Toujeo SoloStar 300 units/ml solution for injection in a pre-filled pen

INJECTION, SOLUTION

**4.2 Posology and method of administration** Posology 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 international units or the units used to express the potency of other insulin analogues (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Flexibility in dosing time_ When needed, patients can administer Toujeo up to 3 hours before or after their usual time of administration (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _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, and children and adolescents from the age of 6 years. _Elderly population (≥65 years old)_ In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements (see section 4.8 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Renal impairment_ In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism (see section 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Hepatic impairment_ In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. _Paediatric population_ Toujeo can be used in adolescents and children from the age of 6 years based on the same principles as for adult patients (see sections 5.1 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). When switching basal insulin to Toujeo, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to minimize the risk of hypoglycaemia (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The safety and efficacy of Toujeo in children below 6 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 in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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. Toujeo is available in pre-filled pen. The dose window shows the number of units of Toujeo to be injected. The Toujeo SoloStar pre-filled pen has been specifically designed for Toujeo and no dose re-calculation is required. Before using Toujeo SoloStar pre-filled pen, the instructions for use included in the package leaflet must be read carefully (see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). With Toujeo SoloStar pre-filled pen, a dose of 1–80 units per injection, in steps of 1 unit, can be injected. Toujeo must not be drawn from the cartridge of the Toujeo SoloStar pre-filled pen into a syringe or severe overdose can result (see section 4.4, 4.9 and 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 (see section 4.4 and 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). To prevent possible transmission of disease, insulin pens should never be used for more than one person, even when the needle is changed (see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).