Navelbine and Pregnancy

Women who are of childbearing potential should use an effective form of birth control during treatment with Navelbine (vinorelbine). This chemotherapy medication has been shown to cause harm to unborn animals when given to pregnant mice and rabbits. As a pregnancy Category D medicine, Navelbine should only be given to a pregnant woman when the benefits outweigh the risks.

Can Pregnant Women Receive Navelbine?

Navelbine® (vinorelbine) is a prescription anticancer medication approved for use in the treatment of lung cancer. It is also used off-label to treat other types of cancer. This medication is considered a pregnancy Category D medicine because it may cause harm to an unborn child if used during pregnancy.

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 her healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
In animal studies, Navelbine caused problems in unborn animals when given to pregnant mice and rabbits in doses lower than the normally recommended human dose. More specifically, the medication reduced the weight of the unborn fetuses and delayed bone development.
Navelbine has not been adequately studied in pregnant women. There are a handful of reports of women being treated with Navelbine, in addition to other chemotherapy medicines, during the second and third trimesters of pregnancy. The only reported problems were anemia in one infant and low white blood cell counts and platelets in another. Both infants' conditions resolved without treatment, and no serious problems were reported in any of the newborns.
Unfortunately, these reports do not provide enough information to fully assess the risks of using this drug during pregnancy. In addition, there is no information available on the use of Navelbine during the first trimester, which is a critical period of fetal development.
In general, Navelbine is not recommended for use in pregnant women, especially in the first trimester and close to delivery. However, because cancer is a serious condition, a healthcare provider may recommend that a pregnant woman use Navelbine despite the risks, such as in cases where safer treatments are not an option.
Women of childbearing potential should use an adequate form of birth control while using this drug to avoid becoming pregnant. Talk to your healthcare provider about possible birth control options for your particular situation.
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Navelbine Chemotherapy Information

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