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Incivek

January 4, 2021

Incivek (telaprevir) is a hepatitis C drug that is taken in combination with peginterferon alfa and ribavirin (Incivek combination treatment). It is used for the treatment of adult patients with compensated liver disease, including patients who have cirrhosis, are treatment-naïve, or who have been previously received interferon-based treatment.

The U.S. Food and Drug Administration (FDA) issued a safety alert in December 2012, warning of the risk of death from severe skin reactions in some patients receiving Incivek combination treatment. The drug label already carries a warning about the potential risk of severe skin reactions such as Stevens-Johnson Syndrome (SJS) and another drug rash with eosinophilia (a higher than normal level of white blood cells called eosinophils) and systemic symptoms (DRESS).

But, the FDA issued the safety alert to warn patients about the seriousness of the skin reactions after receiving reports from Japan of two cases in which patients developed toxic epidermal necrolysis (TENS) after being treated with Incivek, peginterferon alfa and ribavirin. One of the patients died.

According to the FDA, there were 92 cases of DRESS and 20 cases of SJS in patients taking Incivek combination treatment between May 23, 2011 and June 19, 2012.

Are You Being Treated with Incivek?

If you or someone you love is being treated with Incivek combination treatment, your doctor should have notified you of the risk of severe skin reactions. If you develop any of the following symptoms, you should seek medical attention immediately and stop taking all three medications. The following could be signs of a severe and deadly skin reaction to the treatment:

  • Fever
  • Nausea, vomiting
  • Diarrhea
  • Sores or ulcers in the mouth
  • Lesions or ulcerations on the eyes or lips
  • Facial swelling
  • Red or inflamed eyes (similar to pink eye)
  • Rash
  • Rash that does not itch
  • Severe rash with raised bumps or blisters

You should not stop taking your medication without talking to your doctor, but you should contact him or her immediately if you experience any of the signs or symptoms above.

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