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)

teva pharmaceuticals usa, inc. - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg. - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets [see warnings and precautions (5.2)] . - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see drug interactions (7.3) and clinical pharmacology (12.3)]. antiretroviral pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in adults and adolescents exposed to efavirenz, emtricitabine and ten

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

remedyrepack inc. - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg. - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets [see warnings and precautions ( 5.2)] . - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see drug interactions ( 7.3) and clinical pharmacology ( 12.3)]. antiretroviral pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in adults and adolescents exposed to efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at (800) 258-4263. risk summary there are retrospective case reports of neural tube defects in infants whose mothers were exposed to efv-containing regimens in the first trimester of pregnancy. prospective pregnancy data from the apr are not sufficient to adequately assess this risk. although a causal relationship has not been established between exposure to efv in the first trimester and neural tube defects, similar malformations have been observed in studies conducted in monkeys at doses similar to the human dose (see data). in addition, fetal and embryonic toxicities occurred in rats at a dose 10 times less than the human exposure at the recommended clinical human dose (rhd) of efv. because of the potential risk of neural tube defects, efv is not recommended for use in the first trimester of pregnancy. avoid pregnancy while receiving efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets and for 12 weeks after discontinuation. advise pregnant patients of the potential risk to a fetus. available data from the apr show no increase in the overall risk of major birth defects for efv, ftc, or tdf 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 clinically recognized pregnancies in the u.s. general population is 15 to 20%. the background risk of major birth defects and miscarriage for the indicated population is unknown. the apr uses the macdp as the u.s. reference population for birth defects in the general population. the macdp evaluates mothers and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks’ gestation. in animal reproduction studies, no adverse developmental effects were observed when ftc and tdf were administered separately at doses/exposures ≥ 60 (ftc), ≥ 14 (tdf) and 2.7 (tenofovir) times those at the rhd of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets (see data). data human data efavirenz : there are retrospective postmarketing reports of findings consistent with neural tube defects, including meningomyelocele, all in infants of mothers exposed to efv-containing regimens in the first trimester. based on prospective reports to the apr of 1,217 exposures to efv-containing regimens during pregnancy resulting in live births (including over 1,023 live births exposed in the first trimester and 194 exposed in the second/third trimester), there was no increase in overall birth defects with efv compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of birth defects in live births was 2.3% (95% ci: 1.5% to 3.5%) with first trimester exposure to efv-containing regimens, and 1.5% (95% ci: 0.3% to 4.5%) with the second/third trimester exposure to efv-containing regimens. one of these prospectively reported defects with first-trimester exposure was a neural tube defect. a single case of anophthalmia with first-trimester exposure to efv has also been prospectively reported. this case also included severe oblique facial clefts and amniotic banding, which have a known association with anophthalmia. emtricitabine : based on prospective reports from the apr of 4,005 exposures to ftc containing regimens during pregnancy resulting in live births (including 2,785 exposed in the first trimester and 1,220 exposed in the second/third trimester), there was no increase in overall major birth defects with ftc compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of birth defects in live births was 2.4% (95% ci: 1.9% to 3.1%) with first trimester exposure to ftc-containing regimens and 2.3% (95% ci: 1.5% to 3.3%) with the second/third trimester exposure to ftc-containing regimens. tenofovir df : based on prospective reports from the apr of 5,105 exposures to tdf containing regimens during pregnancy resulting in live births (including 3,535 exposed in the first trimester and 1,570 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 the u.s. reference population of the macdp. the prevalence of birth defects in live births was 2.3% (95% ci: 1.8% to 2.9%) with first trimester exposure to tdf-containing regimens, and 2.2% (95% ci: 1.6% to 3.1%) with the second/third trimester exposure to tdf-containing regimens. animal data efavirenz : effects of efv on embryo-fetal development have been studied in three nonclinical species (cynomolgus monkeys, rats, and rabbits). in monkeys, efv 60 mg/kg/day was administered to pregnant females throughout pregnancy (gestation days 20 through 150). the maternal systemic drug exposures (auc) were 1.3 times the exposures at the rhd, with fetal umbilical venous drug concentrations approximately 0.7 times the maternal values. three fetuses of 20 fetuses/infants had one or more malformations; there were no malformed fetuses or infants from placebo-treated mothers. the malformations that occurred in these three monkey fetuses included anencephaly and unilateral anophthalmia in one fetus, microphthalmia in a second, and cleft palate in the third. there was no noael (no observable adverse effect level) established for this study because only one dosage was evaluated. in rats, efv was administered either during organogenesis (gestation days 7 to 18) or from gestation day 7 through lactation day 21 at 50, 100, or 200 mg/kg/day. administration of 200 mg/kg/day in rats was associated with an increase in the incidence of early resorptions, and doses 100 mg/kg/day and greater were associated with early neonatal mortality. the auc at the noael (50 mg/kg/day) in this rat study was 0.1 times that in humans at the rhd. drug concentrations in the milk on lactation day 10 were approximately 8 times higher than those in maternal plasma. in pregnant rabbits, efv was neither embryo lethal nor teratogenic when administered at doses of 25, 50, and 75 mg/kg/day over the period of organogenesis (gestation days 6 through 18). the auc at the noael (75 mg/kg/day) in rabbits was 0.4 times that in humans at the rhd. emtricitabine : ftc was administered orally to pregnant mice (at 0, 250, 500, or 1,000 mg/kg/day), and rabbits (at 0, 100, 300, or 1,000 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 ftc in mice at exposures (auc) approximately 60 times higher and in rabbits at approximately 120 times higher than human exposures at the rhd. in a pre/postnatal development study in mice, ftc was administered orally at 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 df : 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 rhd based on body surface area comparisons and in rabbits at doses up to 19 times the rhd 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 rhd. risk summary 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. based on limited published data, efv, ftc, and tenofovir have been shown to be present in human breast milk. it is not known if the components of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets affect milk production or have effects on the breastfed child. 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 receiving efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets. pregnancy testing perform pregnancy testing in adults and adolescents of childbearing potential before initiation of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets because of potential risk of neural tube defects [see use in specific populations ( 8.1)]. contraception advise adults and adolescents of childbearing potential to use effective contraception during treatment with efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets and for 12 weeks after discontinuing efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets due to the long half-life of efv, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets. hormonal methods that contain progesterone may have decreased effectiveness always use barrier contraception in combination with other methods of contraception [see drug interactions ( 7.1, 7.3)]. the effectiveness and safety of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets as a complete regimen for the treatment of hiv-1 infection was established in pediatric patients with body weight greater than or equal to 40 kg [see dosage and administration ( 2.2)]. use of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets in this age group is supported by adequate and well-controlled studies of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets in adults with hiv-1 infection and data from pediatric studies of the individual components of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets (efv, ftc, and tdf). efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets should only be administered to pediatric patients with a body weight greater than or equal to 40 kg. because efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are a fixed-dose combination tablet, the dose of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets cannot be adjusted for patients of lower weight [see warnings and precautions ( 5.2, 5.9), adverse reactions ( 6.1), and clinical pharmacology ( 12.3)]. clinical trials of efv, ftc, or tdf 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 elderly patients should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. because efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are a fixed-dose combination, and cannot be dose adjusted, it is not recommended in patients with moderate or severe renal impairment (estimated creatinine clearance below 50 ml/min) [see dosage and administration ( 2.3), warnings and precautions ( 5.7)] . efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are not recommended for patients with moderate or severe hepatic impairment because there are insufficient data to determine an appropriate dose. patients with mild hepatic impairment may be treated with efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets at the approved dose. because of the extensive cytochrome p450-mediated metabolism of efv and limited clinical experience in patients with hepatic impairment, caution should be exercised in administering efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets to these patients [see dosage and administration ( 2.4), warnings and precautions ( 5.3), and clinical pharmacology ( 12.3)].

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

aurobindo pharma limited - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets  are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg. - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets [see warnings and precautions (5.2)] . - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see drug interactions (7.3) and clinical pharmacology (12.3)]. antiretroviral pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in adults and adolescents exposed to efavirenz, emtricitabine and tenofovir disoproxil fumarate during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at (800) 258-4263. risk summary there are retrospective case reports of neural tube defects in infants whose mothers were exposed to efv-containing regimens in the first trimester of pregnancy. prospective pregnancy data from the apr are not sufficient to adequately assess this risk. although a causal relationship has not been established between exposure to efv in the first trimester and neural tube defects, similar malformations have been observed in studies conducted in monkeys at doses similar to the human dose (see data). in addition, fetal and embryonic toxicities occurred in rats at a dose 10 times less than the human exposure at the recommended clinical human dose (rhd) of efv. because of the potential risk of neural tube defects, efv is not recommended for use in the first trimester of pregnancy. avoid pregnancy while receiving efavirenz, emtricitabine and tenofovir disoproxil fumarate and for 12 weeks after discontinuation. advise pregnant patients of the potential risk to a fetus. available data from the apr show no increase in the overall risk of major birth defects for efv, ftc, or tdf 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 clinically recognized pregnancies in the u.s. general population is 15 to 20%. the background risk of major birth defects and miscarriage for the indicated population is unknown. the apr uses the macdp as the u.s. reference population for birth defects in the general population. the macdp evaluates mothers and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks’ gestation. in animal reproduction studies, no adverse developmental effects were observed when ftc and tdf were administered separately at doses/exposures ≥60 (ftc), ≥14 (tdf) and 2.7 (tenofovir) times those at the rhd of efavirenz, emtricitabine and tenofovir disoproxil fumarate (see data ). data human data efavirenz: there are retrospective postmarketing reports of findings consistent with neural tube defects, including meningomyelocele, all in infants of mothers exposed to efv-containing regimens in the first trimester. based on prospective reports to the apr of 1,217 exposures to efv-containing regimens during pregnancy resulting in live births (including over 1,023 live births exposed in the first trimester and 194 exposed in the second/third trimester), there was no increase in overall birth defects with efv compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of birth defects in live births was 2.3% (95% ci: 1.5% to 3.5%) with first trimester exposure to efv-containing regimens, and 1.5% (95% ci: 0.3% to 4.5%) with the second/third trimester exposure to efv-containing regimens. one of these prospectively reported defects with first-trimester exposure was a neural tube defect. a single case of anophthalmia with first-trimester exposure to efv has also been prospectively reported. this case also included severe oblique facial clefts and amniotic banding, which have a known association with anophthalmia. emtricitabine: based on prospective reports from the apr of 4,005 exposures to ftc-containing regimens during pregnancy resulting in live births (including 2,785 exposed in the first trimester and 1,220 exposed in the second/third trimester), there was no increase in overall major birth defects with ftc compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of birth defects in live births was 2.4% (95% ci: 1.9% to 3.1%) with first trimester exposure to ftc-containing regimens and 2.3% (95% ci: 1.5% to 3.3%) with the second/third trimester exposure to ftc-containing regimens. tenofovir df: based on prospective reports from the apr of 5,105 exposures to tdf-containing regimens during pregnancy resulting in live births (including 3,535 exposed in the first trimester and 1,570 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 the u.s. reference population of the macdp. the prevalence of birth defects in live births was 2.3% (95% ci: 1.8% to 2.9%) with first trimester exposure to tdf-containing regimens, and 2.2% (95% ci: 1.6% to 3.1%) with the second/third trimester exposure to tdf-containing regimens. animal data efavirenz: effects of efv on embryo-fetal development have been studied in three nonclinical species (cynomolgus monkeys, rats, and rabbits). in monkeys, efv 60 mg/kg/day was administered to pregnant females throughout pregnancy (gestation days 20 through 150). the maternal systemic drug exposures (auc) were 1.3 times the exposures at the rhd, with fetal umbilical venous drug concentrations approximately 0.7 times the maternal values. three fetuses of 20 fetuses/infants had one or more malformations; there were no malformed fetuses or infants from placebo-treated mothers. the malformations that occurred in these three monkey fetuses included anencephaly and unilateral anophthalmia in one fetus, microphthalmia in a second, and cleft palate in the third. there was no noael (no observable adverse effect level) established for this study because only one dosage was evaluated. in rats, efv was administered either during organogenesis (gestation days 7 to 18) or from gestation day 7 through lactation day 21 at 50, 100, or 200 mg/kg/day. administration of 200 mg/kg/day in rats was associated with an increase in the incidence of early resorptions, and doses 100 mg/kg/day and greater were associated with early neonatal mortality. the auc at the noael (50 mg/kg/day) in this rat study was 0.1 times that in humans at the rhd. drug concentrations in the milk on lactation day 10 were approximately 8 times higher than those in maternal plasma. in pregnant rabbits, efv was neither embryo lethal nor teratogenic when administered at doses of 25, 50, and 75 mg/kg/day over the period of organogenesis (gestation days 6 through 18). the auc at the noael (75 mg/kg/day) in rabbits was 0.4 times that in humans at the rhd. emtricitabine : ftc was administered orally to pregnant mice (at 0, 250, 500, or 1,000 mg/kg/day), and rabbits (at 0, 100, 300, or 1,000 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 ftc in mice at exposures (auc) approximately 60 times higher and in rabbits at approximately 120 times higher than human exposures at the rhd. in a pre/postnatal development study in mice, ftc was administered orally at 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 df: 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 rhd based on body surface area comparisons and in rabbits at doses up to 19 times the rhd 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 rhd. risk summary 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. based on limited published data, efv, ftc, and tenofovir have been shown to be present in human breast milk. it is not known if the components of efavirenz, emtricitabine and tenofovir disoproxil fumarate affect milk production or have effects on the breastfed child. 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 receiving efavirenz, emtricitabine and tenofovir disoproxil fumarate. pregnancy testing perform pregnancy testing in adults and adolescents of childbearing potential before initiation of efavirenz, emtricitabine and tenofovir disoproxil fumarate because of potential risk of neural tube defects [see use in specific populations (8.1)] . contraception advise adults and adolescents of childbearing potential to use effective contraception during treatment with efavirenz, emtricitabine and tenofovir disoproxil fumarate and for 12 weeks after discontinuing efavirenz, emtricitabine and tenofovir disoproxil fumarate due to the long half-life of efv, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate. hormonal methods that contain progesterone may have decreased effectiveness always use barrier contraception in combination with other methods of contraception [see drug interactions (7.1, 7.3)] . the effectiveness and safety of efavirenz, emtricitabine and tenofovir disoproxil fumarate as a complete regimen for the treatment of hiv-1 infection was established in pediatric patients with body weight greater than or equal to 40 kg [see dosage and administration (2.2)] . use of efavirenz, emtricitabine and tenofovir disoproxil fumarate in this age group is supported by adequate and well-controlled studies of efavirenz, emtricitabine and tenofovir disoproxil fumarate in adults with hiv-1 infection and data from pediatric studies of the individual components of efavirenz, emtricitabine and tenofovir disoproxil fumarate (efv, ftc, and tdf). efavirenz, emtricitabine and tenofovir disoproxil fumarate should only be administered to pediatric patients with a body weight greater than or equal to 40 kg. because efavirenz, emtricitabine and tenofovir disoproxil fumarate is a fixed-dose combination tablet, the dose of efavirenz, emtricitabine and tenofovir disoproxil fumarate cannot be adjusted for patients of lower weight [see warnings and precautions (5.2, 5.9), adverse reactions (6.1), and clinical pharmacology (12.3)] . clinical trials of efv, ftc, or tdf 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 elderly patients should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. because efavirenz, emtricitabine and tenofovir disoproxil fumarate is a fixed-dose combination, and cannot be dose adjusted, it is not recommended in patients with moderate or severe renal impairment (estimated creatinine clearance below 50 ml/min) [see dosage and administration (2.3), warnings and precautions (5.7)] . efavirenz, emtricitabine and tenofovir disoproxil fumarate is not recommended for patients with moderate or severe hepatic impairment because there are insufficient data to determine an appropriate dose. patients with mild hepatic impairment may be treated with efavirenz, emtricitabine and tenofovir disoproxil fumarate at the approved dose. because of the extensive cytochrome p450-mediated metabolism of efv and limited clinical experience in patients with hepatic impairment, caution should be exercised in administering efavirenz, emtricitabine and tenofovir disoproxil fumarate to these patients [see dosage and administration (2.4), warnings and precautions (5.3), and clinical pharmacology (12.3)] .

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

cipla usa inc. - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg. - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet [see warnings and precautions (5.2)] . - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see drug interactions (7.3) and clinical pharmacology (12.3)] . antiretroviral pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in adults and adolescents expos

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

exelan pharmaceuticals, inc. - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg. - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet [see warnings and precautions (5.2)] . - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see drug interactions (7.3) and clinical pharmacology (12.3)] . antiretroviral pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in adults and adolescents expos

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

macleods pharmaceuticals limited - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg. • efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet. [see warnings and precautions (5.2)]. • efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet is contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see drug interactions (7.3) and clinical pharmacology (12.3)]. antiretroviral pregnancy registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in adults and adolescents exposed to efavirenz, emtricitabine and t

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

laurus labs limited - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg. - efavirenz, emtricitabine and tenofovir disoproxil fumarate is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets [see warnings and precautions (5.2)]. - efavirenz, emtricitabine and tenofovir disoproxil fumarate is contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see drug interactions (7.3) and clinical pharmacology (12.3)] . antiretroviral pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in adults and adolescents exposed to efavirenz, emtricitabine and tenofovir disoproxil

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

camber pharmaceuticals, inc. - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg. •  efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets [see warnings and precautions ( 5.2)]. •  efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see drug interactions ( 7.3) and clinical pharmacology ( 12.3)]. antiretroviral pregnancy registry there is a pregnancy exposure registry that m

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

american health packaging - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg. - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets [see warnings and precautions (5.2)]. - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see drug interactions (7.3) and clinical pharmacology (12.3)]. antiretroviral pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in adults and adolescents exposed to efavir