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

physicians total care, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - linagliptin 2.5 mg - jentadueto tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate [see dosage and administration (2.1) and clinical studies (14.1)]. jentadueto should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. jentadueto has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using jentadueto [see warnings and precautions (5.2)]. jentadueto is contraindicated in patients with: - renal impairment (e.g., serum creatinine ≥1.5 mg/dl for men, ≥1.4 mg/dl for women, or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia [see warnings and precautions (5.1, 5.3)] - ac

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

boehringer ingelheim pharmaceuticals, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - linagliptin 2.5 mg - jentadueto is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use jentadueto is not recommended in patients with type 1 diabetes mellitus. jentadueto has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using jentadueto [see warnings and precautions (5.2)]. jentadueto is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1)]. - acute or chronic metabolic acidosis, including diabetic ketoacidosis [see warnings and precautions (5.1)]. - hypersensitivity to linagliptin, metformin, or any of the excipients in jentadueto, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred with linagliptin [see warnings and precautions (5.4) and adverse reactions (6.1

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

bryant ranch prepack - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - linagliptin 2.5 mg - jentadueto is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see dosage and administration (2.1) and clinical studies (14.1)]. limitations of use jentadueto should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. jentadueto has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using jentadueto [see warnings and precautions (5.2)]. jentadueto is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1)] - acute or chronic metabolic acidosis, including diabetic ketoacidosis. [see warnings and precautions (5.1)] - hypersensitivity to linagliptin, metformin, or any of the excipients in jentadueto, reactions such as anaphylaxis, angioedema, exfoliative

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

cardinal health 107, llc - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - linagliptin 5 mg - tradjenta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use tradjenta should not be used in patients with type 1 diabetes as it would not be effective. tradjenta has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using tradjenta [see warnings and precautions (5.1)]. tradjenta is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in tradjenta, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred [see warnings and precautions (5.3) and adverse reactions (6)]. risk summary the limited data with tradjenta use in pregnant women are not sufficient to inform of drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with poor

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

boehringer ingelheim pharmaceuticals, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - linagliptin 5 mg - tradjenta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use tradjenta is not recommended in patients with type 1 diabetes mellitus as it would not be effective. tradjenta has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using tradjenta [see warnings and precautions (5.1)]. tradjenta is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in tradjenta, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred [see warnings and precautions (5.3) and adverse reactions (6)]. risk summary the limited data with tradjenta use in pregnant women are not sufficient to inform of drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated

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

boehringer ingelheim pharmaceuticals, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - linagliptin 2.5 mg - jentadueto xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use jentadueto xr is not recommended in patients with type 1 diabetes mellitus. jentadueto xr has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using jentadueto xr [see warnings and precautions (5.2)]. jentadueto xr is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1)]. - acute or chronic metabolic acidosis, including diabetic ketoacidosis [see warnings and precautions (5.1)]. - hypersensitivity to linagliptin, metformin, or any of the excipients in jentadueto xr, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred with linagliptin [see warnings and precautions (5.4) and adve

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

a-s medication solutions - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - tradjenta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use tradjenta is not recommended in patients with type 1 diabetes mellitus as it would not be effective. tradjenta has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using tradjenta [see warnings and precautions (5.1)]. tradjenta is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in tradjenta, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred [see warnings and precautions (5.3) and adverse reactions (6)]. risk summary the limited data with tradjenta use in pregnant women are not sufficient to inform of drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations]. in animal reproduction studies, no adverse developmental effects were observed when linagliptin was administered to pregnant rats during the period of organogenesis at doses similar to the maximum recommended clinical dose, based on exposure [see data] . the estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20% to 25% in women with hba1c >10. the estimated background risk of 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. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data animal data no adverse developmental outcome was observed when linagliptin was administered to pregnant wistar han rats and himalayan rabbits during the period of organogenesis at doses up to 240 mg/kg/day and 150 mg/kg/day, respectively. these doses represent approximately 943-times (rats) and 1,943-times (rabbits) the 5 mg maximum clinical dose, based on exposure. no adverse functional, behavioral, or reproductive outcome was observed in offspring following administration of linagliptin to wistar han rats from gestation day 6 to lactation day 21 at a dose 49-times the maximum recommended human dose, based on exposure. linagliptin crosses the placenta into the fetus following oral dosing in pregnant rats and rabbits. risk summary there is no information regarding the presence of linagliptin in human milk, the effects on the breastfed infant, or the effects on milk production. however, linagliptin is present in rat milk. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tradjenta and any potential adverse effects on the breastfed child from tradjenta or from the underlying maternal condition. the safety and effectiveness of tradjenta have not been established in pediatric patients. effectiveness of tradjenta was not demonstrated in a 26-week randomized, double-blind, placebo-controlled trial (nct03429543) in 157 pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes mellitus. in linagliptin studies, 1,085 linagliptin-treated patients were 65 years of age and older and 131 patients were 75 years of age and older. in these linagliptin studies, no overall differences in safety or effectiveness of linagliptin were observed between geriatric patients and younger adult patients. no dosage adjustment is recommended for patients with renal impairment [see clinical pharmacology (12.3)]. in the tradjenta treatment arm of the carmelina trial [see clinical studies (14)] , 2,200 (63%) patients had renal impairment (egfr <60 ml/min/1.73 m2 ). approximately 20% of the population had egfr ≥45 to <60 ml/min/1.73 m2 , 28% of the population had egfr ≥30 to <45 ml/min/1.73 m2 and 15% had egfr <30 ml/min/1.73 m2 . the overall incidence of adverse reactions were generally similar between the tradjenta and placebo treatment arms. no dose adjustment is recommended for patients with hepatic impairment [see clinical pharmacology (12.3)] .

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

boehringer ingelheim pharmaceuticals, inc. - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u), linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - trijardy xr is a combination of empagliflozin, linagliptin, and metformin hydrochloride (hcl) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see clinical studies (14.2)] . limitations of use trijardy xr is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [see warnings and precautions (5.2)] . trijardy xr has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using trijardy xr [see warnings and precautions (5.3)]. trijardy xr is contraindicated in patients with: - severe renal impairment (egfr less than 30 ml/min/1.73 m2 ), end-stage renal disease,

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

boehringer ingelheim pharmaceuticals, inc. - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u), linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - empagliflozin 10 mg - glyxambi is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see clinical studies (14.2)] . limitations of use glyxambi is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [see warnings and precautions (5.1)] . glyxambi has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using glyxambi [see warnings and precautions (5.2)]. glyxambi is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an egfr less than 30 ml/min/1.73 m2 . glyxambi is likely to be ineffecti

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

remedyrepack inc. - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u), linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - glyxambi is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see clinical studies (14.2)] . however, the effectiveness of glyxambi on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established. limitations of use glyxambi is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis [see warnings and precautions (5.4)] . glyxambi has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using glyxambi