Men Home > Ifex and Pregnancy
When studied in pregnant animals, Ifex (ifosfamide) appeared to cause miscarriages and birth defects. Due to the potential risks, this drug is classified as a pregnancy Category D medicine, meaning it is generally not recommended for use during pregnancy. However, a healthcare provider may prescribe it in an off-label fashion to a woman if the benefits outweigh the risks.
Can Pregnant Women Receive Ifex?Ifex® (ifosfamide) is a prescription chemotherapy medication. Based on the results of animal studies, this drug 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. Ifex is classified as a pregnancy Category D medication.
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 the unborn child.
In animal studies, Ifex caused a variety of birth defects, as well as miscarriages, when given to pregnant mice, rats, and rabbits. These problems were observed even at doses that were much lower than the equivalent usual recommended human dose.
Ifex has not been studied in pregnant women. However, low fetal weight and anemia have been reported in babies born to women who received Ifex during pregnancy. In addition, there was a report of kidney damage and other problems occurring in an unborn child after the mother was given Ifex during the second trimester of pregnancy. It is not known for certain whether the drug actually caused the problems; however, it could not be ruled out as a possible cause.
At this time, Ifex is only approved for the treatment of cancer of the testicles, which only occurs in men. However, the drug may be used off-label to treat other types of cancer and, therefore, may be used in a woman.
Women should avoid becoming pregnant and men should avoid fathering a child during Ifex treatment, and for up to six months after treatment ends. If you are of childbearing potential, it is important that you use an effective form of birth control during this time. Talk to your healthcare provider about the best forms of birth control to use during your treatment.