Prostate Cancer Home > Trelstar and Pregnancy

As a pregnancy Category X medication, Trelstar (triptorelin pamoate) should be avoided during pregnancy, due to the risk of miscarriage. This medication is not approved for any use in women; however, it is sometimes prescribed for unapproved uses (also called "off-label" uses) in women. If you are pregnant or thinking about becoming pregnant, tell your healthcare provider before using this drug.

Is Trelstar Safe During Pregnancy?

Trelstar® (triptorelin pamoate) is a prescription medication approved for the treatment of advanced prostate cancer. It is a synthetic (manufactured) form of gonadotropin-releasing hormone (GnRH), a naturally occurring hormone involved in the body's production of testosterone (in men) and estrogen (in women). Based on its effects in the body, Trelstar could cause miscarriage if taken by a pregnant woman.
 

What Is Pregnancy Category X?

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 X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
 
Trelstar has not been studied in pregnant women. When given in high doses to pregnant mice and rats, the drug did not cause birth defects, but did cause miscarriage in the rats.
 
Trelstar works by decreasing the production of testosterone in men and estrogen in women. Because estrogen is necessary for a healthy pregnancy, the medication may cause miscarriage if taken by a pregnant woman.
 
Trelstar is not indicated for use in women. However, it may be used off-label in females. If this medication is to be given to a woman of childbearing potential, pregnancy should be ruled out before starting treatment.
 
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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