Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year.
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, 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 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.
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.
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 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 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.
The recommended daily starting dose is 10 units followed by individual dosage adjustments.
Tresiba is to be used once daily with mealtime insulin and requires subsequent individual dosage adjustments.
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.
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
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.
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, dosage should be adjusted individually.
Tresiba can be used in elderly. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see section 5.2).
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 section 5.2).
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 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 section 4.4).
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 section 4.4).
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 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).
Tresiba comes in a pre-filled pen (FlexTouch) designed to be used with NovoFine or NovoTwist injection needles.
Tresiba comes in a cartridge (Penfill) designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist injection needles.
A specific overdose for insulin cannot be defined. However, hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin than required:
30 months.
Tresiba 100 units/mL solution for injection in pre-filled pen:
After first opening or carried as a spare, the medicinal product may be stored for a maximum of 8 weeks. Do not store above 30°C. Can be stored in a refrigerator (2°C–8°C). Keep the cap on the pen in order to protect from light.
Tresiba 200 units/mL solution for injection in pre-filled pen:
After first opening or carried as a spare, the medicinal product may be stored for a maximum of 8 weeks. Do not store above 30°C. Can be stored in a refrigerator (2°C–8°C). Keep the cap on the pen in order to protect from light.
Tresiba 100 units/mL solution for injection in cartridge:
After first opening or carried as a spare, the medicinal product may be stored for a maximum of 8 weeks. Do not store above 30°C. Do not refrigerate. Keep cartridges in the outer carton in order to protect from light.
Before first use:
Store in a refrigerator (2°C–8°C). Do not freeze.
Keep away from the freezing element.
Keep the cap on the pen in order to protect it from light.
Before first use:
Store in a refrigerator (2°C–8°C). Do not freeze.
Keep away from the freezing element.
Keep the cap on the pen in order to protect it from light.
Before first use:
Store in a refrigerator (2°C–8°C). Do not freeze.
Keep away from the freezing element.
Keep cartridges in the outer carton in order to protect them from light.
For storage conditions after first opening of the medicinal product, see section 6.3.
Tresiba 100 units/mL solution for injection in pre-filled pen:
3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Pack sizes of 1 (with or without needles), 5 (without needles) and multipack containing 10 (2 packs of 5) (without needles) pre-filled pens. Not all pack sizes may be marketed.
Tresiba 200 units/mL solution for injection in pre-filled pen:
3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Pack sizes of 1 (with or without needles), 2 (without needles), 3 (without needles), 5 (without needles) and multipack containing 6 (2 packs of 3) (without needles) pre-filled pens. Not all pack sizes may be marketed.
Tresiba 100 units/mL solution for injection in cartridge:
3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) in a carton.
Pack sizes of 5 and 10 cartridges.
Not all pack sizes may be marketed.
This medicinal product is for use by one person only. It must not be refilled.
Tresiba must not be used if the solution does not appear clear and colourless.
Tresiba which has been frozen must not be used.
A new needle must always be attached before each use. Needles must not be re-used. The patient should discard the needle after each injection.
In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package leaflet.
Any waste material should be disposed of in accordance with local requirements.
For detailed instructions for use, see the package leaflet.
Tresiba in a pre-filled pen is available in two strengths. “Tresiba 100 units/mL” or “Tresiba 200 units/mL” is clearly marked on the pen label and packaging.
Tresiba 100 units/mL solution for injection in pre-filled pen:
Tresiba 100 units/mL packaging and label are light green.
The pre-filled pen (FlexTouch) is designed to be used with NovoFine/NovoTwist injection needles up to a length of 8 mm. It delivers 1–80 units in steps of 1 unit. Detailed instructions accompanying the pre-filled pen must be followed.
Tresiba 200 units/mL solution for injection in pre-filled pen:
Tresiba 200 units/mL packaging and label are dark green with striping with a red box highlighting the formulation strength.
The pre-filled pen (FlexTouch) is designed to be used with NovoFine/NovoTwist injection needles up to a length of 8 mm. It delivers 2–160 units in steps of 2 units. Detailed instructions accompanying the pre-filled pen must be followed.
Tresiba 100 units/mL solution for injection in cartridge:
The cartridge (Penfill) is designed to be used with Novo Nordisk delivery systems (durable devices for repeated use not included in the pack) and NovoFine/NovoTwist injection needles up to a length of 8 mm. Detailed instructions accompanying the delivery system must be followed.
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