Posology: Levemir is a soluble, basal insulin analogue with a prolonged duration of effect (up to 24 hours). Compared to other insulin products, basal-bolus therapy with Levemir is not associated with weight gain. The lower risk of nocturnal hypoglycaemia compared to NPH (Neutral Protamine Hagedorn) insulin allows a more intensive titration towards target blood glucose levels for basal-bolus therapy.
Levemir provides better glycaemic control as measured by Fasting Plasma Glucose (FPG) compared to NPH insulin treatment.
Levemir can be used alone as the basal insulin or in combination with bolus insulin. It can also be used in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists.
Dosage: When Levemir is used in combination with oral antidiabetic medicinal products or when added to GLP-1 receptor agonists, it is recommended to use Levemir once daily, initially at a dose of 0.1-0.2 U/kg, or of 10 U in adult patients. The dose of Levemir should be titrated based on the individual patient’s needs.
When a GLP-1 receptor agonist is added to Levemir, it is recommended to reduce the dose of Levemir by 20% to minimise the risk of hypoglycaemia. Subsequently, dosage should be adjusted individually.
For individual dose adjustments, the following two titration guidelines are recommended for adults: (See Tables 2 and 3.)
Click on icon to see table/diagram/image
Click on icon to see table/diagram/image
When Levemir is used as part of a basal-bolus insulin regimen, Levemir should be administered once or twice daily depending on the patient’s needs. The dose of Levemir should be adjusted individually.
For patients who require twice daily dosing to optimise blood glucose control, the evening dose can be administered in the evening or at bedtime. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Special Populations: As with all insulin products, in elderly patients and patients with renal or hepatic impairment, glucose monitoring should be intensified and the Levemir dosage adjusted on an individual basis.
Paediatric population: Levemir can be used in adolescents and children from the age of 1 year (see Pharmacology: Pharmacodynamics under Actions). When changing basal insulin to Levemir, 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).
In children and adolescents, glucose monitoring should be intensified and the Levemir dose adjusted on an individual basis.
The safety and efficacy of Levemir in children below the age of 1 year has not been established. No data are available.
Transfer from other insulin products: Transfer to Levemir from intermediate or long-acting insulin products may require adjustment of dose and timing of administration (see Precautions).
As with all insulin products, close glucose monitoring is recommended during the transfer and in the initial weeks thereafter.
Concomitant antidiabetic treatment may need to be adjusted (dose and/or timing of oral antidiabetic medicines or concurrent short-acting insulin products).
Method of administration: Levemir is for subcutaneous administration only. Levemir must not be administered intravenously, as it may result in severe hypoglycaemia. Intramuscular administration should also be avoided. Levemir is not to be used in insulin infusion pumps.
Levemir is administered subcutaneously by injection in the abdominal wall, the thigh, the upper arm, the deltoid region or the gluteal region. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy. As with all insulin products, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
Levemir FlexPen is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of 1 unit.
Levemir FlexPen is colour-coded and accompanied by a product information with detailed instructions for use to be followed.