LEVEMIR ® - Insulin detemir
LEVEMIR ® an insulin-based drug detemir
THERAPEUTIC GROUP: Insulin detemir for injectable use - insulins and analogues
Indications LEVEMIR ® - Insulin detemir
LEVEMIR ® is indicated in the treatment of diabetic patients who require insulin therapy to restore a correct glycemic balance.
Mechanism of action LEVEMIR ® - Insulin detemir
LEVEMIR ® is a drug based on insulin detemir, an insulin analogue obtained by substituting threonine in position B30 and associating lysine in position B29, a fatty acid with 14 carbon atoms known as myristic acid.
These two important variations allow respectively to bind plasma albumin in a reversible way, making the activating action of the hormone on the insulin receptors gradual and at the same time facilitating the formation of hexamers in the subcutaneous layer which delay the absorption of this insulin analogue.
These types of peculiarities make insulin detemir more stable from the pharmacokinetic point of view, significantly reducing intra and interindividual variations, and reproducing a more or less similar kinetics of action among the various patients, which is capable in a dose dependent manner of prolonging the "biological effect up to 24 hours after subcutaneous administration.
However, the important structural variations also allow insulin detemir to mediate its hypoglycemic effect through the activation of the insulin receptors expressed by insulin sensitive tissues and at the same time inhibiting the production and release of glucose from the liver, in a completely identical way to what it does. the endogenous hormone.
Studies carried out and clinical efficacy
1. INSULIN DETEMIR IN PEDIATRIC AGE
Pediatr Diabetes. 2011 Mar 21
Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus.
Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V.
The administration of insulin detemir in pediatric patients with type 1 diabetes mellitus ensured excellent glycemic control, a reduction in fasting glycaemia, a reduction in hypoglycemic events and a reduced weight gain in short treatment periods. These results were significantly better than those obtained with another intermediate insulin analog such as isophane insulin.
2. EFFECTIVENESS OF INSULIN DETEMIR
Diabetes Technol Ther. 2010 Dec; 12: 1019-27.
Relationship of insulin dose, A1c lowering, and weight in type 2 diabetes: comparing insulin glargine and insulin detemir.
Dailey G, Admane K, Mercier F, Owens D.
Treatment with insulin detemir in patients with type II diabetes has been shown to be particularly useful in ensuring a significant reduction in glycosylated hemoglobin and fasting glycaemia, avoiding the weight gain observed following the administration of insulin glargine.
3. INSULIN THERAPY AND WEIGHT INCREASE
Prim Care Diabetes. 2010 Apr; 4 Suppl 1: S24-30.
Diabetes and weight management.
Weight gain is one of the most frequent manifestations present in the diabetic patient which is often accentuated by the administration of insulin in the early stages of treatment. Among the various analogues, insulin detemir is the one capable of determining the least weight gain. However, in these conditions, it would be advisable to combine a healthy lifestyle and adequate nutrition.
Method of use and dosage
LEVEMIR ® 100 IU / ml insulin detemir for injection, 3 ml pre-filled pens:
the appropriate dosage of insulin detemir should be defined by the physician on the basis of the type of therapy, the concomitant administration of other insulins, the physio-pathological condition of the patient and his glycemic concentrations.
In most cases, insulin detemir is taken once or twice a day subcutaneously through injections in the thigh, abdominal wall or deltoid.
The different area of administration affects, as is known, the timing of drug absorption.
Warnings LEVEMIR ® - Insulin detemir
Pharmacological therapy with insulin, and in detail with insulin detemir, should provide for the active participation of the patient in order to maintain good glycemic control and avoid unpleasant side effects.
In fact, the patient must be adequately instructed on the correct methods of storage, preparation and administration of the drug and must be able to promptly recognize the warning signs of hypoglycemia in order to promptly resort to remedies avoiding the onset of serious side reactions.
However, medical supervision is necessary throughout the therapeutic treatment with particular relevance in periods that may require therapeutic adjustment such as febrile states, infectious diseases, surgery, changes in eating habits and lifestyle.
The possible onset of hypoglycemia could be accompanied by a significant decrease in the patient's perceptive abilities, making the use of machinery and driving cars dangerous.
PREGNANCY AND BREASTFEEDING
The recent marketing of insulin detemir was not adequately preceded by studies and clinical trials capable of evaluating the impact of this insulin analogue on the health of the fetus when taken during pregnancy.
However, the safety profile on animal models was excellent on a par with the other analogues.
Like other analogues, insulin detemir can interact with different active ingredients by varying its pharmacokinetic properties.
In fact, the simultaneous intake of oral hypoglycemic agents, octreotide, anti-MAO, beta blocking agents, ACE inhibitors, salicylates, alcohol and anabolic steroids could enhance the therapeutic effect of LEVEMIR ®, significantly increasing the risk of hypoglycemia.
On the contrary, the concomitant administration of oral contraceptives, thiazides, glucorticoids, thyroid hormones and sympathomimetics could reduce the hypoglycemic effect of insulin detemir, requiring a possible adjustment of the dosage.
It is also useful to remember how sympatholytics can mask some important signs of hypoglycemia, increasing the risk of serious reactions.
Contraindications LEVEMIR ® - Insulin detemir
LEVEMIR ® contraindicated in case of hypoglycemia and hypersensitivity to human insulin or its excipients.
Undesirable Effects - Side Effects
Insulin detemir therapy has the same side effects as other insulin analogues.
As a result, redness, pain, edema and itching or lipoatrophy may appear at the injection site due to not changing the injection site.
Systemic reactions such as breathing difficulties, edema and hypotension may be due to hypersensitivity to insulin or one of its excipients.
However, the main adverse reaction described following insulin therapy is represented by hypoglycaemia, which could manifest itself with pallor, cold sweats, fatigue, hypotension, somnolence and which could lead in severe cases to loss of consciousness and coma.
LEVEMIR ® sold only under medical prescription.
LEVEMIR ® falls into the doping class: hormones and related substances (prohibited in and out of competition)
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