Cancer Home > Caprelsa and Pregnancy
In animal studies, Caprelsa (vandetanib) caused miscarriage and birth defects when given in doses similar to the ones used in humans. Due to these serious risks, the medication has a pregnancy Category D rating. This means that it should not be used in pregnancy unless the benefits to the mother clearly outweigh the risks to the fetus. Talk to your doctor about your particular situation.
Caprelsa® (vandetanib) is a prescription medication approved to treat a certain rare type of thyroid cancer in the late stages of the disease. This medication may harm an unborn baby 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 the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
Although Caprelsa has not been adequately studied in pregnant women, the drug is expected to cause fetal harm based on how it works and the results of animal studies. When given to pregnant rats, Caprelsa caused miscarriage and birth defects, including heart and bone defects. These problems occurred even at doses that are similar to or lower than the normal human dose.
It is recommended that women of childbearing potential avoid pregnancy by using an adequate form of birth control during Caprelsa treatment. Because this medication may stay in the body for several months after treatment ends, women should continue to use birth control for at least four months after stopping it.