European Union - English - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic acid, ezetimibe - hypercholesterolemia; dyslipidemias - lipid modifying agents - nustendi is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin in addition to ezetimibealone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach ldl-c goals with ezetimibe alone,in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin

Kenya - English - Pharmacy and Poisons Board

dawa limited plot no 7879/8, baba dogo road-ruaraka, p.o box - bempedoic acid and ezetimibe - film-coated tablet - bempedoic acid 180mg/ ezetimibe usp 10mg - bempedoic acid and ezetimibe

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

esperion therapeutics, inc. - bempedoic acid (unii: 1ej6z6q368) (bempedoic acid - unii:1ej6z6q368), ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - nexlizet, a combination of bempedoic acid and ezetimibe, is indicated: - as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (ldl-c) lowering therapies, to reduce ldl-c in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh). the bempedoic acid component of nexlizet is indicated: - to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with: established cardiovascular disease (cvd), or a high risk for a cvd event but without established cvd. - established cardiovascular disease (cvd), or - a high risk for a cvd event but without established cvd. nexlizet is contraindicated in patients with a prior hypersensitivity to ezetimibe or bempedoic acid or any of the excipients in nexlizet [see adverse reactions (6.2)] . serious hypersensitivity reactions, such as anaphylaxis, angioedema, rash and urticaria have been reported with ezetimibe or bempedoic acid. risk summary discontinue nexlizet when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. there are insufficient data on bempedoic acid use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there are insufficient data on ezetimibe use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, bempedoic acid was not teratogenic in rats and rabbits when administered at doses resulting in exposures up to 11 and 12 times, respectively, the human exposures at the maximum clinical dose, based on auc. in oral (gavage) embryo-fetal development studies of ezetimibe conducted in rats and rabbits during organogenesis, there was no evidence of maternal toxicity or embryo-fetal teratogenic or toxicologic effects at exposures up to 10 and 150 times the human exposure, respectively, based on auc (see data) . nexlizet decreases cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol; therefore, nexlizet may cause fetal harm when administered to pregnant women based on the mechanism of action [see clinical pharmacology (12.1)] . in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. 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. report pregnancies to the esperion therapeutics, inc. adverse event reporting line at 1-833-377-7633. data animal data bempedoic acid bempedoic acid was not teratogenic when given orally at doses of 60 and 80 mg/kg/day, resulting in 11 and 12 times the systemic exposure in humans at the maximum recommended human dose (mrhd) of 180 mg to pregnant rats and rabbits, respectively. in an embryofetal development study in rats, bempedoic acid was given orally to pregnant rats at 10, 30, and 60 mg/kg/day during the period of organogenesis from gestation day 6 to 17. there were increases in the incidence of non-adverse fetal skeletal variations (bent long bones and bent scapula and incomplete ossification) at doses ≥ 10 mg/kg/day (less than the clinical exposure) in the absence of maternal toxicity. at maternally toxic doses, bempedoic acid caused decreases in the numbers of viable fetuses, increases in post-implantation loss, and increased total resorptions at 60 mg/kg/day (11 times mrhd) and reduced fetal body weight at ≥ 30 mg/kg/day (4 times the mrhd). no adverse development effects were observed when bempedoic acid was given to pregnant rabbits during the period of organogenesis (gestation day 6 to 18) at doses up to 80 mg/kg/day (12 times mrhd). in a pre- and post-natal development study in pregnant rats given oral doses of bempedoic acid at 5, 10, 20, 30 and 60 mg/kg/day throughout pregnancy and lactation (gestation day 6 to lactation day 20), there were adverse effects on delivery in the presence of maternal toxicity, including: increases in stillborn pups, reductions in numbers of live pups, pup survival, pup growth and slight delays in learning and memory at ≥ 10 mg/kg/day (at exposures equivalent to the mrhd). ezetimibe in oral (gavage) embryo-fetal development studies of ezetimibe conducted in rats (gestation days 6-15) and rabbits (gestation days 7-19), there was no evidence of maternal toxicity or embryolethal effects at the doses tested (250, 500, 1,000 mg/kg/day). in rats, increased incidences of common fetal skeletal findings (extra pair of thoracic ribs, unossified cervical vertebral centra, shortened ribs) were observed at 1,000 mg/kg/day (approximately 10 times the human exposure at 10 mg daily based on auc0-24hr for total ezetimibe). in rabbits treated with ezetimibe, an increased incidence of extra thoracic ribs was observed at 1,000 mg/kg/day (150 times the human exposure at 10 mg daily based on auc0-24hr for total ezetimibe). the animal-to-human exposure multiple for total ezetimibe at the no-observed effect level was 6 times for rat and 134 times for rabbit. fetal exposure to ezetimibe (conjugated and unconjugated) was confirmed in subsequent placental transfer studies conducted using a maternal dose of 1,000 mg/kg/day. the fetal maternal plasma exposure ratio (total ezetimibe) was 1.5 for rats on gestation day 20 and 0.03 for rabbits on gestation day 22. the effect of ezetimibe on prenatal and postnatal development and maternal function was evaluated in pregnant rats at doses of 100, 300 or 1,000 mg/kg/day from gestation day 6 through lactation day 21. no maternal toxicity or adverse developmental outcomes were observed up to and including the highest dose tested (17 times the human exposure at 10 mg daily based on auc0-24hr for total ezetimibe). multiple-dose studies of ezetimibe given in combination with statins in rats and rabbits during organogenesis resulted in higher ezetimibe and statin exposures. reproductive findings occurred at lower doses in combination therapy compared to monotherapy. bempedoic acid/ezetimibe fixed combination drug product (fcdp) in a combination embryofetal development study in rats, bempedoic acid and ezetimibe were given orally at 4 and 112-times mrhd (based on auc) during the period of organogenesis (gestation day 6 to 17) in pregnant rats. bempedoic acid in combination with ezetimibe did not alter the effects on embryo-fetal development profile of bempedoic acid or ezetimibe. risk summary there is no information regarding the presence of bempedoic acid in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. there is no information about the presence of ezetimibe in human milk. ezetimibe is present in rat milk (see data ). when a drug is present in animal milk, it is likely that the drug will be present in human milk. there is no information about the effects of ezetimibe on the breastfed infant or the effects of ezetimibe on milk production. nexlizet decreases cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with nexlizet [see use in specific populations (8.1), clinical pharmacology (12.1)] . data animal data ezetimibe was present in the milk of lactating rats. the pup to maternal plasma ratio for total ezetimibe was 0.5 on lactation day 12. the safety and effectiveness of nexlizet have not been established in pediatric patients. of the 301 patients in the clinical trial of nexlizet, 149 (50%) were 65 years of age and older, while 49 (16%) were 75 years of age and over. no overall differences in safety or effectiveness of nexlizet have been observed between patients 65 years of age and older and younger adult patients. no dosage adjustment is necessary in patients with mild or moderate renal impairment. there is limited experience with bempedoic acid in patients with severe renal impairment (egfr < 30ml/min/1.73 m2 ), and bempedoic acid has not been studied in patients with end-stage renal disease (esrd) receiving dialysis [see clinical pharmacology (12.3)] . no dosage adjustment is necessary in patients with mild hepatic impairment (child-pugh a) [see clinical pharmacology (12.3)] . nexlizet is not recommended in patients with moderate or severe hepatic impairment (child-pugh b or c) due to the unknown effects of the increased exposure to ezetimibe [see clinical pharmacology (12.3)] .

European Union - English - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic acid - hypercholesterolemia; dyslipidemias - lipid modifying agents - nilemdo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl c goals with the maximum tolerated dose of a statin (see sections 4.2, 4.3, and 4.4) or,alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.

Bangladesh - English - DGDA (Directorate General of Drug Administration)

incepta pharmaceuticals ltd. - bempedoic acid + ezetimibe - tablet - 180 mg + 10 mg

Kenya - English - Pharmacy and Poisons Board

bempedoic acid - film-coated tablet - bempedoic acid (ih)…………. 180 mg - other plain lipid modifying agents

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

esperion therapeutics, inc. - bempedoic acid (unii: 1ej6z6q368) (bempedoic acid - unii:1ej6z6q368) - nexletol is indicated: - to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with: established cardiovascular disease (cvd), or a high risk for a cvd event but without established cvd. - established cardiovascular disease (cvd), or - a high risk for a cvd event but without established cvd. - as an adjunct to diet, in combination with other low-density lipoprotein cholesterol (ldl-c) lowering therapies, or alone when concomitant ldl-c lowering therapy is not possible, to reduce ldl-c in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh). nexletol is contraindicated in patients with a prior serious hypersensitivity reaction to bempedoic acid or any of the excipients in nexletol. serious hypersensitivity reactions, such as angioedema, have occurred [see adverse reactions (6.2)]. risk summary discontinue nexletol when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. there are insufficient data on nexletol use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, bempedoic acid was not teratogenic in rats and rabbits when administered at doses resulting in exposures up to 11 and 12 times, respectively, the human exposures at the maximum clinical dose, based on auc (see data) . nexletol decreases cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol; therefore, nexletol may cause fetal harm when administered to pregnant women based on the mechanism of action [see clinical pharmacology (12.1)] . in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. 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. report pregnancies to the esperion therapeutics, inc. adverse event reporting line at 1-833-377-7633. data animal data bempedoic acid was not teratogenic when given orally at doses of 60 and 80 mg/kg/day, resulting in 11 and 12 times the systemic exposure in humans at the maximum recommended human dose (mrhd) of 180 mg to pregnant rats and rabbits, respectively. in an embryofetal development study in rats, bempedoic acid was given orally to pregnant rats at 10, 30, and 60 mg/kg/day during the period of organogenesis from gestation day 6 to 17. there were increases in the incidence of non-adverse fetal skeletal variations (bent long bones and bent scapula and incomplete ossification) at doses ≥ 10 mg/kg/day (less than the clinical exposure) in the absence of maternal toxicity. at maternally toxic doses, bempedoic acid caused decreases in the numbers of viable fetuses, increases in post-implantation loss, and increased total resorptions at 60 mg/kg/day (11 times mrhd) and reduced fetal body weight at ≥ 30 mg/kg/day (4 times the mrhd). no adverse development effects were observed when bempedoic acid was given to pregnant rabbits during the period of organogenesis (gestation day 6 to 18) at doses up to 80 mg/kg/day (12 times mrhd). in a pre- and post-natal development study in pregnant rats given oral doses of bempedoic acid at 5, 10, 20, 30 and 60 mg/kg/day throughout pregnancy and lactation (gestation day 6 to lactation day 20), there were adverse effects on delivery in the presence of maternal toxicity, including: increases in stillborn pups, reductions in numbers of live pups, pup survival, pup growth and slight delays in learning and memory at ≥ 10 mg/kg/day (at exposures equivalent to the mrhd). risk summary there is no information regarding the presence of nexletol in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. nexletol decreases cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with nexletol [see use in specific populations (8.1), clinical pharmacology (12.1)]. the safety and effectiveness of nexletol have not been established in pediatric patients. of the 3,009 adult patients in the primary hyperlipidemia trials of nexletol, 1,753 (58%) were 65 years of age and older, while 478 (16%) were 75 years of age and older. of the 13,970 adult patients in the cardiovascular outcomes trial [see clinical studies (14.2)] , 8,204 (59%) were 65 years of age and older, while 2,107 (15%) were 75 years of age and older. no overall differences in safety or effectiveness of nexletol have been observed between patients 65 years of age and older and younger adult patients. no dosage adjustment is necessary in patients with mild or moderate renal impairment. there is limited experience with nexletol in patients with severe renal impairment (egfr < 30 ml/min/1.73 m2 ), and nexletol has not been studied in patients with end-stage renal disease (esrd) receiving dialysis [see clinical pharmacology (12.3)] . no dosage adjustment is necessary in patients with mild or moderate hepatic impairment (child-pugh a or b) [see clinical pharmacology (12.3)] . patients with severe hepatic impairment (child-pugh c) have not been studied.

Kenya - English - Pharmacy and Poisons Board

dawa limited plot no 7879/8, baba dogo road-ruaraka, p.o box - bempedoic acid - film-coated tablet - each filmed coated tablet contains: bempedoic… - other plain lipid modifying agents

Bangladesh - English - DGDA (Directorate General of Drug Administration)

eskayef pharmaceuticals ltd., tongi,gazipur - bempedoic acid - tablet - 180 mg

Bangladesh - English - DGDA (Directorate General of Drug Administration)

navana pharmaceuticals ltd. - bempedoic acid - tablet - 180 mg