Empagliflozindosage

Assess renal function before initiating and as clinically indicated. Assess volume status and correct volume depletion before initiating. Individualize the starting dosage based on the patient's current regimen and renal function. Initiation is not recommended in patients with an eGFR less than 45 mL/min/1.73 m 2, due to the metformin HCl component. The maximum recommended dosage of TRIJARDY XR is 25 mg empagliflozin, 5 mg linagliptin and 2,000 mg metformin HCl. Take once daily with a meal in the morning. Swallow whole; do not split, crush, dissolve, or chew. TRIJARDY XR may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures. Withhold TRIJARDY XR for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting.

2.1 Testing

Prior to Initiation of TRIJARDY XR Assess renal function before initiating TRIJARDY XR and as clinically indicated. Assess volume status. In patients with volume depletion, correct this condition before initiating TRIJARDY XR.

2.2 Recommended

Dosage and Administration Individualize the starting dosage 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 dosage of metformin HCl and a total daily dosage 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 dosage of metformin HCl, the same total daily dosage of empagliflozin and linagliptin 5 mg. Monitor effectiveness and tolerability, and adjust dosing as appropriate, not to exceed the maximum recommended daily dosage of empagliflozin 25 mg, linagliptin 5 mg and metformin HCl 2,000 mg. Take TRIJARDY XR orally, once daily with a meal in the morning. Take TRIJARDY XR 10 mg/5 mg/1,000 mg or TRIJARDY XR 25 mg/5 mg/1,000 mg as a single tablet once daily. Take TRIJARDY XR 5 mg/2.5 mg/1,000 mg or TRIJARDY XR 12.5 mg/2.5 mg/1,000 mg as two tablets together once daily. Swallow TRIJARDY XR tablets whole. Do not split, crush, dissolve, or chew.

2.3 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 m 2, due to the metformin HCl component. TRIJARDY XR is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m 2.

2.4 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 m 2; 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.

2.5 Temporary

Interruption for Surgery Withhold TRIJARDY XR for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. Resume TRIJARDY XR when the patient is clinically stable and has resumed oral intake.

2.6 Recommendations

Regarding Missed Dose If a dose is missed, instruct patients to take the dose as soon as possible. Advise patients not to double up the next dose.