Prior to Initiation of TRIJARDY XR

• Assess renal function before initiating TRIJARDY XR and as clinically indicated [see Warnings and Precautions (5.1, 5.4)].
• In patients with volume depletion, correct this condition before initiating TRIJARDY XR [see Warnings and Precautions (5.4), Use in Specific Populations (8.5, 8.6)].

Recommended Dosage and Administration

• Individualize the starting dose of TRIJARDY XR based on the patient's current regimen:
  • In patients on metformin HCl, with or without linagliptin, switch to TRIJARDY XR containing a similar total daily dose of metformin HCl and a total daily dose of empagliflozin 10 mg and linagliptin 5 mg;
  • In patients on metformin HCl and any regimen containing empagliflozin, with or without linagliptin, switch to TRIJARDY XR containing a similar total daily dose of metformin HCl, the same total daily dose of empagliflozin and linagliptin 5 mg.
• Monitor effectiveness and tolerability, and adjust dosing as appropriate, not to exceed the maximum recommended daily dose of empagliflozin 25 mg, linagliptin 5 mg and metformin HCl 2000 mg.
• Take TRIJARDY XR orally, once daily with a meal in the morning.
  • Take TRIJARDY XR 10 mg/5 mg/1000 mg or TRIJARDY XR 25 mg/5 mg/1000 mg as a single tablet once daily.
  • Take TRIJARDY XR 5 mg/2.5 mg/1000 mg or TRIJARDY XR 12.5 mg/2.5 mg/1000 mg as two tablets together once daily.
• Swallow TRIJARDY XR tablets whole. Do not split, crush, dissolve, or chew.

Dosage Recommendations in Patients with Renal Impairment

• Initiation of TRIJARDY XR is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2, due to the metformin component.
• TRIJARDY 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, 5.4) and Use in Specific Populations (8.6)].

Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue TRIJARDY 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 TRIJARDY XR if renal function is stable [see Warnings and Precautions (5.1)].