Synribo and Pregnancy

Women of childbearing age who are going to receive Synribo (omacetaxine) should use an effective form of birth control during treatment. When given to pregnant animals, this drug caused a number of problems, such as miscarriages and low fetal weights. As a Category D medicine, Synribo should only be given to a pregnant woman when the benefits outweigh the risks.

Can Pregnant Women Use Synribo?

Synribo™ (omacetaxine mepesuccinate) is a prescription medicine used to treat a slowly progressing type of leukemia called chronic myeloid leukemia. It is a pregnancy Category D medicine, which means it may harm an unborn child if given to a pregnant woman.

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.
In animal studies, Synribo caused a variety of problems when given to pregnant mice, such as miscarriages, low fetal weights, and soft fetal bones. These problems occurred at doses that were about half the equivalent recommended human dose.
Women of childbearing potential should use an effective form of birth control to avoid pregnancy during Synribo treatment. Talk to your healthcare provider about the best forms of birth control for your particular situation.
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Synribo Chemotherapy Information

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