Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: hyprolose; lactose monohydrate; microcrystalline cellulose; silicon dioxide; croscarmellose sodium; magnesium stearate; sodium lauryl sulfate; titanium dioxide; indigo carmine aluminium lake; iron oxide yellow; purified talc; polyvinyl alcohol; macrogol 3350 - stribild is indicated as a single tablet regimen for the treatment of hiv infection in treatment-na?ve adults. stribild is also indicated in certain virologically suppressed (hiv1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of stribild (tenofovir df, emtricitabine or elvitegravir). stribild is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - elvitegravir (unii: 4gdq854u53) (elvitegravir - unii:4gdq854u53), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir alafenamide fumarate (unii: fwf6q91tzo) (tenofovir anhydrous - unii:w4hfe001u5) - elvitegravir 150 mg - 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)]. coadministration of genvoya is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. these drugs and other contraindicated drugs (which may lead to reduced efficacy of genvoya and possible resistance) are listed below [see drug interactions (7.5) and clinical pharmacology (12.3)]

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - tenofovir alafenamide fumarate, quantity: 11.2 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; hyprolose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; microcrystalline cellulose; silicon dioxide; titanium dioxide; indigo carmine aluminium lake; iron oxide yellow; purified talc; polyvinyl alcohol; macrogol 3350 - genvoya is indicated as a single tablet regimen for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment?na?ve; or virologically suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see 5.1 pharmacodynamic properties, clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of genvoya. genvoya is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - elvitegravir (unii: 4gdq854u53) (elvitegravir - unii:4gdq854u53), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - elvitegravir 150 mg - stribild ® is indicated as a complete regimen for the treatment of hiv-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 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/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 stribild [see clinical studies (14)] . coadministration of stribild is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. these drugs and other contraindicated drugs (which may lead to reduced efficacy of stribild and possible resistance) are listed below coadministration of stribild is contraindicated with drugs that are highly dependent on cyp3a for clearance and for whi

United States - English - NLM (National Library of Medicine)

a-s medication solutions - elvitegravir (unii: 4gdq854u53) (elvitegravir - unii:4gdq854u53), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - elvitegravir 150 mg - stribild® is indicated as a complete regimen for the treatment of hiv-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 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/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 stribild [see clinical studies (14)] . coadministration of stribild is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. these drugs and other contraindicated drugs (which may lead to reduced efficacy of stribild and possible resistance) are listed below [see drug interactions (7.5) and clinical pharmacology (12.3)]. - alpha 1-adrenoreceptor antagonist: alfuzosin - anticonv

United States - English - NLM (National Library of Medicine)

a-s medication solutions - elvitegravir (unii: 4gdq854u53) (elvitegravir - unii:4gdq854u53), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir alafenamide fumarate (unii: fwf6q91tzo) (tenofovir anhydrous - unii:w4hfe001u5) - elvitegravir 150 mg - 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)]. coadministration of genvoya is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. these drugs and other contraindicated drugs (which may lead to reduced efficacy of genvoya and possible resistance) are listed in table 1 [see drug interactions (7.5) and clinical pharmacology (12.3)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors

United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - elvitegravir (unii: 4gdq854u53) (elvitegravir - unii:4gdq854u53), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir alafenamide fumarate (unii: fwf6q91tzo) (tenofovir anhydrous - unii:w4hfe001u5) - elvitegravir 150 mg - 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)]. coadministration of genvoya is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. these drugs and other contraindicated drugs (which may lead to reduced efficacy of genvoya and possible resistance) are listed below [see drug interactions (7.5) and clinical pharmacology (12.3)] . - alpha 1-adrenoreceptor antagonist: alfuzosin - anticonvulsants: carbamazepine, phen

United States - English - NLM (National Library of Medicine)

state of florida doh central pharmacy - elvitegravir (unii: 4gdq854u53) (elvitegravir - unii:4gdq854u53), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - elvitegravir 150 mg - stribild® is indicated as a complete regimen for the treatment of hiv-1 infection in adults who are antiretroviral treatment-naïve. coadministration of stribild is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. these drugs and other contraindicated drugs (which may lead to reduced efficacy of stribild and possible resistance) are listed in table 1 [see drug interactions (7.5), clinical pharmacology (12.3)]. pregnancy category b there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, stribild should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. antiretroviral pregnancy registry : to monitor fetal outcomes of pregnant women exposed to stribild, an antiretroviral pregnancy registry has been established. healthcare providers are encourag

United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - elvitegravir (unii: 4gdq854u53) (elvitegravir - unii:4gdq854u53), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - elvitegravir 150 mg - stribild® is indicated as a complete regimen for the treatment of hiv-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 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/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 stribild [see clinical studies (14)] . coadministration of stribild is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. these drugs and other contraindicated drugs (which may lead to reduced efficacy of stribild and possible resistance) are listed below [see drug interactions (7.5) and clinical pharmacology (12.3)]. - alpha 1-adrenoreceptor antagonist: alfuzosin - anticonv

United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - elvitegravir (unii: 4gdq854u53) (elvitegravir - unii:4gdq854u53), cobicistat (unii: lw2e03m5pg) (cobicistat - unii:lw2e03m5pg), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - elvitegravir 150 mg - stribild™ is indicated as a complete regimen for the treatment of hiv-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 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/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 stribild [see clinical studies (14)] . coadministration of stribild is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. these drugs and other contraindicated drugs (which may lead to reduced efficacy of stribild and possible resistance) are listed below [see drug interactions (7.5) and clinical pharmacology (12.3)]. - alpha 1-adrenoreceptor antagonist: alfuzosin - anticonvu