EVIPLERA tenofovir disoproxil fumarate 300 mg /emtricitabine 200 mg /rilpivirine (as HCl) 25 mg tablet bottle Australia - English - Department of Health (Therapeutic Goods Administration)

eviplera tenofovir disoproxil fumarate 300 mg /emtricitabine 200 mg /rilpivirine (as hcl) 25 mg tablet bottle

gilead sciences pty ltd - emtricitabine, quantity: 200 mg; tenofovir disoproxil fumarate, quantity: 300 mg; rilpivirine hydrochloride, quantity: 27.5 mg (equivalent: rilpivirine, qty 25 mg) - tablet, film coated - excipient ingredients: pregelatinised maize starch; microcrystalline cellulose; croscarmellose sodium; polysorbate 20; povidone; lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; sunset yellow fcf aluminium lake; triacetin; iron oxide red; macrogol 3350; indigo carmine aluminium lake - eviplera is indicated for the treatment of hiv infection in treatment-na?ve adult patients with plasma hiv-1 rna =< 100,000 copies/ml at the start of therapy. eviplera is also indicated in certain virologically-suppressed (hiv-1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see clinical trials). patients must not have a history of resistance to any of the components of eviplera (tenofovir df, emtricitabine or rilpivirine).

EVIPLERA Israel - English - Ministry of Health

eviplera

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg; rilpivirine as hydrochloride 25 mg; emtricitabine 200 mg - rilpivirine - rilpivirine - eviplera, a combination of two nucleoside analog hiv 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of hiv-1 infection in adult patients with no antiretroviral treatment history and with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy, and in certain virologically-suppressed (hiv-1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below).the following points should be considered when initiating therapy with eviplera in adult patients with no antiretroviral treatment history: • more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14)]. • regardless of hiv-1 rna level at the start of therapy, more rilpivirine-treated subjects with cd4+ cell count less than 200 cells/mm3 experienced virologic failure compared to rilpivirine-treated subjects with cd4+ cell count greater than or equal to 200 cells/mm3 [see clinical studies (14)]. • the observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the nnrti class compared to efavirenz [see microbiology (12.4)]• more subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [see microbiology (12.4)].

EVIPLERA Israel - English - Ministry of Health

eviplera

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg; rilpivirine as hydrochloride 25 mg; emtricitabine 200 mg - rilpivirine - rilpivirine - eviplera, a combination of two nucleoside analog hiv 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of hiv-1 infection in adult patients with no antiretroviral treatment history and with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy, and in certain virologically-suppressed (hiv-1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below).the following points should be considered when initiating therapy with eviplera in adult patients with no antiretroviral treatment history: • more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14)]. • regardless of hiv-1 rna level at the start of therapy, more rilpivirine-treated subjects with cd4+ cell count less than 200 cells/mm3 experienced virologic failure compared to rilpivirine-treated subjects with cd4+ cell count greater than or equal to 200 cells/mm3 [see clinical studies (14)]. • the observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the nnrti class compared to efavirenz [see microbiology (12.4)]• more subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [see microbiology (12.4)].

EVIPLERA Israel - English - Ministry of Health

eviplera

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir disoproxil as fumarate - film coated tablets - tenofovir disoproxil as fumarate 245 mg; rilpivirine as hydrochloride 25 mg; emtricitabine 200 mg - rilpivirine - eviplera, a combination of two nucleoside analog hiv 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of hiv-1 infection in adult patients with no antiretroviral treatment history and with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy, and in certain virologically-suppressed (hiv-1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below).the following points should be considered when initiating therapy with eviplera in adult patients with no antiretroviral treatment history: • more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14)]. • regardless of hiv-1 rna level at the start of therapy, more rilpivirine-treated subjects with cd4+ cell count less than 200 cells/mm3 experienced virologic failure compared to rilpivirine-treated subjects with cd4+ cell count greater than or equal to 200 cells/mm3 [see clinical studies (14)]. • the observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the nnrti class compared to efavirenz [see microbiology (12.4)]• more subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [see microbiology (12.4)].

COMPLERA- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated United States - English - NLM (National Library of Medicine)

complera- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated

physicians total care, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is indicated for use as a complete regimen for the treatment of hiv-1 infection in antiretroviral treatment-naive adult patients with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy. this indication is based on safety and efficacy analyses through 96 weeks from 2 randomized, double-blind, active controlled, phase 3 trials in treatment-naive subjects comparing rilpivirine to efavirenz [see clinical studies (14)] . the following points should be considered when initiating therapy with complera: - more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14)] . - regardless of hiv-1 rna level at the start of therapy, more rilpivirine-treated subjects with cd4+ cell count less than 200 cells/mm3 exper

COMPLERA- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated United States - English - NLM (National Library of Medicine)

complera- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated

a-s medication solutions - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - complera® , a combination of two nucleoside analog hiv-1 reverse transcriptase inhibitors (nrtis) (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (nnrti) (rilpivirine), is indicated for use as a complete regimen for the treatment of hiv-1 infection in patients 12 years of age and older with no antiretroviral treatment history and with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy, and in certain virologically-suppressed (hiv-1 rna <50 copies/ml) patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below). - the following points should be considered when initiating therapy with complera in patients with no antiretroviral treatment history:   more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared

COMPLERA ACCESS- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated United States - English - NLM (National Library of Medicine)

complera access- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated

gilead sciences, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - complera™ is indicated as a complete regimen for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 35 kg: - as initial therapy in those with no antiretroviral treatment history with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy or - to replace a stable antiretroviral regimen in those who are virologically suppressed (hiv-1 rna less than 50 copies/ml) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of complera [see microbiology (12.4) and clinical studies (14)] . limitations of use : - more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14)] . complera is contraindicated when coadministered with the following drugs; coadministration may result in loss of virologic response and possible resistance to complera or to the class of nnrtis [see warnings and precautions (5.7), drug interactions (7), and clinical pharmacology (12.3)]: - anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin - antimycobacterials: rifampin, rifapentine - glucocorticoid (systemic): dexamethasone (more than a single-dose) - herbal products: st john's wort (hypericum perforatum ) - proton pump inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to complera during pregnancy. healthcare providers are encouraged to register patients on the worldwide antiretroviral pregnancy registry (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 emtricitabine (ftc), rilpivirine (rpv), or tenofovir (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) . in a clinical trial, total rilpivirine exposures were generally lower during pregnancy compared to the postpartum period [see clinical pharmacology (12.3)]. the rate of miscarriage for individual drugs is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15–20%. based on the experience of hiv-1-infected pregnant individuals who completed a clinical trial through the postpartum period with an rpv-based regimen, no dose adjustments are required for pregnant patients who are already on a stable rpv-containing regimen prior to pregnancy and who are virologically suppressed (hiv-1 rna less than 50 copies per ml). lower exposures of rpv were observed during pregnancy, therefore viral load should be monitored closely [see data and clinical pharmacology (12.3)] . in animal studies, no adverse developmental effects were observed when the components of complera were administered separately during the period of organogenesis at exposures up to 60 and 120 times (mice and rabbits, respectively, ftc) and 15 and 70 times (rats and rabbits, respectively; rpv) the exposure of these components in complera and at 14 and 19 times (rats and rabbits, respectively) the human dose of tdf based on body surface area comparisons (see data) . likewise, no adverse developmental effects were seen when ftc was administered to mice and rpv was administered to rats through lactation at exposures up to approximately 60 and 63 times, respectively, the exposure at the recommended daily dose of these components in complera. no adverse effects were observed in the offspring of rats when tdf was administered through lactation at tenofovir exposures of approximately 14 times the exposure at the recommended daily dosage of complera. data human data prospective reports from the apr of overall major birth defects in pregnancies exposed to drug components of complera 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. emtricitabine: based on prospective reports to the apr of exposures to ftc-containing regimens during pregnancy resulting in live births (including over 2,750 exposed in the first trimester and over 1,200 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 major 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. rilpivirine: rpv in combination with a background regimen was evaluated in a clinical trial of 19 hiv-1 infected pregnant subjects on an rpv-based regimen during the second and third trimesters and postpartum. each of the subjects were on an rpv-based regimen at the time of enrollment. twelve subjects completed the trial through the postpartum period (6–12 weeks after delivery) and pregnancy outcomes are missing for six subjects. the exposure (c0h and auc) of total rpv was approximately 30 to 40% lower during pregnancy compared with postpartum (6 to 12 weeks). the protein binding of rpv was similar (>99%) during second trimester, third trimester, and postpartum period [see clinical pharmacology (12.3)]. one subject discontinued the trial following fetal death at 25 weeks gestation due to suspected premature rupture of membranes. among the 12 subjects who were virologically suppressed at baseline (less than 50 copies/ml), virologic response was preserved in 10 subjects (83.3%) through the third trimester visit and in 9 subjects (75%) through the 6–12 week postpartum visit. virologic outcomes during the third trimester visit were missing for two subjects who were withdrawn (one subject was nonadherent to the study drug and one subject withdrew consent). among the 10 infants with available hiv test results, all were negative for hiv-1 at the time of delivery and up to 16 weeks postpartum (all 10 infants received prophylactic treatment with zidovudine). rpv was well tolerated during pregnancy and postpartum. there were no new safety findings compared with the known safety profile of rpv in hiv–1-infected adults. based on prospective reports to the apr of exposures to rpv-containing regimens during pregnancy (including over 290 exposed during first trimester and over 160 exposed in the second/third trimester), there was no significant increase in overall risk of major birth defects with rpv compared to the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of major birth defects in live births was 1.0% (95% ci: 0.2% to 2.9%) and 1.2% (95% ci: 0.2% to 4.4%) following first and second/third trimester exposure, respectively, to rpv-containing regimens. tenofovir df: based on prospective reports to the apr of exposures to tdf-containing regimens during pregnancy resulting in live births (including over 3,500 exposed in the first trimester and over 1,500 exposed in the second/third trimester), there was no increase in overall risk of major birth defects compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of major birth defects in live births was 2.3% (95% ci: 1.8% to 2.9%) 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 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 recommended daily dose. in a pre/postnatal development study in mice, ftc was administered orally at doses up to 1,000 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 recommended daily dose. rilpivirine: rpv was administered orally to pregnant rats (40, 120, or 400 mg/kg/day) and rabbits (5, 10, or 20 mg/kg/day) through organogenesis (on gestation days 6 through 17, and 6 through 19, respectively). no significant toxicological effects were observed in embryo-fetal toxicity studies performed with rpv in rats and rabbits at exposures 15 (rats) and 70 (rabbits) times higher than the exposure in humans at the recommended dose of 25 mg once daily. in a pre/postnatal development study with rpv, where rats were administered up to 400 mg/kg/day through lactation, no significant adverse effects directly related to drug were noted in the offspring. 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 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 complera. risk summary the centers for disease control and prevention recommend that hiv infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv. based on published data, ftc and tenofovir have been shown to be present in human milk. there are no data on the presence of rpv in human milk. rpv has been shown to be present in rat milk (see data) . it is not known if the components of complera 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 complera. data rilpivirine: in animals, no studies have been conducted to assess the excretion of rpv directly; however rpv was measured in rat pups which were exposed through the milk of treated dams (dosed up to 400 mg/kg/day). the safety and effectiveness of complera as a complete regimen for the treatment of hiv-1 infection was established in pediatric subjects 12 years of age and older with body weight greater than or equal to 35 kg [see dosage and administration (2.2)] . use of complera in this age group weighing at least 35 kg is supported by adequate and well-controlled studies of rpv+ftc+tdf in adults with hiv-1 infection as well as data from pediatric studies of the individual components of complera (rpv, ftc, and tdf) [see clinical pharmacology (12.3), and clinical studies (14.2)]. complera should only be administered to pediatric patients with a body weight greater than or equal to 35 kg. because complera is a fixed-dose combination tablet, the dose of complera cannot be adjusted for patients of lower weight. safety and effectiveness for complera have not been established in pediatric patients weighing less than 35 kg [see adverse reactions (6.1) and clinical pharmacology (12.3)] . clinical studies of ftc, rpv, 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 [see clinical pharmacology (12.3)]. because complera is a fixed-dose combination, and cannot be dose adjusted, it is not recommended in patients with moderate, severe, or end-stage renal impairment (estimated creatinine clearance below 50 ml per minute) or that require dialysis [see warnings and precautions (5.5) and clinical pharmacology (12.3)] . no dose adjustment of complera is required in patients with mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment. complera has not been studied in patients with severe hepatic impairment (child-pugh class c) [see clinical pharmacology (12.3)] .

COMPLERA- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated United States - English - NLM (National Library of Medicine)

complera- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated

gilead sciences, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - complera® is indicated as a complete regimen for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 35 kg: - as initial therapy in those with no antiretroviral treatment history with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy or - to replace a stable antiretroviral regimen in those who are virologically suppressed (hiv-1 rna less than 50 copies/ml) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of complera [see microbiology (12.4) and clinical studies (14)] . limitations of use : - more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml [see clinical studies (14)] . complera is contraindicated when coadministered with the following

COMPLERA- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated United States - English - NLM (National Library of Medicine)

complera- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated

remedyrepack inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), rilpivirine hydrochloride (unii: 212wax8kdd) (rilpivirine - unii:fi96a8x663), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine 200 mg - complera ® is indicated as a complete regimen for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 35 kg: - as initial therapy in those with no antiretroviral treatment history with hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy or - to replace a stable antiretroviral regimen in those who are virologically suppressed (hiv-1 rna less than 50 copies/ml) on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of complera [see microbiology (12.4) and clinical studies (14)] . limitations of use : - more rilpivirine-treated subjects with hiv-1 rna greater than 100,000 copies/ml at the start of therapy experienced virologic failure (hiv-1 rna ≥50 copies/ml) compared to rilpivirine-treated subjects with hiv-1 rna less than or equal to 100,000 copies/ml

Eviplera 200mg25mg245mg tablets United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

eviplera 200mg25mg245mg tablets

gilead sciences international ltd - emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate - tablet - 200mg ; 25mg ; 245mg