Bexxar and Pregnancy
Because Bexxar (tositumomab) can harm a fetus, women should not receive this drug while pregnant. This medicine contains a radioactive element that can cause potentially serious problems in a fetus. To help ensure this medicine does not cause fetal harm, women who will be undergoing treatment with Bexxar must take a pregnancy test before they can even receive this drug.
Can Pregnant Women Receive Bexxar?Bexxar® (tositumomab) is a prescription medication approved to treat non-Hodgkin's lymphoma that is slow-growing, or has changed from a slow-growing to a fast-growing type. It belongs to a group of medicines known as monoclonal antibodies. Bexxar is a pregnancy Category X medication, which means it should not be given to pregnant women.
What Is Pregnancy Category X?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 X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the possible benefits.
Bexxar has not been studied in pregnant women or animals. However, Bexxar contains Iodine-131, also called radioiodine. Iodine-131 is radioactive and may harm a developing fetus. In fact, Iodine-131 may cause severe and permanent damage to the fetal thyroid gland if used during pregnancy. This could lead to irreversible hypothyroidism (when the body does not make enough thyroid hormone) in the newborn.
Because of the risks associated with using this medicine during pregnancy, you will need to have a pregnancy test before beginning Bexxar treatment. You will not be able to receive this medication if you are pregnant.
In addition, like other radiation treatment, there is a possibility that Bexxar may damage a woman's eggs or a man's sperm. Therefore, both men and women who receive Bexxar should use an effective form of birth control during treatment, and for at least one year after treatment ends.