Recommendations Prior to Initiation of SYNJARDY

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

Recommended Dosage and Administration

• When switching to SYNJARDY from:
  • Metformin HCl: initiate SYNJARDY at a similar total daily dosage of metformin HCl and a total daily empagliflozin dosage of 10 mg.
  • Empagliflozin: initiate SYNJARDY at the same total daily dosage of empagliflozin and a total daily metformin HCl dosage of 1,000 mg.
  • Empagliflozin and metformin HCl: initiate SYNJARDY at the same total daily dosages of each component.
• Recommended dosage of SYNJARDY:
  • The recommended total daily dosage of empagliflozin is 10 mg.
  • ​For additional glycemic control, empagliflozin may be increased to a maximum total daily dosage of 25 mg in patients tolerating 10 mg daily and metformin may be increased to a maximum total daily dosage of 2,000 mg, with gradual escalation to reduce gastrointestinal adverse reactions with metformin [see Adverse Reactions (6.1)].
• Take SYNJARDY orally twice daily with meals.

Dosage Recommendations in Patients with Renal Impairment

• Initiation of SYNJARDY is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2, due to the metformin component.
• SYNJARDY 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 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 if renal function is stable [see Warnings and Precautions (5.1)].