TRAJENTA DUO®

Dosing and administration

Recommended dosage

TRAJENTA DUO® 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.

Administration

TRAJENTA DUO® 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
  Initiate treatment with 2.5 mg linagliptin/500 mg metformin HCl twice daily.
• In patients already treated with metformin
  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 1,000 mg twice daily would be started on 2.5 mg linagliptin/1,000 mg metformin HCl twice daily with meals).
• In patients already treated with linagliptin and metformin hydrochloride
  Switched to TRAJENTA DUO® containing the same doses of each component.

Recommended Dosing in Renal Impairment

Assess renal function prior to initiation of TRAJENTA DUO® and periodically thereafter.

• TRAJENTA DUO® is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m².
• Initiation of TRAJENTA DUO® in patients with an eGFR between 30-45 mL/min/1.73 m² is not recommended.
• In patients taking TRAJENTA DUO® whose eGFR later falls below 45 mL/min/1.73 m², assess benefit risk of continuing therapy.
• Discontinue TRAJENTA DUO® if the patient’s eGFR later falls below 30 mL/min/1.73 m².