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Mekinist and Pregnancy

Women of childbearing age who are going to receive Mekinist (trametinib) should use an effective form of birth control during treatment. When given to pregnant animals, Mekinist caused a number of problems, such as miscarriages and abnormal bone development. As a Category D medicine, this product should only be given to a pregnant woman when the benefits outweigh the risks.


Can Pregnant Women Take Mekinist?

Mekinist™ (trametinib) is a prescription medication used in the treatment of melanoma, a type of skin cancer. Mekinist is a pregnancy Category D medication, which means it may harm an unborn child if taken 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 the unborn child.
Mekinist has not been studied in pregnant women. However, in animal studies, the drug caused a variety of problems. It decreased the weight of the fetuses and increased the risk for miscarriage when given to pregnant rats and rabbits. Mekinist also caused problems with the bones of the unborn rabbits when given in small doses to pregnant rabbits.
Because the medication may harm an unborn child, it is recommended that women of childbearing potential use a highly effective form of birth control throughout Mekinist treatment, and for at least four months after treatment ends. The four months gives the body enough time to remove the drug from the system. Talk to your healthcare provider about the most effective forms of birth control for your situation.
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