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  • Tregludec
    / Novo Nordisk


    Active Ingredient
    Insulin Degludec 100 IU/ml, 200 IU/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Pen

    5 X 3 ml X 100 IU

    partial basket chart 54934 9762

    Pre-filled Pen

    3 X 3 ml X 200 IU

    partial basket chart

    Related information


    Dosage

    Posology: This is a basal insulin for once-daily subcutaneous administration at any time of the day, preferably at the same time every day. The potency of insulin analogues, including insulin degludec, is expressed in units (U). One (1) unit (U) of insulin degludec corresponds to 1 international unit (IU) of human insulin, 1 unit of insulin glargine or 1 unit of insulin detemir. In patients with type 2 diabetes mellitus, this product can be administered alone, in combination with oral anti‑diabetic medicinal products as well as in combination with bolus insulin. In type 1 diabetes mellitus, this product must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements.
    This product is to be dosed in accordance with the individual patient’s needs. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose. As with all insulin products adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
    This product is available in two strengths. For both, the needed dose is dialled in units. The dose steps, however, differ between the two strengths.
    a dose of 1‑80 units per injection, in steps of 1 unit, can be administered.
    a dose of 2‑160 units per injection, in steps of 2 units, can be administered. The dose is provided in half the volume of 100 units/mL basal insulin products.
    The dose counter shows the number of units regardless of strength and no dose conversion should be done when transferring a patient to a new strength.
    Flexibility in dosing time: On occasions when administration at the same time of the day is not possible, this product allows for flexibility in the timing of insulin administration. A minimum of 8 hours between injections should always be ensured.
    Patients who forget a dose, are advised to take it upon discovery and then resume their usual once-daily dosing schedule.
    Initiation: Patients with type 2 diabetes mellitus: The recommended daily starting dose is 10 units followed by individual dosage adjustments.
    Patients with type 1 diabetes mellitus: This product is to be used once-daily with meal-time insulin and requires subsequent individual dosage adjustments.
    Transfer from other insulin medicinal products: Close glucose monitoring is recommended during the transfer and in the following weeks. Doses and timing of concurrent rapid-acting or short-acting insulin products or other concomitant anti‑diabetic treatment may need to be adjusted.
    Patients with type 2 diabetes mellitus: For patients with type 2 diabetes taking basal, basal-bolus, premix or self-mixed insulin therapy, changing the basal insulin to this product can be done unit-to-unit based on the previous basal insulin dose followed by individual dosage adjustments.
    Patients with type 1 diabetes mellitus: For most patients with type 1 diabetes, changing the basal insulin to this product can be done unit-to-unit based on the previous basal insulin dose with subsequent individual dosage adjustments. For patients with type 1 diabetes transferring from twice-daily basal insulin or having HbA1c < 8.0% at the time of transfer, the dose of this product needs to be determined on an individual basis. Dose reduction needs to be considered followed by individual dosage adjustment based on the glycaemic response.
    Special Populations
    Elderly (≥ 65 years old): It can be used in elderly patients. Glucose-monitoring is to be intensified and the insulin dose adjusted on an individual basis.
    Renal and hepatic impairment: It can be used in renal and hepatic impaired patients. Glucose-monitoring is to be intensified and the insulin dose adjusted on an individual basis.
    Pediatric Population: The safety and efficacy of this product in children and adolescents below 18 years of age have not been established.
    Method of administration: This product is for subcutaneous use only. It must not be administered intravenously as it may result in severe hypoglycaemia. It must not be administered intramuscularly as it may change the absorption. It must not be used in insulin infusion pumps. This product is administered subcutaneously by injection in the thigh, the upper arm or the abdominal wall. Injection sites are always to be rotated within the same region in order to reduce the risk of lipodystrophy.
    It comes in a pre‑filled pen (FlexTouch) designed to be used with NovoFine or NovoTwist injection needles. The 100 units/mL pre‑filled pen delivers 1 – 80 units in steps of 1 unit.
    For full details see prescribing information.


    Indications

    Treatment of diabetes mellitus in adults.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Hypoglycemia :Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycemia. Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement.Patients whose blood-glucose control is greatly improved (e.g. by intensified insulin therapy) may experience a change in their usual warning symptoms of hypoglycemia and must be advised accordingly. Usual warning symptoms may disappear in patients with long-standing diabetes. Concomitant illness, especially infections and fever, usually increases the patient’s insulin requirement. Concomitant diseases in the kidney, liver or diseases affecting the adrenal, pituitary or thyroid gland may require changes in the insulin dose. As with other basal insulin products, the prolonged effect of this product may delay recovery from hypoglycemia.
    Hyperglycemia: Administration of rapid-acting insulin is recommended in situations with severe hyperglycemia Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycemia and potentially to diabetic ketoacidosis. Furthermore, concomitant illness, especially infections, may lead to hyperglycemia and thereby cause an increased insulin requirement.
    Usually, the first symptoms of hyperglycemia develop gradually over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, and loss of appetite as well as acetone odour of breath. In type 1 diabetes mellitus, untreated hyperglycemia events eventually lead to diabetic ketoacidosis, which is potentially lethal.
    Transfer from other insulin medicinal products: Transferring a patient to another type, brand or manufacturer of insulin must be done under medical supervision and may result in the need for a change in dosage.
    Combination of pioglitazone and insulin medicinal products: 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 failure. This should be kept in mind if treatment with the combination of pioglitazone and this product is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and edema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
    Eye disorder: 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.
    Avoidance of medication errors: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between the two different strengths of this product as well as other insulin products.  Patients must visually verify the dialled units on the dose counter of the pen. Therefore, the requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device.
    Insulin antibodies: Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
    See prescribing information for full details.


    Side Effects

    Hypersensitivity, Urticaria, Hypoglycaemia, Lipodystrophy, Injection site reactions, Peripherial Edema, Immune system disorders.
    See prescribing information for full details.


    Drug interactions

    A number of medicinal products are known to interact with glucose metabolism.
    The following substances may reduce the insulin requirement: Oral anti‑diabetic medicinal products, GLP‑1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta‑blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulphonamides.
    The following substances may increase the insulin requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol. Beta‑blockers may mask the symptoms of hypoglycaemia.
    Octreotide/lanreotide may either increase or decrease the insulin requirement.
    Alcohol may intensify or reduce the hypoglycaemic effect of insulin.


    Pregnancy and Lactation

    Pregnancy: There is no clinical experience with use of this product in pregnant women. Animal reproduction studies have not revealed any difference between insulin degludec and human insulin regarding embryotoxicity and teratogenicity. In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually decrease in the first trimester and increase subsequently during the second and third trimester. After delivery, insulin requirements usually return rapidly to pre-pregnancy values.
    See prescribing information for full details.
    Breast-feeding: There is no clinical experience with this product during breast-feeding. In rats, insulin degludec was secreted in milk; the concentration in milk was lower than in plasma. It is unknown whether insulin degludec is excreted in human milk. No metabolic effects are anticipated in the breast-fed newborn/infant. See prescribing information for full details.
    Fertility: Animal reproduction studies with insulin degludec have not revealed any adverse effects on fertility. See prescribing information for full details.


    Overdose

    A specific overdose for insulin cannot be defined; however, hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin than required: Mild hypoglycaemic episodes can be treated by oral administration of glucose or other products containing sugar. It is therefore recommended that the patient always carries glucose-containing products.
    Severe hypoglycaemic episodes, where the patient is not able to treat himself, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional. Glucose must be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.


    Important notes

    This medicinal product must not be mixed with any other product. The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines). Patients must be advised to take precautions to avoid hypoglycaemia while driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.
    See prescribing information for full details.


    Manufacturer
    Novo Nordisk A/S, Denmark
    Licence holder
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