Description
Release form
Solution for subcutaneous administration
Packing
5 pcs.
Pharmacological action
Levemir Flexpen – a hypoglycemic agent, an analogue of human long-acting insulin.
The drug Levemir Flexpen is produced by recombinant DNA biotechnology using the Saccharomyces cerevisiae strain. It is a soluble basal analogue of human insulin prolonged action with a flat profile of action.
The action profile of the drug Levemir Flexpen is significantly less variable compared to isofan-insulin and insulin glargine.
The prolonged action of the drug Levemir Flexpen is due to the pronounced self-association of detemir insulin molecules at the injection site and the binding of the drug molecules to albumin by means of a compound with a side fatty acid chain. Compared with isofan-insulin, detemir insulin is delivered to peripheral target tissues more slowly. These combined delayed distribution mechanisms provide a more reproducible absorption and action profile of Levemir Penfill compared to isofan-insulin.
Interacts with a specific receptor on the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthetase, etc.).
A decrease in blood glucose is caused by an increase in its intracellular transport, increased tissue uptake, stimulation of lipogenesis, glycogenogenesis, a decrease in the rate of glucose production by the liver, etc. For doses of 0.2 – 0, 4 IU / kg 50% of the maximum effect of the drug occurs in the range from 3-4 hours to 14 hours after administration. The duration of action is up to 24 hours, depending on the dose, which makes it possible to administer once or twice daily.
After subcutaneous administration, a pharmacodynamic response was proportional to the dose administered (maximum effect, duration of action, general effect).
Long-term studies have demonstrated low daily diurnal fluctuations in plasma glucose concentrations in patients treated with Levemir Flexpen, as opposed to isofan-insulin.
Indications
Diabetes mellitus.
Contraindications
Increased individual sensitivity to insulin detemir or any of the components of the drug.
It is not recommended to use the drug Levemir Flexpen in children under 6 years, because clinical trials in children under 6 years of age have not been conducted.
Use during pregnancy and lactation
Clinical experience with Levemir Flexpen during pregnancy and breastfeeding is limited.
A study of reproductive function in animals did not reveal differences between insulin detemir and human insulin in terms of embryotoxicity and teratogenicity.
In general, careful monitoring of pregnant women with diabetes during the entire period of pregnancy, as well as when planning pregnancy, is necessary. The need for insulin in the first trimester of pregnancy usually decreases, then in the second and third trimesters it increases. Shortly after birth, the need for insulin quickly returns to the level that was before pregnancy. In lactating women, insulin dosage and dietary adjustments may be required.
Special instructions
Levemir Flexpen is a soluble basal insulin analogue with a flat and predictable activity profile with a prolonged effect.
Unlike other insulins, intensive therapy with Levemir Penfill does not increase body weight.
The lower risk of nocturnal hypoglycemia compared to other insulins allows for more intensive dose selection in order to achieve the target blood glucose.
Levemir Flexpen provides better glycemic control (based on fasting plasma glucose measurements) compared with isofan-insulin. An insufficient dose of the drug or discontinuation of treatment, especially with type 1 diabetes mellitus, can lead to the development of hyperglycemia or diabetic ketoacidosis. As a rule, the first symptoms of hyperglycemia appear gradually, over several hours or days. These symptoms include thirst, rapid urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, smell of acetone in exhaled air. In type 1 diabetes mellitus, without appropriate treatment, hyperglycemia leads to the development of diabetic ketoacidosis and can lead to death.
Hypoglycemia can develop if the dose of insulin is too high in relation to the need for insulin, skipping meals or unplanned intense physical activity.
After compensating for carbohydrate metabolism, for example, with intensified insulin therapy, patients may experience typical symptoms of precursors of hypoglycemia, which patients should be informed about. The usual warning signs may disappear with a long course of diabetes.
Concomitant diseases, especially infectious and accompanied by fever, usually increase the body’s need for insulin.
Transfer of the patient to a new type or insulin preparation of another manufacturer must occur under strict medical supervision. If you change the concentration, manufacturer, type, species (animal, human, analogues of human insulin) and / or its production method (genetically engineered or insulin of animal origin), dose adjustment may be required. Patients switching to treatment with Levemir Flexpen may need to change the dose compared to doses of previously used insulin preparations. The need for dose adjustment may arise after the introduction of the first dose or within the first few weeks or months.
As with other insulin treatments, reactions may develop at the injection site, which is manifested by pain, itching, hives, swelling, and inflammation. Changing the injection site in the same anatomical region can reduce symptoms or prevent the development of a reaction. Reactions usually disappear within a few days to several weeks. In rare cases, reactions at the injection sites require discontinuation of treatment.
Levemir Flexpen should not be administered intravenously, as this can lead to severe hypoglycemia.
Intramuscular absorption is faster and more so than subcutaneous administration.
If Levemir Flexpen is mixed with other insulin preparations, the profile of one or both components will change. Mixing Levemir Penfill with a fast-acting insulin analogue, such as insulin aspart, leads to an action profile with a reduced and delayed maximum effect compared to their separate administration.
Levemir Flexpen is not intended for use in
Composition of
in 1 ml contains: active substance: insulin detemir – 100 PIECES (one syringe pen (3 ml) – 300 PIECES)
excipients: glycerol, phenol, metacresol, zinc acetate, sodium hydrogen phosphate dihydrate, sodium chloride, hydrochloric acid or sodium hydroxide, water for injection.
One unit of detemir insulin contains 0.142 mg of salt-free detemir insulin. One unit of insulin detemir (ED) corresponds to one unit of human insulin (ME).
Dosage and Administration
Levemir Flexpen is intended for subcutaneous administration.
The dose and frequency of administration of the drug Levemir Flexpen is determined individually in each case.
Treatment with Levemir Flexpen in combination with oral hypoglycemic drugs, it is recommended to start once a day at a dose of 10 PIECES or 0.1-0.2 PIECES / kg. The dose of Levemir Penfill should be selected individually based on plasma glucose values.
If Levemir Flexpen is used as part of a bolus-based regimen, it should be prescribed 1 or 2 times a day based on the patient’s needs. Patients, who require the use of the drug twice a day to optimally control the level of glycemia, they can enter the evening dose either during dinner, or before bedtime, or 12 hours after the morning dose.
Levemir Penfill is injected subcutaneously in the thigh, anterior abdominal wall, or shoulder. The injection sites should be changed even when introduced into the same area.
dose adjustment As with other insulins, in elderly patients and patients with renal or hepatic insufficiency, blood glucose concentration should be closely monitored and the dose of detemir individually adjusted for insulin.
Dose adjustment may also be necessary when enhancing the patient’s physical activity, changing his normal diet, or with a concomitant illness.
Transfer from other insulin preparations
Transfer from medium-acting insulins and prolonged insulin to Levemir Flexpen may require dose and time adjustment.
As with other insulin preparations, careful monitoring of blood glucose concentrations during transfer and in the first weeks of a new drug is recommended.
It may be necessary to correct concomitant hypoglycemic therapy (dose and time of administration of short-acting insulin preparations or dose of oral hypoglycemic drugs).
Side effects
Adverse reactions observed in patients using Levemir Flexpen are mainly dose-dependent and develop due to the pharmacological effect of insulin. Hypoglycemia is usually the most common side effect. Hypoglycemia develops when if too high a dose of the drug is administered relative to the body’s need for insulin. From clinical studies it is known that severe hypoglycemia, requiring the intervention of third parties, develop in approximately 6% of patients receiving Levemir Flexpen.
Reactions at the injection site may occur more frequently with Levemir Flexpen, than with human insulin. These reactions include redness, inflammation, bruising, swelling, and itching at the injection site. Most reactions at the injection sites are minor and temporary in nature, i.e. disappear with continued treatment for a few days to several weeks.
The proportion of patients receiving treatment who are expected to develop side effects is estimated at 12%. Incidence of side effects, which are generally estimated to be related to Levemir Flexpen during clinical trials, is presented below.
Metabolic and nutritional disorders: frequent – Hypoglycemia. Symptoms of hypoglycemia usually develop suddenly. They include cold sweat , pallor of the skin, increased fatigue, nervousness or tremor, anxiety, unusual tiredness or weakness, disorientation, decreased concentration of attention, drowsiness, severe hunger, blurred vision, headache, nausea, palpitations. Severe hypoglycemia can lead to loss of consciousness and / or convulsions, temporary or irreversible impairment of brain function up to a fatal outcome.
General disorders and reactions at the injection site: frequent – redness, swelling and itching at the injection site. These reactions are usually temporary and disappear with continued treatment.
Rare – Lipodystrophy. It can develop at the injection site as a result of non-compliance with the rule of changing the injection site within the same area.
Edema can occur at the initial stage of insulin therapy. These symptoms are usually temporary.
Immune system disorders: rare – Allergic reactions, urticaria, skin rash. Such symptoms may develop due to generalized hypersensitivity. Other signs of generalized hypersensitivity may include itching, sweating, gastrointestinal upset, angioedema, difficulty breathing, palpitations, and low blood pressure. Generalized hypersensitivity reactions (anaphylactic reactions) are potentially life-threatening.
Visual disturbances: rare – refractive errors, diabetic retinopathy.
Nervous system disorders: very rare – peripheral neuropathy.
Drug Interactions
There are a number of drugs that affect the need for insulin. The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, monoamine oxidase inhibitors, angiotensin converting enzyme inhibitors, carbonic anhydrase inhibitors, non-selective beta-adrenergic blocking agents, bromocriptine, sulfonamides, anabolic steroids, tetracyclin cyclofiloflofenfloflofloflofloindloinfloflofloflinflodenoflofloflofinflodenofloflofinflodenofloflofinflodenofloflofenflodenofloflofinflodenofloflofenflozenfinflodenofloflofenflodenfinofloflofenfloindofloflofenolfindloflofolindoflofinflozenfolindofloflofenolfindfloflindofloflofenolfindofloflofolfindofloflofolfloindfloflofloflofedinfo containing ethanol. The hypoglycemic effect of insulin is weakened by oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, somatropin, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazole, clonidine, slow calcium channel blockers, morphine, diacidine, diaxid.
Under the influence of reserpine and salicylates, both weakening and enhancing the action of the drug are possible.
Octreotide / lanreotide can both increase and decrease the body’s need for insulin.
Beta-blockers can mask the symptoms of hypoglycemia and delay recovery after hypoglycemia.
Alcohol may enhance and prolong the hypoglycemic effect of insulin.
Some drugs, such as those containing a thiol or sulfite group, when added to Levemir Penfill, can cause the destruction of insulin detemir. Levemir Flexpen should not be added to infusion solutions.
Overdose A specific dose for insulin overdose has not been established, however, hypoglycaemia may develop gradually if too high a dose is given for a particular patient.
Treatment: The patient can eliminate mild hypoglycemia by taking glucose, sugar or carbohydrate-rich foods by himself. Therefore, patients with diabetes mellitus are advised to carry sugar, sweets, cookies or sweet fruit juice all the time.
In case of severe hypoglycemia, when the patient is unconscious, 0.5 to 1 mg of glucagon should be given intramuscularly or subcutaneously (may be administered by a trained person), or intravenous dextrose (glucose) solution (can only be administered by a healthcare professional). Dextrose should also be administered intravenously if the patient does not regain consciousness 10-15 minutes after glucagon administration. After regaining consciousness, the patient is advised to eat carbohydrate-rich foods to prevent the recurrence of hypoglycemia.
Storage conditions
Store at 2 ° C to 8 ° C (in the refrigerator), but not near the freezer. Do not freeze.
Do not store the used syringe pen in the refrigerator. Used or portable as a spare syringe pen with the drug should be stored for 6 weeks at a temperature not exceeding 30 ° C.
After use, close the syringe handle with a cap to protect it from light, out of the reach of children.
Shelf life
30 months.
Deystvuyushtee substance
Insulin detemir
Terms and conditions
prescription
dosage form
injection
Possible product names
LEVEMIR FLEXPEN 100ME / ML 3ML N5 SYRINGE HANDLE PP
Levemir FlexPen syringe pen 100 ME / ml 3 ml, 5 pcs.
Levemir F. Pen100U / ml3ml No. 5
Novo Nordisk, Denmark
