Posology : מינונים

4.2    Posology and method of administration
Posology
This medicinal product is a basal insulin for once-daily subcutaneous administration at any time of the day, preferably at the same time every day.

The potency of insulin analogues, including insulin degludec, is expressed in units. One (1) unit of insulin degludec corresponds to 1 international unit of human insulin, 1 unit of insulin glargine (100 units/mL), or 1 unit of insulin detemir.

In patients with type 2 diabetes mellitus, this medicinal product can be administered alone or in any combination with oral antidiabetic medicinal products, GLP-1 receptor agonists and bolus insulin (see section 5.1).

In type 1 diabetes mellitus, Tregludec 100 units/mL must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements.

Tregludec 100 units/mL is to be dosed in accordance with the individual patient’s needs. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose.

Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.

The needed dose is dialled in units.
A dose of 1–80 units per injection, in steps of 1 unit, can be administered.

The dose counter shows the number of units regardless of strength and no dose conversion should be done when transferring a patient to a new strength.

Flexibility in dosing time
On occasions when administration at the same time of the day is not possible, Tregludec 100 units/mL allows for flexibility in the timing of insulin administration (see section 5.1). A minimum of 8 hours between injections should always be ensured. There is no clinical experience with flexibility in dosing time of Tregludec 100 units/mL in children and adolescents.

Patients who forget a dose are advised to take it upon discovery and then resume their usual once-daily dosing schedule.

Initiation
Patients with type 2 diabetes mellitus
The recommended daily starting dose is 10 units followed by individual dosage adjustments.

Patients with type 1 diabetes mellitus
Tregludec 100 units/mL is to be used once daily with mealtime insulin and requires subsequent individual dosage adjustments.

Transfer from other insulin medicinal products
Close glucose monitoring is recommended during the transfer and in the following weeks. Doses and timing of concurrent rapid-acting or short-acting insulin products or other concomitant antidiabetic treatment may need to be adjusted.


Patients with type 2 diabetes mellitus
For patients with type 2 diabetes taking once-daily basal, basal-bolus, premix or self-mixed insulin therapy, changing the basal insulin to Tregludec 100 units/mL can be done unit-to-unit based on the previous basal insulin dose followed by individual dosage adjustments.

A dose reduction of 20% based on the previous basal insulin dose followed by individual dosage adjustments should be considered when
- transferring to Tregludec 100 units/mL from twice-daily basal insulin - transferring to Tregludec 100 units/mL from insulin glargine (300 units/mL) 
Patients with type 1 diabetes mellitus
For patients with type 1 diabetes a dose reduction of 20% based on the previous basal insulin dose or basal component of a continuous subcutaneous insulin infusion regimen should be considered with subsequent individual dosage adjustments based on the glycaemic response.

Use of Tregludec 100 units/mL in combination with GLP-1 receptor agonists in patients with type 2 diabetes mellitus

When adding Tregludec 100 units/mL to GLP-1 receptor agonists, the recommended daily starting dose is 10 units followed by individual dosage adjustments.

When adding GLP-1 receptor agonists to Tregludec 100 units/mL, it is recommended to reduce the dose of Tregludec 100 units/mL by 20% to minimise the risk of hypoglycaemia. Subsequently, dosage should be adjusted individually.

Special populations
Elderly (≥65 years old)
Tregludec 100 units/mL can be used in elderly. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see section 5.2).

Renal and hepatic impairment
Tregludec 100 units/mL can be used in renal and hepatic impaired patients. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see section 5.2).

Paediatric population
There is no clinical experience with the use of this medicinal product in children below the age of 1 year. This medicinal product can be used in adolescents and children from the age of 1 year (see section 5.1). When changing basal insulin to Tregludec 100 units/mL, dose reduction of basal and bolus insulin needs to be considered on an individual basis in order to minimise the risk of hypoglycaemia (see section 4.4).

Method of administration
Subcutaneous use only.

Tregludec 100 units/mL must not be administered intravenously as it may result in severe hypoglycaemia.
This medicinal product must not be administered intramuscularly as it may change the absorption.
This medicinal product must not be used in insulin infusion pumps.
Tregludec 100 units/mL must not be drawn from the cartridge of the pre-filled pen into a syringe (see section 4.4).

Tregludec 100 units/mL is administered subcutaneously by injection in the thigh, the upper arm or the abdominal wall. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see sections 4.4 and 4.8).

Patients should be instructed to always use a new needle. The re-use of insulin pen needles increases the risk of blocked needles, which may cause under- or overdosing. In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package leaflet (see section 6.6).

Tregludec 100 units/mL comes in a pre-filled pen (FlexTouch) designed to be used with NovoFine or NovoTwist injection needles.
The 100 units/mL pre-filled pen delivers 1–80 units in steps of 1 unit.