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.

Footnote:

  • GI, gastrointestinal; HCI, hydrochloride; eGFR, estimated glomerular filtration rate.

Reference:

  1. TRAJENTA DUO® approved package insert. Updated in December 2020 and approved in February 2021.

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