| Document Date: 2013-04-19 14:05:26
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Company Gilead Sciences Inc. / Gilead Sciences LLC / Bristol-Myers Squibb / / Event FDA Phase / / Facility Laboratory Abnormalities / / IndustryTerm hepatitis B therapy / machinery / treatment of HIV / fixed-dose combination product / combination product / / MedicalCondition DF / Fanconi syndrome / severe hypophosphatemia / HIV / headache / HBV / seizures / liver failure / rash resolves / renal tubular injury / hallucinations / nausea / skin rash / hepatitis B / Stevens-Johnson syndrome / hepatic dysfunction / fatigue / drowsiness / Obesity / erythema multiforme / clinically significant hypersensitivity / hypersensitivity / diarrhea / Hypersensitivity ATRIPLA / liver disease / Steatosis Lactic acidosis / hepatic disease / Immune reconstitution syndrome / insomnia / Convulsions / amnesia / Carcinogenesis / cardiac arrhythmias / chronic HBV infection / pre-existing hepatic disease / confluent rash / C infection / fever / stupor / Lactic acidosis / severe rash / severe depression / hepatic failure / pancreatitis / POST TREATMENT EXACERBATION OF HEPATITIS B / osteoporosis / respiratory depression / infection / dizziness / depression / Rash / chronic hepatitis B / acute renal failure / / MedicalTreatment antiretroviral therapy / alternative therapy / contraception / Barrier contraception / / Organization FDA / / / Position General / / Product Combivir / efavirenz / EMTRIVA / zidovudine / Trizivir / abacavir sulfate / SUSTIVA / TRUVADA / vitamin D / HEPSERA / triazolam / Epivir / rifampin / Epzicom / Epivir-HBV / tenofovir disoproxil fumarate / nevirapine / lamivudine / VIREAD / Didanosine / ATRIPLA / Name Clinical Comment Antifungal / stavudine / / Technology Pharmacokinetics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use ATRIPLA safely and effectively. See full prescribing information