Incivek Label Updated with Black Box Warning

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INCIVEK (telaprevir) 375mg tablets by Vertex Pharmaceuticals
INCIVEK (telaprevir) 375mg tablets by Vertex Pharmaceuticals

Vertex Pharmaceuticals announced that the Incivek (telaprevir) label has been updated to include a boxed warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking Incivek combination treatment. Some fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive Incivek combination treatment after a serous skin reaction was identified.

In Phase 3 clinical trials, <1% of people who received Incivek combination treatment experienced a serious skin reaction. Rash and serious skin reactions were previously included in the Warnings and Precautions section of the label, but the boxed warning further emphasizes the importance of discontinuing treatment in the event of one of these reactions.

In addition, the Incivek label was updated to include additional information on the time to onset and management of anemia.

Incivek is a hepatitis C virus NS3/4A protease inhibitor indicated in chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have previously been treated with interferon-based therapy, including prior null responders, partial responders, and relapsers.

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