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Istodax and Pregnancy

Istodax (romidepsin) may harm an unborn child if used during pregnancy. This medicine is classified as a pregnancy Category D drug, meaning it should only be given to a pregnant woman when the benefits outweigh the risks. When Istodax was given to pregnant animals, it increased the risk for miscarriage and defects of the eyes, limbs, and bones.

Can Pregnant Women Receive Istodax?

Istodax® (romidepsin) is a prescription medication approved to treat certain types of T-cell lymphoma, a cancer of the blood, when other treatments have failed. Istodax may harm 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. Istodax is classified as a pregnancy Category D medicine.
 
Pregnancy Category D is 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.
 
Istodax has not been adequately studied in pregnant women. In animal studies, the drug increased the risk for miscarriage and caused fetal harm when given to pregnant rats at doses lower than the equivalent recommended human dose. Baby rats born to mothers given the medicine had an increased risk for defects of the eyes, limbs, and bones.
 
In general, this medicine should not be used in pregnant women unless absolutely necessary, such as in cases where a safer treatment option does not exist. Women who receive Istodax should use an effective form of birth control to prevent pregnancy throughout treatment. Your healthcare provider can talk to you about the best way to prevent pregnancy in your particular situation.
 
Pregnancy and Pain

Istodax Medication Information

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