| Document Date: 2014-08-21 15:16:08
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City Reference / / Company Janssen Products LP / BR / Tibotec Pharmaceuticals Reference ID / / Event FDA Phase / / Facility Laboratory Abnormalities Observed / Laboratory Abnormalities / / IndustryTerm treatment / food / treatment of HIV / / MedicalCondition inflammatory response / INTELENCE®-related rash / Pneumocystis jiroveci pneumonia / drug hypersensitivity / HIV / Mycobacterium avium infection / ear and labyrinth disorders / sluggishness Hematologic Disorders / Drug Rash / cytolytic hepatitis / NNRTI-related rash / convulsion / vision Gastrointestinal Disorders / hepatitis C / toxic epidermal necrolysis / hepatitis B / hyperhidrosis / Stevens-Johnson syndrome / hypersomnia / syncope / conjunctivitis / prurigo / severe hypersensitivity / StevensJohnson syndrome / fatigue / angina pectoris / gastritis / erythema multiforme / hypoesthesia / Cardiac Disorders / residual opportunistic infections / hypersensitivity / diarrhea / hematemesis / Graves’ disease / hepatitis Immune System Disorders / hepatitis / organ dysfunction / gastroesophageal reflux disease / constipation / confusional state / skin and subcutaneous tissue disorders / Nutrition Disorders / blisters / exertional dyspnea / Mediastinal Disorders / Autoimmune disorders / central obesity / Immune Reconstitution Syndrome Immune reconstitution syndrome / rash / constitutional findings / Urinary Disorders / amnesia / Guillain-Barré syndrome / Carcinogenesis / haemorrhagic stroke / joint aches / disorientation / tremor Psychiatric Disorders / stomatitis General Disorders / fever / lipodystrophy / angioneurotic edema / myocardial infarction / severe rash / diabetes mellitus / hepatic failure / angioedema / pancreatitis / rash and peripheral neuropathy / dyslipidemia Nervous System Disorders / infection / Immune System Disorders / Connective Tissue Disorders / vertigo Eye Disorders / hemolytic anemia Hepatobiliary Disorders / sleep disorders / rash / Breast Disorders / chronic hepatitis B / Eosinophilia / polymyositis / skin and subcutaneous tissue disorders rash / tuberculosis / / MedicalTreatment antiretroviral treatment / medication errors / antiretroviral therapy / / Organization administration of INTELENCE / DOSAGE AND ADMINISTRATION / FDA / / / Position General / / Product efavirenz / INTELENCE / nevirapine / TMC125-C206 / C206 / INTELENCE® / TMC125 / TMC125-C213 / / PublishedMedium Microbiology / / Technology Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use INTELENCE® safely and effectively. See full prescribing information for INTELENCE®.