| Document Date: 2011-08-11 15:26:08
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City Reference / / Company Gilead Sciences Inc. / AST Increased ALT Increased Total Bilirubin Increased / / Event FDA Phase / / Facility Laboratory Parameter Abnormality / Laboratory Abnormalities / / IndustryTerm hepatitis B therapy / medicinal products / treatment of HIV / combination product / / MedicalCondition inflammatory response / DF / severe hypophosphatemia / Fanconi syndrome / cholecystitis / Depressive disorders / HIV / headache / cholelithiasis / HBV / Mycobacterium avium infection / arthralgia / back pain / hyperpigmentation / liver failure / renal tubular injury / adverse reaction depressive disorders / nausea / peripheral neuritis / rhinitis / hepatitis B / peripheral neuropathy / Severe depressive disorders / Torsade de Pointes / fatigue / Obesity / glomerulonephritis / residual opportunistic infections / diarrhea / sinusitis / liver disease / Steatosis Lactic acidosis / upper respiratory tract infection / Immune reconstitution syndrome / abdominal pain / insomnia / pneumonia / central obesity / Immune Reconstitution Syndrome Immune reconstitution syndrome / nasopharyngitis / Carcinogenesis / chronic HBV infection / dysphoria / major depression / Pneumocystis jirovecii pneumonia / fever / vomiting / pain / psychiatric disorders / LACTIC ACIDOSIS / osteomalacia / osteoporosis / infection / dizziness / cough / sleep disorders / depression / rash / chronic hepatitis B / paresthesia / acute renal failure / skin and subcutaneous tissue disorders rash / tuberculosis / / MedicalTreatment antiretroviral treatment / antiretroviral therapy / / Organization Federal Trade Commission / DOSAGE AND ADMINISTRATION / FDA / / / Product COMBIVIR / efavirenz / EMTRIVA / TRIZIVIR / dexamethasone / TRUVADA / carbamazepine / Vitamin D / HEPSERA / EPIVIR / omeprazole / rifampin / pantoprazole / EPZICOM / EPIVIR-HBV / tenofovir disoproxil fumarate / phenytoin / lansoprazole / oxcarbazepine / lamivudine / VIREAD / ATRIPLA / rabeprazole / stavudine / reactions / TMC278-C209 / / Technology Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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• New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Assess creatinine clearance (CrCl) before initiating treatment with COMPLERA. Monitor CrCl and serum phosphorus in pati