Bosulif and Pregnancy

Bosulif (bosutinib) may not be safe for use during pregnancy. Although the drug has not been adequately studied in pregnant women, animal studies have shown that this drug caused miscarriages, birth defects, and other complications when given to pregnant rabbits and rats. It is generally recommended that women use an effective form of birth control during Bosulif treatment.

Can Pregnant Women Take Bosulif?

Bosulif® (bosutinib) is a prescription medication used to treat certain adults who have leukemia, a cancer of the blood and bone marrow. This product is considered a pregnancy Category D medicine, which means it may cause harm to an unborn child if taken 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.
 
Bosulif has not been adequately studied in pregnant women. However, based on animal studies and information about the way the drug works, it is predicted that Bosulif may be harmful to a fetus if taken during pregnancy.
 
When given to pregnant rabbits, the drug caused problems in the offspring, including reduced weight and abnormal development of the sternum. These problems occurred at doses that were high enough to also harm the mother rabbits. When given to pregnant rats, Bosulif caused miscarriages, even at doses lower than the equivalent to the recommended human dose.
 
Women of childbearing potential should use an effective form of birth control to prevent pregnancy during Bosulif treatment and for at least 30 days after treatment ends. Talk to your healthcare provider about the best birth control options for your particular situation.  
 
Pregnancy and Pain

Bosulif Chemotherapy Information

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