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

sigmapharm laboratories, llc - adefovir dipivoxil (unii: u6q8z01514) (adefovir - unii:6gqp90i798) - adefovir dipivoxil 10 mg - adefovir dipivoxil tablets are indicated for the treatment of chronic hepatitis b in patients 12 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. this indication is based on histological, virological, biochemical, and serological responses in adult patients with hbeag+ and hbeag- chronic hepatitis b with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis b virus with either compensated or decompensated liver function. for patients 12 to less than 18 years of age, the indication is based on virological and biochemical responses in patients with hbeag+ chronic hepatitis b virus infection with compensated liver function. adefovir dipivoxil tablets are contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product. pregnancy exposure registry there is a pregnancy exposure registry that moni

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

arrotex pharmaceuticals pty ltd - adefovir dipivoxil, quantity: 10 mg - tablet - excipient ingredients: pregelatinised maize starch; magnesium stearate; purified talc; croscarmellose sodium; lactose monohydrate - ? adefovir dipivoxil is indicated for the treatment of chronic hepatitis b in patients 12 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. ? for adult patients, this indication is based on histological, virological, biochemical, and serological responses in adult patients with hbeag+ and hbeag-/hbvdna+ chronic hepatitis b with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis b virus with either compensated or decompensated liver function. ? for adolescent patients (12 to <18 years of age), the indication is based on virological and biochemical responses in patients with hbeag+ chronic hepatitis b virus with compensated liver function.

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

apotex corp. - adefovir dipivoxil (unii: u6q8z01514) (adefovir - unii:6gqp90i798) - adefovir dipivoxil tablets are indicated for the treatment of chronic hepatitis b in patients 12 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. this indication is based on histological, virological, biochemical, and serological responses in adult patients with hbeag+ and hbeag- chronic hepatitis b with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis b virus with either compensated or decompensated liver function. for patients 12 to less than 18 years of age, the indication is based on virological and biochemical responses in patients with hbeag+ chronic hepatitis b virus infection with compensated liver function. adefovir dipivoxil tablets are contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adefovir dipivoxil 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. adefovir disoproxil (adv) use during pregnancy has been evaluated in a limited number of individuals reported to the apr and the number of exposures to adefovir 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 estimated rate of miscarriage is not reported in the apr. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background rate of miscarriage in the u.s. general population is 15–20%. in animal reproduction studies with oral adv, no adverse developmental effects were observed at exposures (cmax ) 23 times higher in rats and 40 times higher in rabbits than those at the recommended human dose (rhd) of adefovir dipivoxil (see data). data animal data in an embryo-fetal development study, adv was administered orally to pregnant rabbits (at 1, 5, or 20 mg/kg/day) during organogenesis (on gestation day 6 through 18). no adverse developmental effects were observed at up to the highest dose tested, at systemic exposure (cmax ) 40 times that in humans at the rhd of adefovir dipivoxil. in a pre/post-natal development study, adv was administered orally to pregnant rats (at 2.5, 10, or 40 mg/kg/day) from organogenesis, through late gestation, delivery, and lactation (gestation day 7 to lactation/postpartum day 20). reduced body weight of the offspring due to maternal toxicity was observed at systemic exposure 23 times that in humans at the rhd of adefovir dipivoxil. in an embryo-fetal development study, adv was administered intravenously to pregnant rats (at 2.5, 10, and 20 mg/kg/day) during organogenesis (gestation day 6 through 15). embryo-fetal toxicity including malformations (anasarca, depressed eye bulge, umbilical hernia and kinked tail) and skeletal variations (reduction of ossified metacarpal bones, increases in thoracic vertebrae and decreases in lumbar vertebrae) occurred at systemic exposure (cmax) 38 times that in humans at the rhd of adefovir dipivoxil. no adverse developmental effects were observed at an exposure (cmax) 12 times that in humans at the rhd of adefovir dipivoxil. risk summary it is not known whether adefovir is present in human breast milk, affects human milk production, or has effects on the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for adefovir dipivoxil and any potential adverse effects on the breastfed infant from adefovir dipivoxil or from the underlying maternal condition. pediatric patients 12 to less than 18 years : the safety, efficacy, and pharmacokinetics of adefovir dipivoxil in pediatric patients (aged 12 to less than 18 years) were evaluated in a double-blind, randomized, placebo-controlled study (gs-us-103-518, study 518) in 83 pediatric patients with chronic hepatitis b and compensated liver disease. the proportion of patients treated with adefovir dipivoxil who achieved the primary efficacy endpoint of serum hbv dna less than 1,000 copies/ml and normal alt levels at the end of 48 weeks blinded treatment was significantly greater (23%) when compared to placebo-treated patients (0%) [s ee clinical studies (14.4), dosage and administration (2) and adverse reactions (6.3)] . pediatric patients 2 to less than 12 years : patients 2 to less than 12 years of age were also evaluated in study 518. the efficacy of adefovir dipivoxil was not significantly different from placebo in patients less than 12 years of age. adefovir dipivoxil tablets are not recommended for use in children below 12 years of age. clinical studies of adefovir dipivoxil did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. in general, caution should be exercised when prescribing to elderly patients since they have greater frequency of decreased renal or cardiac function due to concomitant disease or other drug therapy. it is recommended that the dosing interval for adefovir dipivoxil be modified in adult patients with baseline creatinine clearance less than 50 ml per minute. the pharmacokinetics of adefovir have not been evaluated in non-hemodialysis patients with creatinine clearance less than 10 ml per minute or in adolescent patients with renal insufficiency; therefore, no dosing recommendations are available for these patients [see dosage and administration (2.2) and warning s and precautions (5.2)] .

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

gilead sciences, inc. - adefovir dipivoxil (unii: u6q8z01514) (adefovir - unii:6gqp90i798) - adefovir dipivoxil 10 mg - hepsera is indicated for the treatment of chronic hepatitis b in patients 12 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. this indication is based on histological, virological, biochemical, and serological responses in adult patients with hbeag+ and hbeag- chronic hepatitis b with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis b virus with either compensated or decompensated liver function. for patients 12 to less than 18 years of age, the indication is based on virological and biochemical responses in patients with hbeag+ chronic hepatitis b virus infection with compensated liver function. hepsera is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to

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

arrotex pharmaceuticals pty ltd - adefovir dipivoxil, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; pregelatinised maize starch; purified talc; magnesium stearate; croscarmellose sodium - ? adefovir dipivoxil is indicated for the treatment of chronic hepatitis b in patients 12 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. ? for adult patients, this indication is based on histological, virological, biochemical, and serological responses in adult patients with hbeag+ and hbeag-/hbvdna+ chronic hepatitis b with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis b virus with either compensated or decompensated liver function. ? for adolescent patients (12 to <18 years of age), the indication is based on virological and biochemical responses in patients with hbeag+ chronic hepatitis b virus with compensated liver function.

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

excella gmbh - adefovir dipivoxil (unii: u6q8z01514) (adefovir - unii:6gqp90i798) - adefovir 10 mg - hepsera is indicated for the treatment of chronic hepatitis b in patients 12 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. this indication is based on histological, virological, biochemical, and serological responses in adult patients with hbeag+ and hbeag- chronic hepatitis b with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis b virus with either compensated or decompensated liver function. for patients 12 to <18 years of age, the indication is based on virological and biochemical responses in patients with hbeag+ chronic hepatitis b virus infection with compensated liver function. hepsera is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies of hepsera in pregnant women. chroni

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

gilead sciences pty ltd - adefovir dipivoxil -

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - adefovir dipivoxil 10mg - tablet - 10 mg - active: adefovir dipivoxil 10mg excipient: croscarmellose sodium lactose monohydrate magnesium stearate pregelatinised maize starch purified talc - adefovir dipivoxil is indicated for the treatment of patients 12 years and older with chronic hepatitis b infection and evidence of hepatitis b viral replication. for adult patients this indication is based on histological, virological, biochemical, and serological responses in adult patients with hbeag+ and hbeag-/hbvdna+ chronic hepatitis b with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis b virus with either compensated or decompensated liver function. for adolescent patients (12 to <18 years of age), the indication is based on virological and biochemical responses in patients with hbeag+ chronic hepatitis b virus with compensated liver function.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - adefovir dipivoxil - tablets - adefovir dipivoxil 10 mg - adefovir dipivoxil - adefovir dipivoxil - hepsera is indicated for the treatment of chronic hepatitis b in adults with: • compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and fibrosis. initiation of hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.• decompensated liver disease in combination with a second agent without cross‐resistance to hepsera

Canada - English - Health Canada

aa pharma inc - adefovir dipivoxil - tablet - 10mg - adefovir dipivoxil 10mg - nucleosides and nucleotides