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Zevalin and Pregnancy

Because of the potential risks, Zevalin (ibritumomab) is considered a pregnancy Category D medicine. This means that pregnant women should only receive this drug if the benefits outweigh the risks. Zevalin could cross the placenta, and because it is a radioactive medicine, it may cause miscarriages, growth problems, or birth defects.

Can Pregnant Women Receive Zevalin?

Zevalin® (ibritumomab) is a prescription medication approved to treat certain types of non-Hodgkin's lymphoma. It is a radioactive medication given as an intravenous injection (an injection into a vein). Zevalin may not be safe for use during pregnancy.

What Is Pregnancy Category D?

Zevalin is classified as a pregnancy Category D drug. 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 her unborn child.
Zevalin has not been adequately studied in pregnant women or animals. However, because it is radioactive, it has the potential to harm a developing fetus. Zevalin may cross the placenta, which would expose a developing fetus to radiation. This may increase the risk for miscarriage, growth problems, and various birth defects.
In addition, Zevalin is associated with potentially dangerous side effects, including a risk for infections. A serious infection during pregnancy could be dangerous to an unborn child.
It should be noted that Zevalin is given as part of a treatment plan that includes rituximab (Rituxan®). There have been reports of a temporary decrease in B-lymphocytes (a type of white blood cell) in newborns exposed to rituximab during pregnancy. This could increase the risk for infections.
(Click Rituxan and Pregnancy for more information about the possible effects of using this drug during pregnancy.)
In general, Zevalin is not recommended for use in pregnant women, except in special situations. For example, if no other treatment options are available, a healthcare provider may recommend Zevalin for a pregnant woman.
The manufacturer recommends that women of childbearing potential use an effective form of birth control for at least 12 months after receiving Zevalin. Talk to your healthcare provider about possible birth control options for your situation.
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Zevalin Medication Information

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