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

teva parenteral medicines, inc. - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide 2 mg in 1 ml - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke - current o

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

amneal pharmaceuticals llc - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide 2 mg in 1 ml - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure > 200 mm hg or diastolic blood pressure > 110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke - current or planned administration of another parenteral gp iib/iiia inhibitor - dependency on renal dialysis - hypersensitivity to eptifibatide or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria) risk summary available data on eptifibatide use in pregnant women from published literature and the pharmacovigilance database are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. untreated myocardial infarction can be fatal to the pregnant woman and fetus (see clinical considerations) . in animal reproduction studies, there was no evidence of adverse developmental effects when eptifibatide was administered intravenously to pregnant rats and rabbits at approximately 4 times the recommended maximum daily human dose. the estimated background risk of major birth defects and miscarriage for the indicated population 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 myocardial infarction is a medical emergency in pregnancy which can be fatal to the pregnant woman and fetus if left untreated. therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of eptifibatide on the fetus. data animal data embryo-fetal development studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats during the period of organogenesis at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits during the period of organogenesis at total daily doses of up to 36 mg/kg/day (also about 4 times the recommended maximum daily human dose on a body surface area basis). these studies revealed no evidence of harm to the fetus due to eptifibatide. risk summary there are no available data on the presence of eptifibatide in human milk, the effects on the breastfed infant, or the effects on milk production. as eptifibatide is a peptide, it is likely to be destroyed in the infant’s gastrointestinal tract and not absorbed orally by the breastfed infant. safety and effectiveness of eptifibatide in pediatric patients have not been studied. the pursuit and impact ii clinical studies enrolled patients up to the age of 94 years (45% were age 65 and over; 12% were age 75 and older). there was no apparent difference in efficacy between older and younger patients treated with eptifibatide. the incidence of bleeding complications was higher in the elderly in both placebo and eptifibatide groups and the incremental risk of eptifibatide-associated bleeding was greater in the older patients. no dose adjustment was made for elderly patients, but patients over 75 years of age had to weigh at least 50 kg to be enrolled in the pursuit study; no such limitation was stipulated in the esprit study [see adverse reactions (6.1)] . approximately 50% of eptifibatide is cleared by the kidney in patients with normal renal function. total drug clearance is decreased by approximately 50% and steady-state plasma eptifibatide concentrations are doubled in patients with an estimated crcl < 50 ml/min (using the cockcroft-gault equation). therefore, the infusion dose should be reduced to 1 mcg/kg/min in such patients [see dosage and administration (2)] . the safety and efficacy of eptifibatide in patients dependent on dialysis has not been established.

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

akorn - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide 0.75 mg in 1 ml - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide injection is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke -

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

eugia us llc - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide 75 mg in 100 ml - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide injection is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke - current or planned administration of another parenteral gp iib/iiia inhibitor - dependency on renal dialysis - hypersensitivity to eptifibatide injection or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria) risk summary available data on eptifibatide use in pregnant women from published literature and the pharmacovigilance database are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. untreated myocardial infarction can be fatal to the pregnant woman and fetus (see clinical considerations) . in animal reproduction studies, there was no evidence of adverse developmental effects when eptifibatide was administered intravenously to pregnant rats and rabbits at approximately 4 times the recommended maximum daily human dose. the estimated background risk of major birth defects and miscarriage for the indicated population 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 myocardial infarction is a medical emergency in pregnancy which can be fatal to the pregnant woman and fetus if left untreated. therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of eptifibatide on the fetus data animal data embryo-fetal development studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats during the period of organogenesis at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits during the period of organogenesis at total daily doses of up to 36 mg/kg/day (also about 4 times the recommended maximum daily human dose on a body surface area basis). these studies revealed no evidence of harm to the fetus due to eptifibatide. risk summary there are no available data on the presence of eptifibatide in human milk, the effects on the breastfed infant, or the effects on milk production. as eptifibatide is a peptide, it is likely to be destroyed in the infant’s gastrointestinal tract and not absorbed orally by the breastfed infant. safety and effectiveness of eptifibatide in pediatric patients have not been studied. the pursuit and impact ii clinical studies enrolled patients up to the age of 94 years (45% were age 65 and over; 12% were age 75 and older). there was no apparent difference in efficacy between older and younger patients treated with eptifibatide. the incidence of bleeding complications was higher in the elderly in both placebo and eptifibatide groups, and the incremental risk of eptifibatide-associated bleeding was greater in the older patients. no dose adjustment was made for elderly patients, but patients over 75 years of age had to weigh at least 50 kg to be enrolled in the pursuit study; no such limitation was stipulated in the esprit study [see adverse reactions (6.1)] . approximately 50% of eptifibatide is cleared by the kidney in patients with normal renal function. total drug clearance is decreased by approximately 50% and steady-state plasma eptifibatide concentrations are doubled in patients with an estimated crcl <50 ml/min (using the cockcroft-gault equation). therefore, the infusion dose should be reduced to 1 mcg/kg/min in such patients [see dosage and administration (2)] . the safety and efficacy of eptifibatide in patients dependent on dialysis has not been established.

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

accord healthcare inc. - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide 2 mg in 1 ml - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide injection is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - histo

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - eptifibatide - myocardial infarction - antithrombotic agents - eptifibatide accord is intended for use with acetylsalicylic acid and unfractionated heparin.eptifibatide accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ecg) changes and/or elevated cardiac enzymes.patients most likely to benefit from eptifibatide accord treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early ptca (percutaneous transluminal coronary angioplasty).

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

hainan poly pharm. co., ltd. - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies ( 14.1, 14.2)] . treatment with eptifibatide injection is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihyperte

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

slate run pharmaceuticals, llc - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies ( 14.1, 14.2)] . treatment with eptifibatide injection is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihyperte

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

teva parenteral medicines, inc. - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide 0.75 mg in 1 ml

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

athenex pharmaceutical division, llc. - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies ( 14.1, 14.2)] . treatment with eptifibatide is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke - current or planned administration of another parenteral gp iib/iiia inhibitor - dependency on renal dialysis - hypersensitivity to eptifibatide or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria) risk summary available data on eptifibatide use in pregnant women from published literature and the pharmacovigilance database are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. untreated myocardial infarction can be fatal to the pregnant woman and fetus (see clinical considerations) . in animal reproduction studies, there was no evidence of adverse developmental effects when eptifibatide was administered intravenously to pregnant rats and rabbits at approximately 4 times the recommended maximum daily human dose. the estimated background risk of major birth defects and miscarriage for the indicated population 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 myocardial infarction is a medical emergency in pregnancy which can be fatal to the pregnant woman and fetus if left untreated. therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of eptifibatide on the fetus. data animal data embryo-fetal development studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats during the period of organogenesis at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits during the period of organogenesis at total daily doses of up to 36 mg/kg/day (also about 4 times the recommended maximum daily human dose on a body surface area basis). these studies revealed no evidence of harm to the fetus due to eptifibatide. risk summary there are no available data on the presence of eptifibatide in human milk, the effects on the breastfed infant, or the effects on milk production. as eptifibatide is a peptide, it is likely to be destroyed in the infant's gastrointestinal tract and not absorbed orally by the breastfed infant. safety and effectiveness of eptifibatide in pediatric patients have not been studied. the pursuit and impact ii clinical studies enrolled patients up to the age of 94 years (45% were age 65 and over; 12% were age 75 and older). there was no apparent difference in efficacy between older and younger patients treated with eptifibatide. the incidence of bleeding complications was higher in the elderly in both placebo and eptifibatide groups, and the incremental risk of eptifibatide-associated bleeding was greater in the older patients. no dose adjustment was made for elderly patients, but patients over 75 years of age had to weigh at least 50 kg to be enrolled in the pursuit study; no such limitation was stipulated in the esprit study [see adverse reactions ( 6.1)] . approximately 50% of eptifibatide is cleared by the kidney in patients with normal renal function. total drug clearance is decreased by approximately 50% and steady-state plasma eptifibatide concentrations are doubled in patients with an estimated crcl <50 ml/min (using the cockcroft-gault equation). therefore, the infusion dose should be reduced to 1 mcg/kg/min in such patients [see dosage and administration ( 2)] . the safety and efficacy of eptifibatide in patients dependent on dialysis has not been established.