August 28, 2009
Severe skin reactions warning added to Intelence labelingThe FDA has notified healthcare professionals that the labeling for Intelence (etravirine tablets, from Tibotec) has been updated to include postmarketing reports of severe skin and hypersensitivity reactions. The reported adverse events include fatality due to toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, and hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. The FDA is recommending that Intelence be discontinued immediately when signs and symptoms of severe skin or hypersensitivity reactions develop.
Intelence is indicated for the treatment of HIV-1 infection, in combination with other antiretrovirals, in treatment-experienced adults with evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretrovirals.
For more information call (877) 732-2488 or visit www.intelence-info.com.