Elitek and Pregnancy

Is it safe to use Elitek (rasburicase) during pregnancy? Although the drug has not been adequately studied in pregnant women, it was shown to cause miscarriages and other problems when given to pregnant animals. However, animals do not always respond to medications the same way that humans do. Healthcare provider may prescribe this drug during pregnancy if the benefits outweigh the risks.

Can Pregnant Women Receive Elitek?

Elitek® (rasburicase) is a prescription medication approved to control uric acid levels in adults and children at risk for high uric acid in the blood due to certain cancer treatment. Based on the results of animal studies, this drug may not be safe for use during pregnancy.  
 

What Is Pregnancy Category C?

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. Elitek is classified as a pregnancy Category C medicine.
 
Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
Elitek has not been adequately studied in pregnant women. When given to pregnant rabbits, the drug caused a variety of problems, including miscarriages, lower-than-normal fetal weight, and heart defects. Elitek also caused heart defects when given to pregnant rats in very high doses (about 250 times the equivalent recommended human dose).
 
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, including Elitek, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
 
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Elitek Medication Information

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