Tempo Digest 78

Tresiba ® 200˜units/mL solution for injection in prefilled pen. Tresiba ® 100˜units/mL solution for injection in cartridge. Composition : Tresiba 200 units/ml: One pre-filled pen contains 600 units of insulin degludec in 3 mL solution. 1 mL solution contains 200 units insulin degludec (rDNA).Tresiba 100 units/ml:One cartridge contains 300°units of insulin degludec in 3°mL solution.1 mL solution contains 100 units insulin degludec (rDNA). Pharmaceutical form :Clear,colourless,neutral solution.Tresiba 200 units/ml:Solution for injection in pre-filled pen (FlexTouch ® ).Tresiba 100 units/ml: Solution for injection in cartridge (Penfill ® ). Indications :Treatment of diabetes mellitus in adults, adoles- cents and children from the age of 1 year. Posology and method of administration: 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, includ- ing insulin degludec, is expressed in units. One (1) unit of insulin degludec corresponds to 1 international unit of human insulin, 1 unit of insu- lin glargine (100 units/mL), or 1 unit of insulin detemir. In patients with type 2 diabetes mellitus, this medicinal product can be administered alone or in any combination with oral antidiabetic medicinal products, GLP-1 receptor agonists and bolus insulin. 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 ad- justment based on fasting plas- ma 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 Tresi- ba 200 units/mL solution for in- jection in a pre-filled pen: Tresi- ba is available in two strengths. For both, the needed dose is di- alled in units. The dose steps, however, differ between the two strengths of the medicinal prod- uct.WithTresiba 100 units/mL a dose of 1–80 units per injection, in steps of 1 unit,can be admin- istered. 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 re- gardless of strength and no dose conversion should be done when transferring a patient to a new strength. Flexibility in dos- ing time: On occasions when administration at the same time of the day is not possible, Tresi- ba allows for flexibility in the timing of insulin administration. A minimum of 8 hours between injections should always be en- sured.There is no clinical expe- rience with flexibility in dosing time of Tresiba in children and adolescents. Patients who for- get a dose are advised to take it upon discovery and then re- sume their usual once-daily dosing schedule. Initiation: Pa- tients with type 2 diabetes melli- tus: The recommended daily starting dose is 10 units fol- lowed by individual dosage ad- justments. Patients with type 1 diabetes mellitus: Tresiba is to be used once daily with meal- time insulin and requires subse- quent individual dosage adjust- ments.Transfer from other insu- lin medicinal products: Close glucose monitoring is recom- mended during the transfer and in the following weeks. Doses and timing of concurrent rap- id-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, bas- al-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 fol- lowed by individual dosage ad- justments. 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 indi- vidual 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. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis. Renal and hepatic impair- ment: Tresiba can be used in renal and hepatic impaired patients. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis. Paediatric population: There is no clinical experience with the use of this medicinal product in children below the age of 1 year. This medicinal product can be used in adolescents and children from the age of 1 year.When changing basal insulin toTresiba,dose reduction of basal and bolus insulin needs to be considered on an individual basis in order to minimise the risk of hypoglycaemia. Method of administra- tion: 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. BE19TSM00003 – 01 May 2019 Tresiba must not be drawn from the cartridge of the pre-filled pen into a syringe.Tresiba is administered subcutaneously by injection in the thigh, the upper arm or the abdominal wall. Injection sites are always to be ro- tated within the same region in order to reduce the risk of lipodystrophy. 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,patients must follow the instructions described in the instructions for use accom- panying the package leaflet. Tresiba 200 units/mL solution for injection in a pre-filled pen: Tresiba comes in a pre-filled pen (FlexTouch) de- signed to be used with NovoFine ® or NovoTwist ® injection needles.The 200 units/mL pre-filled pen delivers 2–160 units in steps of 2 units. Tresiba 100°units/mL solution for injection in a cartridge:Tresiba comes in a cartridge (Penfill) designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist injection needles Contraindications: Hypersensitivity to the active substance or to any of the excipients. Undesirable effects: Summary of the safety profile:The most frequently reported adverse reaction during treatment is hypogly- caemia. List of adverse reac- tions: Adverse reactions listed below are based on clinical trial data. Very common : hypogly- caemia (may occur if the insulin dose is too high in relation to the insulin requirement. Severe hy- poglycaemia may lead to un- consciousness and/or convul- sions and may result in tempo- rary or permanent impairment of brain function or even death). Common : injection site reac- tions (including injection site haematoma, pain, haemor- rhage, erythema, nodules, swelling, discolouration, pruri- tus, warmth and injection site mass. These reactions are usu- ally mild and transitory and they normally disappear during con- tinued treatment). Uncommon: lipodystrophy (including lipohy- pertrophy, lipoatrophy. Continu- ous rotation of the injection site within the particular injection area may help to reduce the risk of developing these reactions), peripheral oedema. Rare: hyper- sensitivity, urticaria. With insulin preparations, allergic reactions may occur. Immediate-type al- lergic reactions to either insulin itself or the excipients may po- tentially be life-threatening.With Tresiba, hypersensitivity (mani- fested with swelling of tongue and lips, diarrhoea, nausea, tiredness and itching) and urti- caria were reported rarely. Pae- diatric population: Tresiba has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties. Safety and efficacy have been demonstrated in a long term trial in children aged 1 to less than 18 years. The frequency, type and severity of adverse reac- tions in the paediatric population do not indicate differences to the experience in the general diabetes population. Other spe- cial populations: Based on re- sults from clinical trials, the fre- quency, type and severity of ad- verse reactions observed in el- derly and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the gen- eral population. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is import- ant. It allows continued monitor- ing of the benefit/risk balance of the medicinal product. Health- care professionals are asked to report any suspected adverse reactions via the FederalAgency for Medicines and Health Prod- ucts: www.fagg-afmps.be . Way of delivery : medical prescrip- tion. Marketing Authorisa- tion (MA) holder: Novo Nor- disk A/S, Bagsvaerd, Denmark. MA numbers: EU/1/12/807/013 (200 units/ml, 3 FlexTouch), EU/1/12/807/007 (100 units/ml, 5 Penfill). Date of revision of the text: 11/2018. Tresiba ® , FlexTouch ® , Penfill ® , NovoFine ® and NovoTwist ® are registered trademark owned by Novo Nordisk A/S, Denmark 1. Tresiba ® (summary of product characteristics). 2. Lane W, Bailey TS, Gerety G, et al. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in PatientsWithType 1 Diabetes:The SWITCH 1 Randomized ClinicalTrial. JAMA 2017;318(1):33-44. 3. Wysham C,Bhargava A et al. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes. The SWITCH 2 Randomized Clinical Trial. JAMA 2017; 318(1):45-56. SWITCH 1 and SWITCH 2 are double-blind, randomized, crossover non-inferiority trials to evaluate hypo rates of insulin degludec vs insulin glargine U100 (n=501 and 721 respectively) . 4. Marso SP, McGuire DK et al. Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes. N Engl J Med 2017; 377:723-732. DEVOTE is a head-to-head, phase 3b, multicenter, interna- tional, randomised, double-blind, event-driven, cardiovascular outcomes trial (CVOT) to evaluate the CV safety of Tresiba ® vs glargine U100 as well as risk of severe hypoglycaemia in 7637 patients with type 2 diabetes at high risk of CV events. * A minimum of 8 hours between injections should always be ensured FlexTouch ® U200 3 x 3ml € 63,85 Penfill ® U100 5 x 3ml € 54,30 Tresiba ® once daily: Successful reduction in HbA 1c 2,3 Significant 53% reduction of severe nocturnal hypoglycaemia vs insulin glargine U100 4 Flexible dosing time from day-to-day when needed 1* A BASAL INSULIN WITH >42H DURATION OF ACTION 1 For patients with T1D and T2D 1

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