Kidneys Home > Simulect and Pregnancy
When pregnant animals were given high doses of Simulect (basiliximab), it did not appear to cause any problems in the mothers or the fetuses. Therefore, the FDA classifies the drug as a pregnancy Category B medication. However, the full risks of using Simulect during pregnancy are unknown, and it should only be prescribed if the benefits outweigh the risks.
Can Pregnant Women Receive Simulect?Simulect® (basiliximab) is a prescription medication used to prevent transplant rejection in people who receive a kidney transplant. It is given as an injection into a vein. Based on the results of animal studies, this drug is likely safe during pregnancy; however, the full risks are currently unknown.
What Is Pregnancy Category B?Simulect is classified as a pregnancy Category B medication. 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 used during pregnancy. Pregnancy Category B is given to medicines that have not been studied in pregnant humans but do not appear to cause harm to the fetus in animal studies.
Also, medicines that have been shown to be safe in humans but caused problems in laboratory animals are given a pregnancy Category B rating.
Simulect has not been studied in pregnant women. However, the medication did not cause any problems in the mothers or fetuses when given in high doses to pregnant monkeys.
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category B medicine, including Simulect, should only be given to a pregnant woman if her healthcare provider believes the benefits to the woman outweigh any possible risks to her unborn child.
The manufacturer of Simulect recommends that women of childbearing potential use an effective form of birth control before, during, and for at least four months after completing Simulect treatment. Talk to your healthcare provider about possible birth control options for your situation.