Intelence and Pregnancy

In animal studies on Intelence (etravirine) and pregnancy, the medication did not cause any problems when it was given to pregnant rats or rabbits. Since animals do not always respond to drugs the same way that humans do, however, this may not be true for humans as well. If you are taking Intelence and pregnancy occurs, notify your healthcare provider to discuss any potential risks.

Using Intelence During Pregnancy: An Overview

Intelence (etravirine) is a prescription HIV treatment. Based on problems in animal studies (and reports of problems in humans), Intelence is probably safe for use during pregnancy, although the full risks to humans are currently unknown.
 

Pregnancy Category B

The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been adequately studied in pregnant humans but do not appear to cause harm to the fetus in animal studies.
 
In the case of Intelence, giving the medication to pregnant rats or rabbits did not cause any problems. However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
 
If you and your healthcare provider decide that it is best for you to take Intelence during pregnancy, you can choose to have your healthcare provider report your case (including any problems that occur) to a special registry that has been set up for this purpose. Doing so will help provide information that may be very useful for both healthcare providers and for women deciding whether to take the medication during pregnancy.
 
(Intelence and Pregnancy Continued: Page 2)
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;
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