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Tresiba is a brand name for Insulin Degludec. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year. 3
Verbatim from this product's EMA label. Tap a section to expand.
Posology This medicinal product 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.
One (1) unit of insulin degludec corresponds to 1 international unit of human insulin, 1 unit of insulin glargine (100 units/mL), or 1 unit of insulin detemir. 1). In type 1 diabetes mellitus, Tresiba must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements.
Tresiba 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. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Tresiba 100 units/mL and Tresiba 200 units/mL FlexTouch solution for injection in a pre-filled pen Tresiba is available in two strengths. For both, the needed dose is dialled in units. The dose steps, however, differ between the two strengths of the medicinal product.
• With Tresiba 100 units/mL a dose of 1–80 units per injection, in steps of 1 unit, can be administered. • With Tresiba 200 units/mL 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. Tresiba 100 units/mL FlexPen solution for injection in a pre-filled pen • With Tresiba 100 units/mL a dose of 1–60 units per injection, in steps of 1 unit, can be administered.
1). A minimum of 8 hours between injections should always be ensured. There is no clinical experience with flexibility in dosing time of Tresiba in children and adolescents. 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 Tresiba is to be used once daily with mealtime insulin and requires subsequent individual dosage adjustments.
Summary of the safety profile The most frequently reported adverse reaction during treatment is hypoglycaemia (see section ‘Description of selected adverse reactions’ below). Tabulated list of adverse reactions Adverse reactions listed below are based on clinical trial data and classified according to MedDRA 8 System Organ Class.
Frequency categories are defined according to the following convention:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data). System organ class Frequency Adverse reaction Immune system disorders Rare Hypersensitivity Urticaria Metabolism and nutrition disorders Very common Hypoglycaemia Skin and subcutaneous tissue disorders Uncommon Lipodystrophy Not known Cutaneous amyloidosis† General disorders and administration site conditions Common Injection site reactions Uncommon Peripheral oedema † ADR from postmarketing sources.
Description of selected adverse reactions Immune system disorders With insulin preparations, allergic reactions may occur. Immediate-type allergic reactions to either insulin itself or the excipients may potentially be life-threatening.
With Tresiba, hypersensitivity (manifested with swelling of tongue and lips, diarrhoea, nausea, tiredness and itching) and urticaria were reported rarely. Hypoglycaemia Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement.
Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. The symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Hypoglycaemia Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia. 9). In children, care should be taken to match insulin doses (especially in basal-bolus regimens) with food intake and physical activities in order to minimise the risk of hypoglycaemia.
g. by intensified insulin therapy) may experience a change in their usual warning symptoms of hypoglycaemia 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 Tresiba may delay recovery from hypoglycaemia.
Hyperglycaemia Administration of rapid-acting insulin is recommended in situations with severe hyperglycaemia. Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycaemia and potentially to diabetic ketoacidosis.
Furthermore, concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased insulin requirement. Usually, the first symptoms of hyperglycaemia 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 hyperglycaemic 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.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4 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 antidiabetic treatment may need to be adjusted.
Patients with type 2 diabetes mellitus For patients with type 2 diabetes taking once-daily basal, basal-bolus, premix or self-mixed insulin therapy, changing the basal insulin to Tresiba can be done unit-to-unit based on the previous basal insulin dose followed by individual dosage adjustments.
A dose reduction of 20% based on the previous basal insulin dose followed by individual dosage adjustments should be considered when - transferring to Tresiba from twice-daily basal insulin - transferring to Tresiba from insulin glargine (300 units/mL) Patients with type 1 diabetes mellitus For patients with type 1 diabetes a dose reduction of 20% based on the previous basal insulin dose or basal component of a continuous subcutaneous insulin infusion regimen should be considered with subsequent individual dosage adjustments based on the glycaemic response.
Use of Tresiba in combination with GLP-1 receptor agonists in patients with type 2 diabetes mellitus When adding Tresiba to GLP-1 receptor agonists, the recommended daily starting dose is 10 units followed by individual dosage adjustments.
When adding GLP-1 receptor agonists to Tresiba, it is recommended to reduce the dose of Tresiba by 20% to minimise the risk of hypoglycaemia. Subsequently, dosage should be adjusted individually. Special populations Elderly (≥65 years old) Tresiba can be used in elderly.
2). Renal and hepatic impairment Tresiba can be used in renal and hepatic impaired patients. 2). Paediatric population There is no clinical experience with the use of this medicinal product in children below the age of 1 year. 1). 4). Method of administration Subcutaneous use only.
Tresiba must not be administered intravenously as it may result in severe hypoglycaemia. This medicinal product must not be administered intramuscularly as it may change the absorption. This medicinal product must not be used in insulin infusion pumps.
4). Tresiba is administered subcutaneously by injection in the thigh, the upper arm or the abdominal wall. 8). 5 Patients should be instructed to always use a new needle. The re-use of insulin pen needles increases the risk of blocked needles, which may cause under- or overdosing.
In the event of blocked needles, […]
Skin and subcutaneous tissue disorders Lipodystrophy (including lipohypertrophy, lipoatrophy) and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. 4). Injection site reactions Injection site reactions (including injection site haematoma, pain, haemorrhage, erythema, nodules, swelling, discolouration, pruritus, warmth and injection site mass) occurred in patients treated with Tresiba.
These reactions are usually mild and transitory and they normally disappear during continued treatment. 2). Safety and efficacy have been demonstrated in a long term trial in children aged 1 to less than 18 years. 1). Other special populations Based on results from clinical trials, the frequency, type and severity of adverse reactions observed in elderly and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
9 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
6 Skin and subcutaneous tissue disorders Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions.
A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site from an affected to an unaffected area, and dose adjustment of antidiabetic medications may be considered.
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 Tresiba is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. 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 Tresiba 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.
To avoid dosing errors and potential overdose, patients and healthcare professionals should never use a syringe to draw the medicinal product from the cartridge in the pre-filled pen. 6). 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. e. it is essentially ‘sodium-free’. Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.