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Jakafi and Pregnancy

Women who are pregnant may not be able to safely take Jakafi (ruxolitinib). The FDA has classified this product as a pregnancy Category C medicine because it appeared to cause problems when given to pregnant animals. Due to the potential risks, this medicine should only be taken if the benefits to the mother outweigh the risks to her unborn child.

Can Pregnant Women Take Jakafi?

Jakafi™ (ruxolitinib) is a prescription medication used to treat people with a condition known as myelofibrosis. Myelofibrosis is a disease of the bone marrow that affects the body's production of blood cells. Based on the results of animal studies, this medicine may not be safe for use during pregnancy.

What Is Pregnancy Category C?

Jakafi is classified as a pregnancy Category C drug. 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 C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Jakafi did not appear to cause birth defects when given to pregnant rats and rabbits. However, it did reduce fetal body weights and increase the risk for miscarriages when used in doses that were high enough to also cause harm to the pregnant rats and rabbits.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
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Jakafi Medication Information

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