Dapagliflozin and Metformin ER (Xigduo XR®)

SELF ADMINISTRATION

Indications for Prior Authorization:

  • Indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 Diabetes Mellitus when treatment with both Dapagliflozin and Metformin is appropriate
  • Limitation of use: Not for treatment of Type 1 Diabetes Mellitus or Diabetic Ketoacidosis

Patients must meet the following criteria for the indication(s) above:

  • Patient has a diagnosis of Type 2 Diabetes Mellitus, AND
  • Patient has tried and failed a preferred SGLT2 inhibitor (e.g. Invokana® or Jardiance®) and Metformin as separate or combined products, OR
  • Chart note documentation is provided documenting a medically appropriate reason why combination therapy is necessary, AND
  • Patient does not have a contraindication to therapy: 
    • Severe renal impairment, end-stage renal disease (ESRD), or patients on dialysis
    • Acute or chronic metabolic acidosis, including Diabetic Ketoacidosis with or without coma

Dosing:

  • Doses are individualized based on the patient's current regimen
  • Xigduo XR® is taken once daily
  • Maximum daily dose of Dapagliflozin is 10mg
  • Maximum daily dose of Metformin is 2,000mg

Approval:

  • 1 year

Last review date: June 10, 2019