks, and the medication will be prescribed to a woman who is pregnant.

Can Pregnant Women Take Tarceva?

Tarceva® (erlotinib) is a prescription medication used to treat certain types of cancer. As a pregnancy Category D medication, Tarceva may be harmful to an unborn child.

What Is Pregnancy Category D?

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 D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents.
A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
Tarceva has not been studied in pregnant humans. In animal studies, the medication caused miscarriage when given to pregnant rabbits in high doses (approximately three times the usual human dose). It also caused miscarriage at lower doses in rats when given to the female rats before and during the first week of pregnancy.
Women of childbearing potential should use an adequate form of birth control during Tarceva treatment, and for at least two weeks after treatment ends. Talk to your healthcare provider for more information about possible birth control options while you are taking this drug.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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