Philippines - English - FDA (Food And Drug Administration)

astrazeneca pharmaceuticals (phils.), inc. - goserelin acetate ( equivalent to goserilin base) - depot soloution for subcutaneous injection - 10.8mg

Philippines - English - FDA (Food And Drug Administration)

astrazeneca pharmaceuticals (phils.), inc. - budesonide/ formoterol fumarate dihydrate - powder for inhalation - 80 mcg/4.5 mcg

Philippines - English - FDA (Food And Drug Administration)

astrazeneca pharmaceuticals (phils.), inc. - metoprolol succinate - controlled-release tablet - 23.75 mg (equivalent to 25 mg metoprolol tartrate)

Philippines - English - FDA (Food And Drug Administration)

astrazeneca pharmaceuticals (phils.), inc. - glycopyrronium (as bromide) , formoterol fumarate dihydrate - pressurized suspension for inhalation - 7.2 mcg/5 mcg per actuation

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

astrazeneca pharmaceuticals lp - olaparib (unii: woh1jd9ar8) (olaparib - unii:woh1jd9ar8) - olaparib 50 mg - lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline brca -mutated (gbrcam ) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. select patients for therapy based on an fda-approved companion diagnostic for lynparza. none. risk summary based on findings in animals and its mechanism of action [see clinical pharmacology (12.1)] , lynparza can cause fetal harm when administered to a pregnant woman. there are no available data on lynparza use in pregnant women to inform the drug associated risk. in an animal reproduction study, the administration of olaparib to pregnant rats during the period of organogenesis caused teratogenicity and embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 400 mg twice daily [see data] . apprise pregnant women of the potential hazard to the fetus and the potential risk for loss of the pregnancy. the estimated background risk of major birth d

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astrazeneca pharmaceuticals lp - dapagliflozin propanediol (unii: 887k2391vh) (dapagliflozin - unii:1ull0qj8uc) - dapagliflozin 5 mg - farxiga (dapagliflozin) is indicated: limitations of use based on animal data showing adverse renal effects, farxiga is not recommended during the second and third trimesters of pregnancy. limited data with farxiga in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes and untreated heart failure in pregnancy (see clinical considerations) . in animal studies, adverse renal pelvic and tubule dilatations, that were not fully reversible, were observed in rats when dapagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at all doses tested; the lowest of which provided an exposure 15-times the 10 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 hba1c greater than 7% and has been reported to be as high as 20 to 25% in women with hba1c greater than 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 embryofetal 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 dapagliflozin dosed directly to juvenile rats from postnatal day (pnd) 21 until pnd 90 at doses of 1, 15, or 75 mg/kg/day, increased kidney weights and increased the incidence of renal pelvic and tubular dilatations at all dose levels. exposure at the lowest dose tested was 15-times the 10 mg clinical dose (based on auc). the renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within a 1-month recovery period. in a prenatal and postnatal development study, dapagliflozin was administered to maternal rats from gestation day 6 through lactation day 21 at doses of 1, 15, or 75 mg/kg/day, and pups were indirectly exposed in utero and throughout lactation. increased incidence or severity of renal pelvic dilatation was observed in 21-day-old pups offspring of treated dams at 75 mg/kg/day (maternal and pup dapagliflozin exposures were 1415-times and 137-times, respectively, the human values at the 10 mg clinical dose, based on auc). dose-related reductions in pup body weights were observed at greater or equal to 29-times the 10 mg clinical dose (based on auc). no adverse effects on developmental endpoints were noted at 1 mg/kg/day (19-times the 10 mg clinical dose, based on auc). these outcomes occurred with drug exposure during periods of renal development in rats that corresponds to the late second and third trimester of human development. in embryofetal development studies in rats and rabbits, dapagliflozin was administered throughout organogenesis, corresponding to the first trimester of human pregnancy. in rats, dapagliflozin was neither embryolethal nor teratogenic at doses up to 75 mg/kg/day (1441-times the 10 mg clinical dose, based on auc). dose-related effects on the rat fetus (structural abnormalities and reduced body weight) occurred only at higher dosages, equal to or greater than 150 mg/kg (more than 2344-times the 10 mg clinical dose, based on auc), which were associated with maternal toxicity. no developmental toxicities were observed in rabbits at doses up to 180 mg/kg/day (1191-times the 10 mg clinical dose, based on auc). risk summary there is no information regarding the presence of dapagliflozin in human milk, the effects on the breastfed infant, or the effects on milk production. dapagliflozin is present in the milk of lactating rats (see data) . however, due to species-specific differences in lactation physiology, the clinical relevance of these data is not clear. 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 breastfed infants, advise women that use of farxiga is not recommended while breastfeeding. data dapagliflozin was present in rat milk at a milk/plasma ratio of 0.49, indicating that dapagliflozin and its metabolites are transferred into milk at a concentration that is approximately 50% of that in maternal plasma. juvenile rats directly exposed to dapagliflozin showed risk to the developing kidney (renal pelvic and tubular dilatations) during maturation. safety and effectiveness of farxiga in pediatric patients under 18 years of age have not been established. no farxiga dosage change is recommended based on age. a total of 1424 (24%) of the 5936 farxiga-treated patients were 65 years and older and 207 (3.5%) patients were 75 years and older in a pool of 21 double-blind, controlled, clinical studies assessing the efficacy of farxiga in improving glycemic control in type 2 diabetes mellitus. after controlling for level of renal function (egfr), efficacy was similar for patients under age 65 years and those 65 years and older. in patients ≥65 years of age, a higher proportion of patients treated with farxiga for glycemic control had adverse reactions of hypotension [see warnings and precautions (5.2) and adverse reactions (6.1)] . in the dapa-ckd, dapa-hf and deliver studies, safety and efficacy were similar for patients age 65 years and younger and those older than 65. in the dapa-hf study, 2714 (57%) out of 4744 patients with hfref were older than 65 years. in the deliver study, 4759 (76%) out of 6263 patients with heart failure (lvef >40%) were older than 65 years. in the dapa-ckd study, 1818 (42%) out of 4304 patients with ckd were older than 65 years. farxiga was evaluated in 4304 patients with chronic kidney disease (egfr 25 to 75 ml/min/1.73 m2 ) in the dapa-ckd study. farxiga was also evaluated in 1926 patients with an egfr of 30 to 60 ml/min/1.73 m2 in the dapa-hf study. the safety profile of farxiga across egfr subgroups in these studies was consistent with the known safety profile [see adverse reactions (6.1) and clinical studies (14.3 and 14.4)]. farxiga was evaluated in two glycemic control studies that included patients with type 2 diabetes mellitus with moderate renal impairment (an egfr of 45 to less than 60 ml/min/1.73 m2 [see clinical studies (14.1)] , and an egfr of 30 to less than 60 ml/min/1.73 m2 , respectively). patients with diabetes and renal impairment using farxiga may be more likely to experience hypotension and may be at higher risk for acute kidney injury secondary to volume depletion. in the study of patients with an egfr 30 to less than 60 ml/min/1.73 m2 , 13 patients receiving farxiga experienced bone fractures compared to none receiving placebo. use of farxiga for glycemic control in patients without established cv disease or cv risk factors is not recommended when egfr is less than 45 ml/min/1.73 m2 [see dosage and administration (2.2)] . efficacy and safety studies with farxiga did not enroll patients with an egfr less than 25 ml/min/1.73 m2 or on dialysis. no dose adjustment is recommended for patients with mild, moderate, or severe hepatic impairment. however, the benefit-risk for the use of dapagliflozin in patients with severe hepatic impairment should be individually assessed since the safety and efficacy of dapagliflozin have not been specifically studied in this population [see clinical pharmacology (12.3)] .

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

astrazeneca pharmaceuticals lp - dapagliflozin propanediol (unii: 887k2391vh) (dapagliflozin - unii:1ull0qj8uc), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - dapagliflozin 10 mg - xigduo xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. dapagliflozin is indicated to reduce limitations of use xigduo xr is contraindicated in patients with: risk summary based on animal data showing adverse renal effects, xigduo xr is not recommended during the second and third trimesters of pregnancy. limited data with xigduo xr or dapagliflozin in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk (see data) . 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 dapagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at all doses tested; the lowest of which provided an exposure 15-times the 10 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 hba1c greater than 7% and has been reported to be as high as 20 to 25% in women with hba1c greater than 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 embryofetal 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 human data published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy. however, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups. animal data dapagliflozin dapagliflozin dosed directly to juvenile rats from postnatal day (pnd) 21 until pnd 90 at doses of 1, 15, or 75 mg/kg/day, increased kidney weights and increased the incidence of renal pelvic and tubular dilatations at all dose levels. exposure at the lowest dose tested was 15-times the 10 mg clinical dose (based on auc). the renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within a 1-month recovery period. in a prenatal and postnatal development study, dapagliflozin was administered to maternal rats from gestation day 6 through lactation day 21 at doses of 1, 15, or 75 mg/kg/day, and pups were indirectly exposed in utero and throughout lactation. increased incidence or severity of renal pelvic dilatation was observed in 21-day-old pups offspring of treated dams at 75 mg/kg/day (maternal and pup dapagliflozin exposures were 1415-times and 137-times, respectively, the human values at the 10 mg clinical dose, based on auc). dose-related reductions in pup body weights were observed at greater or equal to 29-times the 10 mg clinical dose (based on auc). no adverse effects on developmental endpoints were noted at 1 mg/kg/day (19-times the 10 mg clinical dose, based on auc). these outcomes occurred with drug exposure during periods of renal development in rats that corresponds to the late second and third trimester of human development. in embryofetal development studies in rats and rabbits, dapagliflozin was administered throughout organogenesis, corresponding to the first trimester of human pregnancy. in rats, dapagliflozin was neither embryolethal nor teratogenic at doses up to 75 mg/kg/day (1441-times the 10 mg clinical dose, based on auc). dose related effects on the rat fetus (structural abnormalities and reduced body weight) occurred only at higher dosages, equal to or greater than 150 mg/kg (more than 2344-times the 10 mg clinical dose, based on auc), which were associated with maternal toxicity. no developmental toxicities were observed in rabbits at doses up to 180 mg/kg/day (1191-times the 10 mg clinical dose, based on auc). metformin hcl metformin hcl did not cause adverse developmental effects when administered to pregnant sprague dawley rats and rabbits up to 600 mg/kg/day during the period of organogenesis. this represents an exposure of about 2- and 6-times a 2000 mg clinical dose based on body surface area (mg/m2 ) for rats and rabbits, respectively. determination of fetal concentrations demonstrated a partial placental barrier to metformin. risk summary there is no information regarding the presence of xigduo xr or dapagliflozin in human milk, the effects on the breastfed infant, or the effects on milk production. limited published studies report that metformin is present in human milk (see data) . however, there is insufficient information on the effects of metformin on the breastfed infant and no available information on the effects of metformin on milk production. dapagliflozin is present in the milk of lactating rats (see data) . however, due to species specific differences in lactation physiology, the clinical relevance of these data is not clear. 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 breastfed infants, advise women that use of xigduo xr is not recommended while breastfeeding. data dapagliflozin dapagliflozin was present in rat milk at a milk/plasma ratio of 0.49, indicating that dapagliflozin and its metabolites are transferred into milk at a concentration that is approximately 50% of that in maternal plasma. juvenile rats directly exposed to dapagliflozin showed risk to the developing kidney (renal pelvic and tubular dilatations) during maturation. metformin hcl published clinical lactation studies report that metformin is present in human milk which resulted in infant doses approximately 0.11% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1. however, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants. discuss the potential for unintended pregnancy with premenopausal women as therapy with metformin may result in ovulation in some anovulatory women. safety and effectiveness of xigduo xr in pediatric patients under 18 years of age have not been established. xigduo xr no xigduo xr dosage change is recommended based on age. more frequent assessment of renal function is recommended in elderly patients. dapagliflozin a total of 1424 (24%) of the 5936 dapagliflozin-treated patients were 65 years and older and 207 (3.5%) patients were 75 years and older in a pool of 21 double-blind, controlled, clinical studies assessing the efficacy of dapagliflozin in improving glycemic control. after controlling for level of renal function (egfr), efficacy was similar for patients under age 65 years and those 65 years and older. in patients ≥65 years of age, a higher proportion of patients treated with dapagliflozin for glycemic control had adverse reactions of hypotension [see warnings and precautions (5.3) and adverse reactions (6.1)] . in both the dapa-hf and dapa-ckd studies, safety and efficacy were similar for patients age 65 years and younger and those older than 65 in both the overall population and the patients with type 2 diabetes mellitus. in the dapa-hf study, 2714 (57%) out of 4744 patients with heart failure with reduced ejection fraction (hfref) were older than 65 years. out of 2139 patients with hfref and type 2 diabetes mellitus, 1211 (57%) were older than 65 years. in the dapa-ckd study, 1818 (42%) out of 4304 patients with chronic kidney disease were older than 65 years. out of 2906 patients with chronic kidney disease and type 2 diabetes mellitus, 1399 (48%) were older than 65 years. metformin hcl controlled clinical studies of metformin did not include sufficient numbers of elderly patients to determine whether they respond differently than younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis. assess renal function more frequently in elderly patients [see warnings and precautions (5.1)] . initiation of xigduo xr is not recommended in patients with an egfr below 45 ml/min/1.73 m2 and is contraindicated in patients with severe renal impairment (egfr less than 30 ml/min/1.73 m2 ), end-stage renal disease or patients on dialysis [see dosage and administration (2.4), contraindications (4) and  warnings and precautions  (5.1, 5.3)] . dapagliflozin dapagliflozin 10 mg was evaluated in 4304 patients with chronic kidney disease (egfr 25 to 75 ml/min/1.73 m2 ) in the dapa-ckd study. dapagliflozin 10 mg was also evaluated in 1926 patients with an egfr of 30 to 60 ml/min/1.73 m2 in the dapa-hf study. the safety profile of dapagliflozin across egfr subgroups was consistent with the known safety profile [see adverse reactions (6.1) and clinical studies  (14.3 and 14.4)] . dapagliflozin 10 mg was evaluated in two glycemic control studies that included patients with moderate renal impairment (an egfr of 45 to less than 60 ml/min/1.73 m2 , and an egfr of 30 to less than 60 ml/min/1.73 m2 ) [see clinical studies (14.1)] . patients with diabetes and renal impairment using dapagliflozin 10 mg are more likely to experience hypotension and may be at higher risk for acute kidney injury secondary to volume depletion. in the study of patients with an egfr 30 to less than 60 ml/min/1.73 m2 , 13 patients receiving dapagliflozin experienced bone fractures compared to none receiving placebo. use of dapagliflozin 10 mg for glycemic control in patients without established cv disease or cv risk factors is not recommended when egfr is less than 45 ml/min/1.73 m2  [see dosage and administration (2.4)] . metformin hcl metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment. xigduo xr is contraindicated in severe renal impairment, patients with an estimated glomerular filtration rate (egfr) below 30 ml/min/1.73 m2 [see dosage and administration (2.4), contraindications (4), warnings and precautions (5.1), and clinical pharmacology  (12.3)]. use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis. xigduo xr is not recommended in patients with hepatic impairment [see warnings and precautions (5.1)] .

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

astrazeneca pharmaceuticals lp - naloxegol oxalate (unii: 65i14tnm33) (naloxegol - unii:44t7335bke) - naloxegol 12.5 mg - movantik® is indicated for the treatment of opioid-induced constipation (oic) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. movantik is contraindicated in: risk summary limited available data with movantik use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. movantik may precipitate opioid withdrawal in the pregnant women and the fetus (see clinical considerations) . in animal development studies, no effects on embryo-fetal development were observed following administration of naloxegol in pregnant rats during the period of organogenesis at doses up to 1452 times the human auc (area under the plasma concentration-time curve) at the maximum recommended human dose. no effects on embryo-fetal development were observed following administration of naloxegol in pregnant rabbits during the period of organogenesis at

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

astrazeneca pharmaceuticals lp - exenatide (unii: 9p1872d4ol) (exenatide - unii:9p1872d4ol) - exenatide 250 ug in 1 ml - byetta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see clinical studies (14)] . limitations of use byetta is contraindicated in patients with: risk summary limited data with byetta in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). based on animal reproduction studies, there may be risks to the fetus from exposure to byetta during pregnancy. byetta should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal reproduction studies identified increased adverse fetal and neonatal outcomes from exposure to exenatide during pregnancy and lactation in association with maternal effects. in mice, exenatide administered during gestation and lactation caused increased neonatal deaths at systemic exposure 3-times

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

astrazeneca pharmaceuticals lp - saxagliptin hydrochloride (unii: z8j84yix6l) (saxagliptin anhydrous - unii:8i7io46ivq) - saxagliptin anhydrous 5 mg - onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see clinical studies (14) ]. onglyza is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. onglyza is contraindicated in patients with a history of a serious hypersensitivity reaction to onglyza, such as anaphylaxis, angioedema, or exfoliative skin conditions [see warnings and precautions (5.4) and adverse reactions (6.2) ]. limited data with onglyza in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriages. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations ]. no adverse developmental effects independent of maternal toxicity were observed when saxagliptin was administered to pregnant rats and rabbits during the period of organogenesis and in pregnant and lactating rats during the pre- and postnatal period [see data ]. the estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with an hba1c greater than 7 and has been reported to be as high as 20 to 25% in women with an hba1c greater than 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. 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, still birth and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. animal data in embryo-fetal development studies, saxagliptin was administered to pregnant rats and rabbits during the period of organogenesis, corresponding to the first trimester of human pregnancy. no adverse developmental effects were observed in either species at exposures 1503- and 152-times the 5 mg clinical dose in rats and rabbits, respectively, based on auc. saxagliptin crosses the placenta into the fetus following dosing in pregnant rats. in a prenatal and postnatal development study, no adverse developmental effects were observed in maternal rats administered saxagliptin from gestation day 6 through lactation day 21 at exposures up to 470-times the 5 mg clinical dose, based on auc. there is no information regarding the presence of onglyza in human milk, the effects on the breastfed infant, or the effects on milk production. saxagliptin is present in the milk of lactating rats [see data ]. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for onglyza and any potential adverse effects on the breastfed infant from onglyza or from the underlying maternal condition. saxagliptin is secreted in the milk of lactating rats at approximately a 1:1 ratio with plasma drug concentrations. safety and effectiveness of onglyza in pediatric patients under 18 years of age have not been established. additionally, studies characterizing the pharmacokinetics of onglyza in pediatric patients have not been performed. in the seven, double-blind, controlled clinical safety and efficacy trials of onglyza, a total of 4751 (42.0%) of the 11301 patients randomized to onglyza were 65 years and over, and 1210 (10.7%) were 75 years and over. no overall differences in safety or effectiveness were observed between subjects ≥65 years old and younger subjects. while this clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out. saxagliptin and its active metabolite are eliminated in part by the kidney. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly based on renal function [see dosage and administration (2.2) and clinical pharmacology (12.3) ]. in a 12-week randomized placebo-controlled trial, onglyza 2.5 mg was administered to 85 subjects with moderate (n=48) or severe (n=18) renal impairment or end-stage renal disease (esrd) (n=19) [see clinical studies (14) ]. the incidence of adverse events, including serious adverse events and discontinuations due to adverse events, was similar between onglyza and placebo. the overall incidence of reported hypoglycemia was 20% among subjects treated with onglyza 2.5 mg and 22% among subjects treated with placebo. four onglyza-treated subjects (4.7%) and three placebo-treated subjects (3.5%) reported at least one episode of confirmed symptomatic hypoglycemia (accompanying fingerstick glucose ≤50 mg/dl).