Recommended Dosing

The dosage of JENTADUETO should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended dose of 2.5 mg linagliptin/1000 mg metformin hydrochloride (HCl) twice daily. JENTADUETO should be given twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal (GI) side effects associated with metformin use.

Recommended starting dose:

• In patients currently not treated with metformin HCl, initiate treatment with 2.5 mg linagliptin/500 mg metformin HCl twice daily.
• In patients already treated with metformin HCl, start with 2.5 mg linagliptin and the current dose of metformin HCl taken at each of the two daily meals (e.g., a patient on metformin HCl 1000 mg twice daily would be started on 2.5 mg linagliptin/1000 mg metformin HCl twice daily with meals).
• Patients already treated with linagliptin and metformin HCl individual components may be switched to JENTADUETO containing the same doses of each component.

Recommended Dosing in Renal Impairment

Assess renal function prior to initiation of JENTADUETO and periodically thereafter.

JENTADUETO is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2.

Initiation of JENTADUETO in patients with an eGFR between 30-45 mL/min/1.73 m2 is not recommended.

In patients taking JENTADUETO whose eGFR later falls below 45 mL/min/1.73 m2, assess benefit/risk of continuing therapy.

Discontinue JENTADUETO if the patient's eGFR later falls below 30 mL/min/1.73 m2 [see Contraindications (4) and Warnings and Precautions (5.1)].

Discontinuation for Iodinated Contrast Imaging Procedures

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