Farxiga and Xigduo XR Receive Label Updates
February 27, 2019 – The U.S. FDA has approved updates to the labels for Farxiga® (dapagliflozin) and Xigduo® XR (dapagliflozin and metformin HCl extended-release), manufactured by AstraZeneca. Both drugs are indicated for use in conjunction with diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. However, Xigduo XR should only be prescribed when treatment with both dapagliflozin (the active ingredient in Farxiga) and metformin is appropriate.
According to the updated labels, Farxiga and Xigduo can now be used in patients who have an eGFR (an indicator of kidney function) as low as 45mL/min/1.73m2. Previously, patients needed to have an eGFR of at least 60mL/min/1.73m2. The update expands the potential population of patients who have both type 2 diabetes and impaired renal function who may benefit from treatment with either Farxiga or Xigduo. Approximately one in four individuals diagnosed with diabetes also has renal disease.
In a clinical study, patients who had uncontrolled type 2 diabetes as well as an eGFR of 45 to 59mL/ min/1.73m2 achieved statistically significant improvement compared to placebo when treated with Farxiga. The use of Farxiga in this patient group had a similar safety profile to the overall Farxiga clinical study program.
Recommended dosing with Farxiga begins at 5mg once daily, taken in the morning with or without food, and can be increased to 10mg once daily if required and tolerated to achieve glycemic control. For Xigduo, the recommended dose is based on individual patient factors, and a black box warning cautions that metformin-associated lactic acidosis can lead to death, hypothermia, hypotension, and resistant bradyarrhythmias.