BEXAGLIFLOZIN (UNII: EY00JF42FV) (BEXAGLIFLOZIN - UNII:EY00JF42FV) - search results

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

brenzavvy- bexagliflozin tablet

golden state medical supply, inc. - bexagliflozin (unii: ey00jf42fv) (bexagliflozin - unii:ey00jf42fv) - bexagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use bexagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. [see warnings and precautions ( 5.1)] . bexagliflozin is contraindicated in patients: - with hypersensitivity to bexagliflozin or any excipient in bexagliflozin. anaphylaxis and angioedema have been reported with sodium-glucose co-transporter 2 (sglt2) inhibitors. risk summary based on animal data showing adverse renal effects, bexagliflozin is not recommended during the second and third trimesters of pregnancy. the available data on use of bexagliflozin during pregnancy are insufficient to determine a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical consideratio

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

bexagliflozin tablet

theracosbio, llc - bexagliflozin (unii: ey00jf42fv) (bexagliflozin - unii:ey00jf42fv) - bexagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use bexagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. [see warnings and precautions (5.1)] . bexagliflozin tablets are contraindicated in patients: - with hypersensitivity to bexagliflozin or any excipient in bexagliflozin tablets. anaphylaxis and angioedema have been reported with sodium-glucose co-transporter 2 (sglt2) inhibitors. risk summary based on animal data showing adverse renal effects, bexagliflozin is not recommended during the second and third trimesters of pregnancy. the available data on use of bexagliflozin tablets during pregnancy are insufficient to determine a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . in animal studies, adverse renal pelvic and tubule dilatations that were not fully reversible were observed in rats when bexagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy at exposures 11 times the 20 mg clinical dose (see data) . the estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a peri-conceptional hba1c > 7% and has been reported to be as high as 20% to 25% in women with a peri-conceptional 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 hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. 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 bexagliflozin administered to juvenile rats at 0.3, 3 or 30 mg/kg/day by oral gavage from postnatal days 21 to 90 caused a dose dependent increase in the incidence and severity of renal pelvic and tubular dilatation at ≥ 3 mg/kg (11 times the clinical dose of 20 mg based on auc). these outcomes occurred with drug exposure during periods of renal development in rats equivalent to the late second and third trimester of human renal development and did not fully reverse following a 1-month recovery period. in embryofetal development studies in rats and rabbits, bexagliflozin was administered at 7, 40, and 200 mg/kg/day (rats) and 5, 25, and 150 mg/kg/day (rabbits) during organogenesis. no adverse developmental effects were observed in rats at doses up to 200 mg/kg/day (551 times the clinical dose of 20 mg based on auc). reduced maternal body weight, embryo lethality, and fetal malformations were observed in rabbits at 150 mg/kg/day (368 times the clinical dose of 20 mg based on auc). in a prenatal and postnatal development study, bexagliflozin was administered to maternal rats by oral gavage during organogenesis and until weaning at doses of 7, 40, or 200 mg/kg/day. maternal mortality occurred at ≥ 40 mg/kg (79 times the clinical dose of 20 mg based on auc), primarily following parturition. reduced gestational body weight, increased post-implantation loss, and smaller litter size were noted at 200 mg/kg (361 times the clinical dose of 20 mg based on auc). in the offspring, lower body weight gain and decreased survival were noted at 200 mg/kg, which occurred in the presence of significant maternal toxicity. risk summary there is no information regarding the presence of bexagliflozin in human milk, the effects on the breastfed infant or the effects on milk production. bexagliflozin is excreted in the milk of lactating rats (see data) . when a drug is present in animal milk, it is likely that the drug will be present in human milk. since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. because of the potential for serious adverse reactions in a breastfed infant, including the potential for bexagliflozin to affect postnatal renal development, advise patients that use of bexagliflozin tablets is not recommended while breastfeeding. data bexagliflozin was present in rat milk at a milk:plasma ratio of approximately 2. the concentration of bexagliflozin in animal milk does not necessarily predict the concentration of bexagliflozin in human milk. juvenile rats directly exposed to bexagliflozin showed a risk to the developing kidney (renal pelvic and tubular dilatation) during the period of renal development in rats corresponding to the late second and third trimester of human renal development. the safety and effectiveness of bexagliflozin tablets have not been established in pediatric patients. in 9 clinical trials of bexagliflozin tablets, 1047 (40.6%) patients 65 years and older, and 212 (8.2%) patients 75 years and older were exposed to bexagliflozin tablets [see clinical studies (14)] . one of the 9 trials enrolled patients with type 2 diabetes mellitus who had either established cvd or were at increased risk for cvd (trial 6), and had a total of 571 (50%) patients treated with bexagliflozin tablets who were 65 years and older, and 113 (10%) patients treated with bexagliflozin tablets who were 75 years and older [see clinical studies (14.5)] . no overall differences in the effectiveness of bexagliflozin tablets have been observed between patients 65 years of age and older and younger adult patients. among patients aged 65 and older in this trial, volume depletion events were reported in 7.6% and 9.8% of patients in the placebo and bexagliflozin tablets groups, respectively [see warnings and precautions (5.3)] . bexagliflozin is not recommended in patients with an egfr less than 30 ml/min/1.73 m2 due to the decline of the glucose lowering effect of bexagliflozin tablets and reduction in urine output in these patients [see clinical pharmacology (12.3)] . the recommended dosage for patients with an egfr greater than or equal to 30 ml/min/1.73 m2 is the same as the recommended dosage for patients with normal renal function [see dosage and administration (2.1)] . the safety and efficacy of bexagliflozin tablets in adults with type 2 diabetes mellitus and moderate renal impairment (egfr between 30 and 60 ml/min/1.73 m2 ) were evaluated in trial 5 [see clinical studies (14.4)] . efficacy and safety studies with bexagliflozin tablets did not enroll patients with an egfr less than 30 ml/min/1.73 m2 . bexagliflozin-treated patients with renal impairment may be more likely to experience adverse reactions associated with bexagliflozin treatment, including female genital mycotic infection, increased urination, and thirst, and may be at higher risk for volume depletion and acute kidney injury [see warnings and precautions (5.3) and adverse reactions (6.1)] . bexagliflozin tablets have not been studied in patients with severe hepatic impairment and is not recommended for use in this patient population. the recommended dosage for patients with mild to moderate hepatic impairment is the same as the recommended dosage for patients with normal hepatic function [see clinical pharmacology (12.3)] .

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

brenzavvy- bexagliflozin tablet

theracosbio, llc - bexagliflozin (unii: ey00jf42fv) (bexagliflozin - unii:ey00jf42fv) - brenzavvy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use brenzavvy is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. [see warnings and precautions (5.1)] . brenzavvy is contraindicated in patients: - with hypersensitivity to bexagliflozin or any excipient in brenzavvy. anaphylaxis and angioedema have been reported with sodium-glucose co-transporter 2 (sglt2) inhibitors. risk summary based on animal data showing adverse renal effects, brenzavvy is not recommended during the second and third trimesters of pregnancy. the available data on use of brenzavvy during pregnancy are insufficient to determine a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . in animal studies, adverse renal pelvic and tubule dilatations that were not fully reversible were observed in rats when bexagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy at exposures 11 times the 20 mg clinical dose (see data) . the estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a peri-conceptional hba1c > 7% and has been reported to be as high as 20% to 25% in women with a peri-conceptional 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 hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. 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 bexagliflozin administered to juvenile rats at 0.3, 3 or 30 mg/kg/day by oral gavage from postnatal days 21 to 90 caused a dose dependent increase in the incidence and severity of renal pelvic and tubular dilatation at ≥ 3 mg/kg (11 times the clinical dose of 20 mg based on auc). these outcomes occurred with drug exposure during periods of renal development in rats equivalent to the late second and third trimester of human renal development and did not fully reverse following a 1-month recovery period. in embryofetal development studies in rats and rabbits, bexagliflozin was administered at 7, 40, and 200 mg/kg/day (rats) and 5, 25, and 150 mg/kg/day (rabbits) during organogenesis. no adverse developmental effects were observed in rats at doses up to 200 mg/kg/day (551 times the clinical dose of 20 mg based on auc). reduced maternal body weight, embryo lethality, and fetal malformations were observed in rabbits at 150 mg/kg/day (368 times the clinical dose of 20 mg based on auc). in a prenatal and postnatal development study, bexagliflozin was administered to maternal rats by oral gavage during organogenesis and until weaning at doses of 7, 40, or 200 mg/kg/day. maternal mortality occurred at ≥ 40 mg/kg (79 times the clinical dose of 20 mg based on auc), primarily following parturition. reduced gestational body weight, increased post-implantation loss, and smaller litter size were noted at 200 mg/kg (361 times the clinical dose of 20 mg based on auc). in the offspring, lower body weight gain and decreased survival were noted at 200 mg/kg, which occurred in the presence of significant maternal toxicity. risk summary there is no information regarding the presence of bexagliflozin in human milk, the effects on the breastfed infant or the effects on milk production. bexagliflozin is excreted in the milk of lactating rats (see data) . when a drug is present in animal milk, it is likely that the drug will be present in human milk. since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. because of the potential for serious adverse reactions in a breastfed infant, including the potential for bexagliflozin to affect postnatal renal development, advise patients that use of brenzavvy is not recommended while breastfeeding. data bexagliflozin was present in rat milk at a milk:plasma ratio of approximately 2. the concentration of bexagliflozin in animal milk does not necessarily predict the concentration of bexagliflozin in human milk. juvenile rats directly exposed to bexagliflozin showed a risk to the developing kidney (renal pelvic and tubular dilatation) during the period of renal development in rats corresponding to the late second and third trimester of human renal development. the safety and effectiveness of brenzavvy have not been established in pediatric patients. in 9 clinical trials of brenzavvy, 1047 (40.6%) patients 65 years and older, and 212 (8.2%) patients 75 years and older were exposed to brenzavvy [see clinical studies (14)] . one of the 9 trials enrolled patients with type 2 diabetes mellitus who had either established cvd or were at increased risk for cvd (trial 6), and had a total of 571 (50%) patients treated with brenzavvy who were 65 years and older, and 113 (10%) patients treated with brenzavvy who were 75 years and older [see clinical studies (14.5)] . no overall differences in the effectiveness of brenzavvy have been observed between patients 65 years of age and older and younger adult patients. among patients aged 65 and older in this trial, volume depletion events were reported in 7.6% and 9.8% of patients in the placebo and brenzavvy groups, respectively [see warnings and precautions (5.3)] . brenzavvy is not recommended in patients with an egfr less than 30 ml/min/1.73 m2 due to the decline of the glucose lowering effect of brenzavvy and reduction in urine output in these patients [see clinical pharmacology (12.3)] . the recommended dosage for patients with an egfr greater than or equal to 30 ml/min/1.73 m2 is the same as the recommended dosage for patients with normal renal function [see dosage and administration (2.1)] . the safety and efficacy of brenzavvy in adults with type 2 diabetes mellitus and moderate renal impairment (egfr between 30 and 60 ml/min/1.73 m2 ) were evaluated in trial 5 [see clinical studies (14.4)] . efficacy and safety studies with brenzavvy did not enroll patients with an egfr less than 30 ml/min/1.73 m2 . brenzavvy-treated patients with renal impairment may be more likely to experience adverse reactions associated with brenzavvy treatment, including female genital mycotic infection, increased urination, and thirst, and may be at higher risk for volume depletion and acute kidney injury [see warnings and precautions (5.3) and adverse reactions (6.1)] . brenzavvy has not been studied in patients with severe hepatic impairment and is not recommended for use in this patient population. the recommended dosage for patients with mild to moderate hepatic impairment is the same as the recommended dosage for patients with normal hepatic function [see clinical pharmacology (12.3)] .

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

bexacat- bexagliflozin tablets tablet

elanco us inc. - bexagliflozin (unii: ey00jf42fv) (bexagliflozin - unii:ey00jf42fv) - bexacat (bexagliflozin tablets) are flavored pentagonal, 10 mm, speckled white, brown, or tan biconvex with a characteristic odor. the empirical formula is c24h29clo7 and the molecular weight is 464.94 g/mol. the chemical name is (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-(2-cyclopropoxyethoxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol. the chemical structure of bexagliflozin is: