Tasigna and Pregnancy
Women who are undergoing treatment with Tasigna (nilotinib) should use an effective form of birth control, as this chemotherapy drug may cause fetal harm. When given to animals during pregnancy, Tasigna increased the risk for miscarriages and decreased fetal weight. As a result, this medicine should only be taken if the benefits to the mother outweigh the risks to her unborn child.
Tasigna® (nilotinib) is a prescription medication used to treat people with a certain type of leukemia. As a pregnancy Category D medication, Tasigna may harm an unborn baby if taken by a pregnant woman.
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.
Tasigna has not been adequately studied in pregnant women. However, based on the way the drug works and results from animal studies, it may be harmful if used during pregnancy.
When given to pregnant rats and rabbits, Tasigna increased the risk for miscarriages. It also decreased the weight of the baby rats when given to mother rats while pregnant and during breastfeeding, even at low doses. However, Tasigna did not appear to cause birth defects.
Although Tasigna is not generally recommended for use during pregnancy, a healthcare provider may recommend using it if safer medicines are not an option. In such cases, the benefits of treating a pregnant woman for leukemia may outweigh the potential risks to the unborn baby.
Women of childbearing potential should use an effective form of birth control during Tasigna treatment, so as not to become pregnant. Talk to your healthcare provider about the best birth control options for you during Tasigna treatment.