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  • Model:
    1210
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    In stock
  • Availability date:
    2020-07-30
  • Dosage form:
    solution
  • In stock:
    252 Items

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Composition:


active ingredient: insulin degludec;


1 ml of the solution contains 100 units of degludec insulin* (equivalent to 3.66 mg of degludec insulin).


1 pre-filled syringe pen contains 3 mL of the solution, which is equivalent to 300 units of degludec insulin;


excipients: glycerin; metacresol; phenol; zinc acetate, dihydrate; hydrochloric acid (for PH correction); sodium hydroxide (for PH correction); water for injection.


* Produced using rDNA technology in Saccharomyces cerevisiae.


Dosage form. Solution for injection.


Basic physical and chemical properties: clear liquid, without turbidity, practically does not contain mechanical inclusions.


Pharmacotherapeutic group. Drugs that affect the digestive tract and metabolism. Medications used for diabetes mellitus. Long-acting insulins and analogues for injection. ATX code A10A E06.


Pharmacological properties.


Mechanism of action


Degludec insulin specifically binds to the human insulin receptor and results in the same pharmacological effect as human insulin.


The hypoglycemic effect of insulin is to promote the absorption of glucose by tissues after binding insulin to muscle and fat cell receptors, as well as to simultaneously inhibit the release of glucose from the liver.


Pharmacodynamics.


Tresiba Flextach® is a basal insulin that forms a soluble multihexamer after subcutaneous injection, resulting in a depot from which degludec insulin is continuously and slowly absorbed into the bloodstream, which causes an even and stable effect of lowering blood glucose levels. Within 24 hours, the hypoglycemic effect of Tresiba Flextach® when administered once a day, in contrast to insulin glargine,is evenly manifested in the first and second 12 hours (AUCSHVG, 0-12g, PK / AUCSHVG, total PK = 0.5).


The duration of action of Treciba Flextach® exceeds 42 hours within the therapeutic dose range.


The equilibrium concentration in the blood is reached after 2-3 days of taking the drug.


The hypoglycemic effect of insulin degludec at steady state concentration is characterized by a fourfold decrease in daily variability, defined as the subject of variability in glucose reduction (CV) as a percentage for 0-24 hours (AUCSHVG,τ, PK) and 2-24 hours (AUCSHVG2 24h, PK) compared to insulin glargine.


The overall hypoglycemic effect of Tresiba Flextach increases linearly with increasing dose. The average hypoglycemic effect of Tresiba® Flextach® 100 U/mL and Tresiba® Flextach® 200 U/mL is comparable with the same dose of drugs.


There were no differences in the pharmacodynamic effect of the drug in young and elderly adult patients.

Pharmacokinetics.


Absorption.


After subcutaneous injection, soluble and stable degludec insulin multihexamers create an insulin depot in the subcutaneous tissue. Degludec insulin monomers are gradually separated from multihexamers, which leads to a slow and constant flow of degludec insulin into the bloodstream.


The equilibrium concentration of degludec insulin in the blood serum is reached after 2-3 days of daily administration of the drug.


The hypoglycemic effect of Tresiba Flextach® for 24 hours when administered once a day, in contrast to insulin glargine, is evenly manifested in the first and second 12 hours (AUCSHVG,0-12g, PK / AUCSHVG, total PK = 0.5).


Distribution


The affinity of degludec insulin for human plasma albumin is > 99 %.


Metabolism


Degludec insulin degradation is similar to that of human insulin; none of the metabolites produced have biological activity.


Output


After subcutaneous administration of the drug, the Half-Life is determined by the rate of absorption from subcutaneous tissue. The Half-Life of Treciba Flextach is approximately 25 hours, regardless of the dose.


Linearity


Dose proportionality was observed in total exposure after subcutaneous administration in the therapeutic dose range. In direct comparison, the bioequivalence requirements are met for Tresiba® Flextach® 100 U/mL and Tresiba® Flextach® 200 U/ml (based on AUC IDEG, τ, PK and Cmax, IDEG, PK).


Gender


There were no differences in the pharmacokinetic properties of the drug depending on gender.


Age, race, kidney and liver failure


There were no differences in the pharmacokinetics of degludec insulin between elderly and young adult patients, between patients of different races, or between healthy volunteers and patients with renal or hepatic insufficiency.


Children


The pharmacokinetic properties of degludec insulin in children (aged 1 to 11 years) and adolescents (aged 12 to 18 years) at a stable dose were comparable to those in adults with Type 1 diabetes mellitus. Overall exposure after a single dose was higher in children and adolescents than in adults with Type 1 diabetes mellitus.


Clinical characteristics.


Indications.


Treatment of diabetes mellitus in adults, adolescents and children over 1 year of age.


Contraindications.


Hypersensitivity to insulin degludec or to any excipient that is part of the drug.


Interactions with other drugs and other types of interactions.


As you know, a number of medications affect glucose metabolism.


Medications that may reduce the need for insulin


Oral hypoglycemic agents, HPP-1 receptor agonists, monoamine oxidase (MAO) inhibitors, b-blockers, angiotensin-converting enzyme (ACE) inhibitors, salicylates, anabolic steroids, and sulfonamides.


Medications that may increase the need for insulin


Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone, and danazol.


b-blockers can mask the symptoms of hypoglycemia.


Octreotide / lanreotide can both reduce and increase the need for insulin.


Alcohol may increase or decrease the hypoglycemic effect of insulin.


Application features.


Hypoglycemia


Skipping meals or unexpected intense physical activity can lead to hypoglycemia.


Hypoglycemia can occur if the insulin dose is too high relative to the need for insulin.


When using in children, special attention should be paid to the correspondence of insulin doses (especially in the basal bolus mode) to the amount of food consumed and physical activity to reduce the risk of hypoglycemia.


Patients who have significantly improved blood glucose control due to intensive insulin therapy may notice a change in the usual symptoms-harbingers of hypoglycemia, which they should be warned about in advance. The usual harbinger symptoms may disappear in patients with long-term diabetes mellitus.


Comorbidities, especially infections and fever, usually increase the patient's need for insulin. Concomitant diseases of the kidneys, liver, or adrenal, pituitary, or thyroid glands may cause the need to adjust the dose of insulin.


As with other basal insulin preparations, the prolonged action of Treciba Flextach may delay the recovery of blood glucose levels after hypoglycemia.


Hyperglycemia


In case of significant hyperglycemia, short-acting insulin is recommended.


Inappropriate dosage or discontinuation of treatment in patients requiring insulin administration can lead to hyperglycemia and diabetic ketoacidosis. In addition, comorbidities, especially infections, can lead to hyperglycemia and, consequently, an increased need for insulin.


Usually, the first symptoms of hyperglycemia develop gradually, over several hours or days. These include feeling thirsty, frequent urination, nausea, vomiting, drowsiness, redness and dry skin, dry mouth, loss of appetite, and the smell of acetone in the exhaled air. In Type 1 diabetes, untreated hyperglycemia leads to diabetic ketoacidosis, which is deadly.


Transferring a patient from a different type of insulin


Transfer of a patient from a different type or brand of insulin or from an insulin manufacturer should take place under strict medical supervision, since it may be necessary to adjust the dose of insulin.


Combination of pioglitazone with insulin preparations


When using pioglitazone in combination with insulin, cases of congestive heart failure have occurred, especially in patients with risk factors for congestive heart failure. This should be taken into account when prescribing treatment with a combination of pioglitazone with Treciba Flextach®. With the combined use of these drugs, patients should be under the supervision of a doctor for timely detection of symptoms of congestive heart failure, weight gain and the occurrence of edema. In case of any deterioration in cardiac function, treatment with pioglitazone should be discontinued.


Visual impairment

Increasing insulin therapy with a dramatic improvement in glycemic control may temporarily worsen diabetic retinopathy, while long-term improvement in glycemic control reduces the risk of diabetic retinopathy progression.


Preventing accidental errors


Patients should constantly check the labels on insulin before each injection, so as not to accidentally confuse Treciba Flextach with other insulin preparations.


Patients should visually check the number of units typed on the syringe pen dose counter. Blind patients patients with poor eyesight should seek help from another person who has good eyesight and knows how to use an insulin injection device.


To prevent dosage errors and potential overdose, patients and doctors should not use a syringe to collect the drug from the cartridge of a pre-filled syringe pen. If the needles are blocked, patients should follow the instructions described in the instructions for use of Treciba Flextach® for the patient (see the rules of care and handling of the syringe pen).


Production of insulin antibodies


The introduction of insulin can lead to the production of antibodies to it. In rare cases, the presence of such antibodies may require adjusting the dose of insulin to overcome the tendency to hyperglycemia or hypoglycemia.


Use during pregnancy or lactation.


Pregnancy


There is no clinical experience with the use of Treciba Flextach in pregnant women.


Studies on the effects on reproductive function in animals have not found any differences between the effects of degludec insulin and human insulin on embryotoxicity and teratogenicity.


In general, during pregnancy and pregnancy planning, increased blood glucose monitoring and monitoring of pregnant women with diabetes are recommended. The need for insulin usually decreases in the first trimester and increases during the second and third trimesters. After delivery, the need for insulin usually quickly returns to the level that it was before pregnancy.


Breast-feeding

There is no clinical experience with the use of Treciba Flextach during breast-feeding. In animals, degludec insulin passes into breast milk, its concentration in milk was lower than in plasma.


It is not known whether degludec insulin penetrates into human breast milk. No metabolic side effects are expected in newborns/infants who are breastfed.


Fertility

Studies of reproductive function in animals after the use of degludec insulin did not reveal an undesirable effect on fertility.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


The patient's response and ability to concentrate may be impaired with hypoglycemia. This can be a risk factor, for example, when driving a car or other mechanisms.


Patients should take measures to prevent hypoglycemia before driving. This is especially important for patients who have weakened or no symptoms-harbingers of hypoglycemia or episodes of hypoglycemia occur frequently. In such circumstances, it is worth weighing the feasibility of driving a car.


Dosage and administration.


Dosage


Treciba ® Flextach® is an ultra-long-acting basal insulin preparation for subcutaneous administration once a day during the day, preferably at the same time.


The strength of action of insulin analogues, including degludec insulin, is determined in units (units). One (1) unit (OD) of degludec insulin is equal to 1 international unit (IU) of human insulin, 1 unit of glargine insulin (100 U/mL), or 1 unit of detemir insulin.


In patients with Type 2 diabetes mellitus, the drug can be administered alone or in any combination with oral hypoglycemic agents, HPP-1 receptor agonists, and in combination with bolus insulin (see the section "pharmacodynamics").


In patients with Type 1 diabetes mellitus, the drug is used in combination with short-acting insulin to cover the need for insulin during meals.


The dosage of Treciba Flextach® is determined according to the individual needs of the patient. It is recommended to optimize glycemic control by adjusting the dose of basal insulin depending on fasting plasma glucose levels.


As with other insulin preparations, dose adjustment may also be necessary when changing the patient's physical activity or normal diet and with concomitant diseases.


The required dose is determined taking into account the units of action. The Treciba®Flextach® 100 U/ml syringe Pen allows you to administer a dose of 1 to 80 units per injection in increments of 1 unit.


The dose counter shows the number of units regardless of the strength of action.you should not recalculate the dose of insulin when transferring a patient to drugs with a new strength of action.


Flexibility in choosing the time of Drug Administration


In cases where Administration at the same time of day is not possible, administration at a different time is possible, but the interval of at least 8 hours between injections should always be maintained. There is no clinical experience of variability in the time of Administration of Treciba Flextach in children and adolescents.


Patients who forget to administer a dose of insulin in a timely manner are advised to administer it as soon as they remember it, and then return to the usual mode of administration – once a day.


Start of application


Patients with Type 2 diabetes mellitus


The recommended starting dose is 10 units once a day, followed by individual dose adjustment.


Patients with Type 1 diabetes mellitus


The drug should be used once a day in combination with insulin, which is used to cover the need for insulin during meals, followed by individual dose adjustment.


Switching from other insulin medications


Careful monitoring of blood glucose levels is recommended during the transfer to Treciba Flextach®, as well as in the first weeks of treatment. It may be necessary to adjust the dose and time of administration of short-acting insulin or other hypoglycemic agents.


Patients with Type 2 diabetes mellitus


In patients who received once-daily basal insulin, basal bolus insulin therapy, or used pre-mixed insulins or independently mixed insulins, switching to Treciba Flextach® can be carried out in a dose ratio of 1:1 relative to the previous dose of basal insulin, followed by individual dose adjustment.


The need to reduce the dose by 20% from the dose of the previous basal insulin should be weighed, followed by individual dose selection:


when switching to Tresiba® Flextach® from basal insulin, which was used 2 times a day; when switching to Tresiba® Flextach® from insulin glargine (300 U/mL).

Patients with Type 1 diabetes mellitus


For patients with Type 1 diabetes mellitus, it is necessary to consider reducing the dose by 20% from the dose of the previous basal insulin or the basal component of the continuous subcutaneous insulin infusion regimen, followed by individual dose adjustment depending on the individual glycemic response.


Use of Treciba Flextach in combination with HPP-1 receptor agonists in patients with Type 2 diabetes mellitus


When Treciba Flextach® is added to HPP-1 receptor agonists, the recommended starting dose is 10 units once a day, followed by individual dose selection.


When GPP-1 receptor agonists are added to Tresiba Flextach, it is recommended to reduce the dose of Tresiba Flextach by 20% to reduce the risk of hypoglycemia. In the future, the dose should be adjusted individually.

Overdose.


Although a specific concept of overdose has not been formulated for insulin, hypoglycemia of varying severity may develop after its administration if doses that are too high compared to the patient's need are used.


Mild hypoglycemia can be treated by taking oral glucose or foods that contain sugar. Therefore, patients with diabetes are advised to always have foods containing glucose with them. In the case of severe hypoglycemia, when the patient is unconscious, persons who have been instructed should administer glucagon subcutaneously or intramuscularly (0.5–1.0 mg). A healthcare professional may administer intravenous glucose to the patient. Glucose should also be administered intravenously if the patient's condition does not improve within 10-15 minutes after administration of glucagon.

After the patient wakes up, he should take carbohydrates inside to prevent a relapse of hypoglycemia.


Adverse reactions.


The most common side effect reported during treatment is hypoglycemia (see "description of individual adverse reactions").


Below is a list of adverse reactions based on data from clinical studies. Adverse reactions are classified by frequency and organ system class according to MedDRA. According to the frequency of occurrence, these reactions were divided into those that occur very often (≥1/10), often (≥1/100 to >1/1000 to >1/10000 to


From the immune system: rarely – hypersensitivity reactions, urticaria.


From the side of nutrition and metabolism: very often – hypoglycemia.


From the skin and subcutaneous tissue: infrequently – lipodystrophy.


Generalized disorders and disorders at the injection site: often – reactions at the injection site; infrequently – peripheral edema.


Description of individual adverse reactions


From the immune system


Allergic reactions may occur during the use of insulin preparations. Immediate allergic reactions to insulin or excipients can be life-threatening.


Urticaria and hypersensitivity reactions are rarely observed when using Tresiba Flextach, which are manifested by swelling of the tongue and lips, diarrhea, nausea, fatigue and itching.


Hypoglycemia


Hypoglycemia can occur when the dose of insulin significantly exceeds the patient's need for insulin. Severe hypoglycemia can lead to loss of consciousness and/or seizures, followed by temporary or permanent brain dysfunction and even death. Symptoms of hypoglycemia usually occur suddenly. These include cold sweats, pale and cold skin, fatigue, nervousness or tremors, anxiety, unusual fatigue or weakness, confusion, impaired concentration, drowsiness, excessive hunger, visual disturbances, headache, nausea, and rapid heartbeat.


Lipodystrophy


Lipodystrophy, including lipohypertrophy and lipoatrophy, can develop at injection sites. Constantly changing the injection site in one area of the body will reduce the risk of developing these reactions.


Injection site reactions


When Treciba Flextach® is administered at the injection site, skin reactions may occur, including hematomas, pain, bleeding, erythema, nodules, swelling, discoloration, itching, a feeling of warmth and compaction at the injection site. These reactions are usually moderate to temporary and resolve with continued treatment.


Children


The frequency, type and severity of adverse reactions in children do not differ from those in the general population of patients with diabetes mellitus (see the section "pharmacodynamics").


Special populations


According to clinical studies, the frequency, type and severity of adverse reactions observed in elderly patients and patients with impaired renal and hepatic function do not differ from those in the general population.


Expiration date.


2.5 years old.


Storage conditions.


Store in the refrigerator at a temperature of 2-8 °C (not too close to the freezer). Do not freeze. To protect yourself from sunlight, keep the pen with the cap on.


Store the syringe pen after the first use at a temperature not exceeding 30 °C. It can be stored in the refrigerator at a temperature of 2-8 °C. use for 8 weeks.  After each injection, the syringe pen should be closed again with a cap to protect it from light.


Keep out of reach of children.


Incompatibility.


The addition of various substances to Treciba Flextach may lead to degradation of degludec insulin.


Treciba Flextach should not be added to infusion solutions or mixed with any other drug.

Tags: Tresiba® [Insulin degludec]