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Levemir is a brand name for Insulin Detemir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Levemir is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Verbatim from this product's EMA label. Tap a section to expand.
Posology 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. 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.
4 mmol/l (<80 mg/dl) -3 units *Self-Monitored Plasma Glucose 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.
Special populations Elderly (≥65 years old) 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 and hepatic impairment 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. 1). 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. 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).
Method of administration 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.
Summary of the safety profile Adverse reactions observed in patients using Levemir are mainly due to the pharmacologic effect of insulin. The overall percentage of treated patients expected to experience adverse reactions is estimated to be 12%.
8, Description of selected adverse reactions. From clinical investigations, it is known that major hypoglycaemia, defined as requirement for third party intervention, occurs in approximately 6% of the patients treated with Levemir. Injection site reactions are seen more frequently during treatment with Levemir than with human insulin products.
These reactions include pain, redness, hives, inflammation, bruising, swelling and itching at the injection site. e. they normally disappear during continued treatment in a few days to a few weeks. At the beginning of the insulin treatment, refraction anomalies and oedema may occur; these reactions are usually of transitory nature.
Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible. Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Tabulated list of adverse reactions Adverse reactions listed below are based on clinical trial data and classified according to MedDRA frequency and System Organ Class.
Frequency categories are defined according to the following convention:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 8, Description of selected adverse reactions.
5 Before travelling between different time zones, the patient should seek the doctor’s advice since this may mean that the patient has to take the insulin and meals at different times. Hyperglycaemia Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis.
Usually the first symptoms of hyperglycaemia develop gradually over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath.
In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. Hypoglycaemia Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. In children, care should be taken to match insulin doses (especially in basal-bolus regimens) with food intake and physical activities in order to minimise the risk of hypoglycaemia.
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. In case of hypoglycaemia or if hypoglycaemia is suspected, Levemir must not be injected. 9). g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly.
Usual warning symptoms may disappear in patients with longstanding diabetes. Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirements. Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in insulin dose.
When patients are transferred between different types of insulin medicinal products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin. Transfer from other insulin medicinal products Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
1).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. 8). 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 Administration with an insulin delivery system 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 Administration with FlexPen 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 Administration with InnoLet 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 Administration with FlexTouch Levemir FlexTouch is a pre-filled pen (colour-coded) designed […]
† ADR from postmarketing sources. Description of selected adverse reactions Allergic reactions, potentially allergic reactions, urticaria, rash, eruptions Allergic reactions, potentially allergic reactions, urticaria, rash and eruptions are uncommon when Levemir is used in basal-bolus regimen.
2% of allergic reactions and potentially allergic reactions have been observed). Anaphylactic reactions The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure) is very rare but can potentially be life threatening.
Hypoglycaemia The most frequently reported adverse reaction is hypoglycaemia. It may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
The symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentrating, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Skin and subcutaneous tissue disorders Lipodystrophy (including lipohypertrophy, lipoatrophy) and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. 4). Paediatric population Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in the paediatric population do not indicate any differences to the broader experience in the general diabetes population.
9 Other special populations Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin or insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dose. Patients transferred to Levemir from another type of insulin may require a change in dose from that used with their usual insulin medicinal products.
If an adjustment is needed, it may occur with the first dose or during the first few weeks or months. Injection site reactions As with any insulin therapy, injection site reactions may occur and include pain, redness, hives, inflammation, bruising, swelling and itching.
Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions. Reactions usually resolve in a few days to a few weeks. On rare occasions, injection site reactions may require discontinuation of Levemir.
Skin and subcutaneous tissue disorders Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions.
A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site from an affected to an 6 unaffected area, and dose adjustment of antidiabetic medications may be considered.
Hypoalbuminaemia There are limited data in patients with severe hypoalbuminaemia. Careful monitoring is recommended in these patients. Combination of Levemir with pioglitazone Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure.
This should be kept in mind if treatment with the combination of pioglitazone and Levemir is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Avoidance of accidental mix-ups/medication errors Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Levemir and other insulin products. Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.