Abasaglar

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



2 

1. NAME OF THE MEDICINAL PRODUCT 
 
ABASAGLAR 100 units/mL solution for injection in a cartridge 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each mL contains 100 units insulin glargine* (equivalent to 3.64 mg).  
 
Each cartridge contains 3 mL of solution for injection, equivalent to 300 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 aged 2 years and above. 
 
4.2 Posology and method of administration 
 
Posology 
 
ABASAGLAR contains insulin glargine, an insulin analogue and has a prolonged duration of action.  
 
ABASAGLAR should be administered once daily at any time but at the same time each day.  
 
The dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes 
mellitus, ABASAGLAR can also be given together with orally active antidiabetic medicinal products.  
 
The potency of this medicinal product is stated in units. These units are exclusive to insulin glargine 
and are not the same as IU or the units used to express the potency of other insulin analogues (see 
section 5.1).  
 
Special populations 
 
Elderly population (≥65 years old) 
In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin 
requirements. 
 
Renal impairment 
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin 
metabolism. 
 
Hepatic impairment 
In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity 
for gluconeogenesis and reduced insulin metabolism. 



3 

 
Paediatric population 
 
Adolescents and children aged 2 years and older 
The safety and efficacy of insulin glargine have been established in adolescents and children aged 
2 years and older (see section 5.1). The dose regimen (dose and timing) should be individually 
adjusted.  
 
Children below 2 years of age 
The safety and efficacy of insulin glargine have not been established No data are available.  
 
Switch from other insulins to ABASAGLAR 
When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen 
with ABASAGLAR, a change of the dose of the basal insulin may be required and the concomitant 
antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-
acting insulin analogues or the dose of oral antidiabetic medicinal products).  
 
Switch from twice daily NPH insulin to ABASAGLAR 
To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their 
basal insulin regimen from a twice daily NPH insulin to a once daily regimen with ABASAGLAR 
should reduce their daily dose of basal insulin by 20-30 % during the first weeks of treatment.  
 
Switch from insulin glargine 300 units/ml to ABASAGLAR 
ABASAGLAR and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly 
interchangeable. To reduce the risk of hypoglycemia, patients who are changing their basal insulin 
regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen 
with ABASAGLAR should reduce their dose by approximately 20%. 
 
During the first weeks the reduction should, at least partially, be compensated by an increase in 
mealtime insulin, after this period the regimen should be adjusted individually.  
 
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, change of timing of insulin dose or other circumstances arise that 
increase susceptibility to hypoglycaemia or hyperglycaemia (see section 4.4).  
 
Patients with high insulin doses because of antibodies to human insulin may experience an improved 
insulin response with ABASAGLAR. 
 
Method of administration 
 
ABASAGLAR is administered subcutaneously. 
 
ABASAGLAR should not be administered intravenously. The prolonged duration of action of insulin 
glargine is dependent on its injection into subcutaneous tissue. Intravenous administration of the usual 
subcutaneous dose could result in severe hypoglycaemia. 
 
There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid 
or thigh administration of insulin glargine. Injection sites must be rotated within a given injection area 
from one injection to the next. 
 
ABASAGLAR must not be mixed with any other insulin or diluted. Mixing or diluting can change its 
time/action profile and mixing can cause precipitation.  
 
For further details on handling, see section 6.6. 
 



4 

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 
 
ABASAGLAR 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 hyperglycaemic 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. 
 
Transferring a patient to another type or brand of insulin 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. 
 
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. Due to more sustained basal insulin supply 
with insulin glargine, less nocturnal but more early morning hypoglycaemia can be expected. 
 
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 stenoses 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 subcutaneous 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.  
 
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 include: 
-  change in the injection area, 
-  improved insulin sensitivity (e.g., by removal of stress factors), 



5 

-  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. 
 
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 (see section 5.1). 
 
Pens to be used with ABASAGLAR cartridges  
 
The cartridges should only be used in conjunction with a Lilly reusable insulin pen and should not be 
used with any other reusable pen as the dosing accuracy has not been established with other pens.  
 
Medication errors 
 
Medication errors have been reported in which other insulins, particularly short-acting insulins, have 
been accidentally administered instead of insulin glargine. Insulin label must always be checked 
before each injection to avoid medication errors between ABASAGLAR and other insulins. 
 
Combination of ABASAGLAR 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 ABASAGLAR 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. 
 
Sodium content 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., 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 oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) 
inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, 
propoxyphene, salicylates, somatostatin anologues and sulphonamide antibiotics.  
 



6 

Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, 
diazoxide, diuretics, glucagon, isoniazid, oestrogens, 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 
 
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) indicate 
no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor 
feto/neonatal toxicity of insulin glargine.  
 
Animal data do not indicate reproductive toxicity.  
 
The use of ABASAGLAR 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 amino acids in the human gastrointestinal tract.  
 
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 operate machines in these circumstances. 
 
 
 



7 

4.8 Undesirable effects 
 
Summary of safety profile 
 
Hypoglycaemia (very common), 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 (see section 4.4). 
 
Tabulated list of adverse reactions 
 
The following related adverse reactions from clinical trials are listed below as MedDRA preferred 
term 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 
and 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 Uncommo
n 

Rare Very 
rare 

Not 
known 

Immune system disorders   
Allergic reactions    X   
Metabolism and nutrition disorders  
Hypoglycaemia X      
Nervous system disorders  
Dysgeusia     X  
Eyes disorders  
Visual impairment     X   
Retinopathy    X   
Skin and subcutaneous tissue disorders  
Lipohypertrophy  X     
Lipoatrophy   X    
Cutaneous 
amyloidosis 

     X 

Musculoskeletal and connective tissue disorders  
Myalgia     X  
General disorders and administration site conditions  
Injection site 
reactions 

 X     

Oedema    X   
 
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. 
 



8 

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. 
 
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.  
 
Rarely, insulin may cause sodium retention and oedema particularly if previously poor metabolic 
control is improved by intensified insulin therapy. 
 
Paediatric population 
In general, the safety profile for children and adolescents (≤ 18 years of age) is similar to the safety 
profile for adults. The adverse reaction reports received from post marketing surveillance included 
relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin 
reactions (rash, urticaria) in children and adolescents (≤ 18 years of age) than in adults. Clinical study 
safety data are not available for children under 2 years. 
 
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 
 
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. 
 
 
 
 
 
 
 

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


9 

5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting. 
ATC Code: A10AE04. 
 
ABASAGLAR is a biosimilar medicinal product. Detailed information is available on the website of 
the European Medicines Agency http://www.ema.europa.eu. 
 
Mechanism of action 
 
Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH. It is 
completely soluble at the acidic pH of the ABASAGLAR injection solution (pH 4). After injection 
into the subcutaneous tissue, the acidic solution is neutralised leading to formation of micro-
precipitates from which small amounts of insulin glargine are continuously released, providing a 
smooth, peakless, predictable concentration/time profile with a prolonged duration of action. 
 
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 
ABASAGLAR therapy, are considerably lower than the pharmacological concentrations required to 
activate the IGF-1 pathway.  
 
Pharmacodynamic effects 
 
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. 
 
In clinical pharmacology studies, 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. 
 
In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action 
of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was 
smooth and peakless, and the duration of its effect was prolonged. 
 
The following graph shows the results from a study in patients: 
 

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


10 

Figure 1: Activity profile in patients with type 1 diabetes 
 

 
* Determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean 
values) 
 
The longer duration of action of subcutaneous insulin glargine is directly related to its slower rate of 
absorption and supports once daily administration. The time course of action of insulin and insulin 
analogues such as insulin glargine may vary considerably in different individuals or within the same 
individual 
 
In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar 
after intravenous insulin glargine and human insulin both in healthy volunteers and patients with 
type 1 diabetes. 
 
Clinical safety and efficacy 
 
In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed 
with the same frequency in both NPH-insulin and insulin glargine treatment groups. 
 
Effects of insulin glargine (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 glargine was compared to NPH insulin. 
 
The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicenter, 
randomised, 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 
randomised (1:1) to receive insulin glargine (n=6,264), titrated to reach FPG ≤95 mg/dL (5.3 mM), or 
standard care (n=6,273). 
 
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. 
 

Time (h) after s.c injection 

 
____ insulin glargine 

 
 

------ NPH insulin 
 

 

End of observation  
period 

G
lu

co
se

 U
til

iz
at

io
n 

R
at

e*
 (m

g/
kg

/m
in

) 



11 

Insulin glargine 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 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 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 and 0.30 for standard care group and the rates of confirmed non-severe 
hypoglycaemia were 7.71 for insulin glargine and 2.44 for standard care group. Over the course of this 
6-year study, 42% of the insulin glargine 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 group and a mean decrease of 0.8 kg in the standard care group. 
 
Paediatric population 
 
In a randomised, controlled clinical study, paediatric patients (age range 6 to 15 years) with type 1 
diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human 
insulin was used before each meal. Insulin glargine was administered once daily at bedtime and NPH 
human insulin was administered once or twice daily. Similar effects on glycohaemoglobin and the 
incidence of symptomatic hypoglycaemia were observed in both treatment groups, however fasting 
plasma glucose decreased more from baseline in the insulin glargine group than in the NPH group. 
There was less severe hypoglycaemia in the insulin glargine group as well. One hundred forty three of 
the patients treated with insulin glargine in this study continued treatment with insulin glargine in an 
uncontrolled extension study with mean duration of follow-up of 2 years. No new safety signals were 
seen during this extended treatment with insulin glargine. 
 
A crossover study comparing insulin glargine plus lispro insulin to NPH plus regular human insulin 
(each treatment administered for 16 weeks in random order) in 26 adolescent type 1 diabetic patients 
aged 12 to 18 years was also performed. As in the paediatric study described above, fasting plasma 
glucose reduction from baseline was greater in the insulin glargine group than in the NPH group. 
HbA1c changes from baseline were similar between treatment groups; however blood glucose values 
recorded overnight were significantly higher in the insulin glargine/ lispro group than the NPH/regular 
group, with a mean nadir of 5.4 mM vs. 4.1 mM. Correspondingly, the incidences of nocturnal 
hypoglycaemia were 32 % in the insulin glargine / lispro group vs. 52 % in the NPH / regular group. 
 
A 24-week parallel group study was conducted in 125 children with type 1 diabetes mellitus aged 2 to 
6 years, comparing insulin glargine given once daily in the morning to NPH insulin given once or 
twice daily as basal insulin. Both groups received bolus insulin before meals. The primary aim of 
demonstrating non-inferiority of insulin glargine to NPH in all hypoglycaemia was not met and there 
was a trend to an increase of hypoglycaemic events with insulin glargine [insulin glargine: NPH rate 
ratio (95% CI) = 1.18 (0.97-1.44)]. Glycohaemoglobin and glucose variabilities were comparable in 
both treatment groups. No new safety signals were observed in this trial. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and much 
more prolonged absorption and showed a lack of a peak after subcutaneous injection of insulin 
glargine in comparison to human NPH insulin. Concentrations were thus consistent with the time 
profile of the pharmacodynamic activity of insulin glargine. Figure 1 above shows the activity profiles 
over time of insulin glargine and NPH insulin.  
 
Insulin glargine injected once daily will reach steady state levels in 2-4 days after the first dose.  



12 

 
Biotransformation 
 
After subcutaneous injection in diabetic patients, insulin glargine is rapidly metabolised 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 of insulin glargine. 
 
Elimination 
 
When given intravenously the elimination half-life of insulin glargine and human insulin were 
comparable.  
 
Special populations 
 
In clinical studies, subgroup analyses based on age and gender did not indicate any difference in safety 
and efficacy in insulin glargine-treated patients compared to the entire study population. 
 
Paediatric population 
Pharmacokinetics in children aged 2 to less than 6 years with type 1 diabetes mellitus was assessed in 
one clinical study (see section 5.1). Plasma trough levels of insulin glargine and its main M1 and M2 
metabolites were measured in children treated with insulin glargine, revealing plasma concentration 
patterns similar to adults, and providing no evidence for accumulation of insulin glargine or its 
metabolites with chronic dosing. 
 
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 
 
Zinc oxide 
Metacresol 
Glycerol 
Hydrochloric acid (for pH adjustment) 
Sodium hydroxide (for pH adjustment) 
Water for injections 
 
6.2  Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products.  
 
6.3  Shelf life 
 
2 years. 
 
 
 



13 

Shelf life after first use  
 
The medicinal product may be stored for a maximum of 28 days up to 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 use 
 
Store in a refrigerator (2°C - 8°C). 
 
Do not freeze. 
 
Do not store ABASAGLAR next to the freezer compartment or a freezer pack. 
 
Keep the cartridge in the outer carton in order to protect from light. 
 
In use  
 
For storage conditions after first opening of this medicinal product, see section 6.3. 
 
6.5  Nature and contents of container 
 
3 mL solution in a cartridge (type 1 colourless glass) with a plunger (halobutyl rubber) and a disc seal 
(laminate of polyisoprene and halobutyl rubber) with aluminium seal. 
 
Packs of 5 and 10 cartridges. Not all pack sizes may be marketed. 
 
6.6  Special precautions for disposal and other handling 
 
ABASAGLAR must not be mixed with any other insulin or medicinal products or diluted. Mixing or 
diluting can change its time/action profile and mixing can cause precipitation. 
 
Insulin pen 
 
The ABASAGLAR cartridges are to be used only in conjunction with a Lilly reusable insulin pen (see 
section 4.4).  
 
The pen should be used as recommended in the information provided with the device.  
 
The instructions for using the pen must be followed carefully for loading the cartridge, attaching the 
needle, and administering the insulin injection.  
 
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be 
discarded, and a new insulin pen has to be used.  
 
Cartridge 
 
Inspect the cartridge 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 ABASAGLAR is a solution, it does not 
require re-suspension before use. Air bubbles must be removed from the cartridge before injection (see 
instructions for using the pen). 
 
To prevent the possible transmission of disease, each pen must be used by one patient only.  
 



14 

Empty cartridges must not be refilled and must be properly discarded. Insulin label must always be 
checked before each injection to avoid medication errors between insulin glargine and other insulins 
(see section 4.4). 
 
 
7.  MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands 
 
 
8.  MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/14/944/003 
EU/1/14/944/009 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 9 September 2014 
Date of latest renewal: 25 July 2019 
 
 
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 



15 

1. NAME OF THE MEDICINAL PRODUCT 
 
ABASAGLAR 100 units/mL solution for injection in a pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each mL contains 100 units insulin glargine* (equivalent to 3.64 mg).  
 
Each pen contains 3 mL of solution for injection, equivalent to 300 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) in pre-filled pen (KwikPen) 
 
Clear, colourless solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. 
 
4.2 Posology and method of administration 
 
Posology 
 
ABASAGLAR contains insulin glargine, an insulin analogue and has a prolonged duration of action.  
 
ABASAGLAR should be administered once daily at any time but at the same time each day.  
 
The dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes 
mellitus, ABASAGLAR can also be given together with orally active antidiabetic medicinal products.  
 
The potency of this medicinal product is stated in units. These units are exclusive to insulin glargine 
and are not the same as IU or the units used to express the potency of other insulin analogues (see 
section 5.1).  
 
Special populations 
 
Elderly population (≥65 years old) 
In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin 
requirements. 
 
Renal impairment 
In patients with renal impairment, insulin requirements may be diminished due to reduced insulin 
metabolism. 
 
Hepatic impairment 
In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity 
for gluconeogenesis and reduced insulin metabolism. 



16 

 
Paediatric population 
 
Adolescents and children aged 2 years and older 
The safety and efficacy of insulin glargine have been established in adolescents and children aged 
2 years and older (see section 5.1). The dose regimen (dose and timing) should be individually 
adjusted. 
 
Children below 2 years of age 
The safety and efficacy of insulin glargine have not been established. No data are available.  
 
Switch from other insulins to ABASAGLAR 
When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen 
with ABASAGLAR, a change of the dose of the basal insulin may be required and the concomitant 
antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-
acting insulin analogues or the dose of oral antidiabetic medicinal products).  
 
Switch from twice daily NPH insulin to ABASAGLAR 
To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their 
basal insulin regimen from a twice daily NPH insulin to a once daily regimen with ABASAGLAR 
should reduce their daily dose of basal insulin by 20-30 % during the first weeks of treatment. 
  
Switch from insulin glargine 300 units/ml to ABASAGLAR 
ABASAGLAR and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly 
interchangeable. To reduce the risk of hypoglycemia, patients who are changing their basal insulin 
regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen 
with ABASAGLAR should reduce their dose by approximately 20%. 
 
During the first weeks the reduction should, at least partially, be compensated by an increase in 
mealtime insulin, after this period the regimen should be adjusted individually.  
 
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, change of timing of insulin dose or other circumstances arise that 
increase susceptibility to hypoglycaemia or hyperglycaemia (see section 4.4).  
 
Patients with high insulin doses because of antibodies to human insulin may experience an improved 
insulin response with ABASAGLAR. 
 
Method of administration 
 
ABASAGLAR is administered subcutaneously. 
 
ABASAGLAR should not be administered intravenously. The prolonged duration of action of insulin 
glargine is dependent on its injection into subcutaneous tissue. Intravenous administration of the usual 
subcutaneous dose could result in severe hypoglycaemia. 
 
There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid 
or thigh administration of insulin glargine. Injection sites must be rotated within a given injection area 
from one injection to the next. 
 
ABASAGLAR must not be mixed with any other insulin or diluted. Mixing or diluting can change its 
time/action profile and mixing can cause precipitation.  
 
For further details on handling, see section 6.6. 
 



17 

Before using ABASAGLAR solution for injection in pre-filled pen, the instructions for use included in 
the package leaflet must be read carefully (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 
 
ABASAGLAR 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 hyperglycaemic 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. 
 
Transferring a patient to another type or brand of insulin 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. 
 
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. Due to more sustained basal insulin supply 
with insulin glargine, less nocturnal but more early morning hypoglycaemia can be expected. 
 
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 stenoses 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 subcutaneous 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.  
 
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 



18 

susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose 
adjustment. These 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. 
 
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 (see section 5.1). 
 
Medication errors 
 
Medication errors have been reported in which other insulins, particularly short-acting insulins, have 
been accidentally administered instead of insulin glargine. Insulin label must always be checked 
before each injection to avoid medication errors between ABASAGLAR and other insulins. 
 
Combination of ABASAGLAR 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 ABASAGLAR 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. 
 
Sodium content 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., 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 oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) 
inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, 
propoxyphene, salicylates, somatostatin anologues and sulphonamide antibiotics.  
 



19 

Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, 
diazoxide, diuretics, glucagon, isoniazid, oestrogens, 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 
 
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) indicate 
no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor 
feto/neonatal toxicity of insulin glargine.  
 
Animal data do not indicate reproductive toxicity.  
 
The use of ABASAGLAR 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 amino acids in the human gastrointestinal tract.  
 
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 operate machines in these circumstances. 
 
 
 



20 

4.8 Undesirable effects 
 
Summary of safety profile 
 
Hypoglycaemia (very common), 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 (see section 4.4). 
 
Tabulated list of adverse reactions 
 
The following related adverse reactions from clinical trials are listed below as MedDRA preferred 
term 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 
and 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    X   
Metabolism and nutrition disorders  
Hypoglycaemia X      
Nervous system disorders  
Dysgeusia     X  
Eyes disorders  
Visual impairment     X   
Retinopathy    X   
Skin and subcutaneous tissue disorders  
Lipohypertrophy  X     
Lipoatrophy   X    
Cutaneous 
amyloidosis 

     
X 

Musculoskeletal and connective tissue disorders  
Myalgia     X  
General disorders and administration site conditions  
Injection site 
reactions 

 X     

Oedema    X   
 
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. 
 



21 

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. 
 
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.  
 
Rarely, insulin may cause sodium retention and oedema particularly if previously poor metabolic 
control is improved by intensified insulin therapy. 
 
Paediatric population 
In general, the safety profile for children and adolescents (≤ 18 years of age) is similar to the safety 
profile for adults. The adverse reaction reports received from post marketing surveillance included 
relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin 
reactions (rash, urticaria) in children and adolescents (≤ 18 years of age) than in adults. Clinical study 
safety data are not available for children under 2 years. 
 
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 
 
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. 
 
 
 
 
 
 
 

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


22 

5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting. 
ATC Code: A10AE04. 
 
ABASAGLAR is a biosimilar medicinal product. Detailed information is available on the website of 
the European Medicines Agency http://www.ema.europa.eu. 
 
Mechanism of action 
 
Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH. It is 
completely soluble at the acidic pH of the ABASAGLAR injection solution (pH 4). After injection 
into the subcutaneous tissue, the acidic solution is neutralised leading to formation of micro-
precipitates from which small amounts of insulin glargine are continuously released, providing a 
smooth, peakless, predictable concentration/time profile with a prolonged duration of action. 
 
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 
ABASAGLAR therapy, are considerably lower than the pharmacological concentrations required to 
activate the IGF-1 pathway.  
 
Pharmacodynamic effects 
 
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. 
 
In clinical pharmacology studies, 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. 
 
In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action 
of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was 
smooth and peakless, and the duration of its effect was prolonged. 
 
The following graph shows the results from a study in patients: 
 

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


23 

Figure 1: Activity profile in patients with type 1 diabetes 
 

 
* Determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean 
values) 
 
The longer duration of action of subcutaneous insulin glargine is directly related to its slower rate of 
absorption and supports once daily administration. The time course of action of insulin and insulin 
analogues such as insulin glargine may vary considerably in different individuals or within the same 
individual 
 
In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar 
after intravenous insulin glargine and human insulin both in healthy volunteers and patients with 
type 1 diabetes. 
 
Clinical safety and efficacy 
 
In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed 
with the same frequency in both NPH-insulin and insulin glargine treatment groups. 
 
Effects of insulin glargine (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 glargine was compared to NPH insulin. 
 
The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicenter, 
randomised, 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 
randomised (1:1) to receive insulin glargine (n=6,264), titrated to reach FPG ≤95 mg/dL (5.3 mM), or 
standard care (n=6,273). 
 
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. 
 

Time (h) after s.c injection 

 
____ insulin glargine 

 
 

------ NPH insulin 
 

 

End of observation  
period 

G
lu

co
se

 U
til

iz
at

io
n 

R
at

e*
 (m

g/
kg

/m
in

) 



24 

Insulin glargine 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 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 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 and 0.30 for standard care group and the rates of confirmed non-severe 
hypoglycaemia were 7.71 for insulin glargine and 2.44 for standard care group. Over the course of this 
6-year study, 42% of the insulin glargine 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 group and a mean decrease of 0.8 kg in the standard care group. 
 
Paediatric population 
 
In a randomised, controlled clinical study, paediatric patients (age range 6 to 15 years) with type 1 
diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human 
insulin was used before each meal. Insulin glargine was administered once daily at bedtime and NPH 
human insulin was administered once or twice daily. Similar effects on glycohaemoglobin and the 
incidence of symptomatic hypoglycaemia were observed in both treatment groups, however fasting 
plasma glucose decreased more from baseline in the insulin glargine group than in the NPH group. 
There was less severe hypoglycaemia in the insulin glargine group as well. One hundred forty three of 
the patients treated with insulin glargine in this study continued treatment with insulin glargine in an 
uncontrolled extension study with mean duration of follow-up of 2 years. No new safety signals were 
seen during this extended treatment with insulin glargine. 
 
A crossover study comparing insulin glargine plus lispro insulin to NPH plus regular human insulin 
(each treatment administered for 16 weeks in random order) in 26 adolescent type 1 diabetic patients 
aged 12 to 18 years was also performed. As in the paediatric study described above, fasting plasma 
glucose reduction from baseline was greater in the insulin glargine group than in the NPH group. 
HbA1c changes from baseline were similar between treatment groups; however blood glucose values 
recorded overnight were significantly higher in the insulin glargine/ lispro group than the NPH/regular 
group, with a mean nadir of 5.4 mM vs. 4.1 mM. Correspondingly, the incidences of nocturnal 
hypoglycaemia were 32 % in the insulin glargine / lispro group vs. 52 % in the NPH / regular group. 
 
A 24-week parallel group study was conducted in 125 children with type 1 diabetes mellitus aged 2 to 
6 years, comparing insulin glargine given once daily in the morning to NPH insulin given once or 
twice daily as basal insulin. Both groups received bolus insulin before meals. The primary aim of 
demonstrating non-inferiority of insulin glargine to NPH in all hypoglycaemia was not met and there 
was a trend to an increase of hypoglycaemic events with insulin glargine [insulin glargine: NPH rate 
ratio (95% CI) = 1.18 (0.97-1.44)]. Glycohaemoglobin and glucose variabilities were comparable in 
both treatment groups. No new safety signals were observed in this trial. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and much 
more prolonged absorption and showed a lack of a peak after subcutaneous injection of insulin 
glargine in comparison to human NPH insulin. Concentrations were thus consistent with the time 
profile of the pharmacodynamic activity of insulin glargine. Figure 1 above shows the activity profiles 
over time of insulin glargine and NPH insulin.  
 
Insulin glargine injected once daily will reach steady state levels in 2-4 days after the first dose.  



25 

 
Biotransformation 
 
After subcutaneous injection in diabetic patients, insulin glargine is rapidly metabolised 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 of insulin glargine. 
 
Elimination 
 
When given intravenously the elimination half-life of insulin glargine and human insulin were 
comparable.  
 
Special populations 
 
In clinical studies, subgroup analyses based on age and gender did not indicate any difference in safety 
and efficacy in insulin glargine-treated patients compared to the entire study population. 
 
Paediatric population 
Pharmacokinetics in children aged 2 to less than 6 years with type 1 diabetes mellitus was assessed in 
one clinical study (see section 5.1). Plasma trough levels of insulin glargine and its main M1 and M2 
metabolites were measured in children treated with insulin glargine, revealing plasma concentration 
patterns similar to adults, and providing no evidence for accumulation of insulin glargine or its 
metabolites with chronic dosing. 
 
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 
 
Zinc oxide 
Metacresol 
Glycerol 
Hydrochloric acid (for pH adjustment) 
Sodium hydroxide (for pH adjustment) 
Water for injections 
 
6.2  Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products.  
 
6.3  Shelf life 
 
2 years. 
 
 
 



26 

Shelf life after first use  
 
The medicinal product may be stored for a maximum of 28 days up to 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 use 
 
Store in a refrigerator (2°C - 8°C). 
 
Do not freeze. 
 
Do not store ABASAGLAR next to the freezer compartment or a freezer pack. 
 
Keep the pre-filled pen in the outer carton in order to protect from light. 
 
In use  
 
For storage conditions after first opening of this medicinal product, see section 6.3. 
 
6.5  Nature and contents of container 
 
3 mL solution in a cartridge (type 1 colourless glass) with a plunger (halobutyl rubber) and a disc seal 
(laminate of polyisoprene and halobutyl rubber) with aluminium seal. 
 
The cartridge is sealed in a disposable pen injector.  
 
Packs of 5 pens and multipacks containing 10 (2 packs of 5) pens . Not all pack sizes may be 
marketed. 
 
Needles are not included in the pack. 
 
6.6  Special precautions for disposal and other handling 
 
ABASAGLAR must not be mixed with any other insulin or medicinal products or diluted. Mixing or 
diluting can change its time/action profile and mixing can cause precipitation. 
 
Inspect the cartridge 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 ABASAGLAR is a solution, it does not 
require re-suspension before use.  
 
ABASAGLAR must not be mixed with any other insulin or diluted. Mixing or diluting can change its 
time/action profile and mixing can cause precipitation. 
 
Empty pens must never be reused and must be properly discarded.  
 
To prevent the possible transmission of disease, each pen must be used by one patient only.  
 
Insulin label must always be checked before each injection to avoid medication errors between insulin 
glargine and other insulins (see section 4.4). 
 
The patient should be advised to read the instructions for use included in the package leaflet carefully 
before using ABASAGLAR solution for injection in pre-filled pen. 
 



27 

 
7.  MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands 
 
 
8.  MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/14/944/007 
EU/1/14/944/008 
EU/1/14/944/012 
EU/1/14/944/013 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 9 September 2014 
Date of latest renewal: 25 July 2019 
 
 
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 

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


28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 
MANUFACTURER(S) 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 
 

 



29 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S)  AND 
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers of the biological active substance  
 
Lilly del Caribe, Inc. 
12.3 km 65th Infantry Road 
Carolina, PR 00985 
Puerto Rico 
 
Eli Lilly and Company 
Indianapolis  
Indiana 46285  
USA 
 
Name and address of the manufacturer responsible for batch release 
 
ABASAGLAR 100 units/mL solution for injection in a cartridge and pre-filled pen 
 
Lilly France S.A.S. 
2, rue du Colonel Lilly 
F-67640 Fegersheim 
France 
 
ABASAGLAR 100 units/mL solution for injection in a cartridge 
 
Eli Lilly Italia S.p.A.,  
Via Gramsci 731-733,  
50019 Sesto Fiorentino, (FI)  
Italy. 
 
 
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  
 
The requirements for submission of periodic safety update reports 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 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. 
 
 



30 

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.  

 
 



31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



32 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



33 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – Cartridge. Pack of 5 and 10 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ABASAGLAR 100 units/mL solution for injection in a cartridge 
 
insulin glargine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each mL contains 100 units insulin glargine (equivalent to 3.64 mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: zinc oxide, metacresol, glycerol, hydrochloric acid and sodium hydroxide, water for 
injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
5 cartridges of 3 mL. 
10 cartridges of 3 mL 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
These cartridges are for use with a Lilly 3 mL pen only. 
 
Read the package leaflet before use. 
 
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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Discard 28 days after first use. 
 
 



34 

9. SPECIAL STORAGE CONDITIONS 
 
Before use: 
 
Store in a refrigerator. 
Do not freeze.  
Store in original package in order to protect from light. 
 
 
In use:  
 
Store below 30 º C. 
Do not refrigerate or freeze. 
 
 
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 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/944/003 5 cartridges 
EU/1/14/944/009 10 cartridges 
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
ABASAGLAR 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
 



35 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 



36 

 



37 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
CARTRIDGE LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
ABASAGLAR 100 units/mL injection 
insulin glargine 
SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 mL 
 
 
6. OTHER 
 
 
 



38 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON – KwikPen. Pack of 5 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
 
ABASAGLAR 100 units/mL solution for injection in a pre-filled pen 
 
insulin glargine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each mL contains 100 units insulin glargine (equivalent to 3.64 mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: zinc oxide, metacresol, glycerol, hydrochloric acid and sodium hydroxide, water for 
injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. KwikPen 
 
5 pens of 3 mL. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
Discard pen 28 days after first use. 
 
 



39 

9. SPECIAL STORAGE CONDITIONS 
 
Before use: 
 
Store in a refrigerator. 
Do not freeze.  
Store in original package in order to protect from light. 
 
In use:  
 
Store below 30 º C. 
Do not refrigerate or freeze. 
Recap the pen after use 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 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/944/007 5 pens 
EU/1/14/944/012 5 pens 
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
ABASAGLAR 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
 



40 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 



41 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON for multipack (with blue box) – KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ABASAGLAR 100 units/mL solution for injection in a pre-filled pen 
 
insulin glargine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each mL contains 100 units insulin glargine (equivalent to 3.64 mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: zinc oxide, metacresol, glycerol, hydrochloric acid and sodium hydroxide, water for 
injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. KwikPen 
 
Multipack: 10 (2 packs of 5) pens of 3 mL.  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
Discard pen 28 days after first use. 
 
 



42 

9. SPECIAL STORAGE CONDITIONS 
 
Before use: 
 
Store in a refrigerator. 
Do not freeze.  
Store in original package in order to protect from light. 
 
In use:  
 
Store below 30 º C. 
Do not refrigerate or freeze. 
Recap the pen after use 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 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/944/008 5 pens 
EU/1/14/944/013 5 pens 
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
ABASAGLAR 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
 



43 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



44 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE CARTON of a multipack (without blue box) - KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ABASAGLAR 100 units/mL solution for injection in a pre-filled pen 
 
insulin glargine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each mL contains 100 units  insulin glargine (equivalent to 3.64 mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: zinc oxide, metacresol, glycerol, hydrochloric acid and sodium hydroxide, water for 
injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. KwikPen 
 
5 pens of 3 mL. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP 
 
Discard pen 28 days after first use. 
 
 



45 

9. SPECIAL STORAGE CONDITIONS 
 
Before use: 
 
Store in a refrigerator. 
Do not freeze.  
Store in original package in order to protect from light. 
 
In use:  
 
Store below 30 º C. 
Do not refrigerate or freeze. 
Recap the pen after use 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 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/944/008  5 pens 
EU/1/14/944/013  5 pens 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
ABASAGLAR 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 



46 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT –KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
ABASAGLAR 100 units/mL injection 
KwikPen 
insulin glargine 
SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 mL 
 
 
6. OTHER 
 
 



47 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 

B. PACKAGE LEAFLET 



48 

Package leaflet: Information for the user 
 

ABASAGLAR 100 units/mL solution for injection in a cartridge 
insulin glargine 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. The instructions for using the insulin pen are provided with your 
insulin pen. Refer to them before using your medicine. 
 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor, 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, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What ABASAGLAR is and what it is used for  
2. What you need to know before you use ABASAGLAR 
3. How to use ABASAGLAR 
4. Possible side effects  
5. How to store ABASAGLAR 
6. Contents of the pack and other information 
 
 
1. What ABASAGLAR is and what it is used for 
 
ABASAGLAR contains insulin glargine. This is a modified insulin, very similar to human insulin. 
 
ABASAGLAR is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and 
above. 
 
Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of 
blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action. 
 
 
2. What you need to know before you use ABASAGLAR 
 
Do not use ABASAGLAR 
 
If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 
6). 
 
Warnings and precautions  
 
Talk to your doctor, pharmacist or nurse before using ABASAGLAR. 
Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical 
activity (physical work and exercise) as discussed with your doctor. 
 
If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the 
end of this leaflet). 
 
Travel 
Before travelling consult your doctor. You may need to talk about: 
-  the availability of your insulin in the country you are visiting, 
-  supplies of insulin etc. 



49 

-  correct storage of your insulin while travelling, 
-  timing of meals and insulin administration while travelling, 
-  the possible effects of changing to different time zones, 
-  possible new health risks in the countries to be visited, 
-  what you should do in emergency situations when you feel unwell or become ill. 
 
Illnesses and injuries 
In the following situations, the management of your diabetes may require a lot of care (for example, 
adjustment to insulin dose, blood and urine tests): 
-  If you are ill or have a major injury then 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 a doctor. Make sure that you contact a doctor early. 
 
If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue 
to get enough carbohydrates. Always tell people who are caring for you or treating you that you 
require insulin. 
 
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. 
 
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. Inform your 
doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath 
or rapid increase in weight or localised swelling (oedema). 
 
Children 
 
There is no experience with the use of ABASAGLAR in children below the age of 2 years. 
 
Other medicines and ABASAGLAR 
 
Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the 
situation). In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that 
are either too low or too high. Be careful when you start or stop taking another medicine. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. Before taking a medicine ask your doctor if it can affect your blood sugar level and what 
action, if any, you need to take. 
 
Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: 
 
-  all other medicines to treat diabetes, 
-  angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high 

blood pressure), 
-  disopyramide (used to treat certain heart conditions), 
-  fluoxetine (used to treat depression), 
-  fibrates (used to lower high levels of blood lipids), 
-  monoamine oxidase (MAO) inhibitors (used to treat depression), 
-  pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever),  
-  somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you 

make too much growth hormone), 
 -  sulphonamide antibiotics. 
 
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: 
 
-  corticosteroids (such as "cortisone" used to treat inflammation), 
-  danazol (medicine acting on ovulation), 
-  diazoxide (used to treat high blood pressure), 



50 

-  diuretics (used to treat high blood pressure or excessive fluid retention), 
-  glucagon (pancreas hormone used to treat severe hypoglycaemia), 
-  isoniazid (used to treat tuberculosis), 
-  oestrogens and progestogens (such as in the contraceptive pill used for birth control),  
-  phenothiazine derivatives (used to treat psychiatric disorders), 
-  somatropin (growth hormone), 
-  sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to 

treat asthma), 
-  thyroid hormones (used to treat thyroid gland disorders), 
-  atypical antipsychotic medicines (such as clozapine, olanzapine), 
-  protease inhibitors (used to treat HIV). 
 
Your blood sugar level may either rise or fall if you take: 
 
-  beta-blockers (used to treat high blood pressure), 
-  clonidine (used to treat high blood pressure), 
-  lithium salts (used to treat psychiatric disorders). 
 
Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may 
sometimes be followed by hyperglycaemia. 
 
Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may 
weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.  
If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist. 
 
ABASAGLAR with alcohol 
 
Your blood sugar levels may either rise or fall if you drink alcohol. 
 
Pregnancy and breast-feeding 
 
Ask your doctor or pharmacist for advice before taking any medicine. 
Inform your doctor if you are planning to become pregnant, or if you are already pregnant. Your 
insulin dose may need to be changed during pregnancy and after giving birth. Particularly careful 
control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby. 
If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and 
your diet. 
 
Driving and using machines 
 
Your ability to concentrate or react may be reduced if: 
-  you have hypoglycaemia (low blood sugar levels), 
-  you have hyperglycaemia (high blood sugar levels), 
-  you have problems with your sight. 
Keep this possible problem in mind in all situations where you might put yourself and others at risk 
(such as driving a car or using machines). You should contact your doctor for advice on driving if: 
-  you have frequent episodes of hypoglycaemia, 
-  the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent. 
 
Important information about some of the ingredients of ABASAGLAR 
 
This medicine contains less than 1 mmol (23 mg) sodium per dose, which means it is essentially 
‘sodium-free’. 
 
 
 
 



51 

3. How to use ABASAGLAR 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure. 
Although ABASAGLAR contains the same active substance as Toujeo (insulin glargine 
300 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. 
 
Dose 
 
Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin 
usage, your doctor will: 
 
-  determine how much ABASAGLAR per day you will need and at what time, 
-  tell you when to check your blood sugar level, and whether you need to carry out urine tests, 
-  tell you when you may need to inject a higher or lower dose of ABASAGLAR. 
 
ABASAGLAR is a long-acting insulin. Your doctor may tell you to use it in combination with a short-
acting insulin or with tablets used to treat high blood sugar levels. 
 
Many factors may influence your blood sugar level. You should know these factors so that you are 
able to react correctly to changes in your blood sugar level and to prevent it from becoming too high 
or too low. See the box at the end of this leaflet for further information. 
 
Use in children and adolescents 
 
ABASAGLAR can be used in adolescents and children aged 2 years and above. Use this medicine 
exactly as your doctor has told you. 
 
Frequency of administration 
 
You need one injection of ABASAGLAR every day, at the same time of the day. 
 
Method of administration 
 
ABASAGLAR is injected under the skin. Do NOT inject ABASAGLAR in a vein, since this will 
change its action and may cause hypoglycaemia. 
 
Your doctor will show you in which area of the skin you should inject ABASAGLAR. With each 
injection, change the puncture site within the particular area of skin that you are using. 
 
How to handle the cartridges 
 
The ABASAGLAR cartridges are to be used only in Lilly insulin pens to ensure you get the correct 
dose. Not all of these pens may be marketed in your country. 
 
The pen should be used as recommended in the information provided. 
 
The instructions for using the pen must be followed carefully for loading the cartridge, attaching the 
needle, and administering the insulin injection. 
 
To prevent the possible transmission of disease, each pen must be used by one patient only. 
 
Look at the cartridge before you use it. Only use it if the solution is clear, colourless and water-like, 
and has no visible particles in it. Do not shake or mix it before use. 
 



52 

Always use a new cartridge if you notice that your blood sugar control is unexpectedly getting worse. 
This is because the insulin may have lost some of its effectiveness. If you think you may have a 
problem with ABASAGLAR, have it checked by your doctor or pharmacist. 
 
Special care before injection 
 
Before injection remove any air bubbles (see instructions for using the pen). 
 
Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin. 
 
Do not re-fill and re-use empty cartridges. Do not add any other insulin to the cartridge. Do not mix 
ABASAGLAR with any other insulins or medicines. Do not dilute it. Mixing or diluting may change 
the action of ABASAGLAR. 
 
Problems with the insulin pen? 
 
Refer to the instructions for using the pen. 
 
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be 
discarded, and a new insulin pen has to be used. 
 
Insulin Mix-ups 
 
You must always check the insulin label before each injection to avoid mix-ups between 
ABASAGLAR and other insulins. 
 
If you use more ABASAGLAR than you should 
 
-  If you have injected too much ABASAGLAR, your blood sugar level may become too low 

(hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia you 
must eat more food and monitor your blood sugar. For information on the treatment of 
hypoglycaemia, see box at the end of this leaflet. 

 
If you forget to use ABASAGLAR 
-  If you have missed a dose of ABASAGLAR or if you have not injected enough insulin, your 

blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently. 
For information on the treatment of hyperglycaemia, see box at the end of this leaflet. 

-  Do not take a double dose to make up for a forgotten dose. 
 
If you stop using ABASAGLAR 
 
This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in 
the blood because the body is breaking down fat instead of sugar). Do not stop ABASAGLAR without 
speaking to a doctor, who will tell you what needs to be done. 
 
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 the action to increase 
your blood sugar levels inmediately. Hypoglycaemia (low blood sugar) 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 level falls too low, you may pass out 



53 

(become unconscious). Serious hypoglycaemia 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 large-scale 
skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes 
(angiooedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating. Severe 
allergic reactions to insulins may become life-threatening. Tell a doctor straight away if you notice 
signs of severe allergic reaction. 
 
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). Also lumps under 
the skin caused by a build-up of a protein called amyloid may occur (cutaneous amyloidosis, how 
often they occur is not known). The insulin may not work very well. Change the injection site with 
each injection to help prevent these skin changes. 

Common side effects (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. They can spread around the injection site. Most minor reactions to insulins usually 
disappear in a few days to a few weeks. 
 
Rare side effects (may affect up to 1 in 1,000 people) 
 
• Eye reactions 
 
A marked change (improvement or worsening) in your blood sugar control can disturb your vision 
temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe 
hypoglycaemic attacks may cause temporary loss of vision. 
 
• General disorders 
 
In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling 
in the calves and ankles. 
 
Very rare side-effects (may affect up to1 in 10,000 people) 
In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur. 
 
Use in children and adolescents 
 
In general, the side effects in children and adolescents of 18 years of age or less are similar to those 
seen in adults. 
 
Complaints of injection site reactions (injection site pain, injection site reaction) and skin reactions 
(rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age 
or less than in adults. 
 
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


54 

5. How to store ABASAGLAR 
 
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 
cartridge after “EXP”. The expiry date refers to the last day of that month. 
 
Unopened cartridges 
Store in a refrigerator (2°C - 8°C). Do not freeze.  
Do not put ABASAGLAR next to the freezer compartment or a freezer pack.  
Keep the cartridge in the outer carton in order to protect from light. 
 
In-use cartridges 
Cartridges in use (in the insulin pen) or carried as a spare may be stored for a maximum of 28 days up 
to 30°C and away from direct heat or direct light. The cartridge in use must not be stored in a 
refrigerator. Do not use it after this time period. 
 
Do not use ABASAGLAR if you notice particles in it. Only use ABASAGLAR if the solution is clear, 
colourless and water like. 
 
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 ABASAGLAR contains 
 
-  The active substance is insulin glargine. Each millilitre of the solution contains 100 units of the 

active substance insulin glargine (equivalent to 3.64 mg). 
-  The other ingredients are: zinc oxide, metacresol, glycerol, sodium hydroxide (see section 2 

“Important information about some of the ingredients of ABASAGLAR”), hydrochloric acid 
and water for injections. 

 
What ABASAGLAR looks like and contents of the pack 
 
ABASAGLAR 100 units/mL solution for injection in a cartridge is a clear and colourless solution. 
 
ABASAGLAR comes in a special cartridge to be used only in a Lilly insulin pen. Each cartridge 
contains 3 mL of solution for injection (equivalent to 300 units) and they are available in packs of 5 
and 10 cartridges. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder  
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
Manufacturer 
 
Lilly France S.A.S., rue du Colonel Lilly, F-67640 Fegersheim, France. 
Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
 



55 

België/Belgique/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. +359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 
 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 60 00 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 
 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 
Boehringer Ingelheim Pharma GmbH & Co. KG 
Tel: +49 (0) 800 77 90 900 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 
 

Eesti 
Tel: +372 6 817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 
 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges.m.b.H.  
Tel: + 43-(0) 1 711 780 
 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 
Boehringer Ingelheim España S.A. 
Tel: +34 93 404 51 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 
 

France 
Lilly France SAS 
Tél: +33-(0) 1 55 49 34 34 
 
Boehringer Ingelheim France S.A.S. 
Tél: +33 3 26 50 45 33 
 

Portugal 
Lilly Portugal Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 
 
Boehringer Ingelheim, Lda. 
Tel: +351 21 313 53 00 
 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 
 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 
Boehringer Ingelheim Ireland Ltd. 
Tel: +353 1 295 9620 
 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0)1 580 00 10 
 



56 

Ísland 
Icepharma hf. 
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 
Boehringer Ingelheim Italia S.p.A. 
Tel: +39 02 5355 1 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 
 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 
 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel: 
+371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 
 
Boehringer Ingelheim Ltd. 
Tel: +44 1344 424 600 
 

This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

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


57 

HYPERGLYCAEMIA AND HYPOGLYCAEMIA 
 
Always carry some sugar (at least 20 grams) with you. 
 
Carry some information with you to show you are diabetic. 
 
HYPERGLYCAEMIA (high blood sugar levels) 
 
If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin. 
 
Why does hyperglycaemia occur? 
 
Examples include: 
-  you have not injected your insulin or not injected enough, or if it has become less effective, for 

example through incorrect storage, 
-  your insulin pen does not work properly, 
-  you are doing less exercise than usual, you are under stress (emotional distress, excitement), or 

you have an injury, operation, infection or fever, 
-  you are taking or have taken certain other medicines (see section 2, "Other medicines and 

ABASAGLAR"). 
 
Warning symptoms of hyperglycaemia 
Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood 
pressure, fast heartbeat, and glucose and ketone bodies in urine. Stomach pain, fast and deep 
breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) 
resulting from lack of insulin. 
 
What should you do if you experience hyperglycaemia? 
 
Test your blood sugar level and your urine for ketones as soon as any of the above symptoms 
occur. Severe hyperglycaemia or ketoacidosis 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 become unconscious. Serious hypoglycaemia may 
cause a heart attack or brain damage and may be life-threatening. You normally should be able to 
recognise when your blood sugar is falling too much so that you can take the right actions. 
 
Why does hypoglycaemia occur? 
 
Examples include: 
-  you inject too much insulin, 
-  you miss meals or delay them, 
-  you do not eat enough, or eat food containing less carbohydrate than normal (sugar and 

substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT 
carbohydrates), 

-  you lose carbohydrates due to vomiting or diarrhoea, 
-  you drink alcohol, particularly if you are not eating much, 
-  you are doing more exercise than usual or a different type of physical activity, 
-  you are recovering from an injury or 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 ABASAGLAR"). 
 



58 

Hypoglycaemia is also more likely to occur if 
 
-  you have just begun insulin treatment or changed to another insulin preparation (when changing 

from your previous basal insulin to ABASAGLAR, hypoglycaemia, if it occurs, may be more 
likely to occur in the morning than at night), 

-  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 suffer from severe kidney or liver disease, or some other disease such as hypothyroidism. 
 
Warning symptoms of hypoglycaemia 
 
- In your body 
Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: 
sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular 
heartbeat. These symptoms often develop before the symptoms of a low sugar level in the brain. 
 
- In your brain 
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, 
vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in 
concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of 
speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and 
tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after 
yourself, convulsions, loss of consciousness. 
The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker 
or may be missing altogether if 
-  you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of 

nervous disease (diabetic autonomic neuropathy), 
-  you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly, 
-  you have almost normal or, at least, greatly improved blood sugar levels, 
-  you have recently changed from an animal insulin to a human insulin such as ABASAGLAR, 
-  you are taking or have taken certain other medicines (see section 2, "Other medicines and 

ABASAGLAR"). 
In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the 
problem. Be familiar with your warning symptoms. If necessary, more frequent blood sugar testing 
can help to identify mild hypoglycaemic episodes that may otherwise be overlooked. If you are not 
confident about recognising your warning symptoms, avoid situations (such as driving a car) in which 
you or others would be put at risk by hypoglycaemia. 
 
What should you do if you experience hypoglycaemia? 
 
1. Do not inject insulin. Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a 
sugar-sweetened beverage. Caution: Artificial sweeteners and foods with artificial sweeteners (such as 
diet drinks) are of no help in treating hypoglycaemia. 
 
2. Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta). 
Your doctor or nurse should have discussed this with you previously. 
The recovery of hypoglycaemia may be delayed because ABASAGLAR has a long action.' 
 
3. If the hypoglycaemia comes back again, take another 10 to 20 g sugar. 
 
4. Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs. Tell 
your relatives, friends and close colleagues the following: 
 
If you are not able to swallow or if you are unconscious, you will require an injection of glucose or 
glucagon (a medicine which increases blood sugar). These injections are justified even if it is not 
certain that you have hypoglycaemia. 



59 

 
It is advisable to test your blood sugar immediately after taking glucose to check that you really have 
hypoglycaemia. 
 



60 

Package leaflet: Information for the user 
 

ABASAGLAR 100 units/mL solution for injection in a pre-filled pen 
insulin glargine 

 
Read all of this leaflet carefully including the Instructions for Use of the ABASAGLAR 
KwikPen pre-filled pen, 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, 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, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What ABASAGLAR is and what it is used for  
2. What you need to know before you use ABASAGLAR 
3. How to use ABASAGLAR 
4. Possible side effects  
5. How to store ABASAGLAR 
6. Contents of the pack and other information 
 
 
1. What ABASAGLAR is and what it is used for 
 
ABASAGLAR contains insulin glargine. This is a modified insulin, very similar to human insulin. 
 
ABASAGLAR is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and 
above. 
 
Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of 
blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action. 
 
 
2. What you need to know before you use ABASAGLAR 
 
Do not use ABASAGLAR 
 
If you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 
6). 
 
Warnings and precautions  
 
Talk to your doctor, pharmacist or nurse before using ABASAGLAR. 
Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical 
activity (physical work and exercise) as discussed with your doctor. 
 
If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the 
end of this leaflet). 
 
Travel 
Before travelling consult your doctor. You may need to talk about: 
-  the availability of your insulin in the country you are visiting, 
-  supplies of insulin etc. 



61 

-  correct storage of your insulin while travelling, 
-  timing of meals and insulin administration while travelling, 
-  the possible effects of changing to different time zones, 
-  possible new health risks in the countries to be visited, 
-  what you should do in emergency situations when you feel unwell or become ill. 
 
Illnesses and injuries 
In the following situations, the management of your diabetes may require a lot of care (for example, 
adjustment to insulin dose, blood and urine tests): 
-  If you are ill or have a major injury then 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 a doctor. Make sure that you contact a doctor early. 
 
If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue 
to get enough carbohydrates. Always tell people who are caring for you or treating you that you 
require insulin. 
 
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. 
 
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. Inform your 
doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath 
or rapid increase in weight or localised swelling (oedema). 
 
Children 
 
There is no experience with the use of ABASAGLAR in children below the age of 2 years. 
 
Other medicines and ABASAGLAR 
 
Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the 
situation). In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that 
are either too low or too high. Be careful when you start or stop taking another medicine. 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. Before taking a medicine ask your doctor if it can affect your blood sugar level and what 
action, if any, you need to take. 
 
Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: 
 
- all other medicines to treat diabetes, 
- angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high 

blood pressure), 
- disopyramide (used to treat certain heart conditions), 
- fluoxetine (used to treat depression), 
- fibrates (used to lower high levels of blood lipids), 
- monoamine oxidase (MAO) inhibitors (used to treat depression), 
- pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever),  
- somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you 

make too much growth hormone), 
- sulphonamide antibiotics. 
 
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: 
 
- corticosteroids (such as "cortisone" used to treat inflammation), 
- danazol (medicine acting on ovulation), 
- diazoxide (used to treat high blood pressure), 



62 

- diuretics (used to treat high blood pressure or excessive fluid retention), 
- glucagon (pancreas hormone used to treat severe hypoglycaemia), 
- isoniazid (used to treat tuberculosis), 
- oestrogens and progestogens (such as in the contraceptive pill used for birth control),  
- phenothiazine derivatives (used to treat psychiatric disorders), 
- somatropin (growth hormone), 
- sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to 

treat asthma), 
- thyroid hormones (used to treat thyroid gland disorders), 
- atypical antipsychotic medicines (such as clozapine, olanzapine), 
- protease inhibitors (used to treat HIV). 
 
Your blood sugar level may either rise or fall if you take: 
 
- beta-blockers (used to treat high blood pressure), 
- clonidine (used to treat high blood pressure), 
- lithium salts (used to treat psychiatric disorders). 
 
Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may 
sometimes be followed by hyperglycaemia. 
 
Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may 
weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia  
If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist. 
 
ABASAGLAR with alcohol 
 
Your blood sugar levels may either rise or fall if you drink alcohol. 
 
Pregnancy and breast-feeding 
 
Ask your doctor or pharmacist for advice before taking any medicine. 
Inform your doctor if you are planning to become pregnant, or if you are already pregnant. Your 
insulin dose may need to be changed during pregnancy and after giving birth. Particularly careful 
control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby. 
If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and 
your diet. 
 
Driving and using machines 
 
Your ability to concentrate or react may be reduced if: 
-  you have hypoglycaemia (low blood sugar levels), 
-  you have hyperglycaemia (high blood sugar levels), 
-  you have problems with your sight. 
Keep this possible problem in mind in all situations where you might put yourself and others at risk 
(such as driving a car or using machines). You should contact your doctor for advice on driving if: 
-  you have frequent episodes of hypoglycaemia, 
-  the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent. 
 
Important information about some of the ingredients of ABASAGLAR 
 
This medicine contains less than 1 mmol (23 mg) sodium per dose, which means it is essentially 
‘sodium-free’. 
 
 
 
 



63 

3. How to use ABASAGLAR 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure. 
 
Although ABASAGLAR contains the same active substance as Toujeo (insulin glargine 
300 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. 
 
Dose 
 
Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin 
usage, your doctor will: 
 
-  determine how much ABASAGLAR per day you will need and at what time, 
-  tell you when to check your blood sugar level, and whether you need to carry out urine tests, 
-  tell you when you may need to inject a higher or lower dose of ABASAGLAR. 
 
ABASAGLAR is a long-acting insulin. Your doctor may tell you to use it in combination with a short-
acting insulin or with tablets used to treat high blood sugar levels. 
 
Many factors may influence your blood sugar level. You should know these factors so that you are 
able to react correctly to changes in your blood sugar level and to prevent it from becoming too high 
or too low. See the box at the end of this leaflet for further information. 
 
Use in children and adolescents 
 
ABASAGLAR can be used in adolescents and children aged 2 years and above. Use this medicine 
exactly as your doctor has told you. 
 
Frequency of administration 
 
You need one injection of ABASAGLAR every day, at the same time of the day. 
 
Method of administration 
 
ABASAGLAR is injected under the skin. Do NOT inject ABASAGLAR in a vein, since this will 
change its action and may cause hypoglycaemia. 
 
Your doctor will show you in which area of the skin you should inject ABASAGLAR. With each 
injection, change the puncture site within the particular area of skin that you are using. 
 
How to handle ABASAGLAR KwikPen 
 
ABASAGLAR KwikPen is a pre-filled disposable pen containing insulin glargine. 
 
Read carefully the "ABASAGLAR KwikPen Instructions for Use" included with this package 
leaflet. You must use the pen as described in these Instructions for Use. 
 
A new needle must be attached before each use. Only use needles that are compatible for use with 
ABASAGLAR KwikPen (see “ABASAGLAR KwikPen Instructions for Use”). 
 
A safety test must be performed before each injection. 
 



64 

Look at the cartridge before you use the pen. Do not use ABASAGLAR KwikPen if you notice 
particles in it. Only use ABASAGLAR KwikPen if the solution is clear, colourless and water-like. Do 
not shake or mix it before use. 
 
To prevent the possible transmission of disease, each pen must be used by one patient only. 
 
Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin. 
 
Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse. If you 
think you may have a problem with ABASAGLAR KwikPen, consult your doctor, pharmacist or 
nurse. 
 
Empty pens must not be re-filled and must be properly discarded. 
 
Do not use ABASAGLAR KwikPen if it is damaged or not working properly, it has to be discarded 
and a new KwikPen has to be used. 
 
Insulin Mix-ups 
 
You must always check the insulin label before each injection to avoid mix-ups between 
ABASAGLAR and other insulins. 
 
If you use more ABASAGLAR than you should 
 
-  If you have injected too much ABASAGLAR, your blood sugar level may become too low 

(hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia you 
must eat more food and monitor your blood sugar. For information on the treatment of 
hypoglycaemia, see box at the end of this leaflet. 

 
If you forget to use ABASAGLAR 
-  If you have missed a dose of ABASAGLAR or if you have not injected enough insulin, your 

blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently. 
For information on the treatment of hyperglycaemia, see box at the end of this leaflet. 

-  Do not take a double dose to make up for a forgotten dose. 
 
If you stop using ABASAGLAR 
 
This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in 
the blood because the body is breaking down fat instead of sugar). Do not stop ABASAGLAR without 
speaking to a doctor, who will tell you what needs to be done. 
 
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 the action to increase 
your blood sugar levels inmediately. Hypoglycaemia (low blood sugar) 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 level falls too low, you may pass out 
(become unconscious). Serious hypoglycaemia 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 large-scale 
skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes 



65 

(angiooedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating. Severe 
allergic reactions to insulins may become life-threatening. Tell a doctor straight away if you notice 
signs of severe allergic reaction. 
 
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). Also lumps under 
the skin caused by a build-up of a protein called amyloid may occur (cutaneous amyloidosis, how 
often they occur is not known). The insulin may not work very well. Change the injection site with 
each injection to help prevent these skin changes. 
 
Common side effects (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. They can spread around the injection site. Most minor reactions to insulins usually 
disappear in a few days to a few weeks. 
 
Rare side effects (may affect up to 1 in 1,000 people) 
 
• Eye reactions 
A marked change (improvement or worsening) in your blood sugar control can disturb your vision 
temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe 
hypoglycaemic attacks may cause temporary loss of vision. 
 
• General disorders 
In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling 
in the calves and ankles. 

 
Very rare side-effects (may affect up to1 in 10,000 people) 
In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur. 
 
Use in children and adolescents 
 
In general, the side effects in children and adolescents of 18 years of age or less are similar to those 
seen in adults. 
 
Complaints of injection site reactions (injection site pain, injection site reaction) and skin reactions 
(rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age 
or less than in adults. 
 
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. 
 
 
5. How to store ABASAGLAR 
 
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. 

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


66 

 
Not in-use pens 
Store in a refrigerator (2°C - 8°C). Do not freeze.  
Do not put ABASAGLAR next to the freezer compartment or a freezer pack. 
Keep the pre-filled pen in the outer carton in order to protect from light. 
 
In-use pens 
Pre-filled pens in use or carried as a spare may be stored for a maximum of 28 days up to 30°C and 
away from direct heat or direct light. The pen in use must not be stored in the refrigerator. Do not use 
it after this time period. The pen cap must be put back on the pen after each injection 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 ABASAGLAR contains 
 
-  The active substance is insulin glargine. Each millilitre of the solution contains 100 units of the 

active substance insulin glargine (equivalent to 3.64 mg). 
-  The other ingredients are: zinc oxide, metacresol, glycerol, sodium hydroxide (see section 2 

“Important information about some of the ingredients of ABASAGLAR”), hydrochloric acid 
and water for injections. 

 
What ABASAGLAR looks like and contents of the pack 
 
ABASAGLAR 100 units/mL solution for injection in a pre-filled pen, KwikPen, is a clear and 
colourless solution. 
 
ABASAGLAR is available in packs containing 5 pre-filled pens and in multipacks comprising 
2 cartons, each containing 5 pre-filled pens. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder  
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
Manufacturer 
 
Lilly France S.A.S., rue du Colonel Lilly, F-67640 Fegersheim, France. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. +359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 



67 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 
 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 60 00 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 
 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 
Boehringer Ingelheim Pharma GmbH & Co. KG 
Tel: +49 (0) 800 77 90 900 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 
 

Eesti 
Tel: +372 6 817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 
 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges.m.b.H.  
Tel: + 43-(0) 1 711 780 
 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 
Boehringer Ingelheim España S.A. 
Tel: +34 93 404 51 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 
 

France 
Lilly France SAS 
Tél: +33-(0) 1 55 49 34 34 
 
Boehringer Ingelheim France S.A.S. 
Tél: +33 3 26 50 45 33 
 

Portugal 
Lilly Portugal Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 
 
Boehringer Ingelheim, Lda. 
Tel: +351 21 313 53 00 
 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 
 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 
Boehringer Ingelheim Ireland Ltd. 
Tel: +353 1 295 9620 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0)1 580 00 10 
 

Ísland 
Icepharma hf. 
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 
 



68 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 
Boehringer Ingelheim Italia S.p.A. 
Tel: +39 02 5355 1 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 
 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 
 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā  
Tel: +371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 
 
Boehringer Ingelheim Ltd. 
Tel: +44 1344 424 600 
 

This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  

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


69 

HYPERGLYCAEMIA AND HYPOGLYCAEMIA 
 
Always carry some sugar (at least 20 grams) with you. 
 
Carry some information with you to show you are diabetic. 
 
HYPERGLYCAEMIA (high blood sugar levels) 
 
If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin. 
 
Why does hyperglycaemia occur? 
 
Examples include: 
-  you have not injected your insulin or not injected enough, or if it has become less effective, for 

example through incorrect storage, 
-  your insulin pen does not work properly, 
-  you are doing less exercise than usual, you are under stress (emotional distress, excitement), or 

you have an injury, operation, infection or fever, 
-  you are taking or have taken certain other medicines (see section 2, "Other medicines and 

ABASAGLAR"). 
 
Warning symptoms of hyperglycaemia 
Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood 
pressure, fast heartbeat, and glucose and ketone bodies in urine. Stomach pain, fast and deep 
breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) 
resulting from lack of insulin. 
 
What should you do if you experience hyperglycaemia? 
 
Test your blood sugar level and your urine for ketones as soon as any of the above symptoms 
occur. Severe hyperglycaemia or ketoacidosis 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 become unconscious. Serious hypoglycaemia may 
cause a heart attack or brain damage and may be life-threatening. You normally should be able to 
recognise when your blood sugar is falling too much so that you can take the right actions. 
 
Why does hypoglycaemia occur? 
 
Examples include: 
-  you inject too much insulin, 
-  you miss meals or delay them, 
-  you do not eat enough, or eat food containing less carbohydrate than normal (sugar and 

substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT 
carbohydrates), 

-  you lose carbohydrates due to vomiting or diarrhoea, 
-  you drink alcohol, particularly if you are not eating much, 
-  you are doing more exercise than usual or a different type of physical activity, 
-  you are recovering from an injury or 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 ABASAGLAR"). 
 



70 

Hypoglycaemia is also more likely to occur if 
 
-  you have just begun insulin treatment or changed to another insulin preparation (when changing 

from your previous basal insulin to ABASAGLAR, hypoglycaemia, if it occurs, may be more 
likely to occur in the morning than at night), 

-  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 suffer from severe kidney or liver disease, or some other disease such as hypothyroidism. 
 
Warning symptoms of hypoglycaemia 
 
- In your body 
Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: 
sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular 
heartbeat. These symptoms often develop before the symptoms of a low sugar level in the brain. 
 
- In your brain 
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, 
vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in 
concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of 
speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and 
tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after 
yourself, convulsions, loss of consciousness. 
The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker 
or may be missing altogether if 
-  you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of 

nervous disease (diabetic autonomic neuropathy), 
-  you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly, 
-  you have almost normal or, at least, greatly improved blood sugar levels, 
-  you have recently changed from an animal insulin to a human insulin such as ABASAGLAR, 
-  you are taking or have taken certain other medicines (see section 2, "Other medicines and 

ABASAGLAR"). 
In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the 
problem. Be familiar with your warning symptoms. If necessary, more frequent blood sugar testing 
can help to identify mild hypoglycaemic episodes that may otherwise be overlooked. If you are not 
confident about recognising your warning symptoms, avoid situations (such as driving a car) in which 
you or others would be put at risk by hypoglycaemia. 
 
What should you do if you experience hypoglycaemia? 
 
1. Do not inject insulin. Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a 
sugar-sweetened beverage. Caution: Artificial sweeteners and foods with artificial sweeteners (such as 
diet drinks) are of no help in treating hypoglycaemia. 
 
2. Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta). 
Your doctor or nurse should have discussed this with you previously. 
The recovery of hypoglycaemia may be delayed because ABASAGLAR has a long action.' 
 
3. If the hypoglycaemia comes back again, take another 10 to 20 g sugar. 
 
4. Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs. Tell 
your relatives, friends and close colleagues the following: 
 
If you are not able to swallow or if you are unconscious, you will require an injection of glucose or 
glucagon (a medicine which increases blood sugar). These injections are justified even if it is not 
certain that you have hypoglycaemia. 



71 

 
It is advisable to test your blood sugar immediately after taking glucose to check that you really have 
hypoglycaemia. 



72 

Instructions for use 
KwikPen 

ABASAGLAR 100 units/mL solution for injection in a pre-filled pen 

Insulin glargine  

 

 

 

 

 

 

 

PLEASE READ THESE INSTRUCTIONS BEFORE USE 

 
Read the instructions for use before you start taking ABASAGLAR and each time you get another 
ABASAGLAR KwikPen. There may be new information. This information does not take the place of 
talking to your healthcare professional about your medical condition or your treatment. 
 

ABASAGLAR KwikPen (“Pen”) is a disposable pen containing 300 units (3 mL) of insulin glargine. 
You can give yourself multiple doses using one pen. The pen dials 1 unit at a time. You can give from 
1 to 60 80 units in a single injection. If your dose is more than 60 80 units, you will need to give 
yourself more than one injection. The plunger only moves a little with each injection and you may 
not notice that it moves. The plunger will only reach the end of the cartridge when you have used all 
300 units in the pen. 
 
Do not share your pen with other people, even if the needle has been changed. Do not reuse or 
share needles with other people. You may give an infection to them or get an infection from 
them. 
 
This pen is not recommended for use by the blind or visually impaired without the help of someone 
trained to use the pen. 
 

KwikPen Parts 
 Pen Cap  Cartridge Holder  Label Dose Indicator 

 
 Cap Clip Rubber Seal Plunger Pen Body Dose  

Window 
Dose 
Knob 

 



73 

Pen Needle Parts 
(Needles Not Included) 

 Dose Knob 
with 

green ring 
 Needle    

 

 

 
Outer Needle 

Shield 
Inner Needle 

Shield 
Paper Tab   

 
 
How to recognise your ABASAGLAR KwikPen: 
• Pen colour:  Light grey 
• Dose Knob:  Light grey with green ring on the end 
• Labels:   Light grey with green colour bars 

 
Supplies needed to give your injection: 
• ABASAGLAR KwikPen 
• KwikPen compatible needle (BD [Becton, Dickinson and Company] pen needles 

recommended).  
• Swab 
 
Preparing your Pen 
• Wash your hands with soap and water 
• Check the pen to make sure you are taking the right type of insulin. This is especially important 

if you use more than 1 type of insulin. 
• Do not use your pen past the expiration date printed on the label or for more than 28 days after 

you first start using the pen. 
• Always use a new needle for each injection to help prevent infections and blocked needles. 
 

Step 1:  

• Pull the pen cap straight off. 
- Do not remove the pen label. 

 
• Wipe the rubber seal with a swab.  
 
ABASAGLAR should look clear and colourless. 
Do not use if it is cloudy, coloured, or has 
particles or clumps in it. 

 

 

 

Step 2:  
• Select a new needle. 
• Pull off the paper tab from the outer needle 

shield. 

 

 

 

 

Step 3:  
• Push the capped needle straight onto the 

pen and twist the needle on until it is tight. 

 

 

 

 



74 

Step 4:  
• Pull off the outer needle shield. Do not 

throw it away. 
• Pull off the inner needle shield and throw it 

away. 

 

 

 
Priming your pen 
Prime before each injection.  

• Priming your pen means removing the air from the needle and cartridge that may collect 
during normal use and ensures that the pen is working correctly.  

• If you do not prime before each injection, you may get too much or too little insulin. 

 

Step 5:  
• To prime your pen, turn the dose knob to 

select 2 units. 
 

 

 

 
 
 

Step 6:  
• Hold your pen with the needle pointing up. 

Tap the cartridge holder gently to collect air 
bubbles at the top. 

 

 

 
 
 

Step 7:  
• Continue holding your pen with needle 

pointing up. Push the dose knob in until it 
stops, and “0” is seen in the dose window. 
Hold the dose knob in and count to 5 
slowly. 

 
You should see insulin at the tip of the 
needle. 
- If you do not see insulin, repeat the 

priming steps, but not more than 4 times. 
- If you still do not see insulin, change 

the needle and repeat the priming steps. 
 
Small air bubbles are normal and will not affect 
your dose. 

 
 
 
 
 

 
Selecting your dose 

• You can give from 1 to 6080 units in a single injection. 

• If your dose is more than 6080 units, you will need to give more than one injection. 

– If you need help deciding how to divide up your dose, ask your healthcare professional. 

– You should use a new needle for each injection and repeat the priming step. 

 

Keep Throw 
Away 



75 

 
• The pen will not let you dial more than the number of units left in the pen. 
• If you need to inject more than the number of units left in the pen, you may either: 

- inject the amount left in your pen and then use a new pen to give the rest of your dose, or 
- get a new pen and inject the full dose.  

• It is normal to see a small amount of insulin left in the pen that you cannot inject. 

 
Giving your injection 
• Inject your insulin as your healthcare professional has shown you. 
• Change (rotate) your injection site for each injection. 
• Do not try to change your dose while injecting. 

 

Step 8:  
• Turn the dose knob to select the number of 

units you need to inject. The dose indicator 
should line up with your dose. 
- The pen dials 1 unit at a time. 
- The dose knob clicks as you turn it. 
- DO NOT dial your dose by counting 

the clicks because you may dial the 
wrong dose. 

- The dose can be corrected by turning 
the dose knob in either direction until 
the correct dose lines up with the dose 
indicator. 

- The even numbers are printed on the 
dial. 

 
 
 
 
 
 
 

- The odd numbers, after the number 1, 
are shown as full lines. 

 
• Always check the number in the Dose 

Window to make sure you have dialled 
the correct dose. 

 

 

 

 

 

 

 

 

 

 

 

(Example: 12 units shown in the dose window) 

 

 

 

 

 

(Example: 25 units shown in the dose window) 

 

 



76 

Step 9:  
Choose your injection site. 
 
• ABASAGLAR is injected under the skin 

(subcutaneously) of your stomach area, 
buttocks, upper legs or upper arms. 

 
• Prepare your skin as recommended by your 

healthcare professional. 
 

 

 

 

Step 10:  
• Insert the needle into your skin. 

• Push the dose knob all the way in 

• Continue to hold the dose 
knob in and slowly count to 5 
before removing the needle. 

 
Do not try to inject your insulin by turning the dose 
knob. You will NOT receive your insulin by 
turning the dose knob. 

 

 

 

 

 

 

 

 

 

 

Step 11:  
• Pull the needle out of your skin. 
 

- A drop of insulin at the needle tip is 
normal. It will not affect your dose. 

 
• Check the number in the dose window 

 
- If you see “0” in the dose window, you 
have received the full amount you dialled. 
- If you do not see “0” in the dose window, 
do not redial. Insert the needle into your skin 
and finish your injection. 

- If you still do not think you received the 
full amount you dialled for your injection, do 
not start over or repeat that injection. 
Monitor your blood glucose as instructed by 
your healthcare professional. 

- If you normally need to give 2 injections 
for your full dose, be sure to give your 
second injection. 

The plunger only moves a little with each injection 
and you may not notice that it moves. 

If you see blood after you take the needle out of 
your skin, press the injection site lightly with a 
piece of gauze or swab. Do not rub the area. 

 

 

 

5sec 



77 

After your injection 
 

Step 12:  
• Carefully replace the outer needle shield. 
 
 
 
 

 

 

 

 

Step 13:  
• Unscrew the capped needle and dispose of 

it as directed by your healthcare 
professional. 

 
• Do not store the pen with the needle 

attached to prevent leaking, blocking the 
needle, and air from entering the pen. 

 

 

 

Step 14:  
• Replace the pen cap by lining up the cap 

clip with the dose indicator and pushing 
straight on. 

 
 

 

 

 

 

 
Disposing of pens and needles 
• Put used needles in a closable, puncture-resistant sharps container.  
• Do not recycle the filled sharps container. 
• Ask your healthcare professional about options to dispose of the pens and sharps container 

properly. 
• The directions regarding needle handling are not intended to replace local, healthcare 

professional or institutional policies. 
 
Storing your pen 

Unused pens 
• Store unused pens in the refrigerator at 2 ° C to 8 ° C. 
• Do not freeze ABASAGLAR. Do not use if it has been frozen. 
• Unused pens may be used until the expiration date printed on the label, if the pen has been kept 

in the refrigerator. 

In-use pen 
• Store the pen you are currently using at room temperature [below 30 ° C] and away from heat 

and light. 
• Throw away the pen you are using after 28 days, even if it still has insulin left in it.  
 
General information about the safe and effective use of your pen 
• Keep your pen and needles out of the sight and reach of children.  
• Do not use your pen if any part looks broken or damaged. 
• Always carry an extra pen in case yours is lost or damaged. 

 

 



78 

Troubleshooting 
• If you cannot remove the pen cap, gently twist the cap back and forth, and then pull the cap 

straight off. 
• If the dose knob it is hard to push: 

- Pushing the dose knob more slowly will make it easier to inject. 
- Your needle may be blocked. Put on a new needle and prime the pen. 
- You may have dust, food, or liquid inside the pen. Throw the pen away and get a new pen. 

 
If you have any questions or problems with your ABASAGLAR KwikPen, contact your healthcare 
professional for assistance. 
 
This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>. 



79 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

Annex IV 
Scientific conclusions and grounds for the variation to the terms of the marketing 

authorisation(s) 
 
 
 
 
 
 



80 

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(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S)  AND MANUFACTURER(S) 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
	A. LABELLING
	B. PACKAGE LEAFLET
	Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)