Marekani - Kiingereza - 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)].

Marekani - Kiingereza - 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

Marekani - Kiingereza - 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

Marekani - Kiingereza - 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

Kanada - Kiingereza - Health Canada

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

Marekani - Kiingereza - 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)].

Kanada - Kiingereza - Health Canada

sivem pharmaceuticals ulc - tenofovir disoproxil fumarate - tablet - 300mg - tenofovir disoproxil fumarate 300mg

Marekani - Kiingereza - 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

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - efavirenz/emtricitabine/tenofovir disoproxil zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil zentiva prior to initiation of their first antiretroviral treatment regimen., the demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavir

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

alphapharm pty ltd - emtricitabine,tenofovir disoproxil maleate -