Trajenta® (linagliptin) prescribing information for the UK

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TRAJENTA® (linagliptin) 

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Product Overview

The simplicity of one dose, once daily to help lower HbA1c in your adult T2D patients.1

Trajenta® contains the active ingredient linagliptin, which is a dipeptidyl peptidase-4 inhibitor (DPP-4i).1 Trajenta® is indicated in adults with type 2 diabetes mellitus (T2D) as an adjunct to diet and exercise to improve glycaemic control as:1

  • monotherapy when it is not appropriate to use metformin due to intolerance or contraindication as the result of renal impairment

  • combination therapy when other products, including insulin alone or in combination with metformin, do not provide sufficient glycaemic control

See SmPC for available information on different combinations.

TRAJENTA® (linagliptin) 5mg tablets pack shot

Safety & Efficacy quick links

Trajenta

  • Product Overview
  • Mechanism of Action
  • Efficacy
  • Safety Profile
  • Clinical Studies
  • Dose & Administration

Product key facts

Indications
Indications

Type 2 diabetes mellitis in adults

Active Ingredient
Active ingredient

Linagliptin

Legal category
Legal category

Prescription only medicine

Concentration
Concentration

5 mg once a day

Administration form
Administration form

Oral

Dosage-form
Dosage form

Film-coated tablet

Pack sizes
Pack sizes

Perforated alu/alu unit dose blisters in cartons containing 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 and 120 x 1 film-coated tablets. Not all pack sizes may be marketed

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TRAJENTA® (linagliptin) dose and administration

Simple dosing for a broad range of adult patients

Dosing for Trajenta® provides unique simplicity-always 5 mg once daily, independent of age,1 BMI,1 ethnicity,1 background T2D therapy,1† disease duration,2 hepatic function,1* and renal function.1
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TRAJENTA® (linagliptin) efficacy

A broad range of adults with T2D§ can benefit from Trajenta®

In phase III clinical trials, Trajenta® produced clinically significant improvements in glycaemic control,3,4 regardless of renal function,4,5 and patient age.6
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TRAJENTA® (linagliptin) safety profile

Proven safety and efficacy across two CVOTs

In CARMELINA® and CAROLINA®, which included over 13,000 patients, Trajenta® demonstrated a safety profile across a broad range of T2D patients.7-10#
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Footnotes

  • *
    Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking (Trajenta® SmPC).
  • †
    Sulphonylureas and insulin are known to cause hypoglycaemia. Therefore, caution is advised when linagliptin is used in combination with a sulphonylurea and/or insulin. A dose reduction of the sulphonylurea or insulin may be considered (Trajenta® SmPC).
  • #
    CARMELINA® and CAROLINA® included 6,979 and 6,033 patients respectively.7,8 Primary endpoint for these trials: Time to first occurrence of any of the following CV components: CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), or non-fatal stroke (3P-MACE).8
  • §
    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 renal impairment; combination therapy, in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Abbreviations:

3P-MACE: 3-point major adverse cardiac events; BMI: body mass index; CVOT: cardiovascular outcome trial; MI: myocardial infarction; SmPC: Summary of Product Characteristics; T2D: type 2 diabetes.

References

  1. Trajenta® (linagliptin) Summary of Product Characteristics. SmPCs available at EMC.
  2. Lajara R, et al. Clin Ther. 2014;36(11):1595-605.
  3. Del Prato S, et al. J Diab Compl. 2013;27:274–9.
  4. Cooper M, et al. Poster No. 1068-P. The 71st Scientific Sessions of the American Diabetes Association, 24–28 June 2011, San Diego, CA, USA.
  5. McGill JB, et al. Diabetes Care. 2013;36:237-44.
  6. Patel S, et al. European Association for the Study of Diabetes 2011, 12-16 September 2011, Lisbon, Portugal; Poster P832.
  7. Rosenstock J, et al. Cardiovasc Diabetol. 2018;17:39.
  8. Rosenstock J, et al. JAMA 2019; 321(1):69-79.
  9. Marx N, et al. Diab Vasc Res. 2015; 12:164-74.
  10. Rosenstock J, et al. JAMA. 2019;322(12):1155–1166.

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 renal impairment

  • in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control

PC-GB-110495 | December 2024

Reporting adverse events

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Boehringer Ingelheim Drug Safety on 0800 328 1627 (freephone).

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