| Document Date: 2013-02-26 15:30:26
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City Reference / / Company Janssen Products LP / / Event FDA Phase / / IndustryTerm immune systems / food daily / ritonavir oral solution / weight / food / treatment of HIV / / MedicalCondition inflammatory response / HIV / headache / liver dysfunction / myopathy / Mycobacterium avium infection / Sulfa Allergy / Drug-induced hepatitis / pulmonary arterial hypertension / cytolytic hepatitis / pre-existing liver dysfunction / nausea / cirrhosis / hepatitis C / hepatitis B / toxic epidermal necrolysis / Stevens-Johnson Syndrome / syncope / conjunctivitis / StevensJohnson Syndrome / fatigue / diabetic ketoacidosis / residual opportunistic infections / diarrhea / Graves’ disease / hepatitis / hemophilia / hemophilia type A / hypotension / immune reconstitution syndrome / sulfonamide allergy / chronic active hepatitis B / blisters / pre-existing diabetes mellitus / Autoimmune disorders / onset diabetes mellitus / central obesity / Immune Reconstitution Syndrome Immune reconstitution syndrome / disease / Hepatotoxicity Drug-induced hepatitis / Guillain-Barré syndrome / Carcinogenesis / hyperglycemia / cardiac arrhythmias / Pneumocystis jirovecii pneumonia / acute hepatitis / Diabetes Mellitus / Hyperglycemia / joint aches / fever / rhabdomyolysis / New onset diabetes mellitus / vomiting / pain / severe rash / respiratory depression / infection / chronic hepatitis / liver injury / rash / hemarthrosis / eosinophilia / polymyositis / tuberculosis / / MedicalTreatment antiretroviral treatment / medication errors / antiretroviral therapy / / Organization administration of PREZISTA/ritonavir / DOSAGE AND ADMINISTRATION / FDA / / / Position General / / Product simvastatin / triazolam / Oral Suspension / rifampin / PREZISTA / lovastatin / TMC114-C211 / CYP3A / CD4 / / Technology Alpha / Pharmacokinetics / Pharmacodynamics / simulation / / 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 PREZISTA safely and effectively. See Full Prescribing Information for PREZISTA.