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FDA Approves New Dosage Strength for INTELENCE®
Date:1/3/2011

ment response.
  • In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE in combination with only N[t]RTIs.
  • The risks and benefits of INTELENCE have not been established in pediatric patients or in treatment-naïve adult patients.

    • About the DUET studiesThe DUET studies, identical in design and conducted across the Americas, Australia, Canada, Europe and Thailand, examined the use of INTELENCE in combination with other ARV agents in adult treatment-experienced HIV-1 patients with documented resistance to NNRTIs and protease inhibitors (PIs).  Participants in the DUET studies were randomized to receive INTELENCE 200 mg twice daily or placebo, each given in addition to a background regimen (BR).  For all patients, the BR included darunavir/ritonavir, plus at least two investigator-selected antiretroviral drugs (N(t)RTIs with or without enfuvirtide).  

    Important Safety InformationINTELENCE does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

    Warnings & Precautions

  • Severe Skin and Hypersensitivity Reactions:
  • Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking INTELENCE. 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  

    • In the DUET studies, Grade 3 and 4 rashes were reported in 1.3% of patients receiving INTELENCE compared to 0.2% of patients in the placebo arm. Discontinuation rate due to rash was 2.2% in patients taking INTELENCE. Rash occurred most commonly during the first 6 weeks of therapy.

    Discontinue INTELENCE immediately if signs or symptoms of severe skin reactions or hypersen
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    SOURCE Tibotec Therapeutics
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