INCIVEK and Pregnancy
Although INCIVEK (telaprevir) is a pregnancy Category B drug, it is not recommended to use this medicine while pregnant. This is because INCIVEK is only approved for use with other hepatitis C medications, one of which is a pregnancy Category X medicine. Because the potential risks outweigh the benefits, you should not use a Category X medicine during pregnancy.
Can Pregnant Women Take INCIVEK?INCIVEK® (telaprevir) is a prescription medication used to treat chronic hepatitis C. It is only used in combination with other medications. Although INCIVEK is a pregnancy category B medication, one of the medicines it is always used in combination with is a pregnancy category X medication.
What Is Pregnancy Category B?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. Medications that have been shown to be safe for use in pregnancy in humans but have caused problems in laboratory animals are also given a Category B rating.
Although INCIVEK has not been adequately studied in pregnant humans, it did not harm the developing fetus when given to pregnant mice and rats. However, it did decrease sperm count and sperm motility in male rats.
More importantly, INCIVEK is always given in combination with peginterferon alfa (Pegasys®, PEG-Intron®) and ribavirin (Copegus®, Rebetol®, RibaPak®, Ribasphere®). Ribavirin is considered a pregnancy Category X medication.