Severe Skin and Hypersensitivity Reactions Reported with Intelence (etravirine)

Tibotec, a division of Janssen-Ortho Inc. ("Tibotec"), in collaboration with Health Canada, has issued updated safety information regarding severe skin reactions in patients receiving combination therapy including INTELENCE (etravirine) tablets.

Specifically, there have been post-marketing reports of severe hypersensitivity reactions sometimes accompanied by hepatic failure, and a report of a fatality due to toxic epidermal necrolysis.

Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme. Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure.

Etravirine belongs to a class of drugs known as antiretrovirals, specifically non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is used in combination with other antiretroviral medications to treat human immunodeficiency virus type 1 (HIV-1).

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Published on Oct-19-09