Iressa and Pregnancy

It is generally recommended that women of childbearing age use an effective form of birth control during treatment with Iressa (gefitinib), as this drug may not be safe for use during pregnancy. Animal studies have shown that this chemotherapy medication caused miscarriages, reduced fetal weight, and other problems. Iressa should only be given to a pregnant woman when the benefits outweigh the risks.

Can Pregnant Women Take Iressa?

Iressa® (gefitinib) is a prescription medication approved for the treatment of non-small cell lung cancer, the most common type of lung cancer. It is approved for monotherapy, which means it is used alone rather than in combination with other medicines. Based on the results of animal studies, Iressa 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. Iressa 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 her healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
 
Iressa has not been adequately studied in pregnant women. In animal studies, the medication caused miscarriages when given to pregnant rats, even at doses lower than those equivalent to the recommended human doses. Higher doses caused more of the newborn rats to die soon after birth. The medication also reduced fetal weights when given to pregnant rabbits in doses about two times the recommended human dose.
 
Women of childbearing potential should use an adequate form of birth control to avoid becoming pregnant during Iressa treatment. Talk to your healthcare provider about the best birth control options for your particular situation.
 
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Iressa Chemotherapy Information

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