Malaysia - engelsk - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

synerrv sdn bhd - tenofovir disoproxil fumarate; emtricitabine; efavirenz -

Malaysia - engelsk - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

synerrv sdn bhd - tenofovir disoproxil fumarate; emtricitabine -

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

lupin australia pty limited - emtricitabine, quantity: 200 mg; tenofovir disoproxil phosphate, quantity: 291 mg - tablet, film coated - excipient ingredients: mannitol; purified water; colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; stearic acid; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake - treatment of hiv-1 infection tenofovir emt gh is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.,pre-exposure prophylaxis tenofovir emt gh is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in adults at high risk. this indication is based on clinical trials in men who have sex with men (msm) at high risk for hiv-1 infection and in heterosexual serodiscordant couples (see clinical studies).

Irland - engelsk - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - tenofovir disoproxil fumarate - film-coated tablet - 245 milligram(s) - tenofovir disoproxil

Malaysia - engelsk - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

synerrv sdn bhd - tenofovir disoproxil fumarate -

USA - engelsk - NLM (National Library of Medicine)

gilead sciences, inc. - bictegravir sodium (unii: 4l5mp1y7w7) (bictegravir - unii:8gb79loj07), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir alafenamide fumarate (unii: fwf6q91tzo) (tenofovir anhydrous - unii:w4hfe001u5) - bictegravir 50 mg - biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients weighing at least 14 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 with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. biktarvy is contraindicated to be co-administered with: - dofetilide due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events [see drug interactions (7.5)] . - rifampin due to decreased bic plasma concentrations, which may result in the loss of therapeutic effect and development of resistance to biktarvy [see drug interactions (7.5)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to biktarvy during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary there are insufficient human data on the use of biktarvy during pregnancy to inform a drug-associated risk of birth defects and miscarriage. dolutegravir, another integrase inhibitor, has been associated with neural tube defects (ntds) (see data) . discuss the benefit-risk of using biktarvy with individuals of childbearing potential, particularly if pregnancy is being planned. biktarvy use during pregnancy has been evaluated in a limited number of women reported to the apr; consequently, there are insufficient bic data from the apr to adequately assess the risk of major birth defects. reports of pregnant individuals treated with other drug products containing taf or ftc contribute to apr's overall risk assessment for these components. available data from the apr show no statistically significant difference in the overall risk of major birth defects for ftc or taf compared with the background rate for major birth defects of 2.7% in a 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 the clinically recognized pregnancies in the u.s. general population is 15–20%. in animal reproduction studies, no evidence of adverse developmental outcomes was observed with the components of biktarvy at exposures that were either not maternally toxic (rabbits) or greater than (rats and mice) those in humans at the recommended human dose (rhd) (see data ). during organogenesis, systemic exposures (auc) to bic were approximately 36 (rats) and 0.6 times (rabbits), to ftc were approximately 60 (mice) and 108 times (rabbits), and to taf were approximately 2 (rats) and 78 times (rabbits) the exposure at the rhd of biktarvy. in rat pre/postnatal development studies, maternal systemic exposures (auc) were 30 times (bic), 60 times (ftc), and 19 times (tdf) the exposures of each component in humans at the rhd. data human data prospective reports from the apr of overall major birth defects in pregnancies exposed to the components of biktarvy are compared with a u.s. background major birth defect rate. methodological 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. bictegravir (bic): data from an observational study in botswana showed that dolutegravir, another integrase inhibitor, was associated with increased risk of neural tube defects when administered at the time of conception and in early pregnancy. data available to date from other sources including the apr, clinical trials, and postmarketing data are insufficient to address this risk with bic. there are an insufficient number of reports to the apr to adequately assess the risk of major birth defects associated with bic exposure. the apr has received prospective reports of 3 birth defects among 100 (3.0%) first trimester exposures to bic-containing regimens during pregnancy resulting in live births. no birth defects were reported among 40 exposures during the second/third trimester. emtricitabine (ftc): based on prospective reports to the apr of over 5,400 exposures to ftc-containing regimens during pregnancy resulting in live births (including over 3,900 exposed in the first trimester and over 1,500 exposed in the second/third trimester), the prevalence of birth defects in live births was 2.6% (95% ci: 2.2% to 3.2%) and 2.7% (95% ci: 1.9% to 3.7%) following first and second/third trimester exposure, respectively, to ftc-containing regimens. tenofovir alafenamide (taf): based on prospective reports to the apr of over 660 exposures to taf-containing regimens during pregnancy resulting in live births (including over 520 exposed in the first trimester and over 130 exposed in the second/third trimester), the prevalence of birth defects in live births was 4.2% (95% ci: 2.6% to 6.3%) and 3.0% (95% ci: 0.8% to 7.5%) following first and second/third trimester exposure, respectively, to taf-containing regimens. animal data bictegravir: bic was administered orally to pregnant rats (5, 30, or 300 mg/kg/day) and rabbits (100, 300, or 1000 mg/kg/day) on gestation days 7 through 17, and 7 through 19, respectively. no adverse embryo-fetal effects were observed in rats and rabbits at bic exposures (auc) of up to approximately 36 (rats) and 0.6 (rabbits) times the exposure in humans at the rhd of biktarvy. spontaneous abortion, increased clinical signs [fecal changes, thin body, and cold-to-touch], and decreased body weight were observed at a maternally toxic dose in rabbits (1000 mg/kg/day; approximately 1.4 times higher than human exposure at the rhd). in a pre/postnatal development study, bic was administered orally to pregnant rats (up to 300 mg/kg/day) from gestation days 6 to lactation/post-partum day 24. no significant adverse effects were observed in the offspring exposed daily from before birth (in utero ) through lactation at maternal and pup exposures (auc) of approximately 30 and 11 times higher, respectively, than human exposures at the rhd. emtricitabine: ftc was administered orally to pregnant mice (250, 500, or 1000 mg/kg/day) and rabbits (100, 300, or 1000 mg/kg/day) through organogenesis (on gestation days 6 through 15, and 7 through 19, respectively). no significant toxicological effects were observed in embryo-fetal toxicity studies performed with emtricitabine in mice at exposures approximately 60 times higher and in rabbits at approximately 108 times higher than human exposures at the rhd. in a pre/postnatal development study with ftc, mice were administered doses up to 1000 mg/kg/day; no significant adverse effects directly related to drug were observed in the offspring exposed daily from before birth (in utero ) through sexual maturity at daily exposures (auc) of approximately 60 times higher than human exposures at the rhd. tenofovir alafenamide: taf 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 taf exposures of approximately 2 (rats) and 78 (rabbits) times higher than the exposure in humans at the recommended daily dose of biktarvy. taf is rapidly converted to tenofovir; the observed tenofovir exposure in rats and rabbits were 55 (rats) and 86 (rabbits) times higher than human tenofovir exposures at the rhd. since taf is rapidly converted to tenofovir and lower tenofovir exposures in rats and mice were observed after taf administration compared to tdf 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 [19] times higher than the exposures in humans at the rhd of biktarvy. risk summary it is not known whether biktarvy or all of the components of biktarvy are present in human breast milk, affects human milk production, or has effects on the breastfed infant. based on published data, ftc has been shown to be present in human breast milk. bic was detected in the plasma of nursing rat pups likely due to the presence of bic in milk, and tenofovir has been shown to be present in the milk of lactating rats and rhesus monkeys after administration of tdf (see data) . it is unknown if taf is present in animal milk. potential risks of breastfeeding include: (1) hiv-1 transmission to hiv-1 negative infants; (2) developing viral resistance in hiv-1 positive infants; and (3) adverse reactions in a breastfed infant similar to those seen in adults. data animal data bictegravir: bic was detected in the plasma of nursing rat pups in the pre/postnatal development study (post-natal day 10), likely due to the presence of bic in milk. tenofovir alafenamide: 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. 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 safety and effectiveness of biktarvy have been established as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in pediatric patients weighing at least 14 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 with no known or suspected resistance to bictegravir or tenofovir [see indications and usage (1), and dosage and administration (2.2, 2.3)] . use of biktarvy in pediatric patients weighing at least 14 kg is supported by the following: - trials in adults [see clinical studies (14.1)] - an open-label trial in three age-based cohorts of virologically-suppressed pediatric subjects [see clinical studies (14.4)] cohort 1: 12 to less than 18 years of age and weighing at least 35 kg receiving biktarvy through week 48 (n=50), cohort 2: 6 to less than 12 years of age and weighing at least 25 kg receiving biktarvy through week 24 (n=50), and cohort 3: at least 2 years of age and weighing at least 14 to less than 25 kg through week 24 (n=22). no pediatric subjects 2 years of age were enrolled; of the 6 pediatric subjects who were 3 years of age at enrollment, 3 subjects weighed between 14 to less than 15 kg. - cohort 1: 12 to less than 18 years of age and weighing at least 35 kg receiving biktarvy through week 48 (n=50), - cohort 2: 6 to less than 12 years of age and weighing at least 25 kg receiving biktarvy through week 24 (n=50), and - cohort 3: at least 2 years of age and weighing at least 14 to less than 25 kg through week 24 (n=22). no pediatric subjects 2 years of age were enrolled; of the 6 pediatric subjects who were 3 years of age at enrollment, 3 subjects weighed between 14 to less than 15 kg. the safety and efficacy of biktarvy in these pediatric subjects were similar to that in adults, and there was no clinically significant change in exposure for the components of biktarvy [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.4)] . safety and effectiveness of biktarvy in pediatric patients weighing less than 14 kg have not been established. clinical trials in virologically-suppressed subjects (trials 4449, 1844, and 1878) included 111 subjects aged 65 years and over who received biktarvy, including 86 patients from an open-label, single-arm trial of subjects aged 65 years and over who were switched from their previous antiretroviral regimen to biktarvy [see clinical studies (14.3) ]. of the total number of biktarvy-treated patients in these trials, 100 (90%) were 65 to 74 years of age, and 11 (10%) were 75 to 84 years of age. no overall differences in safety or effectiveness were observed between elderly subjects and adults between 18 and less than 65 years of age, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetics, safety, virologic and immunologic responses of ftc and taf (components of biktarvy) were evaluated in a single arm, open-label trial (trial 1825) in virologically-suppressed adults with esrd (estimated creatinine clearance of less than 15 ml/min) on chronic hemodialysis treated with ftc+taf in combination with elvitegravir and cobicistat as a fixed-dose combination tablet for 96 weeks (n=55). in an extension phase of trial 1825, 10 virologically-suppressed subjects switched to biktarvy and all remained virologically suppressed for 48 weeks [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.3)] . no dosage adjustment of biktarvy is recommended in patients with estimated creatinine clearance greater than or equal to 30 ml/min, or in virologically-suppressed adults (estimated creatinine clearance below 15 ml/min) who are receiving chronic hemodialysis. on days of hemodialysis, administer the daily dose of biktarvy after completion of hemodialysis treatment [see dosage and administration (2.2)] biktarvy is not recommended in patients with estimated creatinine clearance of below 30 ml/min, by cockcroft-gault, or patients with esrd (estimated creatinine clearance below 15 ml/min) who are not receiving chronic dialysis, or patients with no antiretroviral treatment history and esrd who are receiving chronic dialysis, as the safety and/or efficacy of biktarvy has not been established in these populations [see dosage and administration (2.4), warnings and precautions (5.4), and clinical pharmacology (12.3)]. no dosage adjustment of biktarvy is recommended in patients with mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment. biktarvy has not been studied in patients with severe hepatic impairment (child-pugh class c). therefore, biktarvy is not recommended for use in patients with severe hepatic impairment [see dosage and administration (2.4), and clinical pharmacology (12.3)] .

USA - engelsk - NLM (National Library of Medicine)

remedyrepack inc. - bictegravir sodium (unii: 4l5mp1y7w7) (bictegravir - unii:8gb79loj07), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir alafenamide fumarate (unii: fwf6q91tzo) (tenofovir anhydrous - unii:w4hfe001u5) - biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (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 with no history of treatment failure and no known substitutions associated with resistance to the individual components of biktarvy. biktarvy is contraindicated to be co-administered with: - dofetilide due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events [see drug interactions (7.5)] . - rifampin due to decreased bic plasma concentrations, which may result in the loss of therapeutic effect and development of resistance to biktarvy [see drug interactions (7.5)] .

USA - engelsk - NLM (National Library of Medicine)

remedyrepack inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir alafenamide fumarate (unii: fwf6q91tzo) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - descovy is indicated, in combination with other antiretroviral agents, for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 35 kg. descovy is indicated, in combination with other antiretroviral agents other than protease inhibitors that require a cyp3a inhibitor, for the treatment of hiv-1 infection in pediatric patients weighing at least 25 kg and less than 35 kg. descovy is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of hiv-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. individuals must have a negative hiv-1 test immediately prior to initiating descovy for hiv-1 prep [see dosage and administration (2.2) and warnings and precautions (5.2)]. limitations of use: the indication does not include use of descovy in individuals at risk of hiv-1 from receptive vaginal sex because effectiveness in this popul

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

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; indigo carmine; triacetin - viread in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults and paediatric patients 12 years of age and older.,viread is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,viread is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels or evidence of active inflammation. viread in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults. viread is indicated for the treatment of chronic hepatitis b in adults with evidence of active viral replication and active liver inflammation.

Canada - engelsk - Health Canada

jamp pharma corporation - tenofovir disoproxil fumarate; emtricitabine - tablet - 300mg; 200mg - tenofovir disoproxil fumarate 300mg; emtricitabine 200mg - nucleoside and nucleotide reverse transcriptase inhibitors