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U.S. Department of Health and Human Services

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Telaprevir (marketed as Incivek) Information

The U.S. Food and Drug Administration (FDA) has received reports of serious skin reactions, some fatal, in patients taking the hepatitis C drug Incivek (telaprevir) in combination with the drugs peginterferon alfa and ribavirin. Significantly, some patients died when they continued to receive Incivek combination treatment after developing a worsening, or progressive rash and systemic symptoms (symptoms affecting the entire body). As a result, FDA is adding a boxed warning to the Incivek drug label stating that Incivek combination treatment and any other drugs also suspected to contribute to serious skin reaction must be immediately stopped in patients experiencing a progressive severe rash alone or along with systemic body symptoms.

 

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