Trijardy XR Dosage

Prior to Initiation of TRIJARDY XR

• Assess renal function prior to initiation of TRIJARDY XR and periodically thereafter [see Warnings and Precautions (5.1, 5.6), Use in Specific Populations (8.5, 8.6)].
• In patients with volume depletion, correct this condition prior to initiation of TRIJARDY XR [see Warnings and Precautions (5.4), Use in Specific Populations (8.5, 8.6)].

Recommended Dosage

• 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

No dose adjustment is needed in patients with an estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m2.

TRIJARDY XR should not be initiated or continued in patients with an eGFR less than 45 mL/min/1.73 m2.

TRIJARDY XR is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2 [see Contraindications (4) and Warnings and Precautions (5.1, 5.6)].

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)].