| Document Date: 2013-10-28 13:55:09
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Company Gilead Sciences Inc. / / Event Product Issues / FDA Phase / / IndustryTerm hepatitis B therapy / treatment of HIV / baby food / treatment of HBV / HBV therapy / soft food / tenofovir-containing products / food / / MedicalCondition Infection VIREAD / abdominal pain / Autoimmune disorders / insomnia / DF / pneumonia / Fanconi syndrome / HBV infection / HIV / opportunistic infections / disease / headache / HBV / Carcinogenesis / hypophosphatemia / dysfunction / nausea / POST TREATMENT EXACERBATION OF HEPATITIS Lactic acidosis / compensated liver disease / Arthralgias / pain / vomiting / LACTIC ACIDOSIS / injury / POST TREATMENT EXACERBATION OF HEPATITIS / Obesity / pancreatitis / osteoporosis / osteomalacia / diarrhea / infection / hepatitis / dizziness / end-stage renal disease / depression / renal dysfunction / liver disease / pruritus / rash / HBeAg-negative chronic hepatitis B / chronic hepatitis B / acute renal failure / Syndrome / inflammatory / polymyositis / tuberculosis / Immune reconstitution syndrome / / MedicalTreatment antiretroviral treatment / antiretroviral therapy / Hemodialysis / dialysis / renal replacement therapy / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Product efavirenz / tenofovir disoproxil fumarate / TRUVADA / Vitamin D / HEPSERA / lamivudine / VIREAD / Didanosine / ATRIPLA / stavudine / Recommended / VIREAD oral / using / Renal Function / / Technology Pharmacokinetics / dialysis / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Assess estimated creatinine