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 2 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.

• 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.

  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.

• Pregnancy Category B: INTELENCE^® should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women.
• Pediatric Use: Treatment with INTELENCE^® is not recommended in pediatric patients less than 2 years of age.
• 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.

• 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.

• INTELENCE^® is not recommended with the following ARVs: fosamprenavir/ritonavir, tipranavir/ritonavir, full-dose ritonavir (600 mg bid), PIs administered without low-dose ritonavir, and other NNRTIs.
• INTELENCE^® should only be used with dolutegravir when coadministered with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. INTELENCE^® should not be coadministered with dolutegravir in the absence of a boosted PI. INTELENCE^® significantly reduces plasma concentrations of dolutegravir.
• 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. Consult the full Prescribing Information for INTELENCE^® for information on significant drug interactions.

Please see full Prescribing Information for INTELENCE^®.

cp-63695v1