Lung Cancer Home > Xalkori and Pregnancy

Although Xalkori (crizotinib) has not been studied in pregnant women, the drug did cause fetal harm when given to pregnant animals. When given to pregnant rats and rabbits, it caused miscarriages, low birth weights, and other problems. Due to the potential risks of this chemotherapy drug, women should only take Xalkori during pregnancy when the benefits outweigh the risks.

Can Pregnant Women Take Xalkori?

Xalkori® (crizotinib) is a prescription medication used in people who have lung cancer due to a defect in a gene known as the anaplastic lymphoma kinase (ALK) gene. As a pregnancy Category D medication, Xalkori may harm an unborn baby.

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 her unborn child.
Although Xalkori has not been adequately studied in pregnant women, it has been studied in pregnant animals. Based on this animal research and the way the medication works in the body, Xalkori is expected to cause fetal harm when used by a pregnant woman.
When given to pregnant rats and rabbits, Xalkori caused low birth weights in the offspring. It also increased the risk for miscarriage in the pregnant rats. These effects were observed at doses comparable to the usual human dose.
Women of childbearing potential should use an adequate form of birth control while taking Xalkori, and for at least 90 days after stopping treatment. Talk to your healthcare provider about effective forms of birth control during treatment.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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