Linagliptindosage

Individualize the starting dosage of JENTADUETO XR based on the patient's current regimen The maximum recommended dosage is 5 mg linagliptin/2,000 mg metformin HCl once daily Take orally once daily with a meal, with gradual dose escalation to reduce the gastrointestinal effects due to metformin Swallow whole; do not split, crush, dissolve, or chew Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) Do not use in patients with eGFR below 30 mL/min/1.73 m 2 Initiation is not recommended in patients with eGFR between 30 - 45 mL/min/1.73 m 2 Assess risk/benefit of continuing if eGFR falls below 45 mL/min/1.73 m 2 Discontinue if eGFR falls below 30 mL/min/1.73 m 2 JENTADUETO XR may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures

2.1 Recommended

Dosage and Administration The dosage of JENTADUETO XR should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dosage of linagliptin 5 mg and metformin hydrochloride (HCl) 2,000 mg. JENTADUETO XR should be given orally once daily with a meal. Dosage escalation should be gradual to reduce the gastrointestinal (GI) side effects associated with metformin use.

Recommended starting dosage: In patients currently not treated with metformin HCl, initiate JENTADUETO XR treatment with 5 mg linagliptin/1,000 mg metformin HCl extended-release once daily with a meal. In patients already treated with metformin HCl, start JENTADUETO XR with 5 mg of linagliptin total daily dosage and a similar total daily dosage of metformin HCl once daily with a meal. In patients already treated with linagliptin and metformin HCl or JENTADUETO, switch to JENTADUETO XR containing 5 mg of linagliptin total daily dosage and a similar total daily dosage of metformin HCl once daily with a meal. JENTADUETO XR should be swallowed whole. The tablets must not be split, crushed, dissolved, or chewed. JENTADUETO XR 5 mg linagliptin/1,000 mg metformin HCl extended-release tablet should be taken as a single tablet once daily. Patients using 2.5 mg linagliptin/1,000 mg metformin HCl extended-release tablets should take two tablets together once daily.

2.2 Recommended

Dosing in Renal Impairment Assess renal function prior to initiation of JENTADUETO XR and periodically thereafter. JENTADUETO XR is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m 2. Initiation of JENTADUETO XR in patients with an eGFR between 30-45 mL/min/1.73 m 2 is not recommended. In patients taking JENTADUETO XR whose eGFR later falls below 45 mL/min/1.73 m 2, assess benefit/risk of continuing therapy. Discontinue JENTADUETO XR if the patient's eGFR later falls below 30 mL/min/1.73 m 2.

2.3 Discontinuation for

Iodinated Contrast Imaging Procedures Discontinue JENTADUETO XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 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 JENTADUETO XR if renal function is stable.