Toujeo Dosage/Direction for Use

General: Insulin glargine 300 U/mL is a long-acting recombinant human insulin analogue product.
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.
Toujeo exhibits a more constant and prolonged glucose-lowering profile than Lantus.
Toujeo is given subcutaneously.
Toujeo is administered once daily, at any time during the day, preferably at the same time every day.
Toujeo allows for adaptability in the once-daily time of administration. When needed, patients can administer their injections up to 3 hours before or after their usual time of administration.
The desired blood glucose levels as well as the doses and timing of anti-hyperglycaemic medications must be determined and adjusted individually.
Dose adjustment may 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 Precautions). Any change of insulin dose should be made cautiously and only under medical supervision.
Toujeo is not the insulin of choice for the treatment of diabetic ketoacidosis. An intravenous, short-acting insulin is the preferred treatment.
Blood glucose monitoring is recommended for all patients with diabetes.
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.
Initiation of Toujeo: 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 U/kg once daily 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.
Changing 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.
Changing 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.
Change from other basal insulins to Toujeo: When changing from a treatment regimen with an intermediate-acting or another long-acting insulin product to a regimen with Toujeo, the amount and timing of short-acting insulin or fast-acting insulin analogue product or of the dose of any anti-hyperglycaemic drug may need to be adjusted.
Changing from once-daily basal insulin products to once-daily Toujeo can be done unit-to-unit based on the previous basal insulin dose.
Changing from twice-daily basal insulin products to once-daily Toujeo, the recommended initial Toujeo dose is 80% of the total daily dose of the basal insulin that is being discontinued.
A program of close metabolic monitoring under medical supervision is recommended during the change and in the initial weeks thereafter. As with all insulin analogues, this is particularly true for patients which, due to antibodies to human insulin, need high insulin doses and may experience a markedly improved insulin response with insulin glargine.
With improved metabolic control and resultant increase in insulin sensitivity (reduced insulin requirements) further adjustment of the doses of Toujeo and other insulin products or non-insulin anti-hyperglycaemic drugs in the 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.
Change from Toujeo to 100 U/mL basal insulins: Medical supervision with close metabolic monitoring is recommended during the change and in the initial weeks thereafter.
Please refer to the prescribing information of the product to which the patient is changing.
Mixing, diluting: Toujeo must not be mixed with any other insulin products. Mixing changes the time/action profile of Toujeo and causes precipitation.
Toujeo must not be diluted. Diluting changes the time/action profile of Toujeo.
Special Population: Toujeo can be used in elderly patients, renal and hepatic impaired patients. Close glucose monitoring is recommended and the insulin dose should be adjusted on an individual basis.
Elderly: In the elderly patients, progressive deterioration of renal function may lead to a steady decrease in insulin requirements (see Precautions and PHARMACOLOGY: PHARMACODYNAMICS: Clinical efficacy and safety and PHARMACOKINETICS under Actions).
Renal impairment: In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism (see Precautions and PHARMACOLOGY: PHARMACODYNAMICS: Clinical efficacy and safety and PHARMACOKINETICS under Actions).
Hepatic impairment: In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism (see Precautions and PHARMACOLOGY: PHARMACODYNAMICS: Clinical efficacy and safety and PHARMACOKINETICS under Actions).
Children: Toujeo can be used in pediatric patients from the age of 6 years. 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 hypoglycemia.
The safety and effectiveness of Toujeo have not been established in paediatric patients (under 6 years of age).
Administration: Toujeo is administered by subcutaneous tissue injection.
As with all insulins, injection sites within an injection area (abdomen, thigh or deltoid) must be rotated from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis (see Precautions and Adverse Reactions).
Toujeo is not intended for intravenous administration.
The prolonged duration of activity of insulin glargine is dependent on injection into the subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.
Toujeo is not intended to be administered via an insulin infusion pump.
Toujeo is a clear solution, not a suspension. As such it does not require resuspension before use.
With Toujeo SoloStar pre-filled pen, a dose of 1-80 units per injection, in steps of 1 unit, can be injected.
The dose counter shows the number of Toujeo units to be injected. The Toujeo SoloStar pre-filled pen has been specifically designed for Toujeo, therefore no dose re-calculation is required.
Toujeo must never be drawn from the cartridge of the pre-filled pen into a syringe or severe overdose can result (see Precautions).
Patients must also be instructed to not re-use needles.