dapagliflozin and metformin hydrochloride

1 INDICATIONS AND USAGE Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. Limitations of Use Dapagliflozin and metformin HCl extended-release tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2) ]. Because of the metformin HCl component, the use of dapagliflozin and metformin HCl extended-release tablets are limited to patients with type 2 diabetes mellitus for all indications. Dapagliflozin and metformin HCl extended-release tablets are not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. Dapagliflozin and metformin HCl extended-release tablets are not expected to be effective in these populations. Pediatric use information is approved for AstraZeneca AB’s Xigduo® XR (dapagliflozin and metformin hydrochloride) Extended-Release Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information. Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Dapagliflozin when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. ( 1 ) Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. ( 1 ) Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. ( 1 ) Limitations of use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) Because of the metformin HCl component, the use of dapagliflozin and metformin HCl extended-release tablets are limited to patients with type 2 diabetes mellitus for all indications. ( 1 ) Not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for the treatment of kidney disease. Dapagliflozin and metformin HCl extended-release tablets are not expected to be effective in these populations. ( 1 )