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

solco healthcare llc - entecavir anhydrous (unii: nnu2o4609d) (entecavir anhydrous - unii:nnu2o4609d) - entecavir anhydrous 0.5 mg - entecavir is indicated for the treatment of chronic hepatitis b virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary prospective pregnancy data from the apr are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes. entecavir use during pregnancy has been evaluated in a limited number of individuals reported to the apr and the number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population. the estimated background rate for major birth

Israel - English - Ministry of Health

teva israel ltd - entecavir as monohydrate - film coated tablets - entecavir as monohydrate 0.5 mg - entecavir - entecavir teva is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: - compensated liver disease and evidence of active viral replication, and persistently elevated serum alanine aminotransferase (alt) levels. - decompensated liver disease.

Israel - English - Ministry of Health

teva israel ltd - entecavir as monohydrate - film coated tablets - entecavir as monohydrate 1 mg - entecavir - entecavir teva is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: - compensated liver disease and evidence of active viral replication, and persistently elevated serum alanine aminotransferase (alt) levels. - decompensated liver disease.

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

avkare - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir 0.5 mg - entecavir tablets are indicated for the treatment of chronic hepatitis b virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. the following points should be considered when initiating therapy with entecavir tablets: - in adult patients, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve and lamivudine-resistant subjects with hbeag-positive and hbeag-negative hbv infection and compensated liver disease and a more limited number of subjects with decompensated liver disease [see clinical studies (14.1)] . pediatric use information is approved for bristol-myers squibb company’s baraclude ® (entecavir) tablets. however, due to bristol-myers squibb company’s marketing exclusivity rights, this drug product is not labeled with that information. none. pregnancy category c there are no adequate and well-controlled studies of entecavir in pregnant women. because animal reproduction studies are not always predictive of human response, entecavir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. antiretroviral pregnancy registry: to monitor fetal outcomes of pregnant women exposed to entecavir, an antiretroviral pregnancy registry has been established. healthcare providers are encouraged to register patients by calling 1-800-258-4263. animal data animal reproduction studies with entecavir in rats and rabbits revealed no evidence of teratogenicity. developmental toxicity studies were performed in rats and rabbits. there were no signs of embryofetal or maternal toxicity when pregnant animals received oral entecavir at approximately 28 (rat) and 212 (rabbit) times the human exposure achieved at the highest recommended human dose of 1 mg/day. in rats, maternal toxicity, embryofetal toxicity (resorptions), lower fetal body weights, tail and vertebral malformations, reduced ossification (vertebrae, sternebrae and phalanges) and extra lumbar vertebrae and ribs were observed at exposures 3100 times those in humans. in rabbits, embryofetal toxicity (resorptions), reduced ossification (hyoid) and an increased incidence of 13th rib were observed at exposures 883 times those in humans. in a peripostnatal study, no adverse effects on offspring occurred when rats received oral entecavir at exposures greater than 94 times those in humans. there are no studies in pregnant women and no data on the effect of entecavir on transmission of hbv from mother to infant. therefore, appropriate interventions should be used to prevent neonatal acquisition of hbv. it is not known whether entecavir is excreted into human milk; however, entecavir is excreted into the milk of rats. because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from entecavir, a decision should be made to discontinue nursing or to discontinue entecavir taking into consideration the importance of continued hepatitis b therapy to the mother and the known benefits of breastfeeding. the efficacy and safety of entecavir have not been established in patients less than 2 years of age. use of entecavir in this age group has not been evaluated because treatment of hbv in this age group is rarely required. pediatric use information is approved for bristol-myers squibb company’s baraclude ® (entecavir) tablets. however, due to bristol-myers squibb company’s marketing exclusivity rights, this drug product is not labeled with that information. clinical studies of entecavir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. entecavir is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.4)] . there are no significant racial differences in entecavir pharmacokinetics. dosage adjustment of entecavir is recommended for patients with creatinine clearance less than 50 ml/min, including patients on hemodialysis or capd [see  dosage and administration (2.4)  and clinical pharmacology (12.3) ] . if entecavir treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function must be carefully monitored both before and during treatment with entecavir [see  dosage and administration (2.4) and clinical pharmacology (12.3)] .

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

marlex pharmaceuticals inc - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir 0.5 mg - entecavir tablets are indicated for the treatment of chronic hepatitis b virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. the following points should be considered when initiating therapy with entecavir tablets: - in adult patients, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve and lamivudine-resistant subjects with hbeag-positive and hbeag-negative hbv infection and compensated liver disease and a more limited number of subjects with decompensated liver disease [see clinical studies (14.1)]. pediatric use information is approved for bristol-myers squibb company’s baraclude (entecavir) tablets. however, due to bristol-myers squibb company’s marketing exclusivity rights, this drug product is not labeled with that information. none. pregnancy category c there are no adequate and well-controlled studies of entecavir in pregnant women.

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

amneal pharmaceuticals llc - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir 0.5 mg - entecavir tablets are indicated for the treatment of chronic hepatitis b virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. none. pregnancy exposure registry there is a  pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary prospective pregnancy data from the apr are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes. entecavir use during pregnancy has been evaluated in a limited number of individuals reported to the apr and the number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population. the estimated background rate for major birth defects is 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp). the rate of miscarriage is not reported in the apr. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15% to 20%. in animal reproduction studies, no adverse developmental effects were observed with entecavir at clinically relevant exposures. no developmental toxicities were observed at systemic exposures (auc) approximately 25 (rats) and 200 (rabbits) times the exposure at the maximum recommended human dose (mrhd) of 1 mg/day (see data ). data animal data entecavir was administered orally to pregnant rats (at 2, 20, and 200 mg per kg per day) and rabbits (at 1, 4, and 16 mg per kg per day) during organogenesis (on gestation days 6 through 15 [rat] and 6 through 18 [rabbit]).  in rats, embryofetal toxicity  including post-implantation loss, resorptions, tail and vertebral malformations, skeletal variations including reduced ossification (vertebrate, sternebrae, and phalanges) and extra lumbar vertebrae and ribs, and lower fetal body weights were observed at systemic exposures (auc) 3,100 times those in humans at the mrhd. maternal toxicity was also observed at this dose level. in rabbits, embryofetal toxicity including post implantation loss, resorptions and skeletal variations, including reduced ossification (hyoid) and increased incidence of 13th rib, were observed at systemic exposures (auc) 883 times those in humans at the mrhd. there were no signs of embryofetal toxicity when pregnant animals received oral entecavir at 28 (rat) and 212 (rabbit) times the human exposure (auc) at the mrhd. in a pre/postnatal development study, entecavir was administered orally to pregnant rats at 0.3, 3, and 30 mg per kg per day from gestation day 6 to lactation/post-partum day 20. no adverse effects on the offspring occurred at up to the highest dose evaluated, resulting in exposures (auc) greater than 94 times those in humans at the mrhd. risk summary it is not known whether entecavir is present in human breast milk, affects human milk production, or has effects on the breastfed infant. when administered to lactating rats, entecavir was present in milk (see data ). the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for entecavir and any potential adverse effects on the breastfed infant from entecavir or from the underlying maternal condition. data entecavir was excreted into the milk of lactating rats following a single oral dose of 10 mg per kg on lactation day 7. entecavir in milk was approximately 25% that in maternal plasma (based on auc). entecavir was evaluated in two clinical trials of pediatric subjects 2 years of age and older with hbeag-positive chronic hbv infection and compensated liver disease. the exposure of entecavir in nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric subjects 2 years of age and older with hbeag-positive chronic hbv infection and compensated liver disease receiving 0.015 mg/kg (up to 0.5 mg once daily) or 0.03 mg/kg (up to 1 mg once daily), respectively, was evaluated in study ai463028. safety and efficacy of the selected dose in treatment-naïve pediatric subjects were confirmed in study ai463189, a randomized, placebo-controlled treatment trial [see indications and usage (1), dosage and administration (2.3), adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.2)] . there are limited data available on the use of entecavir in lamivudine-experienced pediatric patients; entecavir should be used in these patients only if the potential benefit justifies the potential risk to the child. since some pediatric patients may require long-term or even lifetime management of chronic active hepatitis b, consideration should be given to the impact of entecavir on future treatment options [see microbiology (12.4)] . the efficacy and safety of entecavir have not been established in patients less than 2 years of age. use of entecavir in this age group has not been evaluated because treatment of hbv in this age group is rarely required. clinical studies of entecavir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. entecavir is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.4)] . there are no significant racial differences in entecavir pharmacokinetics. the safety and efficacy of entecavir 0.5 mg once daily were assessed in a single-arm, open-label trial of hbeag-positive or -negative, nucleoside-inhibitor-naïve, black/african american (n=40) and hispanic (n=6) subjects with chronic hbv infection. in this trial, 76% of subjects were male, the mean age was 42 years, 57% were hbeag-positive, the mean baseline hbv dna was 7.0 log10 iu/ml, and the mean baseline alt was 162 u/l. at week 48 of treatment, 32 of 46 (70%) subjects had hbv dna <50 iu/ml (approximately 300 copies/ml), 31 of 46 (67%) subjects had alt normalization (≤1 × uln), and 12 of 26 (46%) hbeag-positive subjects had hbe seroconversion. safety data were similar to those observed in the larger controlled clinical trials. because of low enrollment, safety and efficacy have not been established in the us hispanic population. dosage adjustment of entecavir is recommended for patients with creatinine clearance less than 50 ml/min, including patients on hemodialysis or capd [see dosage and administration (2.4)  and clinical pharmacology (12.3) ] . the safety and efficacy of entecavir were assessed in a single-arm, open-label trial in 65 subjects who received a liver transplant for complications of chronic hbv infection. eligible subjects who had hbv dna less than 172 iu/ml (approximately 1,000 copies/ml) at the time of transplant were treated with entecavir 1 mg once daily in addition to usual post-transplantation management, including hepatitis b immune globulin. the trial population was 82% male, 39% caucasian, and 37% asian, with a mean age of 49 years; 89% of subjects had hbeag-negative disease at the time of transplant. four of the 65 subjects received 4 weeks or less of entecavir (2 deaths, 1 re-transplantation, and 1 protocol violation) and were not considered evaluable. of the 61 subjects who received more than 4 weeks of entecavir, 60 received hepatitis b immune globulin post-transplant. fifty-three subjects (82% of all 65 subjects treated) completed the trial and had hbv dna measurements at or after 72 weeks treatment post-transplant. all 53 subjects had hbv dna <50 iu/ml (approximately 300 copies/ml). eight evaluable subjects did not have hbv dna data available at 72 weeks, including 3 subjects who died prior to study completion. no subjects had hbv dna values ≥50 iu/ml while receiving entecavir (plus hepatitis b immune globulin). all 61 evaluable subjects lost hbsag post-transplant; 2 of these subjects experienced recurrence of measurable hbsag without recurrence of hbv viremia. this trial was not designed to determine whether addition of entecavir to hepatitis b immune globulin decreased the proportion of subjects with measurable hbv dna post-transplant compared to hepatitis b immune globulin alone. if entecavir treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function must be carefully monitored both before and during treatment with entecavir [see dosage and administration (2.4) and clinical pharmacology (12.3)] .

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

zydus pharmaceuticals usa inc. - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir 0.5 mg - entecavir tablets are indicated for the treatment of chronic hepatitis b virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary prospective pregnancy data from the apr are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes. entecavir use during pregnancy has been evaluated in a limited number of individuals reported to the apr and the number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population. the estimated background rate for ma

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

american health packaging - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir 0.5 mg - entecavir tablets are indicated for the treatment of chronic hepatitis b virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary prospective pregnancy data from the apr are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes. entecavir use during pregnancy has been evaluated in a limited number of individuals reported to the apr and the number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population. the estimated background rat

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

teva pharmaceuticals usa, inc. - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir 0.5 mg - entecavir tablets are indicated for the treatment of chronic hepatitis b virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary prospective pregnancy data from the apr are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes. entecavir use during pregnancy has been evaluated in a limited number of individuals reported to the apr and the number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population. the estimated background rate for ma

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

camber pharmaceuticals, inc. - entecavir anhydrous (unii: nnu2o4609d) (entecavir anhydrous - unii:nnu2o4609d) - entecavir anhydrous 0.5 mg - entecavir tablet is indicated for the treatment of chronic hepatitis b virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary prospective pregnancy data from the apr are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes. entecavir use during pregnancy has been evaluated in a limited number of individuals reported to the apr and the number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population. the estimated background rate