Cancer Home > SUTENT and Pregnancy

The chemotherapy drug SUTENT (sunitinib) 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 and fetal malformation. 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 SUTENT?

SUTENT® (sunitinib) is a prescription medication used to treat people with certain types of cancer. This medication may cause fetal harm if used during pregnancy.

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 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.
SUTENT caused miscarriage when given in high doses to pregnant rats and rabbits. It also caused malformations of the ribs and vertebra in the fetal rats and cleft lip and palate in the rabbits.
SUTENT has not been adequately studied in pregnant women; therefore, it is difficult to determine how dangerous the medicine may be during pregnancy. Based on the results of animal studies, and the known actions of the medication, it may harm an unborn child if taken by a pregnant woman.
SUTENT is generally not recommended for use in pregnant women. However, if no other treatment options exist, the benefits of using the medicine to treat cancer may outweigh the possible risks to the unborn child.
Women of childbearing potential should use an effective form of birth control to prevent pregnancy during SUTENT treatment. You can talk to your healthcare provider if you would like more information on effective birth control options that may be available for you.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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