Toujeo

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 

 

 

 

 



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1. NAME OF THE MEDICINAL PRODUCT 

 

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

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

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each ml contains 300 units insulin glargine* (equivalent to 10.91 mg). 

 

SoloStar pen 

Each pen contains 1.5 ml of solution for injection, equivalent to 450 units. 

 

DoubleStar pen 

Each pen contains 3 ml of solution for injection, equivalent to 900 units. 

 

* Insulin glargine is produced by recombinant DNA technology in Escherichia coli. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Solution for injection (injection). 

Clear colourless solution. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years. 

 

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 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). 

 



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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. 

 



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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 5.1and 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). 

 



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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). 

 

4.3 Contraindications 
 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

4.4 Special warnings and precautions for use 

 

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. 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 (see section 4.5). 

 

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. 



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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. These factors include: 

- change in the injection area, 

- improved insulin sensitivity (e.g., by removal of stress factors), 

- unaccustomed, increased or prolonged physical activity, 

- intercurrent illness (e.g. vomiting, diarrhoea), 

- inadequate food intake, 

- missed meals, 

- alcohol consumption, 

- certain uncompensated endocrine disorders, (e.g. in hypothyroidism and in anterior pituitary or 

adrenocortical insufficiency), 

- concomitant treatment with certain other medicinal products (see section 4.5). 

 

Switch between insulin glargine 100 units/ml and Toujeo 

Since insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not interchangeable, 

switching may result in the need for a change in dose and should only be done under strict medical 

supervision (see section 4.2). 

 

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. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-

acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may 

result in the need for a change in dose (see section 4.2). 

 

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. Insulin label must always be checked 

before each injection to avoid medication errors between Toujeo and other insulins (see section 6.6). 

 

To avoid dosing errors and potential overdose, the patients must be instructed to never use a syringe to 

remove Toujeo (insulin glargine 300 units/ml) from the Toujeo SoloStar pre-filled pen or Toujeo 

DoubleStar pre-filled pen (see section 4.9 and 6.6). 

 

A new sterile needle must be attached before each injection. Patients must also be instructed to not 

re-use needles. Re-use of needles increases the risk of blocked needles which may cause underdosing 



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or overdosing. 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 6.6). 

 

Patients must visually verify the number of selected units on the dose counter of the pen. Patients who 

are blind or have poor vision should be instructed to get help/assistance from another person who has 

good vision and is trained in using the insulin device. 

 

See also section 4.2 under “Method of administration”. 

 

Excipients 

This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 

‘sodium-free’. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

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. 

 

4.6 Fertility, 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 hyperglycaemia. 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.  



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Breast-feeding women may require adjustments in insulin dose and diet. 

 

Fertility 

Animal studies do not indicate direct harmful effects with respect to fertility. 

 

4.7 Effects on ability to drive and use machines 

 

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or 

hyperglycaemia or, for example, as a result of visual impairment. This may constitute a risk in 

situations where these abilities are of special importance (e.g. driving a car or using machines). 

 

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is 

particularly important in those who have reduced or absent awareness of the warning symptoms of 

hypoglycaemia or have frequent episodes of hypoglycaemia. It should be considered whether it is 

advisable to drive or use machines in these circumstances. 

 

4.8 Undesirable effects  
 

Summary of the safety profile 

The following adverse reactions were observed during clinical studies conducted with Toujeo (see 

section 5.1) 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   

 



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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. In Toujeo clinical 

studies in adult patients, the incidence of allergic reactions was similar in Toujeo-treated patients 

(5.3%) and insulin glargine 100 units/ml-treated patients (4.5%). 

 

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. Continuous rotation of the injection site within the given injection area may help to reduce 

or prevent these reactions (see section 4.4). 

 

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. In Toujeo 

clinical studies in adult patients, the incidence of injection site reactions was similar in Toujeo-treated 

patients (2.5%) and insulin glargine 100 units/ml-treated patients (2.8%). 

 

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. The frequency, type and severity of adverse reactions in the paediatric population do not 

indicate differences to the experience in the general diabetes population (see section 5.1). Clinical 

study safety data are not available for children under 6 years. 

 

Other special populations 

Based on the results from clinical studies, the safety profile of Toujeo in elderly patients and in 

patients with renal impairment was similar to that of the overall population (see section 5.1). 

 

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. 

 

4.9 Overdose 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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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. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting. 

ATC Code: A10A E04. 

 

Mechanism of action 

The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin 

and its analogues lower blood glucose levels by stimulating peripheral glucose uptake, especially by 

skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in the 

adipocyte, inhibits proteolysis and enhances protein synthesis. 

 

Pharmacodynamic effects 

Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH. At pH 4, 

insulin glargine is completely soluble. After injection into the subcutaneous tissue, the acidic solution 

is neutralised leading to formation of a precipitate from which small amounts of insulin glargine are 

continuously released.  

 

As observed in euglycaemic clamp studies in patients with type 1 diabetes, the glucose lowering effect 

of Toujeo was more stable and prolonged in comparison with insulin glargine 100 units/ml after 

subcutaneous injection. Figure 1 shows results from a cross-over study in 18 patients with type 1 

diabetes conducted for a maximum of 36 hours after injection.The effect of Toujeo was beyond 24 

hours (up to 36 hours) at clinically relevant doses. 

 

The more sustained release of insulin glargine from the Toujeo precipitate compared to insulin 

glargine 100 units/ml is attributable to the reduction of the injection volume by two thirds that results 

in a smaller precipitate surface area. 

 

Figure 1: Activity profile at steady state in patients with type 1 diabetes in a 36-hour euglycaemic 

clamp study 



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*GIR: Glucose infusion rate: determined as amount of glucose infused to maintain constant plasma glucose levels (hourly 

mean values). The end of the observation period was 36 hours. 

 

Insulin glargine is metabolised into 2 active metabolites M1 and M2 (see section 5.2). 

 

Insulin receptor binding: In vitro studies indicate that the affinity of insulin glargine and its 

metabolites M1 and M2 for the human insulin receptor is similar to the one of human insulin. 

 

IGF-1 receptor binding: The affinity of insulin glargine for the human IGF-1 receptor is approximately 

5 to 8-fold greater than that of human insulin (but approximately 70 to 80-fold lower than the one of 

IGF-1), whereas M1 and M2 bind the IGF-1 receptor with slightly lower affinity compared to human 

insulin. 

 

The total therapeutic insulin concentration (insulin glargine and its metabolites) found in type 1 

diabetic patients was markedly lower than what would be required for a half maximal occupation of 

the IGF-1 receptor and the subsequent activation of the mitogenic-proliferative pathway initiated by 

the IGF-1 receptor. Physiological concentrations of endogenous IGF-1 may activate the 

mitogenic-proliferative pathway; however, the therapeutic concentrations found in insulin therapy, 

including in Toujeo therapy, are considerably lower than the pharmacological concentrations required 

to activate the IGF-1 pathway. 

 

In a clinical pharmacology study, intravenous insulin glargine and human insulin have been shown to 

be equipotent when given at the same doses. 

 

As with all insulins, the time course of action of insulin glargine may be affected by physical activity 

and other variables. 

 

Clinical efficacy and safety 

The overall efficacy and safety of Toujeo (insulin glargine 300 units/ml) once-daily on glycaemic 

control was compared to that of once-daily insulin glargine 100 units/ml in open-label, randomised, 

active-control, parallel studies of up to 26 weeks of duration, including 546 patients with type 1 

diabetes mellitus and 2,474 patients with type 2 diabetes mellitus (Table 1 and 2). 

Results from all clinical trials with Toujeo indicated that reductions in HbA1c from baseline to end of 

trial were non-inferior to insulin glargine 100 units/ml. Plasma glucose reductions at the end of the 

trial with Toujeo were similar to insulin glargine 100 units/ml with a more gradual reduction during 

the titration period with Toujeo. Glycaemic control was similar when Toujeo was administered once 

daily in the morning or in the evening. 

Improvement in HbA1C was not affected by, gender, ethnicity, age, diabetes duration (<10 years 

and ≥10 years), HbA1c value at baseline (<8% or ≥8%) or baseline body mass index (BMI). 

At the end of these treat-to-target trials, depending on the patient population and concomitant therapy, 

a 10-18% higher dose was observed in the Toujeo group than in the comparator group  (Table 1 and 

2). 



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Results from clinical trials demonstrated that the incidence of confirmed hypoglycaemia (at any time 

of the day and nocturnal) was lower in patients treated with Toujeo compared to insulin glargine 

100 units/ml-treated patients, in patients with type 2 diabetes treated in combination with either 

non-insulin anti-hyperglycaemic medicinal product or mealtime insulin. 

The superiority of Toujeo over insulin glargine 100 units/ml in lowering the risk of confirmed 

nocturnal hypoglycaemia was shown in patients with type 2 diabetes treated with basal insulin in 

combination with either non-insulin anti-hyperglycaemic medicinal product (18% risk reduction) or 

mealtime insulin (21% risk reduction) during the period from week 9 to end of study period. 

Overall, these effects on hypoglycaemia risk were consistently observed whatever the age, gender, 

BMI and duration of diabetes (<10 years and ≥10 years) in Toujeo-treated patients compared to insulin 

glargine 100 units/ml-treated patients. 

 

In patients with type 1 diabetes, the incidence of hypoglycaemia was similar in patients treated with 

Toujeo compared to insulin glargine 100 units/ml-treated patients (Table 3). 

 

Table 1: Results from clinical trials in type 1 diabetes mellitus 

26 weeks of treatment 

 Toujeo  IGlar 

Treatment in combination with Meal-time insulin analogue  

Number of subjects treated (mITTa) 273 273 

HbA1c 

Baseline mean 8.13 8.12 

Adjusted Mean change from baseline -0.40 -0.44 

Adjusted Mean differenceb  0.04 [-0.098 to 0.185] 

Basal insulin dose
c
 (U/kg) 

Baseline mean 0.32 0.32 

Mean change from baseline 0.15 0.09 

Body weight
d
 (kg) 

Baseline mean 

Mean change from baseline 

81.89 

0.46 

81.80 

1.02 

IGlar: Insulin glargine 100 units/ml 

a mITT: Modified intention-to-treat 

b Treatment difference: Toujeo– insulin glargine 100 units/ml; [95% Confidence Interval] 

c Change from baseline to Month 6 (observed case) 

d Change from baseline to Last main 6-month on-treatment value 
 



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Table 2: Results from clinical trials in type 2 diabetes mellitus 

26 weeks of treatment 

 Patients previously 

treated with basal 

insulin 

Patients previously 

treated with basal 

insulin  

Previously insulin 

naive patients 

Treatment in combination with 
Meal-time insulin 

analog+/-metformin 

Non-insulin anti-hyperglycaemic medicinal 

products 

 Toujeo IGlar Toujeo IGlar Toujeo IGlar 

Number of patients treateda 404 400 403 405 432 430 

HbA1c 

Baseline mean 

Adjusted mean change from 

baseline 

8.13 

-0.90 

8.14 

-0.87 

8.27 

-0.73 

8.22 

-0.70 

8.49 

-1.42 

8.58 

-1.46 

Adjusted mean differenceb -0.03 

[-0.144 to 0.083] 

-0.03 

 [-0.168 to 0.099] 

0.04 

 [-0.090 to 0.174] 

Basal insulin dose
c
 (U/kg) 

Baseline mean 

Mean change from baseline 

0.67 

0.31 

0.67 

0.22 

0.64 

0.30 

0.66 

0.19 

0.19 

0.43 

0.19 

0.34 

Body weight
d
 (kg) 

Baseline mean 

Mean change from baseline 

106.11 

0.93 

106.50 

0.90 

98.73 

0.08 

98.17 

0.66 

95.14 

0.50 

95.65 

0.71 

IGlar: Insulin glargine 100 units/ml 

a mITT: Modified intention-to-treat 

b Treatment difference: Toujeo– insulin glargine 100 units/ml; [95% Confidence Interval] 

c Change from baseline to Month 6 (observed case) 

d Change from baseline to Last main 6-month on-treatment value 

 



14 

Table 3 - Summary of the hypoglycaemic episodes of the clinical study in patients with type 1 and 

type 2 diabetes mellitus 

Diabetic 

population 

Type 1 diabetes mellitus 

Patients previously 

treated with basal 

insulin 

Type 2 diabetes mellitus 

Patients previously 

treated with basal 

insulin 

Type2 diabetes mellitus 

Patients previously 

Insulin naive or on basal 

insulin 

Treatment in 

combination 

with 

Meal-time insulin analog 
Meal-time insulin 

analog+/-metformin 

Non-insulin anti-

hyperglycaemic 

medicinal products 

 Toujeo  IGlar Toujeo IGlar Toujeo  IGlar 

Incidence (%) of severe
a
 hypoglycaemia (n/Total N) 

Entire study 

periodd 

6.6 

(18/274) 

9.5 

(26/275) 

5.0 

(20/404) 

5.7 

(23/402) 

1.0 

(8/838) 

1.2 

(10/844) 

RR*: 0.69 [0.39;1.23] RR: 0.87 [0.48;1.55] RR: 0.82 [0.33;2.00] 

Incidence (%) of confirmed
b
 hypoglycaemia (n/Total N) 

Entire study 

period 

93.1 

(255/274) 

93.5 

(257/275) 

81.9 

(331/404) 

87.8 

(353/402) 

57.6 

(483/838) 

64.5 

(544/844) 

RR: 1.00 [0.95;1.04] RR: 0.93 [0.88; 0.99] RR: 0.89 [0.83; 0.96] 

Incidence (%) of confirmed nocturnal
c 
 hypoglycaemia (n/Total N) 

From week 9 to 

end of study 

period 

59.3 

(162/273) 

56.0 

(153/273) 

36.1 

(146/404) 

46.0 

(184/400) 

18.4 

(154/835) 

22.5 

(188/835) 

RR: 1.06 [0.92;1.23] RR: 0.79 [0.67;0.93] RR: 0.82 [0.68;0.99] 

IGlar: Insulin glargine 100 units/ml 
a Severe hypoglycaemia: Episode requiring assistance of another person to actively administer carbohydrate, 

glucagon, or other resuscitative actions. 
b Confirmed hypoglycaemia: Any severe hypoglycaemia and/or hypoglycaemia confirmed by plasma glucose 

value ≤3.9 mmol/l. 
c Nocturnal hypoglycaemia: Episode that occurred between 00:00 and 05:59 hours  
d 6-month treatment period 

*RR: estimated risk ratio; [95% Confidence Interval] 

 

Flexibility in dosing time 

 

The safety and efficacy of Toujeo administered with a fixed or flexible dosing time were also 

evaluated in 2 randomized, open-label clinical studies for 3 months. Type 2 diabetic patients (n=194) 

received Toujeo once daily in the evening, either at the same time of the day (fixed time of 

administration) or within 3 hours before or after the usual time of administration (flexible dosing 

time). Administration with a flexible dosing time had no effect on glycaemic control and the incidence 

of hypoglycaemia. 

 

Antibodies 

 

Results from studies comparing Toujeo and insulin glargine 100 units/ml did not indicate any 

difference in term of development of anti-insulin antibodies, on efficacy, safety or dose of basal 

insulin between Toujeo and insulin glargine 100 units/ml. 

 

Body weight 

 

Mean change in body weight of less than 1 kg at the end of the 6-month period was observed in 

Toujeo-treated patients (see Table 1 and 2). 



15 

 

Results from a study on progression of diabetic retinopathy 

 

Effects of insulin glargine 100 units/ml (once daily) on diabetic retinopathy were evaluated in an 

open-label 5 year NPH-controlled study (NPH given bid) in 1024 type 2 diabetic patients in which 

progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study 

(ETDRS) scale was investigated by fundus photography. No significant difference was seen in the 

progression of diabetic retinopathy when insulin glargine100 units/ml was compared to NPH insulin. 

 

Long term efficacy and safety outcome study 

 

The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicenter, 

randomized, 2x2 factorial design study conducted in 12,537 participants at high cardiovascular (CV) 

risk with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (12% of participants) or 

type 2 diabetes mellitus (treated with ≤1 antidiabetic oral agent) (88% of participants). Participants 

were randomized (1:1) to receive insulin glargine 100 units/ml (n=6264), titrated to reach FPG 

≤95 mg/dl (5.3 mM), or standard care (n=6273). 

The first co-primary efficacy outcome was the time to the first occurrence of CV death, nonfatal 

myocardial infarction (MI), or nonfatal stroke, and the second co-primary efficacy outcome was the 

time to the first occurrence of any of the first co-primary events, or revascularisation procedure 

(coronary, carotid, or peripheral), or hospitalisation for heart failure. 

 

Secondary endpoints included all-cause mortality and a composite microvascular outcome.  

 

Insulin glargine 100 units/ml did not alter the relative risk for CV disease and CV mortality when 

compared to standard of care. There were no differences between insulin glargine and standard care 

for the two co-primary outcomes; for any component endpoint comprising these outcomes; for 

all-cause mortality; or for the composite microvascular outcome.  

Mean dose of insulin glargine 100 units/ml by study end was 0.42 U/kg. At baseline, participants had a 

median HbA1c value of 6.4% and median on-treatment HbA1c values ranged from 5.9 to 6.4% in the 

insulin glargine 100 units/ml group, and 6.2% to 6.6% in the standard care group throughout the 

duration of follow-up.  

The rates of severe hypoglycaemia (affected participants per 100 participant years of exposure) were 

1.05 for insulin glargine 100 units/ml and 0.30 for standard care group and the rates of confirmed 

non-severe hypoglycaemia were 7.71 for insulin glargine 100 units/ml and 2.44 for standard care 

group. Over the course of this 6-year study, 42% of the insulin glargine 100 units/ml group did not 

experience any hypoglycaemia. 

 

At the last on-treatment visit, there was a mean increase in body weight from baseline of 1.4 kg in the 

insulin glargine 100 units/ml group and a mean decrease of 0.8 kg in the standard care group. 

 

Pediatric population 

The efficacy and safety of Toujeo have been studied in a 1:1 randomized controlled open label clinical 

trial in children and adolescents with type 1 diabetes mellitus for a period of 26 weeks (n=463). 

Patients in the Toujeo arm included 73 children aged <12 years and 160 children aged ≥12 years. 

Toujeo dosed once daily showed similar reduction in HbA1c and FPG from baseline to week 26 

compared to insulin glargine 100 units/mL.  

 

The dose-response analysis showed that following the initial titration phase, the body weight adjusted 

doses in pediatric patients are higher than in adult patients at steady state.  

 

Overall the incidence of hypoglycaemia in patients in any category was similar in both treatment 

groups, with 97.9% of patients in the Toujeo group and 98.2% in the insulin glargine 100 units/mL 

group reporting at least one event. Similarly, nocturnal hypoglycaemia was comparable in the Toujeo 

and insulin glargine 100 units/mL treatment groups. The percentage of patients reporting severe 

hypoglycaemia was lower in patients in the Toujeo group as compared to patients in the insulin 

glargine 100 units/mL group, 6% and 8.8% respectively. The percentage of patients with 



16 

hyperglycaemic episodes with ketosis was lower for Toujeo versus insulin glargine 100 units/mL, 

6.4% and 11.8%, respectively. No safety issues were identified with Toujeo with respect to adverse 

events and standard safety parameters. Antibody development was sparse and had no clinical impact. 

Efficacy and safety data for paediatric patients with type 2 diabetes mellitus have been extrapolated 

from data for adolescent and adult patients with type 1 diabetes mellitus and adult patients with type 2 

diabetes mellitus. Results support the use of Toujeo in paediatric patients with type 2 diabetes 

mellitus. 

 

5.2 Pharmacokinetic properties 

 

Absorption and distribution 

In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and more 

prolonged absorption resulting in a flatter time-concentration profile after subcutaneous injection of 

Toujeo in comparison to insulin glargine 100 units/ml. 

 

Pharmacokinetic profiles were consistent with the pharmacodynamic activity of Toujeo. 

 

Steady state level within the therapeutic range is reached after 3-4 days of daily Toujeo administration. 

 

After subcutaneous injection of Toujeo, the intra-subject variability, defined as the coefficient of 

variation for the insulin exposure during 24 hours was low at steady state (17.4%). 

 

Biotransformation 

After subcutaneous injection of insulin glargine, insulin glargine is rapidly metabolized at the carboxyl 

terminus of the Beta chain with formation of two active metabolites M1 (21A-Gly-insulin) and M2 

(21A-Gly-des-30B-Thr-insulin). In plasma, the principal circulating compound is the metabolite M1. 

The exposure to M1 increases with the administered dose of insulin glargine. The pharmacokinetic 

and pharmacodynamic findings indicate that the effect of the subcutaneous injection with insulin 

glargine is principally based on exposure to M1. Insulin glargine and the metabolite M2 were not 

detectable in the vast majority of subjects and, when they were detectable their concentration was 

independent of the administered dose and formulation of insulin glargine. 

 

Elimination 

When given intravenously the elimination half-life of insulin glargine and human insulin were 

comparable. 

 

The half-life after subcutaneous administration of Toujeo is determined by the rate of absorption from 

the subcutaneous tissue. The half-life of Toujeo after subcutaneous injection is 18-19 hours 

independent of dose. 

 

Paediatric population 

Population pharmacokinetic analysis was conducted for Toujeo based on concentration data of its 

main metabolite M1 using data from 75 pediatric subjects (6 to <18 years of age) with type 1 diabetes. 

Body weight affects the clearance of Toujeo in a nonlinear way. As a consequence, exposure (AUC) in 

pediatric patients is slightly lower as compared to adult patients when receiving the same body weight 

adjusted dose. 

 

5.3 Preclinical safety data 

 

Non-clinical data reveal no special hazard for humans based on conventional studies of safety 

pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 



17 

Zinc chloride 

Metacresol 

Glycerol 

Hydrochloric acid (for pH adjustment) 

Sodium hydroxide (for pH adjustment) 

Water for injections. 

 

6.2 Incompatibilities 

 

Toujeo must not be mixed or diluted with any other insulin or other medicinal products.  

Mixing or diluting Toujeo changes its time/action profile and mixing causes precipitation. 

 

6.3 Shelf life 

 

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. 

 

6.4 Special precautions for 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. 

 

After first use or if carried as a spare 

 

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

 

6.5 Nature and contents of container 

 

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. 

 



18 

6.6 Special precautions for disposal and other handling 

 

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. 

o 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). 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany 

 

 



19 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/00/133/033 

EU/1/00/133/034 

EU/1/00/133/035 

EU/1/00/133/036 

EU/1/00/133/037 

EU/1/00/133/038 

EU/1/00/133/039 

EU/1/00/133/040 

EU/1/00/133/041 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 27 June 2000 

Date of latest renewal: 17 February 2015 

 

 

10. DATE OF REVISION OF THE TEXT 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu 

 

  



20 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 

SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR 

BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

 

 

 



21 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer of the biological active substance 

 

Sanofi-Aventis Deutschland GmbH 

Industriepark Höchst 

Brüningstraße 50 

D-65926 Frankfurt / Main 

Germany 

 

Name and address of the manufacturers responsible for batch release  

 

Sanofi-Aventis Deutschland GmbH 

Industriepark Höchst 

Brüningstraße 50 

D-65926 Frankfurt / Main 

Germany 

 

 

B.  CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to medical prescription. 

 

 

C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

 Periodic safety update reports (PSURs) 
 

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 

reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 

subsequent updates published on the European medicines web-portal. 

 

 

D.  CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

 Risk management plan (RMP) 
 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 

activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 

Marketing Authorisation and any agreed subsequent updates of the RMP. 

 

An updated RMP should be submitted: 

 At the request of the European Medicines Agency;  

 Whenever the risk management system is modified, especially as the result of new 
information being received that may lead to a significant change to the benefit/risk profile 

or as the result of an important (pharmacovigilance or risk minimisation) milestone being 

reached. 

 

 

 Additional risk minimisation measures 
 

Prior to launch of Toujeo 300 units/ml in each Member State the MAH must agree the content and 

format of the educational programme, including communication media, distribution modalities, and 

any other aspects, with the National Competent Authority. 



22 

 

The MAH shall ensure that in each Member State where Toujeo 300 units/ml is marketed, all 

healthcare professionals (HCPs) who are expected to prescribe or dispense Toujeo 300 units/ml, as 

well as all patients or their carers who are expected to use Toujeo 300 units/ml, are provided with 

educational material to address the risk(s) of Medication error (switching between 100 units/ml and 

300 units/ml without dose adjustment). 

 

The educational materials consist of: 

 Guide for healthcare professionals 

 Patient/carer guide (patient brochure) 
 

The educational materials for healthcare professionals shall contain the following key elements: 

 Details on how to minimize the safety concern addressed by the additional risk minimization 
measures through appropriate monitoring and management: 

- That insulin glargine 100 units/ml and insulin glargine 300 units/ml (Toujeo SoloStar and Toujeo 

DoubleStar) are not bioequivalent and are therefore not interchangeable without dose adjustment. 

- That dose adjustment is needed when patients are switched from one to the other strength: 

  After titration, on average a 10-18% higher basal insulin dose are needed to achieve 
target ranges for plasma glucose levels when using the 300 units/ml formulation 

compared to the 100 units/ml formulation. 

  Switching from the 300 units/ml to the 100 units/ml concentration results in an increased 
risk of hypoglycaemic events, mainly in the first week after the switch. To reduce the risk 

of hypoglycaemia, patients who are changing their basal insulin regimen from an insulin 

regimen with once daily Toujeo (insulin glargine 300 units/ml) to a once daily regimen 

with insulin glargine 100 units/ml should reduce their dose by 20%; 

  When switching from a treatment regimen with an intermediate or long-acting insulin 
product 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. 

Close metabolic monitoring is recommended during the switch and in the initial weeks 

thereafter; 

 Key messages to convey in patients counselling: 
-  Patients need to be instructed that insulin glargine 100 units/ml products and Toujeo are not 

interchangeable and dose adjustments need to be made; 

-  Blood glucose monitoring by patients is needed during the switch and the initial weeks thereafter; 

 Instructions on how to report medication errors or adverse events: Details for national reporting 
added at country level. 

 Other: The Guide for healthcare professionals is also highlighting the distinction between the 
different Toujeo presentations: 

 That insulin glargine 300 units/ml is available in two different presentations: Toujeo 
SoloStar (1.5 mL prefilled pen/450 units) and Toujeo DoubleStar (3 mL prefilled pen/900 

units).  

 The dose increment in Toujeo SoloStar is one unit and the dose increment in Toujeo 
DoubleStar is 2 units. 

  The dose delivered is the one shown in the dose window. 
 

The educational material for patient/carer guide (patient brochure) shall contain the following key 

elements: 

 Detailed description of the modalities used for the self-administration of insulin glargine: 
- That insulin glargine 100 units/ml and insulin glargine 300 units/ml (Toujeo SoloStar and Toujeo 

DoubleStar) are not bioequivalent and are therefore not interchangeable without dose adjustment. 

-  That the switch from one insulin therapy to another should only be done when prescribed by their 

healthcare provider; 

-  That the dose newly recommended by their healthcare provider should always be followed; 

- That blood glucose need to be closely monitored during the switch and the initial weeks 

thereafter; 

- That they should consult their healthcare provider for further information; 



23 

- That they should report medication errors or any side effects. Details for national reporting added 
at country level; 

-  That insulin glargine 300 units/ml is available in two different presentations: Toujeo SoloStar 

(1.5 mL prefilled pen/450 units) and Toujeo DoubleStar (3 mL prefilled pen/900 units). The dose 

increment in Toujeo SoloStar is one unit and the dose increment in Toujeo DoubleStar is 2 units. The 

dose delivered is the one shown in the dose window. 

 

The target audience and the modalities for distribution of all of these materials are to be agreed at 

Member State Level. The MAH shall agree the final text and the context of the educational material 

for HCPs and patients together with a communication plan, with the National Competent Authority in 

each Member State prior to launch of the medicinal product. 

 

  



24 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



25 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

  



26 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

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

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

insulin glargine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each ml contains 300 units (10.91 mg) insulin glargine. 

SoloStar pen: 

Each pen contains 1.5 ml of solution, equivalent to 450 units. 

DoubleStar pen: 

Each pen contains 3 ml of solution, equivalent to 900 units. 

 

 

3. LIST OF EXCIPIENTS 

 

Zinc chloride, metacresol, glycerol, hydrochloric acid / sodium hydroxide (for pH adjustment), water 

for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection in a pre-filled pen. 

SoloStar pen: 

1 pen 

3 pens 

5 pens 

10 pens 

DoubleStar pen: 

1 pen 

3 pens 

10 pens 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

SoloStar pen 

1 step=1 unit 

DoubleStar pen: 

1 step= 2 units 

Read the package leaflet before use. 

Open here 

Subcutaneous use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 



27 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

Use only in this pen or severe overdose can result. 

Always use a new needle for each injection. 

For single patient use only. 

Use only clear and colourless solutions. 

450 units per pen (SoloStar pen) 

900 units per pen (DoubleStar pen) 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Before first use 

Store in a refrigerator. 

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 

The product may be stored for a maximum of 6 weeks below 30°C. Do not refrigerate. Put the pen cap 

back on the pen after each injection in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Sanofi-Aventis Deutschland GmbH 

D-65926 Frankfurt am Main, 

Germany 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/00/133/033 1 pen (SoloStar) 

EU/1/00/133/034 3 pens (SoloStar) 

EU/1/00/133/035 5 pens (SoloStar) 

EU/1/00/133/036 10 pens (SoloStar) 

EU/1/00/133/037 1 pen (DoubleStar) 

EU/1/00/133/038 3 pens (DoubleStar) 

EU/1/00/133/041 10 pens (DoubleStar) 

 

13. BATCH NUMBER 

 

Lot 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 



28 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Toujeo 300 SoloStar 

Toujeo 300 DoubleStar 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 

  



29 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON Multipack (contains Blue Box) 

 

 

1. NAME OF THE MEDICINAL PRODUCT  

 

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

insulin glargine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S)  

 

Each ml contains 300 units (10.91 mg) insulin glargine. 

Each pen contains 3 ml of solution, equivalent to 900 units. 

 

 

3. LIST OF EXCIPIENTS  

 

Zinc chloride, metacresol, glycerol, hydrochloric acid / sodium hydroxide (for pH adjustment), water 

for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS  

 

Solution for injection in a pre-filled pen. 

 

Multipack: 6 (2 packs of 3) pens 

Multipack: 9 (3 packs of 3) pens 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION  

 

1 step= 2 units 

Read the package leaflet before use. 

Subcutaneous use 

Open here 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN  

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY  

 

Use only in this pen or severe overdose can result. 

Always use a new needle for each injection. 

For single patient use only. 

Use only clear and colourless solutions.  

900 units per pen 

 

 



30 

8. EXPIRY DATE  

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS  

 

Before first use 

Store in a refrigerator. 

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 

The product may be stored for a maximum of 6 weeks below 30°C. Do not refrigerate. Put the pen cap 

back on the pen after each injection in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE  

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER  

 

Sanofi-Aventis Deutschland GmbH 

D-65926 Frankfurt am Main, 

Germany. 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/00/133/039 6 pens (2 packs of 3) 

EU/1/00/133/040 9 pens (3 packs of 3) 

 

 

13. BATCH NUMBER  

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY  

 

 

15. INSTRUCTIONS ON USE  

 

 

 

16. INFORMATION IN BRAILLE 

 

Toujeo 300 DoubleStar 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 



31 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



32 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INNER CARTON without Blue Box 

 

 

1. NAME OF THE MEDICINAL PRODUCT  

 

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

insulin glargine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S)  

 

Each ml contains 300 units (10.91 mg) insulin glargine. 

Each pen contains 3 ml of solution, equivalent to 900 units. 

 

 

3. LIST OF EXCIPIENTS  

 

Zinc chloride, metacresol, glycerol, hydrochloric acid / sodium hydroxide (for pH adjustment), water 

for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS  

 

Solution for injection in a pre-filled pen. 

 

6 pens 

9 pens 

Component of a multipack, can’t be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION  

 

1 step=2 units 

Read the package leaflet before use. 

Subcutaneous use 

Open here 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN  

 

Keep out of the sight and reach of children.  

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY  

 

Use only in this pen or severe overdose can result. 

Always use a new needle for each injection. 

For single patient use only. 

Use only clear and colourless solutions. 

900 units per pen. 

 

 



33 

8. EXPIRY DATE  

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS  

 

Before first use 

Store in a refrigerator. 

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  

The product may be stored for a maximum of 6 weeks below 30°C. Do not refrigerate. Put the pen cap 

back on the pen after each injection in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE  

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER  

 

Sanofi-Aventis Deutschland GmbH 

D-65926 Frankfurt am Main, 

Germany. 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/00/133/039 6 pens (2 packs of 3) 

EU/1/00/133/040 9 pens (3 packs of 3) 

 

 

13. BATCH NUMBER  

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY  

 

 

15. INSTRUCTIONS ON USE  

 

 

16. INFORMATION IN BRAILLE 

 

Toujeo 300 DoubleStar 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 



34 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

PEN LABEL  

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Toujeo 300 units/ml SoloStar injection 

Toujeo 300 units/ml DoubleStar injection 

insulin glargine 

Subcutaneous use 

 

 

2. METHOD OF ADMINISTRATION 

 

Use only in this pen or severe overdose can result. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

1.5 ml (SoloStar) 

3 ml (DoubleStar) 

 

 

6. OTHER  

 

SoloStar pen1 step=1 unit 

DoubleStar pen 

1 step=2 units 

 

 



35 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 

  



36 

Package leaflet: information for the user  

 

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

Insulin glargine  

Each SoloStar pen delivers 1-80 units in steps of 1 unit.  

 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

- Keep this leaflet. You may need to read it again. 

- If you have any further questions, ask your doctor or pharmacist or nurse. 

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 

 

 

What is in this leaflet  

1. What Toujeo is and what it is used for 

2. What you need to know before you use Toujeo 

3. How to use Toujeo 

4. Possible side effects 

5. How to store Toujeo 

6. Contents of the pack and other information 

 

 

1. What Toujeo is and what it is used for 

 

Toujeo contains insulin called “insulin glargine”. This is a modified insulin, very similar to human 

insulin. 

 

Toujeo contains 3 times more insulin in 1 ml than standard insulin, which contains 100 unit/ml. 

 

It is used to treat diabetes mellitus in adults, adolescents and children from the age of 6 years.Diabetes 

mellitus is an illness where your body does not make enough insulin to control your blood sugar. 

 

Toujeo lowers your blood sugar steadily over a long period of time. It is used for once daily dosing. 

You can change the time of your injection if you need to. This is because this medicine lowers your 

blood sugar over a long period of time (for more information, see section 3). 

 

 

2. What you need to know before you use Toujeo 

 

Do not use Toujeo 

- If you are allergic to insulin glargine or to any of the other ingredients of this medicine (listed in 
section 6). 

 

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before using Toujeo. 

 

Follow closely the instructions for dose, monitoring (blood and urine tests), diet and physical activity 

(physical work and exercise) and injection technique, as discussed with your doctor. 

 



37 

Be especially aware of the following: 

 Too low blood sugar (hypoglycaemia). If your blood sugar is too low, follow the guidance for 
hypoglycaemia (see information in the box at the end of this leaflet). 

 If you switch from another type, brand or manufacturer of insulin your insulin dose may need to 
be changed.  

 Pioglitazone. See “Pioglitazone used together with insulin”. 

 Ensure to use the right insulin. Medication errors due to mix-up between insulins, particularly 
between long-acting insulins and rapid-acting insulins have been reported. You must always 

check the insulin label before each injection to avoid mix-ups between Toujeo and other 

insulins. 

 Never use a syringe to remove Toujeo from your SoloStar pre-filled pen. This is to avoid dosing 
errors and potential overdose which may lead to low blood sugar. Please, see also section 3. 

 If you are blind or have poor eye sight, do not use the pre-filled pen without help. This is 
because you will not be able to read the dose window on the pen. Get help from a person with 

good eye sight who is trained in using the pen. If you have poor eyesight, please see section 3. 

 

Skin changes at the injection site 

The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin 

may not work very well if you inject into a lumpy area (see How to use Toujeo). Contact your doctor 

if you are currently injecting into a lumpy area before you start injecting in a different area. Your 

doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other 

antidiabetic medications dose. 

 

Illnesses and injuries  

In the following situations, the management of your diabetes may require extra care (for example, 

blood and urine tests): 

 If you are ill or have a major injury. Your blood sugar level may increase (hyperglycaemia). 

 If you are not eating enough. Your blood sugar level may become too low (hypoglycaemia). 
In most cases you will talk to a doctor. Contact a doctor as soon as you feel ill or get an injury. 

 

If you have “Type 1” diabetes and you have an illness or injury: 

 Do not stop your insulin 

 Keep eating enough carbohydrates. 
Always tell people who are caring or treating you, that you have diabetes. 

 

Insulin treatment can cause the body to produce antibodies to insulin (substances that act against 

insulin). However, only very rarely, this will require a change to your insulin dose. 

 

Travel 

Talk to your doctor before travelling. You may need to talk about: 

 If your type of insulin is available in the country you are visiting. 

 How to arrange the supply of insulin, needles and other items. 

 How to correctly store your insulin while travelling. 

 The time you eat meals and use your insulin. 

 The possible effects of changing to different time zones. 

 Any health risks in the countries you will visit. 

 What you should do in an emergency situation if you feel unwell or become ill. 
 

Children and adolescents 

This medicine should not be used in children under 6 years of age. This is because there is no 

experience with Toujeo in this age group. 

 

Other medicines and Toujeo  

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 

medicines. 

 



38 

Some medicines can change your blood sugar level. This may mean your insulin dose has to change. 

So, before taking a medicine ask your doctor if it will affect your blood sugar and what action, if any, 

you need to take. You also need to be careful when you stop taking a medicine. 

 

Your blood sugar level may fall (hypoglycaemia) if you take: 

 Any other medicine to treat diabetes. 

 Disopyramide – for some heart problems. 

 Fluoxetine – for depression. 

 Sulfonamide antibiotics. 

 Fibrates – for lowering high levels of blood fats. 

 Monoamine oxidase inhibitors (MAOIs) – for depression. 

 Angiotensin converting enzyme (ACE) inhibitors – for heart problems or high blood pressure. 

 Medicines to relieve pain and lower fever, such as pentoxifylline, propoxyphene and salicylates 
(such as acetylsalicylic acid). 

 Pentamidine – for some infections caused by parasites. This may cause too low blood sugar 
which is sometimes followed by too high blood sugar. 

 

Your blood sugar level may rise (hyperglycaemia) if you take: 

 Corticosteroids such as cortisone – for inflammation. 

 Danazol – for endometriosis. 

 Diazoxide – for high blood pressure. 

 Protease inhibitors- for HIV. 

 Diuretics – for high blood pressure or fluid retention. 

 Glucagon – for very low blood sugar. 

 Isoniazid – for tuberculosis. 

 Somatropin – a growth hormone. 

 Thyroid hormones – for thyroid gland problems. 

 Oestrogens and progestogens – such as in the contraceptive pill for birth control. 

 Clozapine, olanzapine and phenothiazine derivatives – for mental health problems. 

 Sympathomimetic medicines such as epinephrine (adrenaline), salbutamol and terbutaline – for 
asthma. 

 

Your blood sugar level may either rise or fall if you take: 

 Beta-blockers or clonidine – for high blood pressure. 

 Lithium salts – for mental health problems. 
 

Beta-blockers 

Beta-blockers like other “Sympatholytic medicines” (such as clonidine, guanethidine, reserpine – for 

high blood pressure) may make it harder to recognise warning signs of your blood sugar being too low 

(hypoglycaemia). It can even hide or stop the first signs that your blood sugar is too low. 

 

Pioglitazone used together with insulin 

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who 

were treated with pioglitazone and insulin experienced the development of heart failure. If you 

experience signs of heart failure such as unusual shortness of breath, a rapid increase in weight or 

localised swelling (oedema). Inform your doctor as soon as possible. 

 

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before 

using Toujeo. 

 

Toujeo with alcohol 

Your blood sugar level may either rise or fall if you drink alcohol. You should check your blood sugar 

level more than usual. 

 

Pregnancy and breast-feeding 



39 

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask 

your doctor for advice before using this medicine. Your insulin dose may need to be changed during 

pregnancy and after giving birth. For the health of your baby, it is particularly important to carefully 

control your diabetes and to prevent hypoglycaemia. 

If you are breast-feeding, talk to your doctor, as your insulin doses and your diet might need to be 

changed. 

 

Driving and using machines 

Having too low or too high blood sugar or sight problems can affect your ability to drive and use tools 

or machines. Your concentration may be affected. This could be dangerous to yourself and others. 

 

Ask your doctor whether you can drive if: 

 Your blood sugar is often too low. 

 You find it hard to recognise when your blood sugar is too low. 
 

Important information about some of the ingredients of Toujeo 

This medicine contains less than 1 mmol (23 mg) sodium per dose. This means it is essentially 

‘sodium-free’. 

 

 

3. How to use Toujeo 

 

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or 

nurse if you are not sure. 

 

Although Toujeo contains the same active substance as insulin glargine 100 units/ml, these medicines 

are not interchangeable. The switch from one insulin therapy to another requires medical prescription, 

medical supervision and blood glucose monitoring. Please, consult your doctor for further information. 

 

How much to use 

The Toujeo SoloStar pre-filled pen can provide a dose of 1 to 80 units in one injection, in steps of 

1 unit. 

The dose window of the SoloStar pen shows the number of units of Toujeo to be injected. Do not 

make any dose re-calculation. 

 

Based on your lifestyle, your blood sugar tests and your previous insulin use, your doctor will tell you: 

 How much Toujeo you need each day and at what time. 

 When to check your blood sugar level and if you need to carry out urine tests.  

 When you may need a higher or lower dose. 
 

Toujeo is a long-acting insulin. Your doctor may tell you to use it with a short-acting insulin, or with 

other medicines for high blood sugar. 

 

If you use more than one insulin always ensure you use the right insulin by checking the insulin label 

before each injection. Medication errors due to mix-up between insulins, particularly between long-

acting insulins and rapid-acting insulins have been reported. The strength “300” is highlighted in 

honey gold on the label of your Toujeo SoloStar pre-filled pen. Ask your doctor or pharmacist if you 

are not sure. 

 

Many factors may affect your blood sugar level. You should know these factors so that you can take 

the right action if your blood sugar level changes and help step it becoming too high or too low. See 

the box at the end of this leaflet for more information. 

 

Flexibility in time of administration 

 Use Toujeo once a day, preferably at the same time every day. 

 When needed, you can inject it up to 3 hours before or after the usual time that you use it. 
 



40 

Use in elderly patients (65 years and over) 

If you are 65 years or older, talk to your doctor as you may need a lower dose. 

 

If you have kidney or liver problems 

If you have kidney or liver problems, talk to your doctor as you may need a lower dose. 

 

Before injecting Toujeo  

 Read the instructions for use that come with this package leaflet. 

 If you do not follow all of these instructions, you may get too much or too little insulin. 
 

How to inject 

 Toujeo is injected under the skin (subcutaneous use or “SC”). 

 Inject it into the front of your thighs, upper arms or the front of your waist (abdomen). 

 Change the place within the area you inject each day. This will reduce the risk of skin shrinking 
or thickening (for more information, see “Other side effects” in section 4). 

 

To prevent the possible transmission of disease, insulin pens should never be used for more than one 

person, even when the needle is changed. 

 

Always attach a new sterile needle before each injection. Never re-use needles. If you re-use a needle 

this increases the risk of it becoming blocked and of you getting too much or too little insulin. 

 

Throw away the used needle in a puncture resistant container, or as told by your pharmacist or local 

authority. 

 

Do not use Toujeo 

 In a vein. This will change the way it works and may cause your blood sugar to become too low. 

 In an insulin infusion pump. 

 If there are particles in the insulin. The solution should be clear, colourless and water-like. 
 

Never use a syringe to remove Toujeo from your SoloStar pen or severe overdose can result. Please, 

see also section 2. 

 

If the SoloStar pen is damaged, has not been stored correctly, if you are not sure that it is working 

properly or you notice that your blood sugar control is unexpectedly getting worse: 

 Throw the pen away and use a new one. 

 Talk to your doctor, pharmacist or nurse if you think you have problem with your pen. 
 

If you use more Toujeo than you should 

If you have injected too much of this medicine, your blood sugar level may become too low. Check 

your blood sugar and eat more food to prevent you blood sugar getting too low. If your blood sugar 

gets too low, see the advice in the box at the end of this leaflet. 

 

If you forget to use Toujeo  

When needed, Toujeo can be injected up to 3 hours before or after the time you usually inject it. 

 

If you have missed a dose of Toujeo or if you have not injected enough insulin, your blood sugar level 

may become too high (hyperglycaemia): 

 Do not inject a double dose to make up for a forgotten dose. 

 Check your blood sugar and then inject your next dose at the usual time. 

 For information on the treatment of hyperglycaemia, see the box at the end of this leaflet. 
 

If you stop using Toujeo  

Do not stop using this medicine without talking to your doctor. If you do, it could lead to very high 

blood sugar and a build-up of acid in the blood (ketoacidosis). 

 



41 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your 

blood sugar level straight away (see the box at the end of this leaflet). 

Hypoglycaemia can be very serious and is very common with insulin treatment (may affect more than 

1 in 10 people). 

Low blood sugar means that there is not enough sugar in your blood. 

If your blood sugar falls too low, you may pass out (become unconscious). 

Serious low blood sugar may cause brain damage and may be life-threatening. 

For more information, see the box at the end of this leaflet. 

 

Severe allergic reactions (rare, may affect up to 1 in 1,000 people).The signs may include rash and 

itching all over the body, swelling of skin or mouth, shortness of breath, feeling faint (a fall in blood 

pressure) with fast heart beat and sweating. Severe allergic reactions may become life-threatening. 

Tell a doctor straight away if you notice signs of a severe allergic reaction. 

 

Other side effects 

Tell your doctor, pharmacist or nurse if you notice any of the following side effects: 

 Skin changes at the injection site:  
If you inject insulin too often at the same place, the skin may either shrink (lipoatrophy) (may 

affect up to 1 in 100 people) or thicken (lipohypertrophy) (may affect up to 1 in 10 people). Lumps 

under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; 

how often this occurs is not known). The insulin may not work very well if you inject into a lumpy 

area. Change the injection site with each injection to help prevent these skin changes. 

 

Common: may affect up to 1 in 10 people 

 Skin and allergic reactions at the injection site: The signs may include reddening, 
unusually intense pain when injecting, itching, hives, swelling or inflammation. This can 

spread around the injection site. Most minor reactions to insulins usually disappear in a 

few days to a few weeks. 

  

Rare: may affect up to 1 in 1,000 people 

 Eye reactions: A big change in your blood sugar control (getting better or worse) can 
disturb your vision. If you have an eye disorder related to diabetes called “proliferative 

retinopathy”, very low blood sugar attack may cause temporary loss of vision. 

 Swelling in the calves and ankles, caused by temporary build-up of water in the body. 
  

Very rare: may affect up to 1 in 10,000 people 

 Changes in taste (dysgeusia). 

 Muscular pain (myalgia). 
Tell your doctor, pharmacist or nurse if you notice any of the side effects above. 

 

Reporting of side effects  

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


42 

5. How to store Toujeo 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen 

after “EXP”. The expiry date refers to the last day of that month. 

 

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 pen in the outer carton in order to protect from light. 

 

After first use or if carried as a spare 

Do not store the pen in a refrigerator. The pen may be stored for a maximum of 6 weeks below 30°C 

and away from direct heat or direct light. Discard the pen after this time period. Do not leave your 

insulin in a car on an exceptionally warm or cold day. Always keep the cap on the pen when you are 

not using it in order to protect from light. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer used. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What Toujeo contains  

 The active substance is insulin glargine. Each ml of the solution contains 300 units of insulin 
glargine (equivalent to 10.91 mg). Each pen contains 1.5 ml of solution for injection, equivalent 

to 450 units. 

 The other ingredients are: zinc chloride, metacresol, glycerol, water for injections, and sodium 
hydroxide (see section 2 “Important information about some of the ingredients of Toujeo”) and 

hydrochloric acid (for pH adjustment). 

 

What Toujeo looks like and contents of the pack  

Toujeo is a clear and colourless solution. 

Each pen contains 1.5 ml of solution for injection (equivalent to 450 units). 

Packs of 1, 3, 5 and 10 pre-filled pens. 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder and Manufacturer  

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder. 

 

België/Belgique/Belgien 

Sanofi Belgium 

Tél/Tel: +32 (0)2 710 54 00 

 

Lietuva 

UAB sanofi-aventis Lietuva 

Tel: +370 5 2755224 

 

България 

SANOFI BULGARIA EOOD 

Тел.: +359 (0)2 970 53 00 

 

Luxembourg/Luxemburg 

Sanofi Belgium  

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) 

 

Česká republika 

sanofi-aventis, s.r.o. 

Tel: +420 233 086 111 

 

Magyarország 

sanofi-aventis zrt., Magyarország 

Tel.: +36 1 505 0050 

 



43 

Danmark 

Sanofi A/S 

Tlf: +45 45 16 70 00 

 

Malta 

Sanofi S.p.A. 

Tel: +39 02 39394275 

Deutschland 

Sanofi-Aventis Deutschland GmbH 

Tel: 0800 52 52010 

Tel : aus dem Ausland +49 69 305 21 131 

 

Nederland 

sanofi-aventis Netherlands B.V. 

Tel: +31 20 245 4000 

 

Eesti 

sanofi-aventis Estonia OÜ 

Tel: +372 627 34 88 

 

Norge 

sanofi-aventis Norge AS 

Tlf: +47 67 10 71 00 

 

Ελλάδα 

sanofi-aventis AEBE 

Τηλ: +30 210 900 16 00 

 

Österreich 

sanofi-aventis GmbH 

Tel: +43 1 80 185 – 0 

 

España 

sanofi-aventis, S.A. 

Tel: +34 93 485 94 00 

 

Polska 

sanofi-aventis Sp. z o.o. 

Tel.: +48 22 280 00 00 

 

France 

sanofi-aventis France 

Tél: 0 800 222 555 

Appel depuis l’étranger : +33 1 57 63 23 23 

 

Portugal 

Sanofi - Produtos Farmacêuticos, Lda 

Tel: +351 21 35 89 400 

 

Hrvatska 

sanofi-aventis Croatia d.o.o. 

Tel: +385 1 600 34 00 

România 

Sanofi Romania SRL 

Tel: +40 (0) 21 317 31 36 

 

Ireland 

sanofi-aventis Ireland Ltd. T/A SANOFI 

Tel: +353 (0) 1 403 56 00 

 

Slovenija 

sanofi-aventis d.o.o. 

Tel: +386 1 560 48 00 

 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

sanofi-aventis Pharma Slovakia s.r.o. 

Tel: +421 2 33 100 100 

 

Italia 

Sanofi S.p.A. 

Tel: 800 13 12 12 (domande di tipo tecnico)  

+39 800 536389 (altre domande e chiamate 

dall'estero) 

 

Suomi/Finland 

Sanofi Oy 

Puh/Tel: +358 (0) 201 200 300 

 

Κύπρος 

sanofi-aventis Cyprus Ltd. 

Τηλ: +357 22 871600 

 

Sverige 

Sanofi AB 

Tel: +46 (0)8 634 50 00 

 

Latvija 

sanofi-aventis Latvia SIA 

Tel: +371 67 33 24 51 

 

United Kingdom 

Sanofi 

Tel: +44 (0) 845 372 7101 

 

 

This leaflet was last revised in  

 

 

Other source of information 



44 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu/ 

 

 

  



45 

HYPERGLYCAEMIA AND HYPOGLYCAEMIA 

 

If you take insulin, you should always carry the following things with you: 

 Sugar (at least 20 grams). 

 Information so that others know you have diabetes. 
 

Hyperglycaemia (high blood sugar levels) 

 

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin. 

 

Reasons why hyperglycaemia may happen: 

Examples include: 

 You have not injected your insulin or not injected enough.  

 Your insulin has become less effective – for example because it was not stored properly.  

 Your insulin pen does not work properly. 

 You are doing less exercise than usual. 

 You are under stress – such as emotional distress or excitement. 

 You have an injury, infection or fever or have had an operation. 

 You are taking or have taken certain other medicines (see section 2, "Other medicines and 
Toujeo"). 

 

Warning signs of hyperglycaemia 

Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood 

pressure, fast heart beat, and glucose and ketone bodies in urine. Stomach pain, fast and deep 

breathing, feeling sleepy or passing out (becoming unconscious) may be signs of a serious condition 

(ketoacidosis) resulting from lack of insulin.  

 

What to do if you experience hyperglycaemia  

 Test your blood sugar level and your urine for ketones as soon as you notice any of the above 
signs 

 Contact your doctor straight away if you have severe hyperglycaemia or ketoacidosis. This must 
always be treated by a doctor, normally in a hospital. 

 

 

Hypoglycaemia (low blood sugar levels) 

 

If your blood sugar level falls too much you may pass out (become unconscious). Serious 

hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You should 

learn to recognise the signs when your blood sugar is falling – so you can take action to stop it getting 

worse.  

 

Reasons why hypoglycaemia may happen: 

Examples include: 

 You inject too much insulin. 

 You miss meals or delay them. 

 You do not eat enough, or eat food containing less sugar (carbohydrate) than normal – artificial 
sweeteners are not carbohydrates. 

 You drink alcohol – especially when you have not eaten much. 

 You lose carbohydrates from being sick (vomiting) or diarrhoea. 

 You are doing more exercise than usual or a different type of physical activity. 

 You are recovering from an injury, operation or other stress. 

 You are recovering from an illness or from fever. 

 You are taking or have stopped taking certain other medicines (see section 2, "Other medicines 
and Toujeo"). 

 



46 

Hypoglycaemia is also more likely to happen if: 

 You have just started insulin treatment or changed to another insulin – if low blood sugar 
occurs, it may be more likely to happen in the morning.  

 Your blood sugar levels are almost normal or are unstable. 

 You change the area of skin where you inject insulin. For example from the thigh to the upper 
arm. 

 You have severe kidney or liver disease, or some other disease such as hypothyroidism. 
 

Warning signs of hypoglycaemia  

The first signs may be in your body generally. Examples of signs that your blood sugar level is falling 

too much or too fast include: sweating, clammy skin, feeling anxious, fast or irregular heart beat, high 

blood pressure and palpitations. These signs often develop before the signs of a low sugar level in the 

brain.  

 

Signs in your brain include: headaches, feeling very hungry, feeling sick (nausea) or being sick 

(vomiting), feeling tired, sleepy, restless, sleeping problems, aggressive behaviour, difficulty 

concentrating, slow reactions, depression, feeling confused, difficulty speaking (sometimes total loss 

of speech), changes in your sight, trembling, being unable to move (paralysis), tingling in the hands or 

arms, feeling numb and tingling often around the mouth, feeling dizzy, loss of self-control, being 

unable to look after yourself, fits, passing out. 

 

When the signs of hypoglycaemia may be less clear: 

The first warning signs of hypoglycaemia may change, be weaker or missing altogether if: 

 You are elderly. 

 You have had diabetes for a long time. 

 You have a certain type of nervous disease (called “diabetic autonomic neuropathy”). 

 You have recently had too low blood sugar (for example the day before). 

 Your low blood sugar comes on slowly. 

 Your low blood sugar is always around “normal” or your blood sugar has got much better.  

 You have recently changed from an animal insulin to a human insulin, like Toujeo. 

 You are taking or have taken certain other medicines (see section 2, "Other medicines and 
Toujeo").  

 

In such cases, you may develop severe hypoglycaemia (and even pass out) before you know what is 

happening. Be familiar with your warning signs. If necessary, you might need to test your blood sugar 

more often. This can help to spot mild hypoglycaemic episodes. If you find it difficult to recognise 

your warning signs, you should avoid situations (such as driving a car) in which you or others would 

be put at risk by hypoglycaemia. 

 

What to do if you experience hypoglycaemia? 

 

1. Do not inject insulin. Take about 10 to 20 grams sugar straight away - such as glucose, sugar 

cubes or a sugary-drink. Do not drink or eat foods that contain artificial sweeteners (such as diet 

drinks). They do not help treat low blood sugar. 

2. Then eat something (such as bread or pasta) that will raise your blood sugar over a longer time. 

Ask your doctor or nurse if you are not sure which foods you should eat. 

With Toujeo, it may take longer to recover from low blood sugar because it is long-acting. 

3. If the hypoglycaemia comes back again, take another 10 to 20 grams of sugar. 

4. Speak to a doctor straight away if you are not able to control the hypoglycaemia, or it comes 

back again. 

 

What other people should do if you have hypoglycaemia 

 

Tell your relatives, friends and close colleagues to get medical help straight away if you are not able to 

swallow or if you pass out (become unconscious).  



47 

You will require an injection of glucose or glucagon (a medicine which increases blood sugar). These 

injections should be given even if it is not certain that you have hypoglycaemia. 

 

You should test your blood sugar straight away after taking glucose to check that you really have 

hypoglycaemia. 



48 

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

INSTRUCTIONS FOR USE  

 

 

Read this first 

 

Toujeo SoloStar contains 300 units/ml insulin glargine in a 1.5 ml disposable prefilled pen 

- Never re-use needles. If you do you might not get your dose (underdosing) or get too much 
(overdosing) as the needle could block. 

- Never use a syringe to remove insulin from your pen. If you do you will get too much 
insulin. The scale on most syringes is made for non-concentrated insulin only. 

 

Important information 

 

Never share your pen – it is only for you. 

Never use your pen if it is damaged or if you are not sure that it is working properly. 

Always perform a safety test 

Always carry a spare pen and spare needles in case they got lost or stop working. 

 

 
Learn to inject 

 

 Talk with your doctor, pharmacist or nurse about how to inject, before using your pen. 

 Ask for help if you have problems handling the pen, for example if you have problems with your 
sight. 

 Read all of these instructions before using your pen. If you do not follow all of these instructions, 
you may get too much or too little insulin. 

 

Need help? 

 

If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or 

call sanofi-aventis number on the front of this leaflet. 

 
Extra items you will need: 

 

 a new sterile needle (see STEP 2). 

 a puncture resistant container for used needles and pens. 
 

Places to inject  

 

 

 

 

 

 

Stomach 

Upper arms 

Thighs 



49 

Get to know your pen 

 

 
 

 
 

* You will not see the plunger until you have injected a few doses. 

 
STEP 1: Check your pen 

 

Take a new pen out of the fridge at least 1 hour before you inject. Cold insulin is more painful 

to inject. 

 

 

A Check the name and expiration date on the label of your pen. 

 Make sure you have the correct insulin. This is especially important if you have other 
injector pens. 

 Never use your pen after the expiration date. 

 

 
 

 
B Pull off the pen cap. 

 

 
 

 
C Check that the insulin is clear. 

 Do not use the pen if the insulin looks cloudy, coloured or contains particles. 

 
 

 
STEP 2: Attach a new needle 

 

Pen cap Rubber seal Insulin scale Insulin name 
Injection button 

Dose selector 

Cartridge holder Plunger* Dose window Dose pointer 



50 

Always use a new sterile needle for each injection. This helps stop blocked needles, 

contamination and infection. 

Only use needles that are compatible for use with Toujeo (e.g. needles from BD, Ypsomed, 

Artsana or Owen Mumford). 

 

 
A Take a new needle and peel off the protective seal. 

 

 
 
 

B Keep the needle straight and screw it onto the pen until fixed. Do not overtighten. 

 

 
 
 

C Pull off the outer needle cap. Keep this for later. 

 

 
 

 
D  Pull off the inner needle cap and throw away. 

 

 
 
 

Handling needles 



51 

 Take care when handling needles – this is to prevent needle injury and cross-infection. 
 

 

STEP 3: Do a safety test 

 

Always do a safety test before each injection – this is to: 

 check your pen and the needle are working properly. 

 make sure that you get the correct insulin dose. 
 

A Select 3 units by turning the dose selector until the dose pointer is at the mark between 2 and 

4. 

 

 

 
 

B Press the injection button all the way in. 

 When insulin comes out of the needle tip, your pen is working correctly. 

 

 
 
If no insulin appears: 

 You may need to repeat this step up to 3 times before seeing insulin. 

 If no insulin comes out after the third time, the needle may be blocked. If this happens: 
- change the needle (see STEP 6 and STEP 2), 
- then repeat the safety test (STEP 3). 

 Do not use your pen if there is still no insulin coming out of the needle tip. Use a new pen. 

 Never use a syringe to remove insulin from your pen. 
 

If you see air bubbles 

 You may see air bubbles in the insulin. This is normal, they will not harm you. 

 

 
STEP 4: Select the dose 

 

Never select a dose or press the injection button without a needle attached. This may damage your 

pen. 



52 

 

A  Make sure a needle is attached and the dose is set to ‘0’. 

 

   
 

 
B Turn the dose selector until the dose pointer lines up with your dose. 

 If you turn past your dose, you can turn back down. 

 If there are not enough units left in your pen for your dose, the dose selector will stop at the 
number of units left. 

 If you cannot select your full prescribed dose, split the dose into two injections or use a new 
pen. 

 

   
 
How to read the dose window 

 

Even numbers are shown in line with the dose pointer: 

 

  
 

 
Odd numbers are shown as a line between even numbers: 

 

  
 

 
Units of insulin in your pen 

 Your pen contains a total of 450 units of insulin. You can select doses from 1 to 80 units in 
steps of 1 unit. Each pen contains more than one dose. 

 You can see roughly how many units of insulin are left by looking at where the plunger is on 
the insulin scale. 

 

STEP 5: Inject your dose 

 

If you find it hard to press the injection button in, do not force it as this may break your pen. See 

the        section below for help. 

30 units selected 

29 units selected 



53 

 

A  Choose a place to inject as shown in the picture  

 

B Push the needle into your skin as shown by your doctor, pharmacist or nurse. 

 Do not touch the injection button yet. 

 

   
 

C Place your thumb on the injection button. Then press all the way in and hold. 

 Do not press at an angle – your thumb could block the dose selector from turning. 

 

   
 
D Keep the injection button held in and when you see "0" in the dose window, slowly count to 

5. 

 This will make sure you get your full dose. 

 
 
E After holding and slowly counting to 5, release the injection button. Then remove the needle 

from your skin. 

 

 

If you find it hard to press the button in: 

 Change the needle (see STEP 6 and STEP 2) then do a safety test (see STEP 3). 

 If you still find it hard to press in, get a new pen. 

 Never use a syringe to remove insulin from your pen. 

 
STEP 6: Remove the needle 

 

Take care when handling needles – this is to prevent needle injury and cross-infection. 

Never put the inner needle cap back on. 

 

A Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.  



54 

 To reduce the risk of accidental needle injury, never replace the inner needle cap. 

 If your injection is given by another person, or if you are giving an injection to another 
person, special caution must be taken by this person when removing and disposing of the 

needle. 

 Follow recommended safety measures for removal and disposal of needles (contact your 
doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and 

transmission of infectious diseases. 

 

B Throw away the used needle in a puncture resistant container, or as told by your pharmacist 

or local authority. 

 

 

   
C Put the pen cap back on. 

 Do not put the pen back in the fridge. 

 

   
 
Use by 

 

 Only use your pen for up to 6 weeks after its first use. 
 

How to store your pen 

 

Before first use 

 Keep new pens in a fridge, at 2°C to 8°C. 

 Do not freeze.  
 

After first use 

 Keep your pen at room temperature, below 30°C. 

 Never put your pen back in the fridge. 

 Never store your pen with the needle attached. 

 Store your pen with the pen cap on. 

 
How to care for your pen 

 

Handle your pen with care 

 Do not drop your pen or knock it against hard surfaces. 

 If you think that your pen may be damaged, do not try to repair it, use a new one. 
 

Protect your pen from dust and dirt 

 You can clean the outside of your pen by wiping it with a damp cloth. Do not soak, wash or 
lubricate your pen – this may damage it. 



55 

 

Throwing your pen away 

 Remove the needle before throwing your pen away. 

 Throw away your used pen as told by your pharmacist or local authority. 



56 

Package leaflet: information for the user  

 

Toujeo 300 units/ml DoubleStar solution for injection in a pre-filled pen  
Insulin glargine  

Each DoubleStar pen delivers 2-160 units in steps of 2 units  

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

- Keep this leaflet. You may need to read it again. 

- If you have any further questions, ask your doctor or pharmacist or nurse. 

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 

 

 

What is in this leaflet 

1. What Toujeo is and what it is used for 

2. What you need to know before you use Toujeo 

3. How to use Toujeo 

4. Possible side effects 

5. How to store Toujeo  

6. Contents of the pack and other information 

 

 

1. What Toujeo is and what it is used for 

 

Toujeo contains insulin called “insulin glargine”. This is a modified insulin, very similar to human 

insulin.  

 

Toujeo contains 3 times more insulin in 1 ml than standard insulin, which contains 100 unit/ml.  

 

It is used to treat diabetes mellitus in adults, adolescents and children from the age of 6 years. Diabetes 

mellitus is an illness where your body does not make enough insulin to control your blood sugar. 

 

Toujeo lowers your blood sugar steadily over a long period of time. It is used for once daily dosing. 

You can change the time of your injection if you need to. This is because this medicine lowers your 

blood sugar over a long period of time (for more information, see section 3). 

 

 

2. What you need to know before you use Toujeo  

 

Do not use Toujeo  

- If you are allergic to insulin glargine or to any of the other ingredients of this medicine (listed in 
section 6). 

 

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before using Toujeo. 

 

Follow closely the instructions for dose, monitoring (blood and urine tests), diet and physical activity 

(physical work and exercise) and injection technique, as discussed with your doctor. 

 



57 

Be especially aware of the following: 

 Too low blood sugar (hypoglycaemia). If your blood sugar is too low, follow the guidance for 
hypoglycaemia (see information in the box at the end of this leaflet). 

 If you switch from another type, brand or manufacturer of insulin your insulin dose may need to 
be changed.  

 Pioglitazone. See “Pioglitazone used together with insulin”. 

 Ensure to use the right insulin. Medication errors due to mix-up between insulins, particularly 
between long-acting insulins and rapid-acting insulins have been reported. You must always 

check the insulin label before each injection to avoid mix-ups between Toujeo and other 

insulins. 

 Never use a syringe to remove Toujeo from your DoubleStar pen. This is to avoid dosing errors 
and potential overdose which may lead to low blood sugar. Please, see also section 3. 

 To avoid an insulin underdose, perform safety tests before the first use of a new pen and also 
before every use of the pen (see Step 3 of the Instrucions for use). Please, see also section 3. 

 If you are blind or have poor eye sight, do not use the pre-filled pen without help. This is 
because you will not be able to read the dose window on the pen. Get help from a person with 

good eye sight who is trained in using the pen. 

 

Skin changes at the injection site 

The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin 

may not work very well if you inject into a lumpy area (see How to use Toujeo). Contact your doctor 

if you are currently injecting into a lumpy area before you start injecting in a different area. Your 

doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other 

antidiabetic medications dose. 

 

Illnesses and injuries 

In the following situations, the management of your diabetes may require extra care (for example, 

blood and urine tests): 

 If you are ill or have a major injury. Your blood sugar level may increase (hyperglycaemia). 

 If you are not eating enough. Your blood sugar level may become too low (hypoglycaemia). 
In most cases you will need to talk to a doctor. Contact a doctor as soon as you feel ill or get an injury.  

 

If you have “Type 1” diabetes and you have an illness or injury: 

 Do not stop your insulin 

 Keep eating enough carbohydrates.  
Always tell people who are caring or treating you, that you have diabetes. 

 

Insulin treatment can cause the body to produce antibodies to insulin (substances that act against 

insulin). However, only very rarely, this will require a change to your insulin dose. 

 

Travel 

Talk to your doctor before travelling. You may need to talk about:  

 If your type of insulin is available in the country you are visiting.  

 How to arrange the supply of insulin, needles and other items.  

 How to correctly store your insulin while travelling.  

 The time you eat meals and use your insulin.  

 The possible effects of changing to different time zones.  

 Any health risks in the countries you will visit. 

 What you should do in an emergency situation if you feel unwell or become ill. 
 

Children and adolescents 

This medicine should not be used in children under 6 years of age. This is because there is no 

experience with Toujeo in this age group. 

 

Other medicines and Toujeo 



58 

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 

medicines.  

 

Some medicines can change your blood sugar level. This may mean your insulin dose has to change. 

So, before taking a medicine ask your doctor if it will affect your blood sugar and what action, if any, 

you need to take. You also need to be careful when you stop taking a medicine. 

 

Your blood sugar level may fall (hypoglycaemia) if you take: 

 Any other medicine to treat diabetes. 

 Disopyramide – for some heart problems. 

 Fluoxetine – for depression. 

 Sulfonamide antibiotics. 

 Fibrates – for lowering high levels of blood fats. 

 Monoamine oxidase inhibitors (MAOIs) – for depression. 

 Angiotensin converting enzyme (ACE) inhibitors – for heart problems or high blood pressure. 

 Medicines to relieve pain and lower fever, such as pentoxifylline, propoxyphene and salicylates 
(such as acetylsalicylic acid). 

 Pentamidine – for some infections caused by parasites. This may cause too low blood sugar 
which is sometimes followed by too high blood sugar. 

 

Your blood sugar level may rise (hyperglycaemia) if you take: 

 Corticosteroids such as cortisone – for inflammation. 

 Danazol – for endometriosis. 

 Diazoxide – for high blood pressure. 

 Protease inhibitors- for HIV. 

 Diuretics – for high blood pressure or fluid retention. 

 Glucagon – for very low blood sugar. 

 Isoniazid – for tuberculosis. 

 Somatropin – a growth hormone. 

 Thyroid hormones – for thyroid gland problems.  

 Oestrogens and progestogens – such as in the contraceptive pill for birth control.  

 Clozapine, olanzapine and phenothiazine derivatives – for mental health problems. 

 Sympathomimetic medicines such as epinephrine (adrenaline), salbutamol and terbutaline – for 
asthma. 

 

Your blood sugar level may either rise or fall if you take: 

 Beta-blockers or clonidine – for high blood pressure. 

 Lithium salts – for mental health problems. 
 

Beta-blockers 

Beta-blockers like other “Sympatholytic medicines” (such as clonidine, guanethidine, reserpine – for 

high blood pressure) may make it harder to recognise warning signs of your blood sugar being too low 

(hypoglycaemia). It can even hide or stop the first signs that your blood sugar is too low. 

 

Pioglitazone used together with insulin 

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who 

were treated with pioglitazone and insulin experienced the development of heart failure. If you 

experience signs of heart failure such as unusual shortness of breath, a rapid increase in weight or 

localised swelling (oedema). Inform your doctor as soon as possible. 

 

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before 

using Toujeo. 

 

Toujeo with alcohol 

Your blood sugar level may either rise or fall if you drink alcohol. You should check your blood sugar 

level more than usual. 



59 

 

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask 

your doctor for advice before using this medicine. Your insulin dose may need to be changed during 

pregnancy and after giving birth. For the health of your baby, it is particularly important to carefully 

control your diabetes and to prevent hypoglycaemia.  

If you are breast-feeding, talk to your doctor, as your insulin doses and your diet might need to be 

changed. 

 

Driving and using machines 

Having too low or too high blood sugar or sight problems can affect your ability to drive and use tools 

or machines. Your concentration may be affected. This could be dangerous to yourself and others.  

 

Ask your doctor whether you can drive if: 

 Your blood sugar is often too low. 

 You find it hard to recognise when your blood sugar is too low. 
 

Important information about some of the ingredients of Toujeo 

This medicine contains less than 1 mmol (23 mg) sodium per dose. This means it is essentially 

‘sodium-free’. 

 

 

3. How to use Toujeo 

 

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or 

nurse if you are not sure. 

 

Although Toujeo contains the same active substance as insulin glargine 100 units/ml, these medicines 

are not interchangeable. The switch from one insulin therapy to another requires medical prescription, 

medical supervision and blood glucose monitoring. Please, consult your doctor for further information. 

 

How much to use 

The Toujeo DoubleStar pre-filled pen can provide a dose of 2 to 160 units per injection, in steps of 

2 units. The pen is recommended for patient who need at least 20 units of insulin per day (see also 

section 2). 

The dose window of the DoubleStar pen shows the number of units of Toujeo to be injected. Do not 

make any dose re-calculation. 

 

Based on your lifestyle, your blood sugar tests and your previous insulin use, your doctor will tell you: 

 How much Toujeo you need each day and at what time. 

 When to check your blood sugar level and if you need to carry out urine tests. 

 When you may need a higher or lower dose. 
 

Toujeo is a long-acting insulin. Your doctor may tell you to use it with a short-acting insulin, or with 

other medicines for high blood sugar. 

 

If you use more than one insulin always ensure you use the right insulin by checking the insulin label 

before each injection. Medication errors due to mix-up between insulins, particularly between long-

acting insulins and rapid-acting insulins have been reported. The strength is highlighted in honey gold 

on the label of your Toujeo DoubleStar pre-filled pen. Ask your doctor or pharmacist if you are not 

sure. 

 

Many factors may affect your blood sugar level. You should know these factors so that you can take 

the right action if your blood sugar level changes and help step it becoming too high or too low. See 

the box at the end of this leaflet for more information. 

 

Flexibility in time of administration 



60 

 Use Toujeo once a day, preferably at the same time every day.  

 When needed, you can inject it up to 3 hours before or after the usual time that you use it. 
 

Use in elderly patients (65 years and over) 

If you are 65 years or older, talk to your doctor as you may need a lower dose. 

 

If you have kidney or liver problems 

If you have kidney or liver problems, talk to your doctor as you may need a lower dose. 

 

Before injecting Toujeo 

 Read the Instructions for Use that come with this package leaflet. 

 If you do not follow all of these instructions, you may get too much or too little insulin. 

 Perform a safety test as described in Step 3 of the Instructions for Use. If you don’t, your full 
dose will not be delivered. If this occurs, you should increase the frequency of checking your 

blood sugar level and might need to administer additional insulin. Please, also see section 2. 

 

How to inject 

 Toujeo is injected under the skin (subcutaneous use or “SC”). 

 Inject it into the front of your thighs, upper arms or the front of your waist (abdomen).  

 Change the place within the area you inject each day. This will reduce the risk of skin shrinking 
or thickening (for more information, see “Other side effects” in section 4). 

 

To prevent the possible transmission of disease, insulin pens should never be used for more than one 

person, even when the needle is changed. 

 

Always attach a new sterile needle before each injection. Never re-use needles. If you re-use a needle 

this increases the risk of it becoming blocked and of you getting too much or too little insulin. 

 

Throw away the used needle in a puncture resistant container, or as told by your pharmacist or local 

authority. 

 

Do not use Toujeo 

 In a vein. This will change the way it works and may cause your blood sugar to become too low. 

 In an insulin infusion pump. 

 If there are particles in the insulin. The solution should be clear, colourless and water-like.  
 

Never use a syringe to remove Toujeo from your DoubleStar pen or severe overdose can result. Please, 

see also section 2. 

 

If the DoubleStar pen is damaged, has not been stored correctly, if you are not sure that it is working 

properly or you notice that your blood sugar control is unexpectedly getting worse: 

 Throw the pen away and use a new one. 

 Talk to your doctor, pharmacist or nurse if you think you have problem with your pen.  
 

If you use more Toujeo than you should 

If you have injected too much of this medicine, your blood sugar level may become too low. Check 

your blood sugar and eat more food to prevent you blood sugar getting too low. If your blood sugar 

gets too low, see the advice in the box at the end of this leaflet. 

 

If you forget to use Toujeo 

When needed, Toujeo can be injected up to 3 hours before or after the time you usually inject it. 

 

If you have missed a dose of Toujeo or if you have not injected enough insulin, your blood sugar level 

may become too high (hyperglycaemia): 

 Do not inject a double dose to make up for a forgotten dose. 

 Check your blood sugar and then inject your next dose at the usual time. 



61 

 For information on the treatment of hyperglycaemia, see the box at the end of this leaflet. 
 

If you stop using Toujeo  

Do not stop using this medicine without talking to your doctor. If you do, it could lead to very high 

blood sugar and a build-up of acid in the blood (ketoacidosis). 

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your 

blood sugar level straight away (see the box at the end of this leaflet). 

Hypoglycaemia can be very serious and is very common with insulin treatment (may affect more than 

1 in 10 people). 

 Low blood sugar means that there is not enough sugar in your blood. 

 If your blood sugar falls too low, you may pass out (become unconscious). 

 Serious low blood sugar may cause brain damage and may be life-threatening. 

 For more information, see the box at the end of this leaflet. 
 

Severe allergic reactions (rare, may affect up to 1 in 1,000 people).The signs may include rash and 

itching all over the body, swelling of skin or mouth, shortness of breath, feeling faint (a fall in blood 

pressure) with fast heart beat and sweating. Severe allergic reactions may become life-threatening. 

Tell a doctor straight away if you notice signs of a severe allergic reaction. 

 

Other side effects 

Tell your doctor, pharmacist or nurse if you notice any of the following side effects: 

 Skin changes at the injection site:  
If you inject insulin too often at the same place, the skin may either shrink (lipoatrophy) (may 

affect up to 1 in 100 people) or thicken (lipohypertrophy) (may affect up to 1 in 10 people). Lumps 

under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; 

how often this occurs is not known). The insulin may not work very well if you inject into lumpy 

areas. Change the injection site with each injection to help prevent these skin changes. 

 

Common: may affect up to 1 in 10 people  

 Skin and allergic reactions at the injection site: The signs may include reddening, 
unusually intense pain when injecting, itching, hives, swelling or inflammation. This can 

spread around the injection site. Most minor reactions to insulins usually disappear in a 

few days to a few weeks. 

  

Rare: may affect up to 1 in 1,000 people  

 Eye reactions: A big change in your blood sugar control (getting better or worse) can 
disturb your vision. If you have an eye disorder related to diabetes called “proliferative 

retinopathy”, very low blood sugar attack may cause temporary loss of vision. 

 Swelling in the calves and ankles, caused by temporary build-up of water in the body. 
  

Very rare: may affect up to 1 in 10,000 people 

 Changes in taste (dysgeusia). 

 Muscular pain (myalgia). 
Tell your doctor, pharmacist or nurse if you notice any of the side effects above. 

 

Reporting of side effects  

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system 



62 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 

 

5. How to store Toujeo 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen 

after “EXP”. The expiry date refers to the last day of that month. 

 

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 pen in the outer carton in order to protect from light. 

 

After first use or if carried as a spare 

Do not store the pen in a refrigerator. The pen may be stored for a maximum of 6 weeks below 30°C 

and away from direct heat or direct light. Discard the pen after this time period. Do not leave your 

insulin in a car on an exceptionally warm or cold day. Always keep the cap on the pen when you are 

not using it in order to protect from light.  

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What Toujeo contains  

 The active substance is insulin glargine. Each ml of the solution contains 300 units of insulin 
glargine (equivalent to 10.91 mg). Each DoubleStar  pen contains 3 ml of solution for injection, 

equivalent to 900 units. 

 The other ingredients are: zinc chloride, metacresol, glycerol, water for injections, and sodium 
hydroxide (see section 2 “Important information about some of the ingredients of Toujeo”) and 

hydrochloric acid (for pH adjustment). 

 

What Toujeo looks like and contents of the pack  

Toujeo is a clear and colourless solution.  

Each DoubleStar  pen contains 3 ml of solution for injection (equivalent to 900 units).  

Packs of 1, 3, 6 (2 packs of 3), 9 (3 packs of 3) and 10 pre-filled pens.  

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder and Manufacturer  

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder. 

 

België/Belgique/Belgien 

Sanofi Belgium 

Tél/Tel: +32 (0)2 710 54 00 

 

Lietuva 

UAB sanofi-aventis Lietuva 

Tel: +370 5 2755224 

 

България 

SANOFI BULGARIA EOOD 

Тел.: +359 (0)2 970 53 00 

 

Luxembourg/Luxemburg 

Sanofi Belgium  

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


63 

Česká republika 

sanofi-aventis, s.r.o. 

Tel: +420 233 086 111 

 

Magyarország 

sanofi-aventis zrt., Magyarország 

Tel.: +36 1 505 0050 

 

Danmark 

Sanofisanofi A/S 

Tlf: +45 45 16 70 00 

 

Malta 

Sanofi S.p.A. 

Tel: +39 02 39394275 

Deutschland 

Sanofi-Aventis Deutschland GmbH 

Tel : 0800 52 52010 

Tel. aus dem Ausland: +49 69 305 21 131 

 

Nederland 

sanofi-aventis Netherlands B.V. 

Tel: +31 20 245 4000 

 

Eesti 

sanofi-aventis Estonia OÜ 

Tel: +372 627 34 88 

 

Norge 

sanofi-aventis Norge AS 

Tlf: +47 67 10 71 00 

 

Ελλάδα 

sanofi-aventis AEBE 

Τηλ: +30 210 900 16 00 

 

Österreich 

sanofi-aventis GmbH 

Tel: +43 1 80 185 – 0 

 

España 

sanofi-aventis, S.A. 

Tel: +34 93 485 94 00 

 

Polska 

sanofi-aventis Sp. z o.o. 

Tel.: +48 22 280 00 00 

 

France 

sanofi-aventis France 

Tél: 0 800 222 555 

Appel depuis l’étranger : +33 1 57 63 23 23 

 

Portugal 

Sanofi - Produtos Farmacêuticos, Lda 

Tel: +351 21 35 89 400 

 

Hrvatska 

sanofi-aventis Croatia d.o.o. 

Tel: +385 1 600 34 00 

România 

Sanofi Romania SRL 

Tel: +40 (0) 21 317 31 36 

 

Ireland 

sanofi-aventis Ireland Ltd. T/A SANOFI 

Tel: +353 (0) 1 403 56 00 

 

Slovenija 

sanofi-aventis d.o.o. 

Tel: +386 1 560 48 00 

 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

sanofi-aventis Pharma Slovakia s.r.o. 

Tel: +421 2 33 100 100 

 

Italia 

Sanofi S.p.A. 

Tel: 800 13 12 12 (domande di tipo tecnico)  

+39 800 536389 (altre domande e chiamate 

dall'estero) 

 

Suomi/Finland 

Sanofi Oy 

Puh/Tel: +358 (0) 201 200 300 

 

Κύπρος 

sanofi-aventis Cyprus Ltd. 

Τηλ: +357 22 871600 

 

Sverige 

Sanofi AB 

Tel: +46 (0)8 634 50 00 

 

Latvija 

sanofi-aventis Latvia SIA 

Tel: +371 67 33 24 51 

 

United Kingdom 

Sanofi 

Tel: +44 (0) 845 372 7101 

 

 



64 

This leaflet was last revised in  

 

 

Other source of information 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu/ 

 

  



65 

HYPERGLYCAEMIA AND HYPOGLYCAEMIA 

 

If you take insulin, you should always carry the following things with you: 

 Sugar (at least 20 grams). 

 Information so that others know you have diabetes. 
 

Hyperglycaemia (high blood sugar levels) 

 

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin. 

 

Reasons why hyperglycaemia may happen: 

Examples include: 

 You have not injected your insulin or not injected enough.  

 Your insulin has become less effective – for example because it was not stored properly.  

 Your insulin pen does not work properly. 

 You are doing less exercise than usual. 

 You are under stress – such as emotional distress or excitement. 

 You have an injury, infection or fever or have had an operation. 

 You are taking or have taken certain other medicines (see section 2, "Other medicines and 
Toujeo"). 

 

Warning signs of hyperglycaemia 

Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood 

pressure, fast heart beat, and glucose and ketone bodies in urine. Stomach pain, fast and deep 

breathing, feeling sleepy or passing out (becoming unconscious) may be signs of a serious condition 

(ketoacidosis) resulting from lack of insulin.  

 

What to do if you experience hyperglycaemia  

 Test your blood sugar level and your urine for ketones as soon as you notice any of the above 
signs. 

 Contact your doctor straight away if you have severe hyperglycaemia or ketoacidosis. This must 
always be treated by a doctor, normally in a hospital. 

 

 

Hypoglycaemia (low blood sugar levels) 

 

If your blood sugar level falls too much you may pass out (become unconscious). Serious 

hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You should 

learn to recognise the signs when your blood sugar is falling – so you can take action to stop it getting 

worse.  

 

Reasons why hypoglycaemia may happen: 

Examples include: 

 You inject too much insulin. 

 You miss meals or delay them. 

 You do not eat enough, or eat food containing less sugar (carbohydrate) than normal – artificial 
sweeteners are not carbohydrates. 

 You drink alcohol – especially when you have not eaten much. 

 You lose carbohydrates from being sick (vomiting) or diarrhoea. 

 You are doing more exercise than usual or a different type of physical activity. 

 You are recovering from an injury, operation or other stress. 

 You are recovering from an illness or from fever. 

 You are taking or have stopped taking certain other medicines (see section 2, "Other medicines 
and Toujeo"). 

 



66 

Hypoglycaemia is also more likely to happen if: 

 You have just started insulin treatment or changed to another insulin – if low blood sugar 
occurs, it may be more likely to happen in the morning.  

 Your blood sugar levels are almost normal or are unstable. 

 You change the area of skin where you inject insulin. For example from the thigh to the upper 
arm. 

 You have severe kidney or liver disease, or some other disease such as hypothyroidism. 
 

Warning signs of hypoglycaemia  

The first signs may be in your body generally. Examples of signs that your blood sugar level is falling 

too much or too fast include: sweating, clammy skin, feeling anxious, fast or irregular heart beat, high 

blood pressure and palpitations. These signs often develop before the signs of a low sugar level in the 

brain.  

 

Signs in your brain include: headaches, feeling very hungry, feeling sick (nausea) or being sick 

(vomiting), feeling tired, sleepy, restless, sleeping problems, aggressive behaviour, difficulty 

concentrating, slow reactions, depression, feeling confused, difficulty speaking (sometimes total loss 

of speech), changes in your sight, trembling, being unable to move (paralysis), tingling in the hands or 

arms, feeling numb and tingling often around the mouth, feeling dizzy, loss of self-control, being 

unable to look after yourself, fits, passing out. 

 

When the signs of hypoglycaemia may be less clear: 

The first warning signs of hypoglycaemia may change, be weaker or missing altogether if: 

 You are elderly. 

 You have had diabetes for a long time. 

 You have a certain type of nervous disease (called “diabetic autonomic neuropathy”). 

 You have recently had too low blood sugar (for example the day before). 

 Your low blood sugar comes on slowly. 

 Your low blood sugar is always around “normal” or your blood sugar has got much better.  

 You have recently changed from an animal insulin to a human insulin, like Toujeo. 

 You are taking or have taken certain other medicines (see section 2, "Other medicines and 
Toujeo").  

 

In such cases, you may develop severe hypoglycaemia (and even pass out) before you know what is 

happening. Be familiar with your warning signs. If necessary, you might need to test your blood sugar 

more often. This can help to spot mild hypoglycaemic episodes. If you find it difficult to recognise 

your warning signs, you should avoid situations (such as driving a car) in which you or others would 

be put at risk by hypoglycaemia. 

 

What to do if you experience hypoglycaemia? 

 

1. Do not inject insulin. Take about 10 to 20 grams sugar straight away - such as glucose, sugar 

cubes or a sugary-drink. Do not drink or eat foods that contain artificial sweeteners (such as diet 

drinks). They do not help treat low blood sugar. 

2. Then eat something (such as bread or pasta) that will raise your blood sugar over a longer time. 

Ask your doctor or nurse if you are not sure which foods you should eat. 

With Toujeo, it may take longer to recover from low blood sugar because it is long-acting. 

3. If the hypoglycaemia comes back again, take another 10 to 20 grams of sugar. 

4. Speak to a doctor straight away if you are not able to control the hypoglycaemia, or it comes 

back again. 

 

What other people should do if you have hypoglycaemia 

 

Tell your relatives, friends and close colleagues to get medical help straight away if you are not able to 

swallow or if you pass out (become unconscious).  



67 

You will require an injection of glucose or glucagon (a medicine which increases blood sugar). These 

injections should be given even if it is not certain that you have hypoglycaemia. 

 

You should test your blood sugar straight away after taking glucose to check that you really have 

hypoglycaemia. 



68 

Toujeo 300 units/ml solution for injection in a pre-filled pen (DoubleStar) 

INSTRUCTIONS FOR USE  

 

 

Read this first 

 

Toujeo DoubleStar contains 300 units/ml insulin glargine in a 3 ml disposable prefilled pen 

- Never re-use needles. If you do you might not get your dose (underdosing) or get too much 
(overdosing) as the needle could block. 

- Never use a syringe to remove insulin from your pen. If you do you will get too much 
insulin. The scale on most syringes is made for non-concentrated insulin only. 

- The dose selector of your Toujeo DoubleStar pen dials in steps of 2 units. 
 

Important information 

 

Never share your pen – it is only for you. 

Never use your pen if it is damaged or if you are not sure that it is working properly. 

Always perform a safety test  before you use a new pen for the first time until you see 

insulin coming out of the needle tip (see STEP 3). If you see insulin coming out the 

needle tip, the pen is ready to use. If you do not see insulin coming out before taking 

your dose, you could get an underdose or no insulin at all. This could cause high 

blood sugar 

To ensure the pen and needle are working, always perform the safety test until you 

see insulin coming out the needle tip before each injection (see STEP 3). If you do not perform 
the safety test before each injection, you may get too little insulin. 

Always carry a spare pen and spare needles in case they get lost or stop working. 

 

 
Learn to inject 

 

 Talk with your doctor, pharmacist or nurse about how to inject, before using your pen. 

 This pen is not recommended for use by people who are blind or have visual impairments without 
the assistance of a person trained in the proper use of the product. 

 Read all of these instructions before using your pen. If you do not follow all of these instructions, 
you may get too much or too little insulin. 

 

Need help? 

 

If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or 

call sanofi-aventis number on the front of this leaflet. 

 
Extra items you will need: 

 

 a new sterile needle (see STEP 2). 

 a puncture resistant container for used needles and pens. 
 

   



69 

 

 
Get to know your pen 

   

 
 

* You will not see the plunger until you have injected a few doses. 

 

 

 
STEP 1: Check your pen 

 

Take a new pen out of the fridge at least 1 hour before you inject. Cold insulin is more painful 

to inject. 

 

 

A Check the name and expiration date on the label of your pen. 

 Make sure you have the correct insulin. This is especially important if you have other 
injector pens. 

 Never use your pen after the expiration date. 

 

 
 

 

 
B Pull off the pen cap. 

 

 
 

 
C Check that the insulin is clear. 

 Do not use the pen if the insulin looks cloudy, coloured or contains particles. 

 
 

Cartridge holder Plunger* 

Pen cap Rubber seal Insulin scale Insulin name 

Dose selector 

Injection button 

Dose pointer Dose window 



70 

 
STEP 2: Attach a new needle 

 

Always use a new sterile needle for each injection. This helps stop blocked needles, 

contamination and infection. 

Only use needles that are compatible for use with Toujeo DoubleStar (e.g. needles from BD, 

Ypsomed, Artsana or Owen Mumford) that are 8 mm long or shorter. 

 

 
A Take a new needle and peel off the protective seal. 

 

 
 
 

B Keep the needle straight and screw it onto the pen until fixed. Do not overtighten. 

 

 
 
 

C Pull off the outer needle cap. Keep this for later. 

 

 
 

 
D  Pull off the inner needle cap and throw away. 

 

 



71 

 
 

Handling needles 

 Take care when handling needles – this is to prevent needle injury and cross-infection. 
 

 

STEP 3: Do a safety test 

 

Always do a safety test before each injection – this is to: 

 check your pen and the needle are working properly. 

 make sure that you get the correct insulin dose. 
 

If the pen is new, you must perform safety tests before you use the pen for the first 

time until you see insulin coming out of the needle tip. If you see insulin coming out 

of the needle tip, the pen is ready to use. If you do not see insulin coming out before 

taking your dose, you could get an underdose or no insulin at all. This could cause 

high blood sugar. 

 

A Select 4 units by turning the dose selector until the dose pointer is at the 4 mark. 

 

 

 
 

B Press the injection button all the way in. 

 When insulin comes out of the needle tip, your pen is working correctly. 

 

 
 
C Repeat this step if no insulin appears: 

 If you are using a new pen for the first time, you may have to repeat this step up to 6 times 
before seeing insulin. 

- Do not use your pen if there is still no insulin coming out of the needle tip. Use a new 
pen. 

 For all injections, if no insulin comes out, the needle may be blocked. If this happens: 
- change the needle (see STEP 6 and STEP 2), 
- then repeat the safety test (STEP 3A and STEP 3 B). 
- Do not use your pen if there is still no insulin coming out of the needle tip. Use a new 

pen. 



72 

 Never use a syringe to remove insulin from your pen. 
 

If you see air bubbles 

 You may see air bubbles in the insulin. This is normal, they will not harm you. 

 

 
STEP 4: Select the dose 

 

Never select a dose or press the injection button without a needle attached. This may damage your 

pen. 

 

Toujeo DoubleStar is made to deliver the number of insulin units that your doctor prescribed. Do not 

perform any dose re-calculation. 

 

A  Make sure a needle is attached and the dose is set to ‘0’. 

 

 
 

 
B Turn the dose selector until the dose pointer lines up with your dose. 

 Set the dose by turning the dose selector to a line in the dose window. Each line equals 2 units 

 The dial clicks as you turn it 

 Do not dial your dose by counting the clicks. You may dial the wrong dose. This may lead 
to you getting too much insulin or not enough insulin. 

 Always check the number in the dose window to make sure you dialled the correct dose 

 If you turn past your dose, you can turn back down. 

 If there are not enough units left in your pen for your dose, the dose selector will stop at the 
number of units left. 

 If you cannot select your full prescribed dose, split the dose into two injections or use a new 
pen. If you use a new pen, perform a safety test (see STEP 3). 

 

 
 
How to read the dose window 

The dose selector adjusts in steps of 2 units. 

Each line in the dose window is an even number: 

 

  
 

 

60 units selected 



73 

 

  
 

 
Units of insulin in your pen 

 Your pen contains a total of 900 units of insulin. You can select doses from 2 to 160 units in 
steps of 2 units at a time. Each pen contains more than one dose. 

 You can see roughly how many units of insulin are left by looking at where the plunger is on 
the insulin scale. 

 

STEP 5: Inject your dose 

 

If you find it hard to press the injection button in, do not force it as this may break your pen. See 

the        section below for help. 
 

A  Choose a place to inject as shown in the picture labelled “Places to inject”  

 

B Push the needle into your skin as shown by your doctor, pharmacist or nurse. 

 Do not touch the injection button yet. 

 

 
 

C Place your thumb on the injection button. Then press all the way in and hold. 

 Do not press at an angle – your thumb could block the dose selector from turning. 

 

 
 
D Keep the injection button held in and when you see "0" in the dose window, slowly count to 

5. 

 This will make sure you get your full dose. 

58 units selected 



74 

 
 
E After holding and slowly counting to 5, release the injection button. Then remove the needle 

from your skin. 

 

 

If you find it hard to press the button in: 

 Change the needle (see STEP 6 and STEP 2) then do a safety test (see STEP 3). 

 If you still find it hard to press in, get a new pen. 

 Never use a syringe to remove insulin from your pen. 

 
STEP 6: Remove the needle 

 

Take care when handling needles – this is to prevent needle injury and cross-infection. 

Never put the inner needle cap back on. 

 

A Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.  

 To reduce the risk of accidental needle injury, never replace the inner needle cap. 

 If your injection is given by another person, or if you are giving an injection to another 
person, special caution must be taken by this person when removing and disposing of the 

needle. 

 Follow recommended safety measures for removal and disposal of needles (contact your 
doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and 

transmission of infectious diseases. 

 
 

B Throw away the used needle in a puncture resistant container, or as told by your pharmacist 

or local authority. 

 

 

  
C Put the pen cap back on. 

 Do not put the pen back in the fridge. 

 



75 

 
 
Use by 

 

 Only use your pen for up to 6 weeks after its first use. 
 

How to store your pen 

 

Before first use 

 Keep new pens in a fridge, at 2°C to 8°C. 

 Do not freeze.  
 

After first use 

 Keep your pen at room temperature, below 30°C. 

 Never put your pen back in the fridge. 

 Never store your pen with the needle attached. 

 Store your pen with the pen cap on. 

 Keep your pen and needles out of the sight and reach of children 

 
How to care for your pen 

 

Handle your pen with care 

 Do not drop your pen or knock it against hard surfaces. 

 If you think that your pen may be damaged, do not try to repair it, use a new one. 
 

Protect your pen from dust and dirt 

 You can clean the outside of your pen by wiping it with a damp cloth. Do not soak, wash or 
lubricate your pen – this may damage it. 

 

Throwing your pen away 

 Remove the needle before throwing your pen away. 

 Throw away your used pen as told by your pharmacist or local authority. 
 

  



76 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Annex IV 

Scientific conclusions and grounds for the variation to the terms of the marketing 

authorisation(s) 

 

 

 

 

 

 



77 

Scientific conclusions 

Taking into account the PRAC Assessment Report on the PSUR(s) for insulin glargine, the 

scientific conclusions of CHMP are as follows:  

The cumulative review of cutaneous amyloidosis included 29 cases of which 15 were well 

documented cases in which the event was confirmed with histopathology. These cases did not 

contain confounders and have a compatible time to onset. Together with the available evidence 

from literature and text books, this signal contains sufficient evidence to establish an association 

between insulin glargine and cutaneous amyloidosis.  As cutaneous amyloidosis may lead to insulin 

resistance due to poor absorption from the infiltrated site, health care professionals and patients 

should be informed of this event in the PI. Absorption of insulin could be improved by rotating the 

injection site. The MAH is therefore requested to include the event cutaneous amyloidosis in the 

SmPC and PIL. 

The CHMP agrees with the scientific conclusions made by the PRAC. 

 

Grounds for the variation to the terms of the marketing authorisation(s) 

On the basis of the scientific conclusions for insulin glargine the CHMP is of the opinion that the 

benefit-risk balance of the medicinal product(s) containing insulin glargine is unchanged subject to 

the proposed changes to the product information 

The CHMP recommends that the terms of the marketing authorisation(s) should be varied. 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE ANDMANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
	INSTRUCTIONS FOR USE
	Annex IVScientific conclusions and grounds for the variation to the terms of the marketingauthorisation(s)