VICTRELIS and Pregnancy
Although VICTRELIS (boceprevir) is a pregnancy Category B medication, it should not be taken during pregnancy. This is because ribavirin -- one of the medications that must be taken with VICTRELIS -- has a Category X rating. In animal studies, ribavirin was shown to cause birth defects, including problems with the eye, jaw, and skeleton. If pregnancy occurs during treatment, contact your doctor right away.
VICTRELIS™ (boceprevir) is a prescription medication approved to treat chronic hepatitis C genotype 1 infection. It is given in combination with peginterferon alfa (Pegasys®, PEG-Intron®) and ribavirin (Copegus®, Rebetol®, Ribapak®, Ribasphere®). This drug is used in people who still have liver function and have never been treated for hepatitis or who have failed previous treatment. Although VICTRELIS is a pregnancy Category B medication, ribavirin is a pregnancy Category X 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 taken during pregnancy. Pregnancy Category B is given to medicines that have not been adequately studied in pregnant humans but do not appear to cause harm to the fetus in animal studies.
In addition, medications that have been shown to be safe for use in pregnancy in humans but have caused problems in laboratory animals are given a Category B rating.
VICTRELIS has not been adequately studied in pregnant humans. In animal studies, it did not cause birth defects or other problems when given in high doses to pregnant rats and rabbits. However, because VICTRELIS is always given in combination with ribavirin, a pregnancy Category X medicine, it should not be used in pregnant women.