Telaprevir (Incivek) with Peginterferon Alfa and Ribavirin
December 21, 2012
FDA is informing healthcare professionals of severe, potentially life threatening reports of skin reactions associated with telaprevir (Incivek), peginterferon alfa, and ribavirin combination therapy Hepatitis C. The product label for telaprevir will now include a black box warning requiring discontinuation of telaprevir, peginterferon alfa, and ribavirin at the first sign of worsening rash with or without systemic symptoms.
Telaprevir has been associated with severe skin reaction such as toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), and Steven-Johnson Syndrome (SJS). A search of the FDA Adverse Event Reporting System database from May 2011 to June 2012 revealed 92 cases of DRESS and 20 cases of SJS with combination telaprevir treatment. Fatal cases have been reported when patients continued to take telaprevir combination therapy despite the development of a severe rash. Vertex Pharmaceuticals, the manufacturer of telaprevir, is currently performing a genetic analysis to determine if severe skin reactions with telaprevir are linked to one’s genetic makeup. FDA will communicate new information with the public as it becomes available.
FDA recommends educating patients about the risk of developing a rash while on telaprevir combination therapy and the signs and symptoms that warrant urgent medical care (eg. worsening rash, diarrhea, upset stomach, fever, mouth sores, redness or swelling on the face or eyes). If a severe rash with systemic symptoms is experienced, immediately discontinue all three components of telaprevir combination treatment and other medications potentially associated with serious skin reactions. Report serious skin reactions associated with telaprevir combination therapy to FDA online at www.fda.gov/MedWatch/report.htm, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mailing the completed form. The MedWatch form is available at www.fda.gov/downloads/Safety/MedWatch/DownloadForms/UCM082725.pdf.
Additional information is available at the following links:
- MedWatch Alert:
- Drug Safety Communication:
- Telaprevir (Incivek) Product Label:
December 21, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.