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April 11, 2022 – Xigduo® XR (dapagliflozin/metformin) has received a new indication for one of its active pharmaceutical ingredients (APIs), dapagliflozin, to reduce the risk of sustained estimated glomerular filtration rate (EGFR) decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults who have chronic kidney disease at risk of progression.
- Xigduo XR’s other API, metformin, is indicated as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes mellitus. Dapagliflozin holds two additional indications to reduce the risk of:
- Hospitalization for heart failure in adults who have type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.
- Cardiovascular death and hospitalization for heart failure in adults who have heart failure (NYHA class II-IV) with reduced ejection fraction.
- Due to the metformin component, Xigduo XR should only be used in the treatment of adults who have type 2 diabetes. The FDA first approved Xigduo XR in 2014.
- Recommended dosing is based on a variety of factors, such as the patient’s current treatment regimen and treatment effectiveness and tolerability. Xigduo XR is taken by mouth once daily in the morning with food.