Toujeo (Previously Optisulin)

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. 1). 1). 3 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.

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.

4). 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. 1). 8). Hepatic impairment In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.

2). 4). 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.

8). 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 two pre-filled pens. The dose window shows the number of units of Toujeo to be injected. The Toujeo SoloStar and Toujeo DoubleStar pre-filled pens have been specifically designed for Toujeo and no dose re-calculation is required for either pen.

6). With Toujeo SoloStar pre-filled pen, a dose of 1-80 units per single injection, in steps of 1 unit, can be injected. With Toujeo DoubleStar pre-filled pen a dose of 2-160 units per single […]

1) and during clinical experience with insulin glargine 100 units/ml. 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.

Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (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; not known: cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. MedDRA system organ classes Very common Common Uncommon Rare Very rare Not known Immune system disorders Allergic reactions Metabolism and nutrition disorders Hypoglycaemia Nervous system disorders Dysgeusia Eyes disorders Visual impairment Retinopathy Skin and subcutaneous tissue disorders Lipohypertrophy Lipoatrophy Cutaneous amyloidosis Musculoskeletal and connective tissue disorders Myalgia General disorders and administration site conditions Injection site reactions Oedema 9 Description of selected adverse reactions Metabolism and nutrition disorders Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.

Prolonged or severe hypoglycaemic episodes may be life-threatening. In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter-regulation. Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.

Immune system disorders Immediate-type allergic reactions to insulin are rare. Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalised skin reactions, angio-oedema, bronchospasm, hypotension and shock, and may be life-threatening.

5%). Eyes disorders A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens. Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.

However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.

Skin and subcutaneous tissue disorders Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. 4). General disorders and administration site conditions Injection site reactions include redness, pain, itching, hives, swelling, or inflammation.

Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks. 8%). Rarely, insulin may cause oedema particularly if previously poor metabolic control is improved by intensified insulin therapy. Paediatric population Safety and efficacy of Toujeo have been demonstrated in a study in children aged 6 to less than 18 years.

1). Clinical study safety data are not available for children under 6 years. 1). 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. 10

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. 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.

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, and dose adjustment of antidiabetic medications may be 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 stenosis 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. 5). 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.

6 Adherence of the patient to the dose and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.

g. g. 5). 2). Switch between other insulins and Toujeo Switching a patient between another type or brand of insulin and Toujeo should be done under strict medical supervision. 2). Intercurrent illness Intercurrent illness requires intensified metabolic monitoring.

In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose. The insulin requirement is often increased. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc.

and they must never omit insulin entirely. 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.

Combination of Toujeo with pioglitazone 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 heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Toujeo 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. Medication errors prevention Medication errors have been reported in which other insulins, particularly rapid-acting insulins, have been accidentally administered instead of long-acting insulins.

6). To avoid dosing errors and potential overdose, the patients […]

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