TRAJENTA DUO FILM-COATED TABLETS 2.5MG / 500MG [SIN14377P]

Product Info

TRAJENTA DUO FILM-COATED TABLETS 2.5MG / 500MG

[SIN14377P]

4.1 Therapeutic indications

TRAJENTA DUO is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate [see Posology and Method of Administration and Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

4.2 Posology and method of administration

Posology

Adults with normal renal function (GFR ≥ 90ml/min)

The recommended dose is 2.5/500 mg, 2.5/ 850 mg or 2.5/1000 mg twice daily.

The dosage should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability. Maximum recommended daily dose of TRAJENTA DUO is 5 mg of linagliptin and 2000 mg of metformin (see table 4 for additional dosing information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

TRAJENTA DUO should be given with meals to reduce the gastrointestinal undesirable effects associated with metformin.

For patients currently not treated with metformin

For patients currently not treated with metformin, the recommended starting dose is 2.5 mg linagliptin/500mg metformin hydrochloride twice daily.

For patients inadequately controlled on maximal tolerated dose of metformin monotherapy

For patients not adequately controlled on metformin alone, the usual starting dose of TRAJENTA DUO should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) plus the dose of metformin already being taken.

For patients switching from co-administration of linagliptin and metformin
For patients switching from co-administration of linagliptin and metformin to the fixed dose combination, TRAJENTA DUO should be initiated at the dose of linagliptin and metformin already being taken.

For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea

The dose of TRAJENTA DUO should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken.
When TRAJENTA DUO is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin

The dose of TRAJENTA DUO should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken.

When TRAJENTA DUO is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For the different doses on metformin, TRAJENTA DUO is available in strengths of 2.5 mg linagliptin plus 500 mg metformin hydrochloride, 850 mg metformin hydrochloride or 1000 mg metformin hydrochloride.

Renal insufficiency
An eGFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter.

In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3–6 months.

Factors that may increase the risk of lactic acidosis (see Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be reviewed before considering initiation of metformin in patients with eGFR<60 ml/min.

Hepatic impairment
TRAJENTA DUO is contraindicated in patients with hepatic impairment due to the metformin component (see section Contraindications).

Elderly
As metformin is excreted via the kidney, and elderly patients have a tendency for decreased renal function, elderly patients taking TRAJENTA DUO should have their renal function monitored regularly (see section Special warnings and precaution for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Experience in patients older than >75 years of age is limited.

Paediatric population
A clinical trial did not establish efficacy of linagliptin in paediatric patients 10 to 17 years of age (see section Clinical Trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Therefore, treatment of children and adolescents with TRAJENTA DUO is not recommended. Linagliptin has not been studied in paediatric patients under 10 years of age.

Method of administration

Missed dose
If a dose is missed, it should be taken as soon as the patient remembers.
However, a double dose should not be taken at the same time. In that case the missed dose should be skipped.

4.3 Contraindications

• Hypersensitivity to active ingredients linagliptin and/or metformin hydrochloride or to any of the excipients

• Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)

• Diabetic pre-coma

• Severe renal failure (CrCl < 30 mL/min or eGFR < 30 ml/min/1.73m²)

• Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see section Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, cardiac or respiratory failure, recent myocardial infarction, shock

• Hepatic impairment

• Acute alcohol intoxication

• Alcoholism