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EDURANT™ 96-Week Phase 3 Safety and Efficacy Data Presented at International AIDS Society Conference
Date:7/19/2011

irologic response and possible resistance and cross-resistance: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, proton pump inhibitors such as esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole, systemic dexamethasone, and products containing St. John's wort (Hypericum perforatum). EDURANT should be used with caution when co administered with drugs that may reduce the exposure of rilpivirine
  • EDURANT should be used with caution when coadministered with a drug with a known risk of Torsade de Pointes
  • EDURANT should not be used in combination with NNRTIs

  • This is not a complete list of potential drug interactions.  Please see full Prescribing Information for more details.Warnings and Precautions

  • Depressive Disorders: Severe depressive disorders, defined as depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, and suicidal ideation, have been reported with EDURANT. Immediate medical evaluation is recommended for severe depressive symptoms
  • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral (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 combination ARV therapy, including EDURANT

  • Use in Specific Populations

  • Hepatic Impairment: EDURANT should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT have not been evaluated in these patients
  • Pregnancy Category B: EDURANT 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

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    SOURCE Janssen Therapeutics, Division of Janssen Products, LP
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