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    Indication Statement

    INTELENCE® (etravirine), in combination with other antiretroviral (ARV) agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in ARV treatment-experienced patients ages 6 years and older, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other ARV agents.

    The indication for adult use is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE®. Both studies were conducted in clinically advanced, 3-class ARV (NNRTI, N[t]RTI, PI) treatment-experienced adults. The indication for pediatric use is based on 24-week analyses of a single arm, Phase 2 trial in ARV treatment-experienced pediatric subjects 6 years to less than 18 years of age.

    In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with INTELENCE®:

    • Treatment history and resistance testing should guide the use of INTELENCE® due to concerns for potential cross-resistance
    • In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE® in combination with only N[t]RTIs
    • The use of other active ARV agents with INTELENCE® is associated with an increased likelihood of treatment response
    • The safety and efficacy of INTELENCE® have not been established in pediatric patients less than 6 years of age or in treatment-naïve adult or pediatric patients

     

    Important Safety Information
    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 including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) 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®. In clinical trials of patients on INTELENCE®, the incidence of rash was higher in women compared to men. Rash occurred most commonly during the first 6 weeks of therapy. In the PIANO study of children ages 6 to ≤17 years of age, rash was seen more commonly than in adults and occurred in 15% (≥Grade 2) of pediatric subjects

      Discontinue INTELENCE® immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, or angioedema)

      • Monitor clinical status including liver transaminases, and initiate appropriate therapy
      • Delay in stopping INTELENCE® treatment after the onset of severe rash may result in a life-threatening reaction
    • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established
    • Immune Reconstitution Syndrome has been reported in patients treated with ARV therapy, including INTELENCE®. Autoimmune disorders (such as Graves disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment
    Use in Specific Populations
    • Hepatic Impairment: INTELENCE® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of INTELENCE® have not been evaluated in these patients
    • Pregnancy Category B: INTELENCE® should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and wellcontrolled studies have been conducted in pregnant women
    Adverse Reactions
    • The most common adverse drug reactions (≥2%) of at least moderate intensity (≥Grade 2) reported in adult patients taking INTELENCE® and that occurred at a higher rate compared with placebo were rash (10% vs 3%) and peripheral neuropathy (4% vs 2%). The most common adverse drug reactions in at least 2% of pediatric subjects were rash and diarrhea
    Drug Interactions
    • INTELENCE® should not be coadministered with the following ARVs: atazanavir/ritonavir, fosamprenavir/ritonavir, tipranavir/ritonavir, full-dose ritonavir (600 mg bid), PIs administered without low-dose ritonavir, and other NNRTIs
    • INTELENCE® should not be coadministered with carbamazepine, phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part of a regimen containing PI/ritonavir), or products containing St. John’s wort (Hypericum perforatum)
    • Caution should be used when prescribing agents such as substrates, inhibitors, or inducers of CYP3A, CYP2C9, CYP2C19, and/or P-glycoprotein in patients receiving INTELENCE® as it may alter the therapeutic effect or adverse reaction profile of INTELENCE® or the coadministered drug(s)

    This is not a complete list of potential drug interactions.

    Please see full Prescribing Information for more details.