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Incivek label updated to reflect risk for potentially fatal skin reactions
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A boxed warning indicating the potential for fatal and nonfatal serious skin reactions has been added to the labeling for hepatitis C medication Incivek, according to a press release.
The labeling change follows reports that using Incivek (telaprevir, Vertex Pharmaceuticals) resulted in fatal skin reactions in patients who developed progressive rash and other systemic symptoms but continued treatment. The initial labeling indicated rashes and serious skin reactions as potential side effects, but the severity of events observed post-marketing warranted the more prominent boxed warning, according to the release.
The drug, approved by the FDA in May 2011, is administered orally as part of combination therapy with pegylated interferon and ribavirin, and is intended for use in adults with chronic HCV genotype 1 infection who were either unresponsive to or had not received previous therapy. Other serious adverse events associated with Incivek include anemia and birth defects or death of an unborn baby, according to the release. Common side effects include nausea, diarrhea, vomiting, itching and anal or rectal problems.
Serious skin reactions occurred in less than 1% of participants in phase 3 clinical trials of Incivek. Immediate discontinuation of treatment and urgent medical care are required in the event of a serious reaction.
“The safety of people taking our medicines is our first priority, and we are committed to ensuring that patients and physicians are aware of the label update to help them use Incivek properly,” Robert Kauffman, MD, PhD, senior vice president and chief medical officer for the company, said in the release. “We will continue to educate physicians to follow the rash management plan developed while Incivek was in clinical trials and the information contained in the updated label.”