| Document Date: 2012-02-22 15:55:22
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City Reference / / Company QT / INVIRASE / Genentech / / Event Product Issues / / IndustryTerm drug product / treatment of HIV / / MedicalCondition inflammatory response / anaphylactic reaction / Neoplasms / Pneumocystis jiroveci pneumonia / HIV / torsades de pointes / lymphatic system disorders / myopathy / congenital long QT syndrome / pulmonary arterial hypertension / psychotic disorder / ischemic heart disease / cirrhosis / Ear disorders / hepatitis B / pancytopenia / thrombocytopenia Cardiac / bradyarrhythmias / cardiac arrhythmia / gastrointestinal hemorrhage / libido disorder / clinically significant hypersensitivity / diarrhea / Graves’ disease / hepatitis / liver disease / nutrition disorders / Endocrine Disorders Diabetes mellitus/hyperglycemia / abdominal pain / Autoimmune disorders / Lipodystrophy / Immune Reconstitution Syndrome Immune reconstitution syndrome / convulsions / hemophilia A / Gastrointestinal Disorders Nausea / arthralgia / urinary disorders / dysphagia / dysgeusia / Guillain-Barré syndrome / Carcinogenesis / hyperglycemia / sleep disorder / neutropenia / labyrinth disorders / cardiomyopathies / Fever / lethargy / pancreatitis General disorders / vomiting / chronic alcoholism / pancreatitis / Lactose Intolerance / respiratory depression / infection / dizziness / complete AV block / depression / acute myeloid leukemia / loss of consciousness / Musculoskeletal Disorders Back Pain / chest pain / headache / erythema / severe cutaneous reaction / Mycobacterium avium infection / Skin disorders / leukopenia / hypoaesthesia / intracranial hemorrhage / subcutaneous tissue disorders / dermatitis / nausea / muscle spasms / alopecia / Administration Site Conditions Fatigue / Stevens-Johnson syndrome / lipid disorders / syncope / paresthesia / peripheral neuropathy / cases diabetic ketoacidosis / fatigue / atrioventricular block / lymphadenopathy / gastritis / Hyperglycemia New onset diabetes mellitus / incl cysts / residual opportunistic infections / pulmonary arterial adverse events / Constipation / gastrointestinal disorders / Hemophilia / Correct hypokalemia / immune reconstitution syndrome / hypotension / long QT syndrome / Pneumonia Bronchitis Influenza Sinusitis Dermatological Disorders Rash Pruritus Dry lips/skin Eczema / intestinal obstruction / insomnia / congestive heart failure / General Disorders / hemolytic anemia / central obesity / thrombophlebitis / hypertension / acne / portal hypertension Immune system disorders / cardiac arrhythmias / certain heart diseases / Hyperlipidemia / system disorders / rhabdomyolysis / diabetes mellitus / thoracic and mediastinal disorders / structural heart disease / chronic active hepatitis / connective tissue disorders / cough / drug eruption / refractory hypokalemia / anemia / syndrome / polymyositis / tuberculosis / dehydration / / MedicalTreatment concomitant therapy / antiretroviral treatment / antiretroviral therapy / alternative therapy / / Organization FDA / INDICATIONS AND USAGE DOSAGE AND ADMINISTRATION / Continued administration / / / Position physician / General / / Product Efavirenz / Simvastatin / phenytoin / digoxin / DOSAGE FORMS AND STRENGTHS Capsules / nevirapine / lidocaine / Saquinavir Soft Gel Capsules / Fortovase / Lactose Intolerance Each capsule / Film-coated tablets / carbamazepine / Triazolam / rifampin / Revatio / INVIRASE / Lovastatin / Hepatic Function OVERDOSAGE DESCRIPTION CLINICAL PHARMACOLOGY / Renal Function / / ProvinceOrState Iowa / / Technology Alpha / AV / 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 INVIRASE safely and effectively. See full prescribing information for INVIRASE.