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FDA adds acute hypersensitivity reaction warning to Victrelis labeling

The FDA recently updated the labeling for Victrelis, a protease inhibitor used to treat adult patients with genotype 1 chronic hepatitis C, to reflect the potential for acute hypersensitivity reactions, according to a press release.

The revision for Victrelis (boceprevir, Schering Corporation) indicates that serious reactions have been observed in some patients during combination therapy with ribavirin and pegylated interferon-alfa. A contraindication for patients with a history of hypersensitivity to boceprevir has been added, with listed potential reactions including urticaria and angioedema.

Doctors are advised to immediately discontinue combination therapy in the event of a hypersensitivity reaction, while patients are warned to seek medical help following the appearance of symptoms indicating hypersensitivity, such as hives, difficulty breathing or swallowing, and swelling of the face, lips, throat, tongue or eyes, according to the release.

Additional adverse events related to the drug also were included in the update. These actions were reported following approval of the drug, and include mouth ulcerations, stomatitis, toxic skin eruption, toxicoderma, rash, dermatitis, Stevens-Johnson syndrome and DRESS syndrome.

This label change follows an update earlier this year acknowledging potential drug-drug interactions between boceprevir and atorvastatin, pravastatin, cyclosporine, tacrolimus and escitalopram, and how doctors should approach cases involving these medications in combination.

The drug is intended for treatment-naive patients with compensated liver disease or for those who were unresponsive to previous treatment with interferon and ribavirin. More information, including the complete label and medication guide, will be made available on the FDA web site.