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Kalbitor and Pregnancy

Although Kalbitor has not been adequately studied in women, research in pregnant rats suggests that high doses of this drug may increase the risk for miscarriages. In general, Kalbitor should only be given to a pregnant woman if the benefits to the mother outweigh the risks to her unborn child.

Can Pregnant Women Use Kalbitor?

Kalbitor® (ecallantide) is a prescription medication approved for the treatment of sudden hereditary angioedema (HAE) attacks. It may not be safe for use during pregnancy, although the full risks are currently unknown.

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. Kalbitor 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.
Kalbitor has not been adequately studied in pregnant women. When given to pregnant rats intravenously, at doses 13 times the equivalent maximum dose recommended for humans, early miscarriages occurred. However, similar problems were not seen in rabbits or at lower doses in rats.
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 Kalbitor, 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.

Final Thoughts

If you are pregnant or thinking about becoming pregnant, let your healthcare provider know before using Kalbitor. He or she will consider the benefits and risks before making a recommendation in your particular situation.
Pregnancy and Pain

Kalbitor Medication Information

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