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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. ®
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Document Date: 2011-12-23 12:58:35


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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 / Monitor for Immune Reconstitution Syndrome / medicinal products / food / treatment of HIV / /

MedicalCondition

inflammatory response / Pneumocystis jiroveci pneumonia / headache / Myopathy / genital herpes / antierectile dysfunction / Hepatitis C / Hepatitis B / toxic epidermal necrolysis / Stevens-Johnson syndrome / conjunctivitis / severe hypersensitivity / fatigue / gastritis / residual opportunistic infections / hypersensitivity / hepatitis / phenylketonuria / organ dysfunction / illness / liver disease / Infections / nephrolithiasis / paranoia / Immune Reconstitution Syndrome / blisters / cancers / abdominal pain / insomnia / cancer / rash / constitutional findings / Nervous System Disorders / Mycobacterium tuberculosis / Carcinogenesis / chronic / joint aches / fever / rhabdomyolysis / vomiting / severe rash / varicella zoster virus / hepatic failure / angioedema / Psychiatric Disorders Insomnia / AIDS / infection / renal failure / depression / rash / psychomotor hyperactivity / eosinophilia / /

MedicalTreatment

antiretroviral treatment / antiretroviral therapy / /

Organization

Pediatrics DOSAGE AND ADMINISTRATION / FDA / /

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Position

investigator / General / /

Product

efavirenz / Chewable Tablet / Chewable Tablets / Film-Coated Tablets / omeprazole / rifampin / OR Chewable tablets / phenytoin / lamivudine / ISENTRESS / OBT ISENTRESS / ISENTRESS Efavirenz / ISENTRESS Placebo / /

PublishedMedium

Baseline / /

Technology

UDP / Pharmacokinetics / Pharmacodynamics / /

URL

www.fda.gov/medwatch / /

SocialTag