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

southern xp ip pty ltd - bivalirudin, quantity: 250 mg - injection, powder for - excipient ingredients: mannitol; sodium hydroxide - bivalirudin sxp is indicated for use as an anticoagulant: ,? in the treatment of patients with moderate to high risk acute coronary syndromes (acs) (unstable angina/non-st segment elevation myocardial infarction (ua/nstemi) who are undergoing early invasive management, and ,? in patients undergoing percutaneous coronary intervention (pci). ,bivalirudin sxp is intended for use with aspirin. ,a p2y12 antagonist (eg clopidogrel or ticlopidine) may be used in addition to aspirin.

Canada - English - Health Canada

sandoz canada incorporated - bivalirudin - powder for solution - 250mg - bivalirudin 250mg - direct thrombin inhibitors

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

eugia us llc - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (pci) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. bivalirudin for injection is contraindicated in patients with: - active major bleeding; - hypersensitivity (e.g., anaphylaxis) to bivalirudin for injection or its components [see adverse reactions (6.3) ]. risk summary there are no data available on use of bivalirudin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times the maximum recommended human dose (mrhd) of 15 mg/kg/day based on body surface area (bsa) during organogenesis, respectively, revealed no evidence of fetal harm. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects

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

mylan institutional llc - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (pci) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. bivalirudin for injection is contraindicated in patients with: there are no data available on use of bivalirudin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times the maximum recommended human dose (mrhd) of 15 mg/kg/day based on body surface area (bsa) during organogenesis, respectively, revealed no evidence of fetal harm. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. reproductive studies have been performed in rats at subcutaneous doses up to 150 mg/kg/day (1.6 times the maximum recommended human dose based on body surface area) and rabbits at subcutaneous doses up to 150 mg/kg/day (3.2 times the maximum recommended human dose based on body surface area). these studies revealed no harm to the fetus attributable to bivalirudin. at 500 mg/kg/day (equivalent to 5.4 times the maximum recommended human dose based on body surface area) subcutaneously, litter sizes and live fetuses in rats were reduced. fetal skeletal variations were also noted. some of these changes could be attributed to maternal toxicity observed at high doses. there is no study covering the peri-natal period because of the potential complications of drug-induced hemorrhage during delivery. it is not known whether bivalirudin is present in human milk. no data are available on the effects on the breastfed child or on milk production. bivalirudin was administered to lactating rats in reproduction studies (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bivalirudin for injection and any potential adverse effects on the breastfed child from bivalirudin or from the underlying maternal condition. reproduction studies conducted in lactating female rats dosed subcutaneously daily with bivalirudin at doses up to 150 mg/kg/day (1.6 times the maximum recommended human dose, based on body surface area) from day 2 through day 20 of lactation revealed no adverse developmental outcomes to the pups. the safety and effectiveness of bivalirudin in pediatric patients have not been established. in studies of patients undergoing pci, 44% were ≥ 65 years of age and 12% of patients were ≥ 75 years old. elderly patients experienced more bleeding events than younger patients. the disposition of bivalirudin was studied in ptca patients with mild, moderate and severe renal impairment. the clearance of bivalirudin was reduced approximately 21% in patients with moderate and severe renal impairment and was reduced approximately 70% in dialysis-dependent patients [see clinical pharmacology (12.3)] . reduce the infusion dose of bivalirudin and monitor the anticoagulant status more frequently in patients with renal impairment creatinine clearance less than 30 ml/min (by cockcroft gault equation) [see dosage and administration (2.2)] .

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

accord healthcare, inc. - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (pci) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. bivalirudin for injection is contraindicated in patients with: - active major bleeding; - hypersensitivity (e.g., anaphylaxis) to bivalirudin for injection or its components [see adverse reactions ( 6.3)] . risk summary there are no data available on use of bivalirudin for injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes. reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times the maximum recommended human dose (mrhd) of 15 mg/kg/day based on body surface area (bsa) during organogenesis, respectively, revealed no evidence of fetal harm. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data reproductive studies have been performed in rats at subcutaneous doses up to 150 mg/kg/day (1.6 times the maximum recommended human dose based on body surface area) and rabbits at subcutaneous doses up to 150 mg/kg/day (3.2 times the maximum recommended human dose based on body surface area). these studies revealed no harm to the fetus attributable to bivalirudin. at 500 mg/kg/day (equivalent to 5.4 times the maximum recommended human dose based on body surface area) subcutaneously, litter sizes and live fetuses in rats were reduced. fetal skeletal variations were also noted. some of these changes could be attributed to maternal toxicity observed at high doses. there is no study covering the peri-natal period because of the potential complications of drug-induced hemorrhage during delivery. risk summary it is not known whether bivalirudin is present in human milk. no data are available on the effects on the breastfed child or on milk production.   bivalirudin was administered to lactating rats in reproduction studies (see data). the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bivalirudin for injection and any potential adverse effects on the breastfed child from bivalirudin for injection or from the underlying maternal condition.   data animal data reproduction studies conducted in lactating female rats dosed subcutaneously daily with bivalirudin at doses up to 150 mg/kg/day (1.6 times the maximum recommended human dose, based on body surface area) from day 2 through day 20 of lactation revealed no adverse developmental outcomes to the pups. the safety and effectiveness of bivalirudin for injection in pediatric patients have not been established. in studies of patients undergoing pci, 44% were ≥65 years of age and 12% of patients were ≥75 years old. elderly patients experienced more bleeding events than younger patients. the disposition of bivalirudin for injection was studied in ptca patients with mild, moderate and severe renal impairment. the clearance of bivalirudin was reduced approximately 21% in patients with moderate and severe renal impairment and was reduced approximately 70% in dialysis-dependent patients [see clinical pharmacology ( 12.3)] . reduce the  infusion dose of bivalirudin for injection and monitor the anticoagulant status more frequently in patients with renal impairment creatinine clearance less than 30ml/min (by cockcroft gault equation)  [see dosage and administration ( 2.2)] .

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

cipla usa inc. - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (pci) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. bivalirudin is contraindicated in patients with: - active major bleeding; - hypersensitivity (e.g., anaphylaxis) to bivalirudin or its components [see adverse reactions (6.3)]. risk summary there are no data available on use of bivalirudin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times the maximum recommended human dose (mrhd) of 15 mg/kg/day based on body surface area (bsa) during organogenesis, respectively, revealed no evidence of fetal harm. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indica

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

sagent pharmaceuticals - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (pci) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. bivalirudin is contraindicated in patients with: - active major bleeding; - hypersensitivity (e.g., anaphylaxis) to bivalirudin or its components [see adverse reactions (6.3)]. risk summary there are no data available on use of bivalirudin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times the maximum recommended human dose (mrhd) of 15 mg/kg/day based on body surface area (bsa) during organogenesis, respectively, revealed no evidence of fetal harm. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indica

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

accord healthcare b.v. - bivalirudin 250 mg - powder for concentrate for solution for injection/infusion - 250 mg - bivalirudin 250 mg - bivalirudin

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

hainan shuangcheng pharmaceuticals co., ltd. - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (pci) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. bivalirudin is contraindicated in patients with: - active major bleeding; - hypersensitivity (e.g., anaphylaxis) to bivalirudin or its components [see adverse reactions (6.3)] . risk summary there are no data available on use of bivalirudin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times the maximum recommended human dose (mrhd) of 15 mg/kg/day based on body surface area (bsa) during organogenesis, respectively, revealed no evidence of fetal harm. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indic

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

athenex pharmaceutical division, llc. - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (pci) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. bivalirudin is contraindicated in patients with: - active major bleeding; - hypersensitivity (e.g., anaphylaxis) to bivalirudin or its components [see adverse reactions ( 6.3)]. risk summary there are no data available on use of bivalirudin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times the maximum recommended human dose (mrhd) of 15 mg/kg/day based on body surface area (bsa) during organogenesis, respectively, revealed no evidence of fetal harm. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. data animal data reproductive studies have been performed in rats at subcutaneous doses up to 150 mg/kg/day (1.6 times the maximum recommended human dose based on body surface area) and rabbits at subcutaneous doses up to 150 mg/kg/day (3.2 times the maximum recommended human dose based on body surface area). these studies revealed no harm to the fetus attributable to bivalirudin. at 500 mg/kg/day (equivalent to 5.4 times the maximum recommended human dose based on body surface area) subcutaneously, litter sizes and live fetuses in rats were reduced. fetal skeletal variations were also noted. some of these changes could be attributed to maternal toxicity observed at high doses. there is no study covering the peri-natal period because of the potential complications of drug-induced hemorrhage during delivery. risk summary it is not known whether bivalirudin is present in human milk. no data are available on the effects on the breastfed child or on milk production. bivalirudin was administered to lactating rats in reproduction studies ( see data ). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for bivalirudin and any potential adverse effects on the breastfed child from bivalirudin or from the underlying maternal condition. data animal data reproduction studies conducted in lactating female rats dosed subcutaneously daily with bivalirudin at doses up to 150 mg/kg/day (1.6 times the maximum recommended human dose, based on body surface area) from day 2 through day 20 of lactation revealed no adverse developmental outcomes to the pups. the safety and effectiveness of bivalirudin in pediatric patients have not been established. in studies of patients undergoing pci, 44% were ≥65 years of age and 12% of patients were ≥75 years old. elderly patients experienced more bleeding events than younger patients. the disposition of bivalirudin was studied in ptca patients with mild, moderate and severe renal impairment. the clearance of bivalirudin was reduced approximately 21% in patients with moderate and severe renal impairment and was reduced approximately 70% in dialysis-dependent patients [see clinical pharmacology ( 12.3)] . reduce the infusion dose of bivalirudin and monitor the anticoagulant status more frequently in patients with renal impairment creatinine clearance less than 30 ml/min (by cockcroft gault equation) [see dosage and administration ( 2.2)] .