TOUJEO Solution for injection Ref.[7286] Active ingredients: Insulin glargine

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 IU or the units used to express the potency of other insulin analogues (see section 5.1).

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).

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).

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).

Renal impairment

In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism (see section 4.8).

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). When switching basal insulin to Toujeo, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to mimimize the risk of hypoglycaemia (see section 4.4).

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. 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).

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.

Before using Toujeo SoloStar pre-filled pen or Toujeo DoubleStar pre-filled pen, the instructions for use included in the package leaflet must be read carefully (see section 6.6).

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 injection, in steps of 2 units, can be injected.

When changing from Toujeo SoloStar to Toujeo DoubleStar, if the patient’s previous dose was an odd number (e.g. 23 units) then the dose must be increased or decreased by 1 unit (e.g. 24 or 22 units).

Toujeo DoubleStar prefilled pen is recommended for patients requiring at least 20 units per day. (see section 6.6).

Toujeo must not be drawn from the cartridge of the Toujeo SoloStar pre-filled pen or Toujeo DoubleStar pre-filled pen into a syringe or severe overdose can result (see section 4.4, 4.9 and 6.6).

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).

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).

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.

Toujeo SoloStar: 30 months.

Toujeo DoubleStar: 24 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.

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.

After first use or if carried as a spare

For storage conditions after first opening of this medicinal product, see section 6.3.

SoloStar pen

Cartridge (type 1 colourless glass) with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber).The cartridge is sealed in a disposable pen injector. Each cartridge contains 1.5 ml solution.

Packs of 1, 3, 5 and 10 pens are available. Not all pack sizes may be marketed.

Needles are not included in the pack.

DoubleStar pen

Cartridge (type 1 colourless glass) with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber).The cartridge is sealed in a disposable pen injector. Each cartridge contains 3 ml solution.

Packs of 1, 3, 6 (2 packs of 3), 9 (3 packs of 3) and 10 pens are available. Not all pack sizes may be marketed.

Needles are not included in the pack.

Before first use, the pen must be stored at room temperature at least 1 hour before use.

Before using Toujeo SoloStar or Toujeo DoubleStar pre-filled pen, the Instructions for Use included in the package leaflet must be read carefully. Toujeo pre-filled pens have to be used as recommended in these Instructions for Use (see section 4.2). Instruct patients to perform a safety test as described in Step 3 of the Instructions for Use. If they don’t, the full dose might not be delivered. If this occurs, patients should increase the frequency of checking their blood glucose levels and might need to administer additional insulin.

The cartridge should be inspected before use. It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency. Since Toujeo is a clear solution, it does not require resuspension before use.

Insulin label must always be checked before each injection to avoid medication errors between Toujeo and other insulins. The strength “300” is highlighted in honey gold on the label (see section 4.4).

Patients should be informed that the dose counter of Toujeo SoloStar or Toujeo DoubleStar pre-filled pen shows the number of units of Toujeo to be injected. No dose re-calculation is required.

• The Toujeo SoloStar pen contains 450 units of Toujeo. It delivers doses of 1-80 units per injection, in steps of 1 unit.
• The Toujeo DoubleStar pen contains 900 units of Toujeo. It delivers doses of 2-160 units per injection, in steps of 2 units.
  • To reduce potential underdose, Toujeo DoubleStar is recommended for patients requiring at least 20 units per day.
• If safety tests are not performed before the first use of a new pen, insulin underdose can occur.

A syringe must never be used to withdraw Toujeo from the cartridge of the pre-filled pen or severe overdose can result (see section 4.2, 4.4 and 4.9).

A new sterile needle must be attached before each injection. Needles must be discarded immediately after use. Needles must not be re-used. Re-use of needles increases the risk of blocked needles which may cause underdosing or overdosing. Using a new sterile needle for each injection also minimizes the risk of contamination and infection. In the event of blocked needle, the patients must follow the instructions described in Step 3 of the Instructions for Use accompanying the package leaflet (see section 4.2 and 4.4).

Used needles should be thrown away in a puncture resistant container or disposed of in accordance with local requirements.

Empty pens must never be reused and must be properly discarded.

To prevent possible transmission of disease, insulin pen should never be used by for more than one person, even when the needle is changed (see section 4.2).