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

bristol-myers squibb australia pty ltd - apixaban, quantity: 5 mg - tablet, film coated - excipient ingredients: sodium lauryl sulfate; microcrystalline cellulose; lactose; purified water; magnesium stearate; croscarmellose sodium; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red - eliquis is indicated for the prevention of venous thromboembolic events (vte) in adult patients who have undergone elective total hip or total knee replacement surgery.,eliquis is indicated for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.,eliquis is indicated for the treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) in adult patients.,eliquis is indicated for the prevention of recurrent dvt and pe in adult patients.

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

a-s medication solutions - apixaban (unii: 3z9y7uwc1j) (apixaban - unii:3z9y7uwc1j) - apixaban 2.5 mg - eliquis is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. eliquis is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe), in patients who have undergone hip or knee replacement surgery. eliquis is indicated for the treatment of dvt. eliquis is indicated for the treatment of pe. eliquis is indicated to reduce the risk of recurrent dvt and pe following initial therapy. eliquis is contraindicated in patients with the following conditions: the limited available data on eliquis use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes. treatment may increase the risk of bleeding during pregnancy and delivery. in animal reproduction studies, no adverse developmental effects were seen when apixaban was administered to rats (orally), rabbits (intravenously) and mice (orally) during organogenesis at unbound apixaban exposure levels up to 4, 1 and 19 times, respectively, the human exposure based on area under plasma-concentration time curve (auc) at the maximum recommended human dose (mrhd) of 5 mg twice daily. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. 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 major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnancy confers an increased risk of thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. fetal/neonatal adverse reactions use of anticoagulants, including eliquis, may increase the risk of bleeding in the fetus and neonate. labor or delivery all patients receiving anticoagulants, including pregnant women, are at risk for bleeding. eliquis use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. consider use of a shorter acting anticoagulant as delivery approaches [see warnings and precautions (5.3)] . data animal data no developmental toxicities were observed when apixaban was administered during organogenesis to rats (orally), rabbits (intravenously) and mice (orally) at unbound apixaban exposure levels 4, 1, and 19 times, respectively, the human exposures at the mrhd. there was no evidence of fetal bleeding, although conceptus exposure was confirmed in rats and rabbits. oral administration of apixaban to rat dams from gestation day 6 through lactation day 21 at maternal unbound apixaban exposures ranging from 1.4 to 5 times the human exposures at the mrhd was not associated with reduced maternal mortality or reduced conceptus/neonatal viability, although increased incidences of peri-vaginal bleeding were observed in dams at all doses. there was no evidence of neonatal bleeding. risk summary there are no data on the presence of apixaban or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. apixaban and/or its metabolites were present in the milk of rats (see data). because human exposure through milk is unknown, breastfeeding is not recommended during treatment with eliquis. data animal data maximal plasma concentrations were observed after 30 minutes following a single oral administration of a 5 mg dose to lactating rats. maximal milk concentrations were observed 6 hours after dosing. the milk to plasma auc (0-24) ratio is 30:1 indicating that apixaban can accumulate in milk. the concentrations of apixaban in animal milk does not necessarily predict the concentration of drug in human milk. females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. the risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including eliquis should be assessed in females of reproductive potential and those with abnormal uterine bleeding. safety and effectiveness in pediatric patients have not been established. of the total subjects in the aristotle and averroes clinical studies, >69% were 65 years of age and older, and >31% were 75 years of age and older. in the advance-1, advance-2, and advance-3 clinical studies, 50% of subjects were 65 years of age and older, while 16% were 75 years of age and older. in the amplify and amplify-ext clinical studies, >32% of subjects were 65 years of age and older and >13% were 75 years of age and older. no clinically significant differences in safety or effectiveness were observed when comparing subjects in different age groups. the recommended dose is 2.5 mg twice daily in patients with at least two of the following characteristics [see dosage and administration (2.1)] : clinical efficacy and safety studies with eliquis did not enroll patients with end-stage renal disease (esrd) on dialysis. in patients with esrd maintained on intermittent hemodialysis, administration of eliquis at the usually recommended dose [see dosage and administration (2.1)] will result in concentrations of apixaban and pharmacodynamic activity similar to those observed in the aristotle study [see clinical pharmacology (12.3)] . it is not known whether these concentrations will lead to similar stroke reduction and bleeding risk in patients with esrd on dialysis as was seen in aristotle. no dose adjustment is recommended for patients with renal impairment, including those with esrd on dialysis [see dosage and administration (2.1)] . clinical efficacy and safety studies with eliquis did not enroll patients with esrd on dialysis or patients with a crcl <15 ml/min; therefore, dosing recommendations are based on pharmacokinetic and pharmacodynamic (anti-fxa activity) data in subjects with esrd maintained on dialysis [see clinical pharmacology (12.3) ] . no dose adjustment is required in patients with mild hepatic impairment (child-pugh class a). because patients with moderate hepatic impairment (child-pugh class b) may have intrinsic coagulation abnormalities and there is limited clinical experience with eliquis in these patients, dosing recommendations cannot be provided [see clinical pharmacology (12.2)] . eliquis is not recommended in patients with severe hepatic impairment (child-pugh class c) [see clinical pharmacology (12.2)] .

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

bryant ranch prepack - apixaban (unii: 3z9y7uwc1j) (apixaban - unii:3z9y7uwc1j) - eliquis is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. eliquis is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe), in patients who have undergone hip or knee replacement surgery. eliquis is indicated for the treatment of dvt. eliquis is indicated for the treatment of pe. eliquis is indicated to reduce the risk of recurrent dvt and pe following initial therapy. eliquis is contraindicated in patients with the following conditions: the limited available data on eliquis use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes. treatment may increase the risk of bleeding during pregnancy and delivery. in animal reproduction studies, no adverse developmental effects were seen when apixaban was administered to rats (orally), rabbits (intravenously) and mice (orally) during organogenesis at unbound apixaban exposu

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

bryant ranch prepack - apixaban (unii: 3z9y7uwc1j) (apixaban - unii:3z9y7uwc1j) - eliquis is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. eliquis is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe), in patients who have undergone hip or knee replacement surgery. eliquis is indicated for the treatment of dvt. eliquis is indicated for the treatment of pe. eliquis is indicated to reduce the risk of recurrent dvt and pe following initial therapy. eliquis is contraindicated in patients with the following conditions: the limited available data on eliquis use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes. treatment may increase the risk of bleeding during pregnancy and delivery. in animal reproduction studies, no adverse developmental effects were seen when apixaban was administered to rats (orally), rabbits (intravenously) and mice (orally) during organogenesis at unbound apixaban exposu

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - apixaban 2.5mg;  ;   - film coated tablet - 2.5 mg - active: apixaban 2.5mg     excipient: croscarmellose sodium lactose magnesium stearate microcrystalline cellulose opadry yellow sodium laurilsulfate - eliquis is indicated for the prevention of venous thromboembolic events in adult patients who have undergone elective total hip or total knee replacement surgery.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - apixaban 5mg;  ;   - film coated tablet - 5 mg - active: apixaban 5mg     excipient: croscarmellose sodium lactose magnesium stearate microcrystalline cellulose opadry sodium laurilsulfate - eliquis is indicated for the prevention of venous thromboembolic events in adult patients who have undergone elective total hip or total knee replacement surgery.

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

bristol-myers squibb australia pty ltd - apixaban -

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - apixaban - tablet, film coated - 5mg - apixaban 5mg

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - apixaban - tablet, film coated - 2.5mg - apixaban 2.5mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pfizer (malaysia) sdn. bhd. - apixaban -