Kidneys Home > Inlyta and Pregnancy
Because Inlyta (axitinib) caused birth defects and abnormal bone development when given to pregnant animals, the Food and Drug Administration has classified it as a pregnancy Category D medication. This means that pregnant women should only receive this medicine if the benefits of the drug outweigh the potential risks to the baby.
Can Pregnant Women Take Inlyta?Inlyta® (axitinib) is a prescription medication used in certain people with advanced kidney cancer. This product is a pregnancy Category D medication, which means it may harm 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.
Inlyta has not been adequately studied in pregnant women. However, in animal studies, the drug caused birth defects when given to pregnant mice in doses that were lower than the equivalent standard recommended human dose. Specifically, Inlyta caused cleft palate (a birth defect in which the roof of the mouth does not develop properly) and abnormal bone development in the baby mice. In addition, the drug increased the risk for miscarriage when given to pregnant mice at high doses.
Inlyta is generally not recommended for use in pregnant women. However, because advanced kidney cancer is a serious condition, your healthcare provider may recommend taking Inlyta if you are pregnant and safer treatments are not an option.
The manufacturer of Inlyta recommends that women and men of childbearing potential use an effective form of birth control during Inlyta treatment. Talk to your healthcare provider about the best birth control options for your particular situation.