Stivarga and Pregnancy
Classified as a pregnancy Category D medication, Stivarga (regorafenib) caused birth defects and miscarriages during animal studies. Therefore, it should only be given to a pregnant woman if the benefits to the mother outweigh the risks to her unborn child. Both women and men are advised to use an effective form of birth control during chemotherapy treatment with Stivarga.
Stivarga® (regorafenib) is a prescription medication approved to treat colon or rectal cancer (also called colorectal cancer) that has progressed after other treatment, and spread to other areas of the body. Based on animal studies, and the way the medication works, Stivarga may harm an unborn child if used during pregnancy.
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Stivarga is classified as a pregnancy Category D medication.
Pregnancy Category D is 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 her healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
Stivarga has not been adequately studied in pregnant women. In animal studies, the medication caused miscarriages and a variety of birth defects when given to pregnant rabbits and rats, including heart defects, abnormal bones, and problems with the urinary organs (including small, deformed, or completely missing kidneys). These defects occurred at doses that were lower than the normally recommended human dose.
In addition, Stivarga works by blocking the action of certain naturally occurring proteins in the body known as kinases. These proteins play important roles in many of the functions of cells in the body. Blocking the action of these vital proteins could interfere with the normal development of a fetus.
Because of the potential effects on an unborn baby, adequate birth control is recommended for both women and men during Stivarga treatment, and for at least two months after the last Stivarga dose. Talk to your healthcare provider about the best birth control options for your particular situation.