cobicistat 150 MG elvitegravir 150 MG emtricitabine 200 MG tenofovir alafenamide 10 MG Oral Tablet Genvoya
1 INDICATIONS AND USAGE GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of GENVOYA [see Clinical Studies (14) ]. GENVOYA is a four-drug combination of elvitegravir (EVG), an HIV-1 integrase strand transfer inhibitor (INSTI), cobicistat (COBI), a CYP3A inhibitor, and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of GENVOYA. ( 1 )
gilead sciences, inc.
OVAL GREEN GSI 510
GSI 510 OVAL GREEN
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16 HOW SUPPLIED/STORAGE AND HANDLING GENVOYA tablets are available in bottles containing 30 tablets with a silica gel desiccant, polyester coil, and child-resistant closure as follows: GENVOYA tablets each contain 150 mg of elvitegravir (EVG), 150 mg of cobicistat (COBI), 200 mg of emtricitabine (FTC), and 10 mg of tenofovir alafenamide (TAF). These tablets are green, capsule-shaped, film-coated, debossed with "GSI" on one side of the tablet and the number "510" on the other side (NDC 61958-1901-1). Store below 30 °C (86 °F). Keep container tightly closed. Dispense only in original container.
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