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A TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS, IN ADDITION TO DIET AND EXERCISEDosing & Administration

CONVENIENT ONCE-DAILY DOSING

The first sodium-glucose cotransporter 2 (SGLT2) inhibitor + metformin combination therapy available in extended release for once-daily dosing1
 
  • ONCE-DAILY DOSING
  • TAKEN IN THE MORNING WITH FOOD

MULTIPLE DOSING OPTIONS AVAILABLE

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Tablets shown are not actual size.

  • *For patients requiring a dose of 5 mg dapagliflozin and 2000 mg metformin HCl extended-release, use two of the 2.5 mg dapagliflozin/1000 mg metformin HCl extended-release tablets.
  • For patients requiring a dose of 10 mg dapagliflozin and 2000 mg metformin HCl extended-release, use two of the 5 mg dapagliflozin/1000 mg metformin HCl extended-release tablets.
  • To improve glycemic control for patients not already taking dapagliflozin, the recommended starting dose for dapagliflozin is 5 mg once daily
  • To reduce the risk of hospitalization for heart failure, the recommended dose for dapagliflozin is 10 mg once daily
  • Gradual dose escalation is recommended to reduce GI side effects of metformin
  • Tablets must be swallowed whole and never crushed, cut, or chewed
  • The maximum daily recommended dose is 10 mg for dapagliflozin and 2000 mg for metformin
  • Patients taking an evening dose of metformin XR should skip their last dose before starting XIGDUO XR
  • In patients with volume depletion, correcting this condition prior to initiation of XIGDUO XR is recommended
  • Before initiation of XIGDUO XR, and periodically thereafter, renal function should be assessed. XIGDUO XR is not recommended when the estimated glomerular filtration rate (eGFR) is <45 mL/min/1.73 m2
  • No dosage adjustment is indicated in patients with an eGFR greater or equal to 45 mL/min/1.73 m2. XIGDUO XR is contraindicated in patients with an eGFR below 30 mL/min/1.73 m2
  • Acute Kidney Injury: Dapagliflozin causes intravascular volume contraction and can cause acute kidney injury. Reports of acute kidney injury requiring hospitalization and dialysis have occurred with dapagliflozin. If acute kidney injury occurs, discontinue and promptly treat.

    Increases in serum creatinine and decreases in eGFR may be observed with initiation of dapagliflozin. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. Before initiating XIGDUO XR, evaluate renal function and monitor periodically. XIGDUO XR is not recommended when the eGFR is <45 mL/min/1.73 m2.

WHEN TREATMENT WITH BOTH DAPAGLIFLOZIN AND METFORMIN IS APPROPRIATE IN ADDITION TO DIET AND EXERCISE

START EARLY WITH XIGDUO XR

Consider XIGDUO XR for patients who:
  • Need A1C reduction beyond monotherapy
  • Could also benefit from weight reduction
XIGDUO XR is not indicated for weight loss.

Vs metformin XR or dapagliflozin.