| Document Date: 2014-04-10 13:31:43
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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 / antacids containing divalent metal cations / Monitor for Immune Reconstitution Syndrome / food / treatment of HIV / / MedicalCondition inflammatory response / Pneumocystis jiroveci pneumonia / headache / Mycobacterium avium infection / Myopathy / genital herpes / 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 / paranoia / Administration Fatigue Nervous System Disorders Headache Dizziness Psychiatric Disorders / Immune Reconstitution Syndrome / blisters / cancers / abdominal pain / Autoimmune disorders / insomnia / Immune Reconstitution Syndrome Immune reconstitution syndrome / rash / constitutional findings / cancer / Nervous System Disorders / Guillain-Barré syndrome / Carcinogenesis / chronic / joint aches / fever / rhabdomyolysis / severe rash / hepatic failure / angioedema / AIDS / infection / dizziness / depression / Gastrointestinal Disorders Nausea General Disorders / rash / psychomotor hyperactivity / eosinophilia / polymyositis / tuberculosis / / MedicalTreatment antiretroviral treatment / antiretroviral therapy / / Organization DOSAGE AND ADMINISTRATION / FDA / ISENTRESS administration / / / Position investigator / Gastrointestinal Disorders Nausea General / General / / Product efavirenz / Chewable Tablet / Chewable Tablets / For Oral Suspension / Film-Coated Tablets / rifampin / phenytoin / lamivudine / 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. ------------------------WARNINGS