Leukemia Home > Leustatin and Pregnancy

Women of childbearing potential should use an effective form of birth control during chemotherapy treatment with Leustatin (cladribine). As a pregnancy Category D medication, Leustatin may cause fetal harm. Because this drug caused birth defects and miscarriages during animal studies, Leustatin should only be used if the benefits to the mother outweigh the risks to her unborn child.

Can Pregnant Women Receive Leustatin?

Leustatin® (cladribine) is a prescription medication approved to treat hairy cell leukemia, a cancer that affects a certain type of white blood cell. Leustatin is a pregnancy Category D medicine, meaning it may cause harm to your unborn child.

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.
Leustatin has not been adequately studied in pregnant women. However, in animal studies, the drug increased the risk for miscarriages and birth defects when given to pregnant mice and rabbits. In addition, medicines that work in similar ways to Leustatin have been reported to cause birth defects when used by pregnant women.
In general, this medication is not recommended for use in pregnant women. Women of childbearing potential should use a highly effective form of birth control during Leustatin treatment to prevent pregnancy. Talk to your healthcare provider about the best birth control options for your particular situation.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
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