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

cipla australia pty ltd - emtricitabine, quantity: 200 mg; tenofovir disoproxil fumarate, quantity: 300 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; pregelatinised starch; croscarmellose sodium; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake - treatment of hiv-1 infection: cipla tenofovir + emtricitabine 300/200 is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents. pre-exposure prophylaxis: cipla tenofovir + emtricitabine 300/200 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.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

mylan laboratories limited, india - emtricitabine, tenofovir disoproxil , efavirenz - tablets - tenofovir disoproxil fumarate / efavirenz/ emtricitabine 300 mg/600 mg and 200 mg

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

remedyrepack inc. - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - viread is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. viread is indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 2 years of age and older weighing at least 10 kg . none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to viread 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 increase in the overall risk of major birth defects with first trimester exposure for tenofovir disoproxil fumarate (tdf) (2.1%) 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 rat

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

gilead sciences, inc - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate 300 mg - viread™ is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 12 years of age and older. viread is indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to viread during pregnancy. healthcare providers are encouraged to register patients on the worldwide antiretroviral pregnancy register (apr) at www.apregistry.com/. risk summary available data from the apr show no increase in the overall risk of major birth defects with first trimester exposure for tenofovir disoproxil fumarate (tdf) (2.1%) 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 for individual drugs is

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

quinn pharmaceuticals - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 2 years of age and older weighing at least 35 kg. tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 2 years of age and older weighing at least 35 kg. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to tenofovir disoproxil fumarate 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 increase in the overall risk of major birth defects with first trimester exposure for tenofovir disoproxil fumarate (tdf) (2.1%) compared with the background rate for major birth defects of 2.7% in a u.s. reference population of the metropoli

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

chartwell rx, llc. - 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 human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 2 years of age and older weighing at least 10 kg. none. p r eg n an cy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to tenofovir disoproxil fumarate 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 increase in the overall risk of major birth defects with first trimester exposure for tenofovir disoproxil fumarate (tdf) (2.1%) compared with the background rate for major birth defects of 2.7% in a u.s. refe

Kenya - English - Pharmacy and Poisons Board

mylan laboratories limited c/o surgilinks ltd mylan laboratories limited r&d centre plot no. - tenofovir disoproxil fumarate emtricitabine… - film-coated tablet - tenofovir disoproxil fumarate 300mg emtricitabine… - antivirals for systemic use: combinations of

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

sandoz pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; triacetin - tenofovir sandoz 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 sandoz is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,tenofovir sandoz 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)

avpak - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 12 years of age and older pediatric use information is approved for gilead sciences, inc.'s viread® (tenofovir disoproxil fumarate) tablets. however, due to gilead sciences, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to tenofovir disoproxil fumarate 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 increase in the overall risk of major birth defects with first trimester exposure for tenofovir disoproxil fumarate (tdf) (2.1%) 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 for individual drugs is not reported in the apr. in the u.s. general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15–20%. published studies in hbv-infected subjects do not report an increased risk of adverse pregnancy- related outcomes with the use of tenofovir disoproxil fumarate during the third trimester of pregnancy (see data). in animal reproduction studies, no adverse developmental effects were observed when tdf was administered at doses/exposures ≥ 14 (tdf) and 2.7 (tenofovir) times those of the recommended daily dose of tenofovir disoproxil fumarate (see data). data human data based on prospective reports from the apr exposures to tdf-containing regimens during pregnancy resulting in live births (including 3,342 exposed in the first trimester and 1,475 exposed in the second/third trimester), there was no increase in overall major birth defects with tdf compared with the background birth defect rate of 2.7% in a u.s. reference population of the macdp. the prevalence of major birth defects in live births was 2.3% (95% ci: 1.8% to 2.8%) with first trimester exposure to tdf-containing regimens, and 2.1% (95% ci: 1.4% to 3.0%) with the second/third trimester exposure to tdf-containing regimens. prospective reports from the apr of overall major birth defects in pregnancies exposed to tdf 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. limitations of using an external comparator include differences in methodology and populations, as well as confounding due to the underlying disease. in published data from three controlled clinical trials, a total of 327 pregnant women with chronic hbv infection were administered tenofovir disoproxil fumarate from 28 to 32 weeks gestation through 1 to 2 months postpartum and followed for up to 12 months after delivery. there were no new safety findings in pregnant women compared with the known safety profile of tenofovir disoproxil fumarate in hbv-infected adults. an increased risk of adverse pregnancy-related outcomes was not observed; 2 stillbirths were identified, and there was 1 major birth defect (talipes) and 1 occurrence of multiple congenital abnormalities (not further specified) in tenofovir disoproxil fumarate -exposed infants. infants were followed for up to 12 months after delivery; there were no clinically relevant drug-related safety findings in infants exposed to tenofovir disoproxil fumarate during late gestation. animal data tdf was administered orally to pregnant rats (at 0, 50, 150, or 450 mg/kg/day) and rabbits (at 0, 30, 100, or 300 mg/kg/day) through organogenesis (on gestation days 7 through 17, and 6 through 18, respectively). no significant toxicological effects were observed in embryo-fetal toxicity studies performed with tdf in rats at doses up to 14 times the human dose based on body surface area comparisons and in rabbits at doses up to 19 times the human dose based on body surface area comparisons. in a pre/postnatal development study in rats, tdf was administered orally through lactation at doses up to 600 mg/kg/day; no adverse effects were observed in the offspring at tenofovir exposures of approximately 2.7 times higher than human exposures at the recommended daily dose of tenofovir disoproxil fumarate risk summary based on published data, tenofovir has been shown to be present in human breast milk (see data). it is not known if tenofovir affects milk production or has effects on the breastfed child. treatment of hiv-1 infection: 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. because of the potential for: (1) hiv transmission (in hiv-negative infants); (2) developing viral resistance (in hiv-positive infants); and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are taking tenofovir disoproxil fumarate for the treatment of hiv-1. treatment of hbv infection: the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tenofovir disoproxil fumarate and any potential adverse effects on the breastfed infant from tenofovir disoproxil fumarate or from the underlying maternal condition. data in a study of 50 hiv-uninfected, breastfeeding women on a tenofovir-containing regimen initiated between 1 and 24 weeks postpartum (median 13 weeks), tenofovir was undetectable in the plasma of most infants after 7 days of treatment in mothers. there were no serious adverse events in mothers or infants. pediatric patients 2 years and older with hiv-1 infection the safety and effectiveness of tenofovir disoproxil fumarate in pediatric patients 2 years to less than 18 years of age is supported by data from two randomized trials. trial 352 was a randomized controlled trial in 92 hiv-1 treatment experienced subjects 2 years to less than 12 years of age who were virologically suppressed on a stavudine- or zidovudine-containing regimen and were randomized to either switch to a tenofovir disoproxil fumarate -containing regimen (n=44) or stay on their original regimen (n=48) for 48 weeks. at week 48, 89% of subjects in the tenofovir disoproxil fumarate treatment group and 90% of subjects in the d4t or azt treatment group had hiv-1 rna concentrations <400 copies/ml. trial 321 was a placebo-controlled trial in 87 hiv-1 treatment experienced subjects 12 years to less than 18 years of age who were treated with tenofovir disoproxil fumarate (n=45) or placebo (n=42) in combination with an optimized background regimen for 48 weeks. overall, the trial failed to show a difference in virologic response between the tenofovir disoproxil fumarate and placebo 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 and obr [see adverse reactions (6.1) and clinical studies (14.3)]. although changes in hiv-1 rna in these highly treatment-experienced subjects in trial 321 were less than anticipated, the pharmacokinetic profile of tenofovir in patients 2 years 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)] . the effects of tenofovir disoproxil fumarate -associated changes in bmd and biochemical markers on long-term bone health and future fracture risk in hiv-1 pediatric patients 2 years and older are unknown. the long- term effect of lower spine and total body bmd on skeletal growth in pediatric patients 2 years and older, and in particular, the effects of long-duration exposure in younger children is unknown [see warnings and precautions (5.5), adverse reactions (6.1)] . safety and effectiveness of tenofovir disoproxil fumarate in pediatric patients younger than 2 years of age and weighing less than 10 kg with hiv-1 infection have not been established. pediatric patients 12 years of age and older with chronic hepatitis b the safety and effectiveness of tenofovir disoproxil fumarate in pediatric patients 12 years to less than 18 years of age is supported by data from one randomized trials (trial 115) in which tenofovir disoproxil fumarate was administered to hbv-infected treatment-experienced subjects . in trial 115, 106 hbeag negative (9%) and positive (91%) subjects 12 years to less than 18 years of age with chronic hbv infection were randomized to receive blinded treatment with tenofovir disoproxil fumarate or placebo for 72 weeks. at week 72, 88% of subjects in the tenofovir disoproxil fumarate group and 0% of subjects in the placebo group had hbv dna <400 copies/ml (69 iu/ml). the effects of tenofovir disoproxil fumarate -associated changes in bmd and biochemical markers on long-term bone health and future fracture risk in chronic hbv-infected pediatric patients 2 years and older are unknown. the long-term effect of lower spine and total body bmd on skeletal growth in pediatric patients 2 years and older, and in particular, the effects of long-duration exposure in younger children is unknown [see warnings and precautions (5.5), adverse reactions (6.1)] . safety and effectiveness of tenofovir disoproxil fumarate in chronic hbv-infected pediatric patients younger than 2 years of age and weighing less than 10 kg have not been established. pediatric use information is approved for gilead sciences, inc.'s viread® (tenofovir disoproxil fumarate) tablets. however, due to gilead sciences, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information clinical trials of tenofovir disoproxil fumarate 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. the dosing interval for tenofovir disoproxil fumarate should be modified in adult patients with estimated creatinine clearance below 50 ml/min or in patients with end stage renal disease requiring dialysis [see dosage and administration (2.4) and clinical pharmacology (12.3)].