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  • Toujeo
    / Sanofi


    Active Ingredient
    Insulin Glargine 300 U/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Pen

    3 X 1.5 ml

    partial basket chart 27283 20807

    Related information


    Dosage

    Toujeo is a basal insulin for once-daily administration at any time of the day, preferably at the same time every day.
    The dose regimen (dose and timing) should be adjusted according to individual response.
    In type 1 diabetes mellitus, Toujeo must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements.
    In patients with type 2 diabetes mellitus, Toujeo can also be given together with other anti-hyperglycaemic medicinal products.
    The potency of this medicinal product is stated in units. These units are exclusive to Toujeo and are not the same as IU or the units used to express the potency of other insulin analogues.
    Flexibility in dosing time: When needed, patients can administer Toujeo up to 3 hours before or after their usual time of administration.
    Patients who forget a dose, should be advised to check their blood sugar and then resume their usual once-daily dosing schedule. Patients should be informed not to inject a double dose to make up for a forgotten dose.
    Initiation:
    Patients with type 1 diabetes mellitus: Toujeo is to be used once-daily with meal-time insulin and requires individual dose adjustments.
    Patients with type 2 diabetes mellitus:The recommended daily starting dose is 0.2 units/kg followed by individual dose adjustments.
    Switch between insulin glargine 100 units/ml and Toujeo: Insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not directly interchangeable.
    – When switching from insulin glargine 100 units/ml to Toujeo, this can be done on a unit-to-unit basis, but a higher Toujeo dose (approximately 10-18%) may be needed to achieve target ranges for plasma glucose levels.
    – When switching from Toujeo to insulin glargine 100 units/ml, the dose should be reduced (approximately by 20%) to reduce the risk of hypoglycaemia.
    Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.
    Switch from other basal insulins to Toujeo: When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with Toujeo, a change of the dose of the basal insulin may be required and the concomitant anti-hyperglycaemic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of non-insulin anti-hyperglycaemic medicinal products).
    – Switching from once-daily basal insulins to once-daily Toujeo can be done unit-to-unit based on the previous basal insulin dose.
    – Switching from twice-daily basal insulins to once-daily Toujeo, the recommended initial Toujeo dose is 80% of the total daily dose of basal insulin that is being discontinued.
    Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Toujeo.
    Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.
    With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. Dose adjustment may also be required, for example, if the patient’s weight or life-style changes, if there is a change in the timing of insulin dose or if other circumstances arise that increase susceptibility to hypo-or hyperglycaemia.
    Switch from Toujeo to other basal insulins: Medical supervision with close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.
    Please refer to the prescribing information of the medicinal product to which the patient is switching.
    Special populations: Toujeo can be used in elderly people, renal and hepatic impaired patients.
    Elderly population (≥65 years old): In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
    Renal impairment: In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
    Hepatic impairment: In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
    Paediatric population: The safety and efficacy of Toujeo in children and adolescents below 18 years of age have not been established. No data are available.
    Method of administration: Toujeo is for subcutaneous use only.
    Toujeo is administered subcutaneously by injection in the abdominal wall, the deltoid or the thigh.
    Injection sites must be rotated within a given injection area from one injection to the next.
    Toujeo must not be administered intravenously. The prolonged duration of action of Toujeo is dependent on its injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.
    Toujeo must not be used in insulin infusion pumps.
    With Toujeo SoloStar pre-filled pen, a dose of 1-80 units per injection, in steps of 1 unit, can be injected. The dose window shows the number of Toujeo units to be injected. The Toujeo SoloStar prefilled pen has been specifically designed for Toujeo, therefore no dose re-calculation is required.
    Toujeo must not be drawn from the cartridge of the SoloStar pre-filled pen into a syringe or severe overdose can result.
    A new sterile needle must be attached before each injection. Re-use of needles increases the risk of blocked needles which may cause underdosing or overdosing.
    To prevent possible transmission of disease, insulin pens should never be used for more than one person, even when the needle is changed.
    Before using Toujeo SoloStar pre-filled pen, the instructions for use included in the package leaflet must be read carefully.


    Indications

    Treatment of diabetes mellitus in adults.


    Contra-Indications

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


    Special Precautions

    Toujeo is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular insulin administered intravenously is recommended in such cases.
    In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient’s adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
    Hypoglycaemia: The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed.
    Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
    Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished. The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups. These include patients:
    – in whom glycaemic control is markedly improved,
    – in whom hypoglycaemia develops gradually,
    – who are elderly,
    – after transfer from animal insulin to human insulin,
    – in whom an autonomic neuropathy is present,
    – with a long history of diabetes,
    – suffering from a psychiatric illness,
    – receiving concurrent treatment with certain other medicinal products.
    Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient’s awareness of hypoglycaemia.
    The prolonged effect of insulin glargine may delay recovery from hypoglycaemia.
    If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
    See prescribing information for full details.


    Side Effects

    Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
    Common: Lipohypertrophy, Injection site reactions.
    See prescribing information for full details.


    Drug interactions

    A number of substances affect glucose metabolism and may require dose adjustment of insulin glargine.
    Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include anti-hyperglycaemic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
    Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e.g. clozapine and
    olanzapine) and protease inhibitors.
    Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.
    In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.


    Pregnancy and Lactation

    Pregnancy: There is no clinical experience with use of Toujeo in pregnant women. For insulin glargine no clinical data on exposed pregnancies from controlled clinical studies are available. A large amount of data on pregnant women (more than 1,000 pregnancy outcomes with a medicinal product containing insulin glargine 100 units/ml) indicate no specific adverse effects on
    pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine.
    Animal data do not indicate reproductive toxicity.
    The use of Toujeo may be considered during pregnancy, if clinically needed.
    It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycemia. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential.
    Breast-feeding: It is unknown whether insulin glargine is excreted in human milk. No metabolic effects of ingested insulin glargine on the breast-fed newborn/infant are anticipated since insulin glargine as a peptide is digested into aminoacids in the human gastrointestinal tract.
    Breast-feeding women may require adjustments in insulin dose and diet.


    Overdose

    Symptoms: Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.
    Management: Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates. Adjustments in dose of the medicinal product, meal patterns, or physical activity may be needed.
    More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.


    Important notes

    Storage: Before first use: Store in a refrigerator (2°C-8°C). Do not freeze or place next to the freezer compartment or a freezer pack. Keep the pre-filled pen in the outer carton in order to protect from light.
    Shelf life: 30 months.
    Shelf life after first use of the pen: The medicinal product may be stored for a maximum of 6 weeks below 30°C and away from direct heat or direct light. Pens in use must not be stored in the refrigerator. The pen cap must be put back on the pen after each injection in order to protect from light.


    Manufacturer
    Sanofi-Aventis Deutschland GmbH, Germany
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