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
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
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
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
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