Recommendations Prior to Initiation of SYNJARDY XR

• Assess renal function before initiating SYNJARDY XR and as clinically indicated [see Warnings and Precautions (5.1, 5.3)].
• In patients with volume depletion, correct this condition before initiating SYNJARDY XR [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5, 8.6)].

Recommended Dosage and Administration

• When switching to SYNJARDY XR from:
  • Metformin HCl: initiate SYNJARDY XR at a similar total daily dosage of metformin HCl and a total daily empagliflozin dosage of 10 mg.
  • Empagliflozin: initiate SYNJARDY XR at the same total daily dosage of empagliflozin and a total daily metformin HCl dosage of extended-release 1,000 mg.
  • Empagliflozin and metformin HCl: initiate SYNJARDY XR at the same total daily dosages of each component.
• Recommended dosage of SYNJARDY XR:
  • ​The recommended dosage of empagliflozin is 10 mg once daily.
  • ​For additional glycemic control, empagliflozin may be increased to a maximum once daily dosage of 25 mg in patients tolerating 10 mg once daily and metformin may be increased to a maximum once daily dosage of 2,000 mg, with gradual escalation to reduce gastrointestinal adverse reactions with metformin [see Adverse Reactions (6.1)].
• Take SYNJARDY XR orally once daily with a meal in the morning.
• Swallow SYNJARDY XR tablets whole. Do not split, crush, dissolve, or chew.

Dosage Recommendations in Patients with Renal Impairment

• Initiation of SYNJARDY XR is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2, due to the metformin component.
• SYNJARDY XR is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2 or in patients on dialysis [see Contraindications (4), Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].

Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue SYNJARDY XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR less than 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart SYNJARDY XR if renal function is stable [see Warnings and Precautions (5.1)].