| Document Date: 2014-03-31 07:24:10
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Company QT / INVIRASE / Pediatric Subjects Limited / Genentech / / Event Product Issues / / IndustryTerm drug product / treatment of HIV / / MedicalCondition inflammatory response / anaphylactic reaction / Pneumocystis jiroveci pneumonia / 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 / HIV1 infection / libido disorder / clinically significant hypersensitivity / diarrhea / Graves’ disease / hepatitis / liver disease / nutrition disorders / Endocrine Disorders Diabetes mellitus/hyperglycemia / Abdominal Pain / Autoimmune disorders / pneumonia / Lipodystrophy / Immune Reconstitution Syndrome Immune reconstitution syndrome / hemophilia A / Gastrointestinal Disorders Nausea / arthralgia / urinary disorders / dysphagia / dysgeusia / Guillain-Barré syndrome / Carcinogenesis / hyperglycemia / sleep disorder / neutropenia / Eczema / diabetes / labyrinth disorders / cardiomyopathies / Fever / Dermatological Disorders Rash / 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 / glucose intolerance / chest pain / headache / erythema / severe cutaneous reaction / Mycobacterium avium infection / Skin disorders / leukopenia / Bronchitis / hypoaesthesia / intracranial hemorrhage / subcutaneous tissue disorders / dermatitis / Respiratory Disorders Pneumonia / nausea / muscle spasms / lipodystrophy and abdominal pain / alopecia / Administration Site Conditions Fatigue / Stevens-Johnson syndrome / lipid disorders / syncope / paresthesia / peripheral neuropathy / cases diabetic ketoacidosis / fatigue / atrioventricular block / lymphadenopathy / gastritis / incl cysts / residual opportunistic infections / pulmonary arterial adverse events / Sinusitis / Constipation / Pruritus / gastrointestinal disorders / Influenza / Hemophilia / Correct hypokalemia / immune reconstitution syndrome / hypotension / long QT syndrome / 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 / Diabetes Mellitus / Hyperglycemia / Hyperlipidemia / polyarthritis Neoplasms / rhabdomyolysis / papillomatosis Nervous system disorders / New onset diabetes mellitus / 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 DOSAGE AND ADMINISTRATION / FDA / Administration for Patients Unable / Continued administration / / / Position physician / General / / Product Efavirenz / Simvastatin / phenytoin / digoxin / Swallow Capsules / DOSAGE FORMS AND STRENGTHS Capsules / nevirapine / lidocaine / Saquinavir Soft Gel Capsules / Fortovase / Lactose Intolerance Each capsule / Film-coated tablets / carbamazepine / Triazolam / rifampin / Revatio / INVIRASE / sorbitol / FDAapproved Medication / 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. •