Torisel and Pregnancy

Due to the potential risks, Torisel (temsirolimus) is considered a pregnancy Category D medicine. This means that women should only receive this drug if the benefits outweigh the risks. When the medication was given to pregnant animals, it caused reduced fetal weight, skeletal problems, and certain birth defects.

Can Pregnant Women Receive Torisel?

Torisel® (temsirolimus) is a prescription medication used in certain people who have renal cell carcinoma (kidney cancer). It is in a class of medicines known as kinase inhibitors. As a pregnancy Category D medication, Torisel may harm the fetus if used during pregnancy.

What Is Pregnancy Category D?

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 D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women, but may still offer benefits that outweigh the risks the drug presents.
A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
When Torisel was given by mouth to pregnant rats and rabbits, it reduced fetal weight and caused skeletal problems in the offspring. The drug also caused a birth defect in the rabbit offspring in which the intestines or other organs in the abdomen (stomach) area stuck out through the belly button. These problems occurred even at low Torisel doses.
There is limited information available on the use of Torisel during pregnancy in humans. Based on the results of animal studies, and the known effects of the medicine, it may be harmful to a fetus if it is given to a pregnant woman. There may be times, however, when the benefits of using this drug to treat kidney cancer in a pregnant woman outweigh the potential risks to the unborn child.
The manufacturer of Torisel recommends that women of childbearing potential use an effective form of birth control throughout treatment and for at least three months after the last Torisel dose. The manufacturer also recommends that men who have partners of childbearing potential use reliable birth control during treatment and for three months after treatment ends. Your healthcare provider can help you choose the best birth control option for your individual situation.
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Torisel Medication Information

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