Levemir FlexPen
Levemir FlexPen: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Levemir FlexPen
ATX code: A10AE05
Active ingredient: insulin detemir (Insulin detemir)
Manufacturer: Novo Nordisk A / S (Denmark); OOO "Novo Nordisk" (Russia)
Description and photo update: 2019-24-07
Prices in pharmacies: from 2300 rubles.
Buy
Levemir FlexPen is a hypoglycemic drug, a long-acting soluble analogue of human insulin.
Release form and composition
The drug is available in the form of a solution for subcutaneous (s / c) administration: a clear, colorless liquid (3 ml in glass cartridges, in a plastic multi-dose disposable FlexPen syringe pen for multiple injections 1 cartridge, in a cardboard box 5 syringe pens and instructions for use Levemira FlexPen).
1 ml of solution contains:
- active substance: insulin detemir - 100 U (unit of action), which is equivalent to 14.2 mg of salt-free insulin detemir;
- auxiliary components: metacresol, glycerol, phenol, zinc acetate, sodium chloride, sodium hydroxide (hydrochloric acid), sodium hydrogen phosphate dihydrate, water for injection.
Pharmacological properties
Pharmacodynamics
Levemir FlexPen is a hypoglycemic drug with prolonged action. Its active ingredient, insulin detemir, is a soluble basal analogue of human insulin with a flat profile of action. Insulin detemir is obtained by using biotechnological methods of recombinant DNA (deoxyribonucleic acid) using the Saccharomyces cerevisiae strain. Compared with insulin glargine and insulin isophane, the action profile of insulin detemir is significantly less variable. Pharmacodynamic parameters of the maximum glucose infusion rate for insulin detemir are 0.053; for insulin isophane and insulin glargine - 0.209 and 0.13, respectively. The area under the infusion rate curve within 24 hours after the administration of insulin preparations: for insulin detemir - 0.074; for insulin glargine - 0.231; for insulin-isophane - 0.466.
The prolonged action of insulin detemir is due to the pronounced self-association of its molecules at the injection site and their binding to albumin through connection with the side fatty acid chain. The drug is characterized by a slow flow to the peripheral target tissues. Due to these combined mechanisms of delayed distribution, a more reproducible profile of absorption and action of insulin detemir is provided compared to insulin-isophane.
Depending on the dose of the drug, its action can last up to 24 hours, so the therapeutic effect can be achieved against the background of a single or double daily administration. When administered twice, the equilibrium plasma concentration of insulin detemir (C ss) is reached after the administration of 2-3 doses of Levemir FlexPen. When using doses of 0.2-0.4 U per 1 kg of the patient's body weight (U / kg), half of the maximum effect of the drug occurs in the interval from 3 to 14 hours after injection.
The pharmacodynamic response of the drug (duration of action, maximum and general effects) is directly dependent on the administered SC dose of insulin detemir.
The results of long-term studies of Levemir FlexPen indicate low variability in fasting plasma glucose levels, in contrast to insulin-isophane.
In patients with type 2 diabetes mellitus who are on combination therapy with basal insulin and oral hypoglycemic agents, glycemic control during drug therapy is comparable to glycemic control when using insulin-isophane or insulin glargine, while patients have a low body weight gain.
It was found that the combination of Levemir FlexPen with oral hypoglycemic agents reduces the risk of developing mild nocturnal hypoglycemia by 61–65% in comparison with insulin-isophane.
The incidence of hypoglycemia in the basal-bolus regimen of insulin therapy with the drug is comparable to that of isophane insulin. In patients with type 1 diabetes mellitus against the background of the use of insulin detemir, the development of mild nocturnal hypoglycemia, which the patient can eliminate on his own, occurs much less frequently compared with insulin-isophane. In patients with type 2 diabetes mellitus, there was no difference between these insulins in the frequency of episodes of mild nocturnal hypoglycemia. The nocturnal glycemic profile is flatter and even in Levemir FlexPen compared to insulin-isophane, so the risk of developing nocturnal hypoglycemia is lower. The observed production of antibodies when using the drug does not affect glycemic control.
The results of a randomized controlled clinical trial in pregnant women showed a similarity in the overall profile of HbA 1c (glycated hemoglobin) throughout the entire period of pregnancy in patients treated with insulin detemir and insulin-isophane. No significant differences in the incidence of hypoglycemic episodes were found.
If the frequency of occurrence of adverse events during the entire period of pregnancy demonstrates similar results, then a greater number of patients receiving insulin treatment with detemir and their children (during intrauterine development and after birth) are susceptible to the occurrence of serious adverse events compared with the use of insulin isophane.
The efficacy and safety of Levemir FlexPen in adolescents with type 2 diabetes mellitus have been confirmed by the results of clinical studies.
Pharmacokinetics
After subcutaneous administration, the maximum concentration (Cmax) of insulin detemir in blood plasma is reached after 6–8 hours. Intraindividual variability (fluctuations in the measured value in individual patients at different times and under different conditions) of its absorption is lower compared to other basal insulins.
The average volume of distribution (V d) is approximately 0.1 l / kg, which indicates that most of it circulates in the blood.
The absence of clinically significant interactions between insulin detemir and other drugs that bind to proteins or fatty acids was found.
Insulin metabolism detemir is similar to the inactivation of human insulin preparations, its metabolites are inactive.
After subcutaneous injection, the terminal half-life (T 1/2) can range from 5 to 7 hours, depending on the dose and the individual degree of absorption from the subcutaneous tissue.
In the range of therapeutic doses, the concentration of the drug in the blood plasma is linear and proportional to the administered dose.
The sex of the patient does not affect the pharmacokinetics of insulin detemir.
In patients with type 2 diabetes mellitus, with the simultaneous administration of Levemir FlexPen at a single dose of 0.5 U / kg and liraglutide at a dose of 1.8 mg in an equilibrium state, no pharmacokinetic or pharmacodynamic interaction was detected.
Clinical differences in the pharmacokinetic properties of insulin detemir between children aged 1–12 years, adolescents (13–17 years) and adults have not been established.
In case of impaired renal and liver function, the pharmacokinetics of Levemir FlexPen does not change.
In vitro, insulin detemir has a low affinity for insulin receptors and IGF-1 (insulin-like growth factor 1) and has little effect on cell growth compared to human insulin. The results of studies of pharmacological safety, genotoxicity, toxic effects on reproductive function, toxicity of repeated doses, carcinogenic potential indicate that there is no danger to humans.
Indications for use
The use of Levemir FlexPen is indicated for the treatment of diabetes mellitus in patients over the age of 1 year as a basal insulin in monotherapy, in combination with another bolus insulin or oral hypoglycemic drugs and / or agonists of glucagon-like peptide-1 (GLP-1) receptors.
Contraindications
Absolute:
- age up to 1 year;
- individual intolerance to the components of Levemir FlexPen.
With caution, more closely monitoring the blood glucose concentration, insulin detemir should be used in patients with renal or hepatic insufficiency, impaired adrenal, thyroid or pituitary gland function, in old age.
Levemir Flexpen, instructions for use: method and dosage
Do not allow intramuscular (i / m) and intravenous (i / v) administration of the drug, as well as its use in insulin pumps!
Syringe-pens Levemir FlexPen are designed exclusively for subcutaneous injection into such anatomical areas as the anterior abdominal wall, anterior thigh, buttocks, and shoulder. The procedure is performed daily, always at the same time of day, convenient for the patient.
To reduce the risk of lumps and / or ulceration at the injection site, the injection site should be changed each time.
The solution is in a FlexPen syringe pen equipped with a dispenser, designed for multiple injections of insulin in the range of doses from 1 to 60 U, which can be adjusted in steps of 1 U. It should be used to treat only one patient using disposable NovoFine and NovoTvist needles up to 8 mm long. Needles should not be reused, as this increases the risk of contamination, blockage and misdosing of insulin, drug leakage, or infection.
Before the introduction of Levemir FlexPen, you must make sure that the pen contains the required type of insulin. After removing the cap from the pen, you should tightly screw the needle onto the pen. Then remove and store the large outer needle cap, remove the inner needle cap and discard immediately.
For the correct supply of insulin and to prevent air bubbles from entering the skin, the patient should check the operation of the syringe pen before each injection. To do this, he sets the pointer to 2 units with the dose selector. Then, holding the syringe pen with the needle up, with the tip of your finger gently taps the cartridge several times to move the existing air bubbles to the upper part of the cartridge, and pushes the trigger button all the way. A drop of insulin should appear at the end of the needle and the dose selector should return to zero. If no drop appears, replace the needle and repeat the procedure. If insulin does not come out of the needle after changing it six times, it is recommended to use a new pen. Should be considered,that the appearance of a drop of insulin at the end of the needle when checking is a prerequisite and a guarantee of the required dose of Levemir FlexPen entering the body.
Before setting the individual dose, the dose selector must be in the "0" position. Turning the dosage selector in any direction, you should dial the number of units required for the injection. If the number of units in the cartridge is less than the required dose, then it cannot be set. The dose selector and pointer show the number of units of insulin the patient has drawn.
The clicks of the pen should not be counted when inserting. You cannot use the residual insulin scale to set the dose, as it displays the approximate amount of Levemir FlexPen in the pen.
The technique of self-administered subcutaneous administration of the drug to the patient should be taught by a doctor or nurse.
To make an injection, you must press the trigger button all the way and hold it in this position until the dosage indicator is opposite "0" again, and then remove the needle from under the skin. After injection, the needle must remain under the skin for at least 6 seconds to ensure the required dose of insulin is delivered. After the procedure, put the cap on the needle, unscrew it and discard.
If the dose selector stops before it reads “0”, this indicates that an incomplete dose of insulin was delivered. An incomplete dose of insulin can result in too high blood glucose levels.
Do not allow the pen to fall, immerse it in the liquid, or exert strong mechanical impact on it. You can use a cotton swab soaked in alcohol to clean the surface of the pen.
The use of Levemir FlexPen requires regular monitoring of blood glucose levels.
The dose is selected individually, taking into account the patient's fasting blood glucose concentration.
The recommended dosage for adults when Levemir FlexPen is combined with oral hypoglycemic agents or GLP-1 receptor agonists: the initial dose is 10 IU or at the rate of 0.1–0.2 IU per 1 kg of patient's weight once a day. To minimize the risk of hypoglycemia, when combined with GLP-1 receptor agonists, the dose of the drug should be reduced by 20%. Further, the dose is selected individually.
Individual dose adjustment in adult patients with type 2 diabetes mellitus is made taking into account the average value of the plasma glucose, which is determined independently every day before breakfast. To do this, it is proposed to use the following recommendations:
- more than 10 mmol / l: + 8 units;
- 9.1-10 mmol / l: + 6 units;
- 8.1-9 mmol / l: + 4 units;
- 6.1–8 mmol / l: + 2 units;
- 4.1–6 mmol / L: usual dose (no change);
- 3.1-4 mmol / l: - 2 units;
- less than 3.1 mmol / l: - 4 U
When using Levemir FlexPen as part of the base-bolus regimen, it is prescribed in an individual dose 1 or 2 times a day, based on the patient's needs. For a two-fold dosing regimen, the evening dose should be administered during dinner or at bedtime.
The need for dose adjustment may arise with an increase in physical activity, a change in the patient's usual diet, or the appearance of a concomitant disease.
When transferring from medium or long-acting insulin, it is recommended to carefully monitor the blood glucose concentration for timely dose adjustment.
In patients on combined hypoglycemic therapy, it may be necessary to adjust the dose of oral hypoglycemic agents or short-acting insulin preparations and the time of their administration.
The duration of action of Levemir FlexPen depends both on the dose and site of administration, as well as on temperature, blood flow intensity or degree of physical activity.
Do not administer the drug if your blood sugar is low.
Do not use the drug if the insulin has ceased to have a transparent and colorless structure or if the storage conditions have been violated. Also, a syringe pen that was damaged as a result of falling is unusable.
Side effects
When using Levemir FlexPen, undesirable disorders of systems and organs may occur (classified as follows: very often - ≥ 1/10, often - ≥ 1/100 and <1/10, infrequently - ≥ 1/1000 and <1/100, rarely - ≥ 1/10 000 and <1/1000, very rarely - <1/10 000, including isolated cases):
- on the part of metabolism and nutrition: very often - hypoglycemia;
- on the part of the immune system: often (against the background of a combination with other oral hypoglycemic agents) - allergic reactions; infrequently (with monotherapy) - allergic reactions, skin rashes, skin rashes, urticaria; very rarely - anaphylactic reactions or generalized hypersensitivity reactions (including sweating, generalized skin rash, itching, gastrointestinal upset, difficulty breathing, angioedema, heart palpitations, lowering blood pressure);
- from the nervous system: rarely - peripheral neuropathy (transient acute painful neuropathy);
- on the part of the organ of vision: infrequently - a violation of refraction (observed at the beginning of therapy and is usually temporary), diabetic retinopathy;
- dermatological reactions: infrequently - lipodystrophy (including lipohypertrophy, lipoatrophy);
- violations at the injection site: often - reactions at the injection site, such as swelling, itching and / or redness at the injection site, pain, urticaria, inflammation, hematomas (as a rule, they are temporary, that is, they disappear with continued therapy);
- general disorders: infrequently - edema (usually of a transient nature).
Overdose
Symptoms: An insulin overdose is accompanied by symptoms of hypoglycemia, which may include pallor of the skin, cold sweats, increased fatigue, anxiety, nervousness (tremor), severe hunger, weakness, unusual fatigue, nausea, headache, decreased concentration, disorientation, drowsiness, blurred vision, palpitations. Severe hypoglycemia can be accompanied by loss of consciousness, seizures, temporary or irreversible dysfunction of the brain and lead to the death of the patient.
Treatment: the patient can eliminate the symptoms of mild hypoglycemia on his own by eating sugar-containing foods or taking glucose orally. Severe hypoglycemia requires immediate medical attention. If the patient has lost consciousness, he needs to inject s / c or i / m glucagon in a dose of 0.5-1 mg or i / v dextrose (glucose) solution. Intravenous administration of dextrose is also indicated in cases where the patient does not regain consciousness within 10-15 minutes after the administration of glucagon. After regaining consciousness, it is recommended to consume food rich in carbohydrates to prevent recurrence of hypoglycemia.
special instructions
In case of unforeseen force majeure, the patient should always have a spare insulin system with him, along with the syringe pen used. In addition, to independently eliminate the symptoms of mild hypoglycemia, the patient is advised to always wear refined sugar or sugar-containing products.
Adverse reactions at the injection site usually disappear on their own within a few days. In rare cases, they require discontinuation of therapy. To reduce the risk of developing lipodystrophy at the injection site, it is necessary to carefully follow the rules for changing the injection site within the same anatomical region.
Before a long trip that involves changing time zones, the patient should consult with the attending physician about meal times and insulin administration.
An insufficient dose, skipping the next dose or stopping the use of Levemir FlexPen can lead to the development of hyperglycemia or diabetic ketoacidosis.
Symptoms of hyperglycemia usually appear within hours or days. These include: drowsiness, thirst, dry mouth, nausea, vomiting, increased urination, redness and dryness of the skin, the smell of acetone in the exhaled air, loss of appetite. In patients with type 1 diabetes mellitus, the absence of appropriate timely treatment with hyperglycemia can cause the development of diabetic ketoacidosis and lead to death.
Hypoglycemia can develop with the introduction of too high a dose of insulin in relation to the patient's needs, skipping meals, or unplanned intense physical activity. Especially carefully, taking into account the food consumed and the child's physical activity, the dose of insulin in children should be selected (including with a basal-bolus regimen).
Patients should be informed that with prolonged diabetes mellitus, the usual predictive symptoms of hypoglycemia may disappear.
Concomitant infectious and other diseases accompanied by fever increase the body's need for insulin.
When transferring a patient from other insulin preparations, careful medical supervision is required. This is because changing the method of production, manufacturer, concentration, type and / or type of insulin may require dose adjustments, which are carried out with the introduction of the first dose of a new insulin preparation or within several weeks of treatment with a new insulin.
The doctor must strictly instruct the patient about the need to check the markings on the label of the syringe pen before each injection in order to prevent accidental administration of another insulin, especially when using several drugs at once.
When Levemir FlexPen is combined with drugs of the thiazolidinedione group, the risk of developing chronic heart failure increases, especially in the presence of risk factors for its development. Therefore, such treatment must be accompanied by a medical examination of patients for weight gain, edema and symptoms of chronic heart failure. If the symptoms of heart failure worsen, then the use of thiazolidinediones should be discontinued.
Influence on the ability to drive vehicles and complex mechanisms
The decision on the advisability of driving vehicles or performing potentially hazardous types of work should be made taking into account the doctor's recommendations individually, especially in patients with diabetes mellitus with frequent episodes of hypoglycemia, reduced or absent symptoms, precursors of hypoglycemia.
Application during pregnancy and lactation
When prescribing Levemir FlexPen during pregnancy, it is necessary to assess the benefits of its use over the possible risk.
Data from controlled clinical and post-marketing studies on the efficacy and safety of the drug in pregnant women indicate the absence of undesirable effects leading to the development of congenital defects and toxic effects on the health of the fetus or newborn.
Careful observation is required when planning pregnancy and during the entire period of gestation. It should be borne in mind that in the first trimester the need for insulin usually decreases, in the II-III - it increases, after childbirth - quickly returns to the level that provided a sufficient decrease in blood glucose levels before pregnancy.
The penetration of the drug into breast milk has not been established. Insulin detemir belongs to a group of peptides that are easily absorbed by the body, breaking down into amino acids in the digestive tract. This suggests that it does not affect the metabolic processes in the body of infants during lactation. When breastfeeding, a dose adjustment of Levemir FlexPen may be necessary.
Pediatric use
The use of Levemir FlexPen in children under 1 year of age is contraindicated due to the lack of information on the efficacy and safety of treatment of patients of this age category.
With impaired renal function
Caution should be exercised when using Levemir FlexPen in patients with renal insufficiency.
For violations of liver function
Levemir FlexPen should be used with caution in patients with hepatic impairment.
Use in the elderly
With caution, carefully monitoring the fasting blood glucose level, the drug should be used in elderly patients.
Drug interactions
With the simultaneous use of Levemir FlexPen with other drugs, it is necessary to take into account their effect on glucose metabolism.
A decrease in the need for insulin occurs when Levemir FlexPen is combined with oral hypoglycemic agents, GLP-1 receptor agonists, monoamine oxidase inhibitors, angiotensin-converting enzyme inhibitors, non-selective beta-blockers, salicylates, sulfonamides, anabolic steroids.
It may be necessary to increase the dose of insulin with concomitant therapy with glucocorticosteroids, thiazide diuretics, sympathomimetics, danazol, as well as when taking thyroid hormones, somatropin, oral hormonal contraceptives.
It should be borne in mind that beta-blockers can mask the symptoms of hypoglycemia.
Against the background of a combination with octreotide and lanreotide, both an increase and a decrease in the body's need for insulin are possible.
The hypoglycemic effect of insulin can increase and decrease with the simultaneous use of alcohol or ethanol-containing drugs.
Mixing insulin detemir with other solutions in the same container is contraindicated.
Analogs
The analogues of Levemir FlexPen are: Levemir Penfill, Insulin Detemir, Humulin M, Humulin NPH, Apidra, Humalog Mix 50, Lente, NovoRapid FlexPen, Actrapid, Protafan NM Penfill, Insuman Rapid GT, Recombinant Basal-insulin and other insulin.
Terms and conditions of storage
Keep out of the reach of children.
Store in a refrigerator (away from the freezer) at a temperature of 2 to 8 ° C, protected from moisture and light, do not freeze.
The shelf life is 2.5 years.
The used syringe pen with insulin should be stored with the cap put on, out of the reach of unauthorized persons, at a temperature not exceeding 30 ° C, but not in the refrigerator. Once opened, insulin is stable for 28 days.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Levemir FlexPen
Reviews about Levemir FlexPen are positive. Patients with diabetes mellitus indicate the high effectiveness of the drug. The absence of a pronounced peak of action contributes to maintaining a stable blood sugar level throughout the day. The advantages include simplicity and ease of use. The device of the syringe pen allows for easy and accurate dosing and administration of insulin. The disadvantage of Levemir FlexPen is considered a short period of validity after opening the cartridge.
Price for Levemir FlexPen in pharmacies
The price of Levemir FlexPen for a package containing 5 syringe pens with 3 ml cartridges can be 2,180–2558 rubles.
Levemir FlexPen: prices in online pharmacies
|
Drug name Price Pharmacy |
|
Levemir FlexPen 100 U / ml solution for subcutaneous administration 3 ml 5 pcs. RUB 2300 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
