Active Ingredient: Insulin degludec
Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 10 international units insulin degludec, once daily.
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.
Insulin degludec 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.
On occasions when administration at the same time of the day is not possible, insulin degludec allows for flexibility in the timing of insulin administration. A minimum of 8 hours between injections should always be ensured. There is no clinical experience with flexibility in dosing time of insulin degludec 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.
When adding insulin degludec 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 insulin degludec, it is recommended to reduce the dose of insulin degludec by 20% to minimise the risk of hypoglycaemia. Subsequently, dosage should be adjusted individually.
Insulin degludec is administered subcutaneously by injection in the thigh, the upper arm or the abdominal wall. Injection sites are always to be rotated within the same region in order to reduce the risk of lipodystrophy.
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