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)

cipla usa inc. - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir 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 tablets 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

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

northstar rxllc - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir 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. the following points should be considered when initiating therapy with entecavir tablet: - 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) ]. - in pediatric patients 2 years of age and older and weighing greater than 30 kg, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve and in a limited number of lamivudine-experienced subjects with hbeag-positive chronic hbv infe

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

zydus lifesciences limited - 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)

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)

aurobindo pharma limited - 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

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)

acetris health, 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. 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)]. - in pediatric patients 2 years of age and older, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve and in a limited number of lamivudine-experienced subjects with hbeag-positive chronic hbv infection and compensated liver disease [see clinical studies (14