European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide - hiv infections - antivirals for systemic use, - genvoya is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (hiv 1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.,

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

janssen-cilag pty ltd - tenofovir alafenamide, quantity: 10 mg; darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg; emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; silicon dioxide; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - symtuza is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). genotypic testing should guide the use of symtuza (see section 4.2 dose and method of administration, section 4.4 special warnings and precautions for use and section 5.1 pharmacodynamic properties).

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; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - 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.

Israel - English - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir alafenamide - film coated tablets - tenofovir alafenamide 10 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat - gendevra is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• in adults and adolescents aged from 12 years and with body weight at least 35 kg• in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

Israel - English - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir alafenamide - film coated tablets - tenofovir alafenamide 10 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat - gendevra is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• in adults and adolescents aged from 12 years and with body weight at least 35 kg• in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

Israel - English - Ministry of Health

gilead sciences israel ltd - cobicistate; elvitegravir; emtricitabine; tenofovir alafenamide - film coated tablets - tenofovir alafenamide 10 mg; emtricitabine 200 mg; cobicistate 150 mg; elvitegravir 150 mg - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat - gendevra is indicated for the treatment of human immunodeficiency virus 1 (hiv 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• in adults and adolescents aged from 12 years and with body weight at least 35 kg• in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019addition of new info to posology section: precaution in pregnant women

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

gilead sciences, inc. - tenofovir alafenamide fumarate (unii: fwf6q91tzo) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir alafenamide 25 mg - vemlidy is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults and pediatric patients 12 years of age and older with compensated liver disease [see clinical studies (14)] . none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to vemlidy during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no statistically significant difference in the overall risk of birth defects for tenofovir alafenamide (taf) compared with the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp) (see data). the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15% to 20%. in animal studies, no adverse developmental effects were observed when tenofovir alafenamide was administered during the period of organogenesis at exposure equal to or 51 times (rats and rabbits, respectively) the tenofovir alafenamide exposure at the recommended daily dose of vemlidy (see data). no adverse effects were observed in the offspring when tdf was administered through lactation at tenofovir exposures of approximately 12 times the exposure at the recommended daily dosage of vemlidy. data human data based on prospective reports to the apr of over 800 exposures to taf-containing regimens during pregnancy resulting in live births (including over 650 exposed in the first trimester and over 150 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.5% (95% ci: 2.3% to 5.2%) and 3.3% (95% ci: 1.1% to 7.5%) following first and second/third trimester exposure, respectively, to taf-containing regimens. methodologic limitations of the apr include the use of macdp as the external comparator group. the macdp population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at less than 20 weeks gestation. animal data embryonic fetal development studies performed in rats and rabbits revealed no evidence of impaired fertility or harm to the fetus. the embryo-fetal noaels (no observed adverse effect level) in rats and rabbits occurred at tenofovir alafenamide exposures similar to and 51 times higher than, respectively, the exposure in humans at the recommended daily dose. tenofovir alafenamide is rapidly converted to tenofovir; the observed tenofovir exposure in rats and rabbits were 54 (rats) and 85 (rabbits) times higher than human tenofovir exposures at the recommended daily dose. tenofovir alafenamide was administered orally to pregnant rats (25, 100, or 250 mg/kg/day) and rabbits (10, 30, or 100 mg/kg/day) through organogenesis (on gestation days 6 through 17, and 7 through 20, respectively). no adverse embryo-fetal effects were observed in rats and rabbits at tenofovir alafenamide exposures approximately similar to (rats) and 51 (rabbits) times higher than the exposure in humans at the recommended daily dose of vemlidy. tenofovir alafenamide is rapidly converted to tenofovir; the observed tenofovir exposures in rats and rabbits were 54 (rats) and 85 (rabbits) times higher than human tenofovir exposures at the recommended daily dose. since tenofovir alafenamide is rapidly converted to tenofovir and a lower tenofovir exposure in rats and mice was observed after tenofovir alafenamide administration compared to tdf, another prodrug for tenofovir administration, a pre/postnatal development study in rats was conducted only with tdf. doses up to 600 mg/kg/day were administered through lactation; no adverse effects were observed in the offspring on gestation day 7 [and lactation day 20] at tenofovir exposures of approximately 12 [18] times higher than the exposures in humans at the recommended daily dose of vemlidy. risk summary it is not known whether vemlidy and its metabolites are present in human breast milk, affect human milk production, or have effects on the breastfed infant. tenofovir has been shown to be present in the milk of lactating rats and rhesus monkeys after administration of tdf (see data). it is not known if tenofovir alafenamide can be present in animal milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vemlidy and any potential adverse effects on the breastfed infant from vemlidy or from the underlying maternal condition. data studies in rats and monkeys have demonstrated that tenofovir is secreted in milk. tenofovir was excreted into the milk of lactating rats following oral administration of tdf (up to 600 mg/kg/day) at up to approximately 24% of the median plasma concentration in the highest dosed animals at lactation day 11 (see data 8.1). tenofovir was excreted into the milk of lactating monkeys following a single subcutaneous (30 mg/kg) dose of tenofovir at concentrations up to approximately 4% of plasma concentration, resulting in exposure (auc) of approximately 20% of plasma exposure. the pharmacokinetics, safety, and effectiveness of vemlidy for the treatment of chronic hbv infection have been established in pediatric patients between the ages of 12 to less than 18 years (n=47) in trial 1092 for 24 weeks. no clinically meaningful differences in pharmacokinetics or safety were observed in comparison to those observed in adults [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.5)]. safety and effectiveness of vemlidy has not been established in pediatric patients with chronic hbv infection who are less than 12 years of age. in clinical trials, vemlidy was administered to 89 subjects aged 65 and over. no clinically significant differences in safety or efficacy have been observed between elderly subjects and subjects between 18 and less than 65 years of age. no dosage adjustment of vemlidy is required in patients with mild, moderate, or severe renal impairment, or in patients with esrd (estimated creatinine clearance below 15 ml per minute) who are receiving chronic hemodialysis. on days of hemodialysis, administer vemlidy after completion of hemodialysis treatment [see dosage and administration (2.3)]. the safety and efficacy of vemlidy in hbv-infected adult subjects with moderate to severe renal impairment (estimated creatinine clearance between 15 and 59 ml per minute by cockcroft-gault method) and esrd (estimated creatinine clearance of less than 15 ml per minute by cockcroft-gault method) receiving chronic hemodialysis were evaluated in 78 and 15 subjects, respectively, in an open-label trial (trial 4035, part a). overall, 98% of subjects achieved hbv dna <20 iu/ml at week 24 (cohort 1, 97%; cohort 2, 100%) and the safety of vemlidy was similar to that observed in clinical trials of vemlidy in subjects with compensated liver disease but without renal impairment [see adverse reactions (6.1) and clinical studies (14.4)]. the safety and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150/150/200/10 mg was previously evaluated in 55 virologically suppressed hiv-1 infected subjects with esrd receiving chronic hemodialysis in an open-label trial (trial 1825). tenofovir alafenamide exposures are similar when comparing tenofovir alafenamide 25 mg and tenofovir alafenamide 10 mg as part of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. among subjects with esrd receiving chronic hemodialysis and administered tenofovir alafenamide, higher exposures of tenofovir were observed in hbv-infected subjects (trial 4035 part a) compared to hiv-infected subjects (trial 1825). the clinical significance of these higher exposures is not established [see clinical pharmacology (12.3)] . vemlidy is not recommended in patients with esrd (estimated creatinine clearance below 15 ml per minute by cockcroft-gault method) who are not receiving chronic hemodialysis as the safety of vemlidy has not been established in this population [see dosage and administration (2.3) and clinical pharmacology (12.3)]. no dosage adjustment of vemlidy is required in patients with mild hepatic impairment (child-pugh a). the safety and efficacy of vemlidy in patients with decompensated cirrhosis (child-pugh b or c) have not been established; therefore, vemlidy is not recommended in patients with decompensated (child-pugh b or c) hepatic impairment [see dosage and administration (2.4) and clinical pharmacology (12.3)] .

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate - hiv infections - antivirals for treatment of hiv infections, combinations, antivirals for systemic use - treatment of human immunodeficiency virus 1 (hiv 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with hiv 1 without known mutations associated with resistance to any of the three antiretroviral agents in stribild.

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

gilead sciences pty ltd - tenofovir alafenamide fumarate, quantity: 28.04 mg (equivalent: tenofovir alafenamide, qty 25 mg) - tablet - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - vemlidy is indicated for the treatment of chronic hepatitis b in adults.

European Union - English - EMA (European Medicines Agency)

gilead sciences ireland uc - elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide - hiv infections - antivirals for systemic use, - genvoya is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (hiv 1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.,