European Union - English - EMA (European Medicines Agency)

zentiva k.s. - emtricitabine, tenofovir disoproxil phosphate - hiv infections - antivirals for systemic use - treatment of hiv-1 infectionemtricitabine/tenofovir disoproxil zentiva is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults.emtricitabine/tenofovir disoproxil zentiva is also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents.pre-exposure prophylaxis (prep)emtricitabine/tenofovir disoproxil zentiva is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults and adolescents at high risk.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - treatment of hiv-1 infectionemtricitabine/tenofovir disoproxil krka is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults.emtricitabine/tenofovir disoproxil krka is also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years (see section 5.1pre-exposure prophylaxis (prep)emtricitabine/tenofovir disoproxil krka is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults at high risk.

Australia - English - 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).

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

lupin australia pty limited - tenofovir disoproxil phosphate, quantity: 291 mg - tablet, film coated - excipient ingredients: stearic acid; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake - tenofovir lapl in combination with other antiretroviral agents is indicated for the treatment of hiv infected adults and paediatric patients 12 years of age and older. tenofovir lapl is indicated for the treatment of chronic hepatitis b in adults (see clinical trials). tenofovir lapl 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.

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

alphapharm pty ltd - emtricitabine, quantity: 200 mg; efavirenz, quantity: 600 mg; tenofovir disoproxil maleate, quantity: 300 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium metabisulfite; hyprolose; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; ferric oxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - tenofovir disoproxil/ emtricitabine/ efavirenz mylan 300/200/600 is indicated for the treatment of hiv infected adults over the age of 18 years.,this indication is based on analyses of plasma hiv-1 rna levels and cd4 cell counts in controlled studies of viread, emtriva and stocrin in treatment-na?ve and treatment experienced adults.

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

avkare - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 2 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hiv-1 infection: - tenofovir disoproxil fumarate tablets should not be used in combination with atripla ® , biktarvy ® , complera ® , descovy ® , genvoya ® , odefsey ® , stribild ® , truvada ® , or vemlidy ® [see warnings and precautions (5.4)]. tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis b in adults and pediatric patients 12 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of chronic hepatitis b infection: - the indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced with documented resistance to lamivudine. subjects were adults with hbeag-positive and hbeag-negative chronic hepatitis b with compensated liver disease [see clinical studies (14.2)]. - tenofovir disoproxil fumarate tablets were evaluated in a limited number of subjects with chronic hepatitis b and decompensated liver disease [see adverse reactions (6.1),clinical studies (14.2)]. - the numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy [see microbiology (12.4),clinical studies (14.2)]. none. 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, tenofovir disoproxil fumarate tablets should be used during pregnancy only if clearly needed. antiretroviral pregnancy registry: to monitor fetal outcomes of pregnant women exposed to tenofovir disoproxil fumarate tablets, an antiretroviral pregnancy registry has been established. healthcare providers are encouraged to register patients by calling 1-800-258-4263. risk summary animal data reproduction studies have been performed in rats and rabbits at doses up to 14 and 19 times the human dose based on body surface area comparisons and revealed no evidence of impaired fertility or harm to the fetus due to tenofovir. nursing mothers: the centers for disease control and prevention recommend that hiv-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv-1. samples of breast milk obtained from five hiv-1 infected mothers in the first post-partum week show that tenofovir is secreted in human milk. the impact of this exposure in breastfed infants is unknown. because of both the potential for hiv-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving tenofovir disoproxil fumarate tablets. pediatric patients 2 years of age and older with hiv-1 infection the safety of tenofovir disoproxil fumarate tablets in pediatric patients aged 2 to less than 18 years is supported by data from two randomized trials in which tenofovir disoproxil fumarate tablets were administered to hiv-1 infected treatment-experienced subjects. in addition, the pharmacokinetic profile of tenofovir in patients 2 to less than 18 years of age at the recommended doses was similar to that found to be safe and effective in adult clinical trials [see clinical pharmacology (12.3)]. in study 352, 92 treatment-experienced subjects 2 to less than 12 years of age with stable, virologic suppression on stavudine- or zidovudine-containing regimen were randomized to either replace stavudine or zidovudine with tenofovir disoproxil fumarate tablets (n=44) or continue their original regimen (n=48) for 48 weeks. five additional subjects over the age of 12 were enrolled and randomized (tenofovir disoproxil fumarate tablets n=4, original regimen n=1) but are not included in the efficacy analysis. after 48 weeks, all eligible subjects were allowed to continue in the study receiving open-label tenofovir disoproxil fumarate tablets. at week 48, 89% of subjects in the tenofovir disoproxil fumarate treatment group and 90% of subjects in the stavudine or zidovudine treatment group had hiv-1 rna concentrations less than 400 copies/ml. during the 48 week randomized phase of the study, 1 subject in the tenofovir disoproxil fumarate tablets group discontinued the study prematurely because of virologic failure/lack of efficacy and 3 subjects (2 subjects in the tenofovir disoproxil fumarate tablets group and 1 subject in the stavudine or zidovudine group) discontinued for other reasons. in study 321, 87 treatment-experienced subjects 12 to less than 18 years of age were treated with tenofovir disoproxil fumarate tablets (n=45) or placebo (n=42) in combination with an optimized background regimen (obr) for 48 weeks. the mean baseline cd4 cell count was 374 cells/mm 3 and the mean baseline plasma hiv-1 rna was 4.6 log 10 copies/ml. at baseline, 90% of subjects harbored nrti resistance-associated substitutions in their hiv-1 isolates. overall, the trial failed to show a difference in virologic response between the tenofovir disoproxil fumarate tablets and placebo treatment groups. subgroup analyses suggest the lack of difference in virologic response may be attributable to imbalances between treatment arms in baseline viral susceptibility to tenofovir disoproxil fumarate tablets and obr. although changes in hiv-1 rna in these highly treatment-experienced subjects were less than anticipated, the comparability of the pharmacokinetic and safety data to that observed in adults supports the use of tenofovir disoproxil fumarate tablets in pediatric patients 12 years of age and older who weigh greater than or equal to 35 kg and whose hiv-1 isolate is expected to be sensitive to tenofovir disoproxil fumarate tablets. [see warnings and precautions (5.6), adverse reactions (6.1), and clinical pharmacology (12.3)]. safety and effectiveness of tenofovir disoproxil fumarate tablets in pediatric patients younger than 2 years of age with hiv-1 infection have not been established. pediatric patients 12 years of age and older with chronic hepatitis b in study 115, 106 hbeag negative (9%) and positive (91%) subjects aged 12 to less than 18 years with chronic hbv infection were randomized to receive blinded treatment with tenofovir disoproxil fumarate tablets 300 mg (n=52) or placebo (n=54) for 72 weeks. at study entry, the mean hbv dna was 8.1 log10 copies/ml and mean alt was 101 u/l. of 52 subjects treated with tenofovir disoproxil fumarate tablets, 20 subjects were nucleos(t)ide-naïve and 32 subjects were nucleos(t)ide-experienced. thirty-one of the 32 nucleos(t)ide-experienced subjects had prior lamivudine experience. at week 72, 88% (46/52) of subjects in the tenofovir disoproxil fumarate tablets group and 0% (0/54) of subjects in the placebo group had hbv dna <400 copies/ml (69 iu/ml). among subjects with abnormal alt at baseline, 74% (26/35) of subjects receiving tenofovir disoproxil fumarate tablets had normalized alt at week 72 compared to 31% (13/42) in the placebo group. one tenofovir disoproxil fumarate-treated subject experienced sustained hbsag-loss and seroconversion to anti-hbs during the first 72 weeks of study participation. safety and effectiveness of tenofovir disoproxil fumarate tablets in pediatric patients younger than 12 years of age or less than 35 kg with chronic hepatitis b have not been established. clinical trials of tenofovir disoproxil fumarate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. it is recommended that the dosing interval for tenofovir disoproxil fumarate tablets be modified in patients with estimated creatinine clearance below 50 ml/min or in patients with esrd who require dialysis [see dosage and administration (2.3),clinical pharmacology (12.3)].

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

doh central pharmacy - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 2 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate for the treatment of hiv-1 infection: - tenofovir disoproxil fumarate should not be used in combination with atripla®, complera® , descovy® , genvoya® , odefsey® , stribild® , truvad® or vemlidy® [see warnings and precautions (5.4)]. tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b in adults and pediatric patients 12 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate for the treatment of hbv infection: - the indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced with documented res

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

northstar rxllc - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 2 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hiv-1 infection: • tenofovir disoproxil fumarate tablets should not be used in combination with atripla® , biktarvy® , complera® , descovy® , genvoya® , odefsey® , stribild® , truvada® , or vemlidy® [see warnings and precautions (5.4)]. tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis b in adults and pediatric patients 12 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of chronic hepatitis b infection: • the indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects

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

remedyrepack inc. - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 2 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of hiv-1 infection: • tenofovir disoproxil fumarate tablets should not be used in combination with atripla ® , biktarvy ® , complera ® , descovy ® , genvoya ® , odefsey ® , stribild ® , truvada ® , or vemlidy ® [see warnings and precautions (5.4)]. tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis b in adults and pediatric patients 12 years of age and older. the following points should be considered when initiating therapy with tenofovir disoproxil fumarate tab

Canada - English - Health Canada

sanis health inc - tenofovir disoproxil fumarate - tablet - 300mg - tenofovir disoproxil fumarate 300mg - nucleoside and nucleotide reverse transcriptase inhibitors