Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark
Levemir is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
The potency of insulin analogues, including insulin detemir, is expressed in units, whereas the potency of human insulin is expressed in international units. 1 unit insulin detemir corresponds to 1 international unit of human insulin.
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.
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 units/kg or of 10 units 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:
Adult type 2 diabetes titration guideline:
| Average pre-breakfast SMPG* | Levemir dose adjustment |
|---|---|
| >10,0 mmol/l (180 mg/dl) | +8 units |
| 9,1-10,0 mmol/l (163–180 mg/dl) | +6 units |
| 8,1-9,0 mmol/l (145–162 mg/dl) | +4 units |
| 7,1-8,0 mmol/l (127–144 mg/dl) | +2 units |
| 6,1-7,0 mmol/l (109–126 mg/dl) | +2 units |
| 4,1-6,0 mmol/l (73–108 mg/dl) | No change in dose (target) |
| If one SMPG measurement | |
| 3,1-4,0 mmol/l (56–72 mg/dl) | -2 units |
| <3,1 mmol/l (<56 mg/dl) | -4 units |
Adult type 2 diabetes simple self-titration guideline:
| Average pre-breakfast SMPG* | Levemir dose adjustment |
|---|---|
| >6,1 mmol/l (> 110 mg/dl) | +3 units |
| 4,4-6,1 mmol/l (80-110 mg/dl) | No change in dose (target) |
| <4,4 mmol/l (< 80 mg/dl) | -3 units |
When Levemir is used as part of a basal-bolus insulin regimen, Levemir should be administered once or twice daily depending on patients' needs. The dose of Levemir should be adjusted individually.
Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
When adjusting dose in order to improve glucose control, patients should be advised to be aware of signs of hypoglycaemia.
Levemir can be used in elderly patients. In elderly patients, glucose monitoring should be intensified and the Levemir dose adjusted on an individual basis.
Renal or hepatic impairment may reduce the patient’s insulin requirements. In patients with renal or hepatic impairment, glucose monitoring should be intensified and the Levemir dose adjusted on an individual basis.
Levemir can be used in adolescents and children from the age of 1 year (see section 5.1). 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 section 4.4).
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 have not been established.
No data are available.
When transferring from other intermediate or long-acting insulin medicinal products, adjustment of the dose and timing of administration may be necessary (see section 4.4).
Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see section 4.4).
Concomitant antidiabetic treatment may need to be adjusted (dose and/or timing of oral antidiabetic medicinal products or concurrent short/rapid-acting insulin medicinal products).
Levemir is a long-acting insulin analogue used as a basal insulin. 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. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. The injection can be given at any time during the day, but at the same time each day. For patients who require twice daily dosing to optimise blood glucose control, the evening dose can be administered in the evening or at bedtime.
For detailed user instructions, please refer to the package leaflet.
Levemir Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles. Levemir Penfill is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used.
Levemir FlexPen is a pre-filled pen (colour-coded) 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 only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used.
Levemir InnoLet is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. InnoLet delivers 1–50 units in increments of 1 unit. Levemir InnoLet is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used.
Levemir FlexTouch is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexTouch delivers 1–80 units in increments of 1 unit. Levemir FlexTouch is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used.
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’s requirement are administered:
Before opening: 30 months.
During use or when carried as a spare: The product can be stored for a maximum of 6 weeks.
For storage conditions of the medicinal product, see section 6.3.
Before opening: Store in a refrigerator (2°C–8°C). Keep away from the cooling element. Do not freeze.
During use or when carried as a spare: Store below 30°C. Do not refrigerate. Do not freeze. Keep the cartridge in the outer carton in order to protect it from light.
During use or when carried as a spare: Store below 30°C. Can be stored in a refrigerator (2°C–8°C). Do not freeze. Keep the pen cap on the pen in order to protect it from light.
During use or when carried as a spare: Store below 30°C. Do not refrigerate. Do not freeze. Keep the pen cap on the pen in order to protect it from light.
Levemir Penfill: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).
Pack sizes of 1, 5 and 10 cartridges. Not all pack sizes may be marketed.
Levemir FlexPen: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens. Not all pack sizes may be marketed.
Levemir InnoLet: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Pack sizes of 1, 5 and 10 pre-filled pens. Not all pack sizes may be marketed.
Levemir FlexTouch: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Pack sizes of 1 (with or without needles), 5 (without needles) or a multipack with 2 × 5 (without needles) pre-filled pens of 3 ml. Not all pack sizes may be marketed.
Do not use this medicinal product if you notice that the solution is not clear, colourless and aqueous.
Levemir which has been frozen must not be used.
The patient should be advised to discard the needle after each injection.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Needles, cartridges and pre-filled pens must not be shared.
The cartridge must not be refilled.
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