General.

TRAJENTA® is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as:

Monotherapy: when metformin is inappropriate due to intolerance, or contraindicated due to kidney impairment.

Combination therapy: in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.1

  1. TRAJENTA® EMA Summary of Product Characteristics.

Efficacy.

Though a crucial part of T2D management, achieving glycaemic control in daily practice can be difficult. So when a DPP4i is needed, you need an effective treatment option.1

TRAJENTA® offers proven efficacy for your T2D patients.2

  1. Davies M, et al. Diabetologia 2018; published online before print; DOI: 10.1007/s00125-018-4729-5.
  2. Del Prato S, et al. J Diab Compl. 2013;27:274–9

Dosing.

TRAJENTA® tablets can be taken with or without a meal at any time of the day.1

  1. TRAJENTA® EMA Summary of Product Characteristics.
  • If a dose of TRAJENTA® is missed, it should be taken as soon as the patient remembers.
    A double dose should not be taken on the same day.1
  1. TRAJENTA® EMA Summary of Product Characteristics.

The dose of TRAJENTA® is 5 mg once daily. When TRAJENTA® is added to metformin, the dose of metformin should be maintained, and TRAJENTA® administered concomitantly.1
When TRAJENTA® is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia.1

Special populations1

Kidney impairment
For patients with kidney impairment, no dose adjustment for TRAJENTA® is required.

Hepatic impairment

Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking.

Elderly

No dose adjustment is necessary based on age.
However, clinical experience in patients > 80 years of age is limited and caution should be exercised when treating this population.

  1. TRAJENTA® EMA Summary of Product Characteristics.

Safety profile.

TRAJENTA® has a safety and tolerability profile established across a broad range of T2D patients.1

  1. TRAJENTA® EMA Summary of Product Characteristics.

Cardiovascular safety is an important concern when managing T2D patients.1

With this in mind, two unique cardiovascular outcome trials were designed to establish the long-term safety profile of TRAJENTA® across a broad range of T2D patients.2,3

While CARMELINA® includes a patient population at high risk for heart and/or chronic kidney disease, CAROLINA® is an ongoing trial in early T2D patients.2,3

Together, CARMELINA® and CAROLINA® will provide additional evidence concerning the established safety and tolerability profile of TRAJENTA® in T2D patients.2-4

  1. Davies M, et al. Diabetologia 2018; published online before print; DOI: 10.1007/s00125-018-4729-5.
  2. Rosenstock J et al. Cardiovasc Diabetol 2018;17:39.
  3. Marx N et al. Diab Vasc Res 2015;12:164-174.
  4. TRAJENTA® EMA Summary of Product Characteristics.