Iclusig and Pregnancy
Iclusig (ponatinib) may not be safe for use during pregnancy. Although the drug has not been adequately studied in pregnant women, animal studies have shown that it causes miscarriages, problems with bone formation, and other complications when given to pregnant rats. It is generally recommended that women use an effective form of birth control during Iclusig treatment.
Iclusig® (ponatinib) is a prescription medication used to treat certain adults who have leukemia, a cancer of the blood and bone marrow. This product is considered a pregnancy Category D medicine, which means it may cause harm to an unborn child if taken during pregnancy.
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 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 her healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
Iclusig has not been adequately studied in pregnant women. However, based on animal studies and information about the way the drug works, it is predicted that Iclusig may be harmful to the fetus if taken during pregnancy.
When given to pregnant rats, the drug caused problems in the rat fetuses, including reduced weight, increased miscarriages, and increased bone or soft tissue problems.
Women of childbearing potential should use an effective form of birth control to prevent pregnancy during Iclusig treatment.