| Document Date: 2012-08-15 16:02:36
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City Reference / / Company Merck / Laboratory Abnormalities / Merck Sharp & Dohme Corp. / Merck & Co. Inc. / Alteon Inc. / / Currency pence / / Event FDA Phase / / Facility Laboratory Abnormalities The / Laboratory Parameter Preferred Term / Laboratory Parameter Preferred Term LDL / Laboratory Abnormalities Reported / / IndustryTerm treatment / immune systems / Monitor for Immune Reconstitution Syndrome / food / treatment of HIV / / MedicalCondition inflammatory response / Pneumocystis jiroveci pneumonia / headache / Mycobacterium avium infection / Myopathy / genital herpes / Administration Fatigue / antierectile dysfunction / nausea / Hepatitis C / toxic epidermal necrolysis / Hepatitis B / Stevens-Johnson syndrome / conjunctivitis / severe hypersensitivity / fatigue / gastritis / residual opportunistic infections / hypersensitivity / Graves’ disease / hepatitis / phenylketonuria / organ dysfunction / illness / liver disease / Infections / nephrolithiasis / Immune Reconstitution Syndrome / blisters / cancers / abdominal pain / Autoimmune disorders / insomnia / General Disorders / Immune Reconstitution Syndrome Immune reconstitution syndrome / rash / constitutional findings / cancer / Gastrointestinal Disorders Nausea / Nervous System Disorders / Guillain-Barré syndrome / Carcinogenesis / chronic / joint aches / fever / rhabdomyolysis / severe rash / hepatic failure / angioedema / Psychiatric Disorders Insomnia / AIDS / infection / Nervous System Disorders Headache / renal failure / depression / rash / psychomotor hyperactivity / eosinophilia / polymyositis / tuberculosis / / MedicalTreatment antiretroviral treatment / antiretroviral therapy / / Organization Pediatrics DOSAGE AND ADMINISTRATION / FDA / / / Position investigator / General / / Product efavirenz / Chewable Tablet / Chewable Tablets / Film-Coated Tablets / rifampin / OR Chewable tablets / phenytoin / lamivudine / ISENTRESS / T-05181207 / OBT ISENTRESS / ISENTRESS Efavirenz / ISENTRESS Placebo / / PublishedMedium Baseline / / Technology UDP / Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS. ®