Invirase and Pregnancy

Animal studies on Invirase and pregnancy showed that the medication did not cause any problems to the fetus. As a result, the FDA has classified it as a pregnancy Category B medication. However, studies have not been done on the use of Invirase with ritonavir. Therefore, if you are taking Invirase and pregnancy occurs, your healthcare provider will consider the benefits and risks in your particular situation.

 

Is Invirase Safe for Pregnant Women?

Invirase® (saquinavir mesylate) is a prescription AIDS and HIV medication. It belongs to a group of medications known as protease inhibitors. Based on information from animal studies, Invirase is probably safe for use during pregnancy.
 

Invirase and Pregnancy Category B

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 B is given to medicines that have not been studied in pregnant humans but that do not appear to cause harm to the fetus in animal studies. In animal studies, Invirase did not cause any problems when given during pregnancy.
 
It is important to note that Invirase is always used in combination with ritonavir (Norvir®), another HIV medication that is used to increase the level of Invirase in the blood, making it more effective. Studies have not evaluated the combination of Invirase with ritonavir in pregnant animals.
 
It is also important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category B medicine should only be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
 
(Invirase and Pregnancy Continued: Page 2)
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;