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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 (U). One (1) unit (U) 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 PHARMACOLOGY: Pharmacodynamics under Actions).
In type 1 diabetes mellitus, Tresiba must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements.
Tresiba 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.
Tresiba 100 units/mL and Tresiba 200 units/mL solution for injection in a pre-filled pen: Tresiba is available in two strengths. For both, the needed dose is dialled in units. The dose steps, however, differ between the two strengths of the medicinal product.
With Tresiba 100 units/mL a dose of 1-80 units per injection, in steps of 1 unit, can be administered.
With Tresiba 200 units/mL a dose of 2-160 units per injection, in steps of 2 units, can be administered. The dose is provided in half the volume of 100 units/mL basal insulin products.
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, Tresiba allows for flexibility in the timing of insulin administration (see PHARMACOLOGY: Pharmacodynamics under Actions). A minimum of 8 hours between injections should always be ensured. There is no clinical experience with flexibility in dosing time of Tresiba 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: Tresiba 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 Tresiba 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 Tresiba from twice-daily basal insulin; transferring to Tresiba 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 Tresiba in combination with GLP-1 receptor agonists in patients with type 2 diabetes mellitus: When adding Tresiba 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 Tresiba, it is recommended to reduce the dose of Tresiba by 20% to minimise the risk of hypoglycaemia. Subsequently, the dosage should be adjusted individually.
Special populations: Elderly (≥65 years old): Tresiba can be used in elderly. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see PHARMACOLOGY: Pharmacokinetics under Actions).
Renal and hepatic impairment: Tresiba 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 PHARMACOLOGY: Pharmacokinetics under Actions).
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 PHARMACOLOGY: Pharmacodynamics under Actions). When changing basal insulin to Tresiba, dose reduction of basal and bolus insulin needs to be considered on an individual basis in order to minimise the risk of hypoglycaemia (see Precautions).
Method of administration: Subcutaneous use only.
Tresiba 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.
Tresiba must not be drawn from the cartridge of the pre-filled pen into a syringe (see Precautions).
Tresiba 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 Precautions and Adverse Reactions).
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 this monograph (see Special precautions for disposal and other handling under Cautions for Usage).
Tresiba 100 units/mL and Tresiba 200 units/mL solution for injection in a pre-filled pen: Tresiba 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.
The 200 units/mL pre-filled pen delivers 2-160 units in steps of 2 units.
