|February 2013 · Vol. 25, No. 2
FDA adds black box warning
to INCIVEK® (telaprevir)
for hepatitis C
Vertex Pharmaceuticals must alert consumers to both fatal and nonfatal serious skin reactions with the combined use of INCIVEK, peginterferon alfa, and ribavirin. If a progressive rash occurs, all three components must immediately be stopped, and urgent medical care received.
After receiving reports of serious skin reactions, some fatal, in patients taking the hepatitis C drug INCIVEK (telaprevir) in combination with drugs peginterferon alfa and ribavirin (INCIVEK combination treatment), the US Food and Drug Administration (FDA) has added a black box warning to the label of this Vertex Pharmaceutical Inc. product.1
Some patients have died when they continued to receive INCIVEK combination treatment after developing a progressive rash and systemic symptoms.1
The label must state that INCIVEK combination treatment must be immediately stopped in patients experiencing a rash with systemic symptoms or a progressive severe rash. If serious skin reactions occur, all three components of INCIVEK combination treatment must be immediately discontinued, and the patient should receive urgent medical care.1
INCIVEK is one of two hepatic C virus protease inhibitors for use in triple combination therapy with interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including patients who have cirrhosis, are treatment-naïve, or who have previously received interferon-based treatment.1,2
Health-care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm, or by calling 800-332-1088 to request a reporting form.1
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1. US Food and Drug Administration. Safety. Incivek (telaprevir) in combination with drugs peginterferon alfa and ribavirin (incivek combination treatment): Drug safety communication—serious skin reactions. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm332860.htm. Published December 19, 2012. Accessed January 28, 2013.
2. Vertex announces update to US prescribing information for INCIVEK® (telaprevir) [press release]. http://investors.vrtx.com/releasedetail.cfm?ReleaseID=727785. Published December 19, 2012. Accessed January 28, 2013.
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