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U.S. Department of Health and Human Services

Safety

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Intelence (etravirine) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009, October 2011 and August 2012

 

August 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Immune Reconstitution Syndrome
  • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral 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.

 

October 2011 

Summary View

 

DRUG INTERACTIONS

  • table 3 modified

PATIENT PACKAGE INSERT

  • “Tell your doctor if you take other HIV medicines” section buprenorphine and buprenorphine/naloxone drug interaction.

 

September 2009

Summary View

 

WARNINGS AND PRECAUTIONS

Severe Skin and Hypersensitivity Reactions
  • Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme...
  • Discontinue Intelence immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions...

ADVERSE REACTIONS

Postmarketing Experience
  • The following events have been identified during postmarketing use of Intelence. Because these events are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Fatal cases of toxic epidermal necrolysis have been reported. Severe hypersensitivity reactions including cases of hepatic failure have been reported