Canada - English - Health Canada

astrazeneca canada inc - saxagliptin (saxagliptin hydrochloride); metformin hydrochloride - tablet - 2.5mg; 850mg - saxagliptin (saxagliptin hydrochloride) 2.5mg; metformin hydrochloride 850mg - biguanides

Canada - English - Health Canada

astrazeneca canada inc - saxagliptin (saxagliptin hydrochloride); metformin hydrochloride - tablet - 2.5mg; 1000mg - saxagliptin (saxagliptin hydrochloride) 2.5mg; metformin hydrochloride 1000mg - biguanides

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).

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

cardinal health 107, llc - 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

Canada - English - Health Canada

teva canada limited - saxagliptin (saxagliptin hydrochloride) - tablet - 2.5mg - saxagliptin (saxagliptin hydrochloride) 2.5mg - dipeptidyl peptidase-4 (dpp-4) inhibitors

Canada - English - Health Canada

teva canada limited - saxagliptin (saxagliptin hydrochloride) - tablet - 5mg - saxagliptin (saxagliptin hydrochloride) 5mg - dipeptidyl peptidase-4 (dpp-4) inhibitors

Israel - English - Ministry of Health

astrazeneca (israel) ltd - saxagliptin as hydrochloride - film coated tablets - saxagliptin as hydrochloride 5 mg - saxagliptin - saxagliptin - monotherapy: onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.onglyza should not be used in patients with esrdcombination therapy: add-on combination: onglyza is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin, a thiazolidinedione (tzd), or a sulfonylurea (su), when the single agent alone, with diet and exercise, does not provide adequate glycemic control.initial combination: onglyza is indicated for use as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus when dual saxagliptin and metformin therapy is appropriate.onglyza should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. in combination with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - saxagliptin as hydrochloride - film coated tablets - saxagliptin as hydrochloride 2.5 mg - saxagliptin - saxagliptin - monotherapy: onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.onglyza should not be used in patients with esrdcombination therapy: add-on combination: onglyza is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin, a thiazolidinedione (tzd), or a sulfonylurea (su), when the single agent alone, with diet and exercise, does not provide adequate glycemic control.initial combination: onglyza is indicated for use as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus when dual saxagliptin and metformin therapy is appropriate.onglyza should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. in combination with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

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

physicians total care, inc. - saxagliptin hydrochloride (unii: z8j84yix6l) (saxagliptin - unii:9gb927lajw) - saxagliptin 5 mg - onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. [see clinical studies (14) .] onglyza should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. onglyza 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 onglyza. [see warnings and precautions (5.1) .] history of a serious hypersensitivity reaction to onglyza, such as anaphylaxis, angioedema, or exfoliative skin conditions. [see warnings and precautions (5.3) and adverse reactions (6.2) .] there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, onglyza, like other antidiabetic medications, should be used during pregnancy only if clearly

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - saxagliptin hydrochloride 2,789 mg - eq. saxagliptin 2,5 mg - film-coated tablet - 2,5 mg - saxagliptin hydrochloride 2.789 mg - saxagliptin