Lyumjev

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ANNEX I 

 
SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions.  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 100 units/mL solution for injection in vial 
Lyumjev 100 units/mL solution for injection in cartridge 
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen 
Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each mL contains 100 units of insulin lispro* (equivalent to 3.5 mg).   
 
Lyumjev 100 units/mL solution for injection in vial 
 
Each vial contains 1000 units insulin lispro in 10 mL solution. 
 
Lyumjev 100 units/mL solution for injection in cartridge 
 
Each cartridge contains 300 units of insulin lispro in 3 mL solution. 
 
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen 
 
Each pre-filled pen contains 300 units of insulin lispro in 3 mL solution. 
Each KwikPen delivers 1-60 units in steps of 1 unit in a single injection. 
 
Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen 
 
Each pre-filled pen contains 300 units of insulin lispro in 3 mL solution. 
Each Junior KwikPen delivers 0.5 - 30 units in steps of 0.5 units in a single injection. 
 
*produced in E.coli by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection. 
 
Clear, colourless, aqueous solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of diabetes mellitus in adults. 
 



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4.2 Posology and method of administration 
 
Posology 
 
Lyumjev is a mealtime insulin for subcutaneous injection and should be administered zero to two 
minutes before the start of the meal, with the option to administer up to 20 minutes after starting the 
meal (see section 5.1).  
 
Lyumjev 100 units/mL is suitable for continuous subcutaneous insulin infusion (CSII) and is used for 
both the bolus and basal insulin requirement. 
 
The initial dosage should take into account the type of diabetes, weight of the patient and their blood 
glucose levels.  
 
The early onset of action must be considered when prescribing Lyumjev (see section 5.1). Continued 
adjustment of the dose of Lyumjev should be based on the patient’s metabolic needs, blood glucose 
monitoring results, and glycaemic control goal. Dose adjustments may be needed, when switching 
from another insulin, with changes in physical activity, changes in concomitant medicinal products, 
changes in meal patterns (i.e., amount and type of food, timing of food intake), changes in renal or 
hepatic function or during acute illness to minimize the risk of hypoglycaemia or hyperglycaemia (see 
sections 4.4 and 4.5).  
 
Switching from another mealtime insulin medicinal product 
 
If converting from another mealtime insulin to Lyumjev, the change can be done on a unit-to-unit 
basis. The potency of insulin analogues, including Lyumjev, is expressed in units. One (1) unit of 
Lyumjev corresponds to 1 international unit (IU) of human insulin or 1 unit of other fast-acting insulin 
analogues.  
 
Missed doses 
 
Patients who forget a mealtime dose should monitor their blood glucose level to decide if an insulin 
dose is needed, and to resume their usual dosing schedule at the next meal. 
 
Special populations 
 
Elderly (≥ 65 years old)  
The safety and efficacy of Lyumjev has been established in elderly patients aged 65 to 75 years. Close 
glucose monitoring is recommended and the insulin dose should be adjusted on an individual basis 
(see sections 4.8, 5.1 and 5.2). The therapeutic experience in patients ≥ 75 years of age is limited. 
 
Renal impairment 
Insulin requirements may be reduced in the presence of renal impairment. In patients with renal 
impairment, glucose monitoring should be intensified and the dose adjusted on an individual basis. 
 
Hepatic impairment 
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for 
gluconeogenesis and reduced insulin breakdown. In patients with hepatic impairment, glucose 
monitoring should be intensified and the dose adjusted on an individual basis. 
 
Paediatric population 
The safety and efficacy of Lyumjev in children and adolescents below 18 years of age have not yet 
been established. No data are available. 
 



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Method of administration 
 
Patients should be trained on proper use and injection technique before initiating Lyumjev. Patients 
should be told to: 
• Always check insulin labels before administration. 
• Inspect Lyumjev visually before use and discard for particulate matter or discolouration. 
• Rotate injection or infusion sites to reduce the risk of lipodystrophy. 
• Carry a spare or alternative administration method in case their delivery system breaks. 
 
Subcutaneous injection 
 
Lyumjev should be injected subcutaneously into the abdomen, upper arm, thigh or buttocks (see 
section 5.2). 
 
Lyumjev should generally be used in combination with an intermediate or long-acting insulin.  A 
different injection site should be used if injecting at the same time as another insulin.  
 
When injecting a blood vessel should not be entered.  
 
Devices should be discarded if any part looks broken or damaged.  
 
The needle should be discarded after each injection.  
 
Lyumjev vials 
If subcutaneous administration by syringe is necessary, a vial should be used. 
 
The syringe must have 100 units/mL markings. 
 
Patients using vials must never share needles or syringes. 
 
Lyumjev cartridges 
Lyumjev in cartridges is only suitable for subcutaneous injections from a Lilly reusable pen.  
 
Lyumjev cartridges should not be used with any other reusable pen as the dosing accuracy has not 
been established with other pens. 
 
The instructions with each individual pen must be followed for loading the cartridge, attaching the 
needle and administering the insulin injection. 
 
To prevent the possible transmission of disease, each cartridge must be used by one patient only, even 
if the needle on the delivery device is changed. 
 
Lyumjev KwikPens 
The KwikPen and Junior KwikPen are only suitable for subcutaneous injections. 
 
Lyumjev is available in two concentrations: Lyumjev 100 units/mL KwikPen and Lyumjev 
200 units/mL KwikPen. See the separate SmPC for Lyumjev 200 units/mL KwikPen. The KwikPen 
delivers 1 - 60 units in steps of 1 unit in a single injection. The Lyumjev 100 units/mL Junior KwikPen 
delivers 0.5 - 30 units in steps of 0.5 units in a single injection. The number of insulin units is shown 
in the dose window of the pen regardless of concentration and no dose conversion should be done 
when transferring a patient to a new concentration or to a pen with a different dose step.  
 
Lyumjev 100 units/mL Junior KwikPen is suitable for patients who may benefit from finer insulin 
dose adjustments. 
 



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For detailed user instructions, please refer to the instructions for use provided with the package leaflet. 
 
To prevent the possible transmission of disease, each pen must be used by one patient only, even if the 
needle is changed. 
 
CSII (insulin pump) 
Use a pump suitable for insulin infusion. Fill the pump reservoir from a Lyumjev 100 units/mL vial.  
 
Patients using a pump should follow the instructions provided with the pump and infusion set.  
Use the correct reservoir and catheter for the pump. 
 
When filling the pump reservoir avoid damaging it by using the correct needle length on the filling 
system. The infusion set (tubing and cannula) should be changed in accordance with the instructions in 
the product information supplied with the infusion set. 
 
A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels (see 
section 4.4). 
 
Intravenous use 
 
Lyumjev 100 units/mL is available in vials if administration of intravenous injection is necessary. This 
medicinal product must not be mixed with any other insulin or any other medicinal product except 
those mentioned in section 6.6. 
 
For instructions on dilution of the medicinal product before administration, see section 6.6. 
 
Intravenous administration of Lyumjev 100 units/mL must be performed under medical supervision. 
 
4.3 Contraindications 
 
Hypoglycaemia. 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered medicinal product should be clearly recorded. 
 
Hypoglycaemia 
 
Hypoglycaemia is the most common adverse reaction of insulin therapy. The timing of hypoglycaemia 
usually reflects the time-action profile of the administered insulin formulations. Hypoglycaemia may 
occur earlier after an injection/infusion when compared to other mealtime insulins due to the earlier 
onset of action of Lyumjev (see section 5.1). 
 
Hypoglycaemia can happen suddenly and symptoms may differ in each individual and change over 
time in the same individual. Severe hypoglycaemia can cause seizures, may lead to unconsciousness, 
may be life-threatening, or cause death. Symptomatic awareness of hypoglycaemia may be less 
pronounced in patients with longstanding diabetes. 
 
Hyperglycaemia 
 
The use of inadequate doses or discontinuation of treatment, may lead to hyperglycaemia and diabetic 
ketoacidosis; conditions which are potentially lethal. 
 



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Patients should be educated to recognize the signs and symptoms of ketoacidosis and to get immediate 
help when ketoacidosis is suspected. 
 
Insulin requirements and dose adjustments 
 
Changes in insulin, insulin concentration, manufacturer, type, or method of administration may affect 
glycaemic control and predispose to hypoglycaemia or hyperglycaemia. These changes should be 
made cautiously under close medical supervision and the frequency of glucose monitoring should be 
increased. For patients with type 2 diabetes, dosage adjustments in concomitant anti-diabetic treatment 
may be needed (see sections 4.2 and 4.5). 
 
In patients with renal or hepatic impairment, glucose monitoring should be intensified and dosage 
adjusted on an individual basis (see section 4.2). 
 
Insulin requirements may be increased during illness or emotional disturbances. 
 
Adjustment of dosage may also be necessary if patients undertake increased physical activity or 
change their usual diet. Exercise taken immediately after a meal may increase the risk of 
hypoglycaemia. 
 
Hyperglycaemia and ketoacidosis due to insulin pump device malfunction 
 
Malfunction of the insulin pump or insulin infusion set can rapidly lead to hyperglycaemia and 
ketoacidosis. Prompt identification and correction of the cause of hyperglycaemia or ketosis is 
necessary. Interim subcutaneous injections with Lyumjev may be required. 
 
Thiazolidinediones (TZDs) used in combination with insulin 
 
TZDs can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid 
retention may lead to or exacerbate heart failure. Patients treated with insulin and a TZD should be 
observed for signs and symptoms of heart failure. If heart failure develops, consider discontinuation of 
the TZD. 
 
Hypersensitivity and allergic reactions 
 
Severe, life-threatening, generalised allergy, including anaphylaxis, can occur with insulin medicinal 
products, including Lyumjev. If hypersensitivity reactions occur, discontinue Lyumjev. 
 
Medication errors 
 
Lyumjev should not be used by patients with visual impairment without help of a trained person. 
 
To avoid medication errors between Lyumjev and other insulins, patients need to always check the 
insulin label before each injection.  
 
Patients should always use a new needle for each injection to prevent infections and a blocked needle. 
In the event of a blocked needle it should be replaced with a new needle.   
 
Excipients 
 
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 
 
The following substances may reduce insulin requirement: Antidiabetic medicinal products (oral or 
injectable), salicylates, sulphonamides, certain antidepressants (monoamine oxidase inhibitors 



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(MAOIs), selective serotonin reuptake inhibitors), angiotensin converting enzyme (ACE) inhibitors, 
angiotensin II receptor blocking agents, or somatostatin analogues. 
 
The following substances may increase insulin requirement: oral contraceptives, corticosteroids, 
thyroid hormones, danazol, sympathomimetic agents, diuretics, or growth hormone. 
 
Alcohol may increase or decrease the blood glucose lowering effect of Lyumjev. Consumption of 
large amounts of ethanol concomitantly with insulin use may lead to severe hypoglycaemia.  
 
Beta-blockers may blunt the signs and symptoms of hypoglycaemia. 
 
TZDs can cause dose-related fluid retention, particularly when used in combination with insulin, and 
exacerbate heart failure (see section 4.4). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no 
malformative nor feto/neonatal toxicity of insulin lispro. Lyumjev can be used during pregnancy 
if clinically needed. 
 
It is essential to maintain good control of an insulin-treated (insulin-dependent or gestational) diabetes 
patient throughout pregnancy. Insulin requirements usually fall during the first trimester and increase 
during the second and third trimesters. After delivery, insulin requirements normally return rapidly to 
pre-pregnancy values. Patients with diabetes should be advised to inform their doctor if they are 
pregnant or are contemplating pregnancy. Careful monitoring of glucose control is essential in 
pregnant patients with diabetes.  
 
Breast-feeding 
 
Lyumjev can be used during breast-feeding. Patients with diabetes who are breast-feeding may require 
adjustments in insulin dose, diet or both. 
 
Fertility 
 
Insulin lispro did not induce fertility impairment in animal studies. 
 
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. This may 
constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using 
machinery). 
 
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is 
particularly important in those patients who have reduced or absent awareness of the warning signs of 
hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be 
considered in these circumstances. 
 
4.8 Undesirable effects 
 
Summary of safety profile  
 
The most frequently reported adverse reaction during treatment is hypoglycaemia (very common) (see  
sections 4.2, 4.4 and 4.9). 
 



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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). 
 
Table 1. Adverse reactions  
 

MedDRA System 
Organ Class Very common Common Uncommon 

Metabolism and 
nutrition disorders 

Hypoglycaemia   

Skin and subcutaneous 
tissue disorders 

  Lipodystrophy 
Rash 
Pruritus 

General disorders and 
administration site 
conditions 

 Injection site 
reactions 

Oedema 

 Allergic 
reactions* 

 
  

*See section 4.8 Description of selected adverse events 
 
Description of selected adverse reactions 
 
Hypoglycaemia 
 
Hypoglycaemia is the most commonly observed adverse reaction in patients using insulin. The 
incidence of severe hypoglycaemia in the 26 week Phase 3 clinical studies was 5.5 % in patients with 
type 1 diabetes mellitus and 0.9 % in patients with type 2 diabetes (see tables 2 and 3). 
 
The symptoms of hypoglycaemia usually occur suddenly. They may include listlessness, confusion, 
palpitations, sweating, vomiting, and headache.  
 
There were no clinically significant differences in the frequency of hypoglycaemia with administration 
of Lyumjev or the comparator (another medicinal product containing insulin lispro) across all studies. 
In studies where Lyumjev and the comparator were administered at different times relative to meals, 
there were no clinically relevant differences in the frequency of hypoglycaemia.    
 
Hypoglycaemia may occur earlier after an injection/infusion of Lyumjev compared to other mealtime 
insulins due to the earlier onset of action. 
 
Allergic reactions 
 
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, 
angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including Lyumjev. 
 
Injection site reactions 
 
As with other insulin therapy, patients may experience rash, redness, inflammation, pain, bruising or 
itching at the site of Lyumjev injection. These reactions are usually mild and usually disappear during 
continued treatment. 
 
Immunogenicity 
 
Administration of insulin can cause formation of insulin antibodies. The presence of anti-drug 
antibodies did not have a clinically meaningful effect on the pharmacokinetics, efficacy, or safety of 
Lyumjev. 



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Lipodystrophy 
 
Administration of insulin, including Lyumjev, may result in lipodystrophy [lipohypertrophy 
(enlargement or thickening of tissue), lipoatrophy (depression in the skin)] or cutaneous amyloidosis 
(lumps under the skin). Continuous rotation of the injection site within the particular injection area 
may help to reduce the risk of developing these reactions. 
 
Oedema  
 
Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic 
control is improved by intensified insulin therapy. 
 
Special populations  
 
Based on results from clinical trials with insulin lispro in general, the frequency, type and severity of 
adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not 
indicate any differences to the broader experience in the general population. The safety information in 
very elderly patients (≥ 75 years) or patients with moderate to severe renal impairment or hepatic 
impairment is limited (see section 5.1). 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Overdose causes hypoglycaemia with accompanying symptoms that include listlessness, confusion, 
palpitations, sweating, vomiting, and headache.  
 
Hypoglycaemia may occur as a result of an excess of insulin lispro relative to food intake, energy 
expenditure, or both. Mild episodes of hypoglycaemia usually can be treated with oral glucose. More 
severe episodes with coma, seizure, or neurologic impairment may be treated with glucagon or 
concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary 
because hypoglycaemia may recur after apparent clinical recovery. Adjustments in drug dosage, meal 
patterns, or exercise may be needed. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting, 
ATC code: A10AB04. 
 
Mechanism of action 
 
The primary activity of Lyumjev is the regulation of glucose metabolism. Insulins, including insulin 
lispro, the active substance in Lyumjev, exert their specific action through binding to insulin receptors. 
Receptor-bound insulin lowers blood glucose by stimulating peripheral glucose uptake by skeletal 
muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, 
and enhance protein synthesis. 
 



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Lyumjev is a formulation of insulin lispro that contains citrate and treprostinil. Citrate increases local 
vascular permeability and treprostinil induces local vasodilation to achieve accelerated absorption of 
insulin lispro. 
 
Pharmacodynamic effects 
 
Early and late insulin action 
 
A glucose clamp study was conducted in 40 type 1 diabetes patients given Lyumjev and Humalog 
subcutaneously as a single 15 unit dose. Results are provided in Figure 1. Lyumjev has been shown to 
be equipotent to Humalog on a unit for unit basis but its effect is more rapid with a shorter duration of 
action. 
 
• Onset of action of Lyumjev was 20 minutes post dose, 11 minutes faster than Humalog. 
• During the first 30 minutes post dose, Lyumjev had a 3-fold greater glucose lowering effect 

compared to Humalog. 
• Maximum glucose-lowering effect of Lyumjev occurred between 1 and 3 hours after injection. 
• The late insulin action, from 4 hours until the end of the glucose clamp, was 54 % lower with 

Lyumjev than observed with Humalog. 
• The duration of action of Lyumjev was 5 hours, 44 minutes shorter than Humalog. 
• The total glucose infused during the clamp was comparable between Lyumjev and Humalog. 
 
Figure 1. Mean glucose infusion rate (GIR) in patients with type 1 diabetes after subcutaneous 
injection of Lyumjev or Humalog (15 unit dose) 
 

 

 
 

Similarly, a faster early insulin action and a reduced late insulin action was observed with Lyumjev in 
type 2 diabetes patients. 
 
Total and maximum glucose lowering effect of Lyumjev increased with dose within the therapeutic 
dose range. The early onset and total insulin action were similar when Lyumjev was administered in 
the abdomen, upper arm, or thigh. 
 
Postprandial Glucose (PPG) Lowering 
 
Lyumjev reduced the PPG during a standardized test meal over the complete 5 hour test meal period 
(change from premeal AUC(0-5h)) compared to Humalog.  



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• In patients with type 1 diabetes, Lyumjev reduced the PPG during the 5 hour test meal period by 
32 % when given at the start of the meal and 18 % when given 20 minutes after the start of the 
meal compared to Humalog. 

• In patients with type 2 diabetes, Lyumjev reduced the PPG during the 5 hour test meal period by 
26 % when given at the start of the meal and 24 % when given 20 minutes after the start of the 
meal compared to Humalog. 

 
Comparison of Lyumjev 200 units/mL and Lyumjev 100 units/mL 
 
The maximum and total glucose lowering were comparable for Lyumjev 200 units/mL or Lyumjev 
100 units/mL. No dose conversion is required if transferring a patient between the strengths. 
 
Clinical efficacy and safety 
 
The efficacy of Lyumjev was evaluated in 3 randomized, active controlled trials in adults.  
 
Type 1 Diabetes – Adults 
 
PRONTO-T1D was a 26 week, treat-to-target, trial that evaluated the efficacy of Lyumjev in 
1222 patients on multiple daily injection therapy. Patients were randomized to either blinded 
mealtime Lyumjev, blinded mealtime Humalog, or open-label postmeal Lyumjev, all in combination 
with either insulin glargine or insulin degludec . Mealtime Lyumjev or Humalog was injected 0 to 
2 minutes before the meal and postmeal Lyumjev was injected 20 minutes after the start of the meal. 
 
Efficacy results are provided in Table 2 and Figure 2. 
 
37.4 % of patients treated with mealtime Lyumjev, 33.6 % of patients treated with mealtime Humalog 
and 25.6 % of patients treated with postmeal Lyumjev reached a target HbA1c of < 7 %. 
 
Basal, bolus and total insulin doses were similar among study arms at 26 weeks. 
 
Following the 26 week period, the two blinded treatment arms continued to 52 weeks. HbA1c was not 
statistically significantly different between treatments at the 52 week endpoint. 
 



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Table 2 Results from 26  week basal-bolus clinical trial in patients with type 1 diabetes  
 
 Mealtime Lyumjev 

+ basal insulin 
Mealtime 

Humalog + 
basal insulin 

Postmeal Lyumjev 
+ basal insulin 

Number of randomized subjects (N) 451 442 329 
HbA1c (%) 
 Baseline  week 26  7.34  7.21 7.337.29 7.367.42 
 Change from baseline -0.13 -0.05 0.08 
 Treatment difference  -0.08 [-0.16, -0.00]C  0.13 [0.04, 0.22]D 
HbA1c (mmol/mol) 
 Baseline  week 26 56.755.3 56.756.1 56.957.6 
 Change from baseline -1.4 -0.6 0.8 
 Treatment difference  -0.8 [-1.7, 0.00]C  1.4 [0.5, 2.4]D 
1 hour postprandial glucose excursion (mg/dL) A 
 Baseline  week 26  77.3 46.4 71.5 74.3 76.387.5 
 Change from baseline  -28.6 -0.7 12.5 
 Treatment difference -27.9 [-35.3, -20.6]C,E  13.2 [5.0, 21.4]D 
1 hour postprandial glucose excursion (mmol/L) A 
 Baseline  week 26  4.292.57 3.97 4.13 4.244.86 
 Change from baseline  -1.59 -0.04 0.70 
 Treatment difference -1.55[-1.96, -1.14]C,E  0.73 [0.28,1.19]D 
2 hour postprandial glucose excursion (mg/dL) A 
 Baseline  week 26  112.772.7 101.6 103.9 108.0 97.2 
 Change from baseline  -34.7 -3.5 -10.2 
 Treatment difference -31.2 [-41.1, -21.2]C,E  -6.7 [-17.6, 4.3] D.   
2 hour postprandial glucose excursion (mmol/L) A 
 Baseline  week 26  6.264.04 5.645.77 5.995.40 
 Change from baseline  -1.93 -0.20 -0.56 
 Treatment difference -1.73 [-2.28, -1.18]C,E  -0.37 [-0.98, -0.24]D 
Body weight (Kg)    
 Baseline  week 26 77.377.9 77.378.2 77.678.1 
 Change from baseline  0.6 0.8 0.7 
 Treatment difference -0.2 [-0.6, 0.1]A  -0.1[-0.5, 0.3]D 
Severe hypoglycaemia B (% of patients) 5.5 % 5.7 % 4.6 % 

Week 26 and change from baseline values are based on the least-squares means (adjusted means).  
The 95 % confidence interval is stated in ‘[ ]’.   
A Meal test  
B Severe hypoglycaemia is defined as episode requiring assistance of another person due to patient’s 
neurological impairment. 
C The difference is for mealtime Lyumjev – mealtime Humalog.  
D The difference is for postmeal Lyumjev – mealtime Humalog. 
E Statistically significant in favour of mealtime Lyumjev. 



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Figure 2. Time course of blood glucose excursion during mixed-meal tolerance test at week 26 in 
patients with type 1 diabetes 
 

 
 

PPG = Postprandial glucose 
Lyumjev and Humalog administered at mealtime 
Lyumjev + 20 = Lyumjev was injected 20 minutes after the start of the meal. 
*p < 0.05 for pairwise comparison on Lyumjev versus Humalog 
^p < 0.05 for pairwise comparison on Lyumjev +20 versus Humalog 
#p < 0.05 for pairwise comparison on Lyumjev +20 versus Lyumjev 
 
Continuous glucose monitoring (CGM) in Type 1 Diabetes – Adults 
 
A subset of patients (N = 269) participated in an evaluation of the 24 hour ambulatory glucose profiles 
captured with blinded CGM. At the 26 week assessment, patients treated with mealtime Lyumjev 
demonstrated statistically significant improvement in PPG control during CGM assessment of glucose 
excursions or incremental area under the curve (AUC) 0 - 2 hours, 0 - 3 hours, and 0 - 4 hours after 
meals compared to patients treated with Humalog. Patients treated with mealtime Lyumjev reported 
statistically significantly longer time in range (6 am to midnight) with 603 minutes in range, (3.9 to 
10 mmol/L, 71 – 180 mg/dL), and 396 minutes in range (3.9 to 7.8 mmol/L, 71 to 140  mg/dL), 44 and 
41 minutes longer than Humalog patients respectively.  
 
Type 2 Diabetes – Adults 
 
PRONTO-T2D was a 26 week, treat-to-target trial that evaluated the efficacy of Lyumjev in 
673 patients were randomized to either blinded mealtime Lyumjev or to blinded mealtime Humalog, 
both in combination with a basal insulin (insulin glargine or insulin degludec) in a basal-bolus 
regimen. Mealtime Lyumjev or mealtime Humalog was injected 0 - 2 minutes before the meal. 
Efficacy results are provided in Table 3 and Figure 3. 
 
58.2 % of patients treated with mealtime Lyumjev and 52.5 % of patients treated with mealtime 
Humalog reached a target HbA1c of < 7 %.  
 



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Basal, bolus and total insulin doses were similar among study arms at the end of the trial.  
 
Table 3 Results from 26 week basal-bolus clinical trial in patients with type 2 diabetes  
 
 Mealtime Lyumjev 

+ basal insulin 
Mealtime Humalog 

+ basal insulin 

Number of randomized subjects (N) 336 337 
HbA1c (%) 
 Baseline  week 26 7.286.92 7.316.86 
 Change from baseline -0.38 -0.43 
 Treatment difference  0.06 [-0.05, 0.16]  
HbA1c (mmol/mol) 
 Baseline  week 26 56.052.1 56.451.5 
 Change from baseline -4.1 -4.7 
 Treatment difference  0.6 [-0.6, 1.8]  
1 hour postprandial glucose excursion (mg/dL)A 

 Baseline  week 26 76.663.1 77.174.9 
 Change from baseline  -13.8 -2.0 
 Treatment difference -11.8 [-18.1, -5.5]C 

1 hour postprandial glucose excursion (mmol/L)A   
 Baseline  week 26 4.253.50 4.284.16 
 Change from baseline  -0.77 -0.11 
 Treatment difference -0.66 [-1.01, -0.30]C 
2 hour postprandial glucose excursion (mg/dL)A 
 Baseline  week 26 99.380.4 99.697.8 
 Change from baseline  -19.0 -1.6 
 Treatment difference -17.4 [-25.3, -9.5]C 
2 hour postprandial glucose excursion (mmol/L)A 
 Baseline  week 26 5.514.47 5.535.43 
 Change from baseline  -1.06 -0.09 
 Treatment difference -0.96 [-1.41, -0.52]C 
Body weight (Kg)   
 Baseline  week 26 89.891.3 90.0 91.6 
 Change from baseline  1.4 1.7 
 Treatment difference -0.2 [-0.7, 0.3] 
Severe hypoglycaemia (% of patients)B 0.9 % 1.8 % 

Week 26 and change from baseline values are based on the least-squares means (adjusted means).  
The 95 % confidence interval is stated in ‘[ ]’. The difference is for mealtime Lyumjev – mealtime 
Humalog.  
A Meal test  
B Severe hypoglycaemia is defined as episode requiring assistance of another person due to patient’s 
neurological impairment. 
C Statistically significant in favour of mealtime Lyumjev. 
 
 



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Figure 3. Time course of blood glucose excursion during mixed-meal tolerance test at week 26 in 
patients with type 2 diabetes 
 

 
 
PPG = Postprandial glucose 
Lyumjev and Humalog administered at mealtime 
Data are LSM (SE), *p < 0.05  
 
Elderly  
 
In the two 26 week clinical studies, 187 of 1,116 (17 %) Lyumjev treated patients with type 1 diabetes 
or type 2 diabetes were ≥ 65 years of age and 18 of 1,116 (2 %) were ≥ 75 years of age. No overall 
differences in safety or effectiveness were observed between elderly patients and younger patients. 
 
Type 1 Diabetes – Adults. CSII 
 
PRONTO-Pump was a 12 week cross over design (2 periods of 6 weeks), double-blind, trial that 
evaluated the compatibility and safety of Lyumjev and Humalog with an external CSII System in 
patients who wore a continuous glucose monitor throughout the study. There were no statistically 
significant treatment difference in the rate or incidence of infusion set failures (n = 49). 
 
In period 1 of the cross over study, Lyumjev had a numerically greater reduction in mean HbA1c than 
Humalog. Lyumjev reduction was -0.39 % [- 4.23 mmol/mol] from a baseline of 6.97 % 
[52.68 mmol/mol] and Humalog reduction was - 0.25 % [- 2.78 mmol/mol] from a baseline of 7.17 % 
[54.89 mmol/mol]. Lyumjev had a statistically significantly longer mean duration of time with glucose 
in target ranges 71 – 140 mg/dL (3.9 to 7.8 mmol/L) within 1 and 2 hours after the start of breakfast 
compared to Humalog. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Absorption of insulin lispro was accelerated and the duration of exposure was shorter in healthy 
subjects and patients with diabetes following injection of Lyumjev compared to Humalog. In patients 
with type 1 diabetes: 



16 
 

• Insulin lispro appeared in circulation approximately 1 minute after injection of Lyumjev, which 
was five minutes faster than Humalog . 

• Time to 50 % maximum concentration was 14 minutes shorter with Lyumjev compared to 
Humalog. 

• Following injection of Lyumjev, there was seven times more insulin lispro in circulation during 
the first 15 minutes compared to Humalog and three times more insulin lispro during the first 
30 minutes compared to Humalog. 

• After administration of Lyumjev the time to maximum insulin lispro concentration was 
achieved at 57 minutes.  

• Following injection of Lyumjev there was 41 % less insulin lispro in circulation after 3 hours 
following injection compared to Humalog.  

• The duration of insulin lispro exposure for Lyumjev was 60 minutes shorter compared to 
Humalog. 

• The total insulin lispro exposure (ratio and 95 % CI of 1.03 (0.973, 1.09) and maximum 
concentration (ratio and 95 % CI of 1.06 (0.97, 1.16) were comparable between Lyumjev and 
Humalog. 

 
In type 1 patients, the day-to-day variability [CV %] of Lyumjev was 13 % for total insulin lispro 
exposure (AUC, 0 - 10h) and 23 % for maximum insulin lispro concentration (Cmax).The absolute 
bioavailability of insulin lispro after subcutaneous administration of Lyumjev in the abdomen, upper 
arm and thigh was approximately 65 %. The accelerated absorption of insulin lispro is maintained 
regardless of injection site (abdomen, upper arm and thigh). No exposure data are available following 
injection in the buttocks.  
 
Maximum concentration and time to maximum concentration were comparable for the abdomen and 
upper arm regions; time to maximum concentration was longer and maximum concentration lower for 
the thigh. 
 
Total insulin lispro exposure and maximum insulin lispro concentration increased proportionally with 
increasing subcutaneous doses of Lyumjev within the dose range from 7U to 30U. 
 
CSII  
 
The absorption of insulin lispro was accelerated when Lyumjev was administered by CSII in patients 
with type 1 diabetes.  
• Time to reach 50 % maximum concentration was 14 minutes, 9 minutes shorter than for 

Humalog. 
• Following administration of Lyumjev, 1.5 times more insulin lispro was available during the 

first 30 minutes compared to Humalog. 
 
Comparison of Lyumjev 200 units/mL and Lyumjev 100 units/mL 
 
The results of a study in healthy subjects demonstrated that Lyumjev 200 units/mL is bioequivalent to 
Lyumjev 100 units/mL following administration of a single 15 unit dose for the area under serum 
insulin lispro concentration-time curve from time zero to infinity and maximum insulin lispro 
concentration. The accelerated insulin lispro absorption after administration of 200 units/mL was 
similar to that observed with Lyumjev 100 units/mL. No dose conversion is required if transferring a 
patient between the strengths.  
 
Distribution 
 
The geometric mean (% coefficient of variation [CV %]) volume of distribution of insulin lispro (Vd) 
was 34 L (30 %) after intravenous administration of Lyumjev as a bolus injection of a 15 unit dose in 
healthy subjects. 
 
 



17 
 

Elimination 
 
The geometric mean (CV %) clearance of insulin lispro was 32 L/hour (22 %) and the median half-life 
of insulin lispro was 44 minutes after intravenous administration of Lyumjev as a bolus injection of a 
15 unit dose in healthy subjects. 
 
Special populations 
 
In adult subjects, age, gender, and race did not affect the pharmacokinetics and pharmacodynamics of 
Lyumjev. No data are available on children and adolescents below 18 years of age. 
 
Patients with renal and hepatic impairment 
 
Renal and hepatic impairment is not known to impact the pharmacokinetics of insulin lispro.  
 
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 
and development after exposure to insulin lispro. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Glycerol 
Magnesium chloride hexahydrate 
Metacresol 
Sodium citrate dihydrate 
Treprostinil sodium 
Zinc oxide 
Water for injections 
Hydrochloric acid and sodium hydroxide (for pH adjustment)  
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with any other insulin or any other medicinal product 
except those mentioned in section 6.6. 
 
6.3 Shelf life 
 
Before use 
 
2 years 
 
After first use 
 
28 days 
 
Lyumjev 100 units/mL solution for injection in vial 
 
When the vial is diluted for intravenous use 
 
Chemical, physical in-use stability has been demonstrated for 14 days at 2–8 °C and 20 hours at 
20-25 °C when protected from light. From a microbiological point of view, the medicinal product 
should be used immediately. If not used immediately, in-use storage times and conditions prior to use 



18 
 

are the responsibility of the user and would not normally be longer than 24 hours at 2-8 °C, unless 
dilution has taken place in controlled and validated aseptic conditions (see section 6.6). 
 
6.4 Special precautions for storage 
 
Before use 
 
Store in the refrigerator (2 °C - 8 °C). 
Do not freeze.  
Store in the original package in order to protect from light 
 
After first use  
 
Do not store above 30 °C.  
Do not freeze.  
 
Lyumjev 100 units/mL solution for injection in vial 
 
Store in the original package in order to protect from light. 
 
Lyumjev 100 units/mL solution for injection in cartridge 
 
Do not refrigerate.  
Keep the cap on the pen once cartridge inserted, in order to protect from light. 
 
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen 
 
Do not refrigerate.  
Keep the cap on the pen in order to protect from light. 
 
Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen 
 
Do not refrigerate.  
Keep the cap on the pen in order to protect from light. 
 
6.5 Nature and contents of container  
 
Lyumjev 100 units/mL solution for injection in vial 
 
Type I clear glass vials, sealed with halobutyl stoppers and secured with aluminium seals.  
 
10 mL vial: Packs of 1 or 2 vials or 5 (5 packs of 1) vials.  
 
Lyumjev 100 units/mL solution for injection in cartridge 
 
Type I clear glass cartridges, sealed with disc seals secured with aluminium seals and halobutyl 
plungers.  
 
3 mL cartridge: Packs of 2, 5 or 10 cartridges.  
 
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen 
 
Type I clear glass cartridges, sealed with disc seals secured with aluminium seals and halobutyl 
plungers.  
 
The 3 mL cartridges are sealed in a disposable pen injector KwikPen .  
 



19 
 

The medicinal product is packed in a white carton with dark blue bands and an image of the pen. The 
KwikPen is taupe, the dose knob is blue with raised edges. 
 
3 mL KwikPen: Packs of 2 pre-filled pens, 5 pre-filled pens or a multipack of 10 (2 packs of 5) pre-
filled pens.  
 
Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen 
 
Type I clear glass cartridges, sealed with disc seals secured with aluminium seals and halobutyl 
plungers. 
  
The 3 mL cartridges are sealed in a disposable pen injector Junior KwikPen .  
 
The medicinal product is packed in a white carton with stripes of peach, light blue and dark blue bands 
and an image of the pen. The Junior KwikPen is taupe, the dose knob is peach with raised edges. 
 
3 mL Junior KwikPen: Packs of 2 pre-filled pens, 5 pre-filled pens or a multipack of 10 (2 packs of 5) 
pre-filled pens.  
 
Not all pack sizes may be marketed. 
 
 
6.6 Special precautions for disposal and other handling 
 
Lyumjev should look clear and colourless. It should not be used if it is cloudy, coloured, or has 
particles or clumps in it. 
 
Lyumjev should not be used if it has been frozen. 
 
A new needle must always be attached before each use. Needles must not be re-used. Needles are not 
included. 
 
Lyumjev 100 units/mL solution for injection in vial 
 
Intravenous use 
 
Lyumjev 100 units/mL vial can be diluted to concentrations of 0.1 to 1.0 unit/mL in 5 % glucose 
solution for injection or sodium chloride 9 mg/mL (0.9 %) solution for injection for intravenous use. 
Compatibility has been demonstrated in ethylene-propylene copolymer and polyolefin with polyvinyl 
chloride bags. 
 
It is recommended that the system is primed before starting the infusion to the patient. 
 
CSII   
 
Lyumjev 100 units/mL vial can be used to fill a continuous insulin infusion pump for a maximum of 
9 days. Tubings in which the inner surface materials are made of polyethylene or polyolefin have been 
evaluated and found compatible with pump use. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 



20 
 

 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1422/001 
EU/1/20/1422/002 
EU/1/20/1422/003 
EU/1/20/1422/004 
EU/1/20/1422/005 
EU/1/20/1422/006 
EU/1/20/1422/007 
EU/1/20/1422/008 
EU/1/20/1422/009 
EU/1/20/1422/010 
EU/1/20/1422/011 
EU/1/20/1422/012 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 24 March 2020 
 
 
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 
 



21 
 

This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions.  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 200 units/mL KwikPen solution for injection in pre-filled pen 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each mL contains 200 units insulin lispro*(equivalent to 6.9 mg).  
 
Each pre-filled pen contains 600 units of insulin lispro in 3 mL solution. 
 
Each KwikPen delivers 1 - 60 units in steps of 1 unit in a single injection. 
 
* produced in E.coli by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection. 
 
Clear, colourless, aqueous solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of diabetes mellitus in adults. 
 
4.2 Posology and method of administration 
 
Posology 
 
Lyumjev is a mealtime insulin for subcutaneous injection and should be administered zero to two 
minutes before the start of the meal, with the option to administer up to 20 minutes after starting the 
meal (see section 5.1). 
 
The initial dosage should take into account the type of diabetes, weight of the patient and their blood 
glucose levels.  
 
The early onset of action must be considered when prescribing Lyumjev (see section 5.1). Continued 
adjustment of the dose of Lyumjev should be based on the patient’s metabolic needs, blood glucose 
monitoring results, and glycaemic control goal. Dose adjustments may be needed, when switching 
from another insulin, with changes in physical activity, changes in concomitant medicinal products, 
changes in meal patterns (i.e., amount and type of food, timing of food intake), changes in renal or 
hepatic function or during acute illness to minimize the risk of hypoglycaemia or hyperglycaemia (see 
sections 4.4 and 4.5).  
 
 
 



22 
 

Switching from another mealtime insulin medicinal product 
 
If converting from another mealtime insulin to Lyumjev, the change can be done on a unit-to-unit 
basis. The potency of insulin analogues, including Lyumjev, is expressed in units. One (1) unit of 
Lyumjev corresponds to 1 international unit (IU) of human insulin or 1 unit of other fast-acting insulin 
analogues.  
 
Missed doses 
 
Patients who forget a mealtime dose should monitor their blood glucose level to decide if an insulin 
dose is needed, and to resume their usual dosing schedule at the next meal. 
 
Special populations 
 
Elderly (≥ 65 years old)  
The safety and efficacy of Lyumjev has been established in elderly patients aged 65 to 75 years. Close 
glucose monitoring is recommended and the insulin dose should be adjusted on an individual basis 
(see sections 4.8, 5.1 and 5.2). The therapeutic experience in patients ≥ 75 years of age is limited. 
 
Renal impairment 
Insulin requirements may be reduced in the presence of renal impairment. In patients with renal 
impairment, glucose monitoring should be intensified and the dose adjusted on an individual basis. 
 
Hepatic impairment 
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for 
gluconeogenesis and reduced insulin breakdown. In patients with hepatic impairment, glucose 
monitoring should be intensified and the dose adjusted on an individual basis. 
 
Paediatric population 
The safety and efficacy of Lyumjev in children and adolescents below 18 years of age have not yet 
been established. No data are available. 
 
Method of administration 
 
Patients should be trained on proper use and injection technique before initiating Lyumjev. Patients 
should be told to: 
• Always check insulin labels before administration. 
• Inspect Lyumjev visually before use and discard for particulate matter or discolouration. 
• Rotate injection sites to reduce the risk of lipodystrophy. 
• Ensure when injecting that a blood vessel has not been entered.  
• Discard the needle after each injection  
• Discard devices if any part looks broken or damaged.  
• Carry a spare or alternative administration method in case their delivery system breaks. 
 
Lyumjev should be injected subcutaneously into the abdomen, upper arm, thigh or buttocks (see 
section 5.2). 
 
Lyumjev should generally be used in combination with an intermediate or long-acting insulin. A 
different injection site should be used if injecting at the same time as another insulin.  
 
The Lyumjev 200 units/mL KwikPen is only suitable for subcutaneous injections. 
 
Lyumjev 200 units/mL should not be administered using a continuous subcutaneous insulin infusion 
(CSII) pump. 
 
Lyumjev 200 units/mL should not be administered intravenously. 



23 
 

 
Lyumjev is available in two concentrations: Lyumjev 200 units/mL KwikPen and Lyumjev 
100 units/mL KwikPen. See the separate SmPC for Lyumjev 100 units/mL KwikPen. The KwikPen 
delivers 1 - 60 units in steps of 1 unit in a single injection. The number of insulin units is shown in the 
dose window of the pen regardless of concentration and no dose conversion should be done when 
transferring a patient to a new concentration or to a pen with a different dose step.  
 
For detailed user instructions, please refer to the instructions for use provided with the package leaflet. 
 
To prevent the possible transmission of disease, each pen must be used by one patient only, even if the 
needle is changed. 
 
4.3 Contraindications 
 
Hypoglycaemia. 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered medicinal product should be clearly recorded. 
 
Hypoglycaemia 
 
Hypoglycaemia is the most common adverse reaction of insulin therapy. The timing of hypoglycaemia 
usually reflects the time-action profile of the administered insulin formulations. Hypoglycaemia may 
occur earlier after an injection when compared to other mealtime insulins due to the earlier onset of 
action of Lyumjev (see section  5.1). 
 
Hypoglycaemia can happen suddenly and symptoms may differ in each individual and change over 
time in the same individual. Severe hypoglycaemia can cause seizures, may lead to unconsciousness, 
may be life-threatening, or cause death. Symptomatic awareness of hypoglycaemia may be less 
pronounced in patients with longstanding diabetes. 
 
Hyperglycaemia 
 
The use of inadequate doses or discontinuation of treatment, may lead to hyperglycaemia and diabetic 
ketoacidosis; conditions which are potentially lethal. 
 
Patients should be educated to recognize the signs and symptoms of ketoacidosis and to get immediate 
help when ketoacidosis is suspected. 
 
Insulin requirements and dose adjustments 
 
Changes in insulin, insulin concentration, manufacturer, type, or method of administration may affect 
glycaemic control and predispose to hypoglycaemia or hyperglycaemia. These changes should be 
made cautiously under close medical supervision and the frequency of glucose monitoring should be 
increased. For patients with type 2 diabetes, dosage adjustments in concomitant anti-diabetic treatment 
may be needed (see sections 4.2 and 4.5). 
 



24 
 

In patients with renal or hepatic impairment, glucose monitoring should be intensified and dosage 
adjusted on an individual basis (see section 4.2). 
 
Insulin requirements may be increased during illness or emotional disturbances. 
 
Adjustment of dosage may also be necessary if patients undertake increased physical activity or 
change their usual diet. Exercise taken immediately after a meal may increase the risk of 
hypoglycaemia. 
 
Thiazolidinediones (TZDs) used in combination with insulin 
 
TZDs can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid 
retention may lead to or exacerbate heart failure. Patients treated with insulin and a TZD should be 
observed for signs and symptoms of heart failure. If heart failure develops, consider discontinuation of 
the TZD. 
 
Hypersensitivity and allergic reactions 
 
Severe, life-threatening, generalised allergy, including anaphylaxis, can occur with insulin medicinal 
products, including Lyumjev. If hypersensitivity reactions occur, discontinue Lyumjev. 
 
Medication errors 
 
Lyumjev should not be used by patients with visual impairment without help of a trained person. 
 
To avoid medication errors between Lyumjev and other insulins, patients need to always check the 
insulin label before each injection. 
 
Do not transfer insulin from the Lyumjev Pen 200 units/mL to a syringe. The markings on the insulin 
syringe will not measure the dose correctly and can result in overdose and severe hypoglycaemia. 
 
Patients should always use a new needle for each injection to prevent infections and a blocked needle. 
In the event of a blocked needle it should be replaced with a new needle.   
 
Excipients 
 
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 
 
The following substances may reduce insulin requirement: Antidiabetic medicinal products (oral or 
injectable), salicylates, sulphonamides, certain antidepressants (monoamine oxidase inhibitors 
(MAOIs), selective serotonin reuptake inhibitors), angiotensin converting enzyme (ACE) inhibitors, 
angiotensin II receptor blocking agents, or somatostatin analogues. 
 
The following substances may increase insulin requirement: oral contraceptives, corticosteroids, 
thyroid hormones, danazol, sympathomimetic agents, diuretics, or growth hormone. 
 
Alcohol may increase or decrease the blood glucose lowering effect of Lyumjev. Consumption of 
large amounts of ethanol concomitantly with insulin use may lead to severe hypoglycaemia. 
 
Beta-blockers may blunt the signs and symptoms of hypoglycaemia. 
 
TZDs can cause dose-related fluid retention, particularly when used in combination with insulin, and 
exacerbate heart failure (see section 4.4). 
 



25 
 

4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no 
malformative nor feto/neonatal toxicity of insulin lispro. Lyumjev can be used during pregnancy 
if clinically needed. 
 
It is essential to maintain good control of an insulin-treated (insulin-dependent or gestational) diabetes 
patient throughout pregnancy. Insulin requirements usually fall during the first trimester and increase 
during the second and third trimesters. After delivery, insulin requirements normally return rapidly to 
pre-pregnancy values. Patients with diabetes should be advised to inform their doctor if they are 
pregnant or are contemplating pregnancy. Careful monitoring of glucose control is essential in 
pregnant patients with diabetes.  
 
Breast-feeding 
 
Lyumjev can be used during breast-feeding. Patients with diabetes who are breast-feeding may require 
adjustments in insulin dose, diet or both. 
 
Fertility 
 
Insulin lispro did not induce fertility impairment in animal studies. 
 
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. This may 
constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using 
machinery). 
 
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is 
particularly important in those patients who have reduced or absent awareness of the warning signs of 
hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be 
considered in these circumstances. 
 
4.8 Undesirable effects 
 
Summary of safety profile  
 
The most frequently reported adverse reaction during treatment is hypoglycaemia (very common) (see 
sections 4.2, 4.4 and 4.9). 
 
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). 
 



26 
 

Table 1. Adverse reactions  
 

MedDRA System 
Organ Class Very common Common Uncommon 

Metabolism and 
nutrition disorders 

Hypoglycaemia   

Skin and subcutaneous 
tissue disorders 

  Lipodystrophy 
Rash 
Pruritus 

General disorders and 
administration site 
conditions 

 Injection site 
reactions 

Oedema 

 Allergic 
reactions* 

 

*See section 4.8 Description of selected adverse events 
 
Description of selected adverse reactions 
 
Hypoglycaemia 
 
Hypoglycaemia is the most commonly observed adverse reaction in patients using insulin The 
incidence of severe hypoglycaemia in the 26 week Phase 3 clinical studies was 5.5 % in patients with 
type 1 diabetes mellitus and 0.9 % in patients with type 2 diabetes (see tables  2 and 3). 
The symptoms of hypoglycaemia usually occur suddenly. They may include listlessness, confusion, 
palpitations, sweating, vomiting, and headache.  
 
There were no clinically significant differences in the frequency of hypoglycaemia with administration 
of Lyumjev or the comparator (another medicinal product containing insulin lispro) across all studies. 
In studies where Lyumjev and the comparator were administered at different times relative to meals, 
there were no clinically relevant differences in the frequency of hypoglycaemia.    
 
Hypoglycaemia may occur earlier after an injection of Lyumjev compared to other mealtime insulins 
due to the earlier onset of action. 
 
Allergic reactions 
 
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, 
angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including Lyumjev. 
 
Injection site reactions 
 
As with other insulin therapy, patients may experience rash, redness, inflammation, pain, bruising or 
itching at the site of Lyumjev injection. These reactions are usually mild and usually disappear during 
continued treatment. 
 
Immunogenicity 
 
Administration of insulin can cause formation of insulin antibodies. The presence of anti-drug 
antibodies did not have a clinically meaningful effect on the pharmacokinetics, efficacy, or safety of 
Lyumjev. 
 
Lipodystrophy 
 
Administration of insulin, including Lyumjev, may result in lipodystrophy [lipohypertrophy 
(enlargement or thickening of tissue), lipoatrophy (depression in the skin)]  or cutaneous amyloidosis 



27 
 

(lumps under the skin). Continuous rotation of the injection site within the particular injection area 
may help to reduce the risk of developing these reactions. 
 
Oedema  
 
Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic 
control is improved by intensified insulin therapy. 
 
Special populations  
 
Based on results from clinical trials with insulin lispro in general, the frequency, type and severity of 
adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not 
indicate any differences to the broader experience in the general population. The safety information in 
very elderly patients (≥ 75 years) or patients with moderate to severe renal impairment or hepatic 
impairment is limited (see section 5.1). 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Overdose causes hypoglycaemia with accompanying symptoms that include listlessness, confusion, 
palpitations, sweating, vomiting, and headache.  
 
Hypoglycaemia may occur as a result of an excess of insulin lispro relative to food intake, energy 
expenditure, or both. Mild episodes of hypoglycaemia usually can be treated with oral glucose. More 
severe episodes with coma, seizure, or neurologic impairment may be treated with glucagon or 
concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary 
because hypoglycaemia may recur after apparent clinical recovery. Adjustments in drug dosage, meal 
patterns, or exercise may be needed. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting, 
ATC code: A10AB04. 
 
Mechanism of action 
 
The primary activity of Lyumjev is the regulation of glucose metabolism. Insulins, including insulin 
lispro, the active substance in Lyumjev, exert their specific action through binding to insulin receptors. 
Receptor-bound insulin lowers blood glucose by stimulating peripheral glucose uptake by skeletal 
muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, 
and enhance protein synthesis. 
 
Lyumjev is a formulation of insulin lispro that contains citrate and treprostinil. Citrate increases local 
vascular permeability and treprostinil induces local vasodilation to achieve accelerated absorption of 
insulin lispro. 
 
 
 



28 
 

Pharmacodynamic effects 
 
Early and late insulin action 
 
A glucose clamp study was conducted in 40 type 1 diabetes patients given Lyumjev and Humalog 
subcutaneously as a single 15 unit dose. Results are provided in Figure 1. Lyumjev has been shown to 
be equipotent to Humalog on a unit for unit basis but its effect is more rapid with a shorter duration of 
action. 
 
• Onset of action of Lyumjev was 20 minutes post dose, 11 minutes faster than Humalog. 
• During the first 30 minutes post dose, Lyumjev had a 3-fold greater glucose lowering effect 

compared to Humalog. 
• Maximum glucose-lowering effect of Lyumjev occurred between 1 and 3 hours after injection. 
• The late insulin action, from 4 hours until the end of the glucose clamp, was 54 % lower with 

Lyumjev than observed with Humalog. 
• The duration of action of Lyumjev was 5 hours, 44 minutes shorter than Humalog. 
• The total glucose infused during the clamp was comparable between Lyumjev and Humalog. 
 
Figure 1. Mean glucose infusion rate (GIR) in patients with type 1 diabetes after subcutaneous 
injection of Lyumjev or Humalog (15 unit dose) 
 

 

 
 

Similarly, a faster early insulin action and a reduced late insulin action was observed with Lyumjev in 
type 2 diabetes patients. 
 
Total and maximum glucose lowering effect of Lyumjev increased with dose within the therapeutic 
dose range. The early onset and total insulin action were similar when Lyumjev was administered in 
the abdomen, upper arm, or thigh. 
 
Postprandial Glucose (PPG) Lowering 
 
Lyumjev reduced the PPG during a standardized test meal over the complete 5 hour test meal period 
(change from premeal AUC(0-5h)) compared to Humalog. 
 
• In patients with type 1 diabetes, Lyumjev reduced the PPG during the 5 hour test meal period by 

32 % when given at the start of the meal and 18 % when given 20 minutes after the start of the 
meal compared to Humalog. 



29 
 

• In patients with type 2 diabetes, Lyumjev reduced the PPG during the 5 hour test meal period by 
26 % when given at the start of the meal and 24 % when given 20 minutes after the start of the 
meal compared to Humalog. 

 
Comparison of Lyumjev 200 units/mL and Lyumjev 100 units/mL 
 
The maximum and total glucose lowering were comparable for Lyumjev 200 units/mL or Lyumjev 
100 units/mL No dose conversion is required if transferring a patient between the strengths. 
 
Clinical efficacy and safety 
 
The efficacy of Lyumjev was evaluated in 2 randomized, active controlled trials in adults.  
 
Type 1 Diabetes – Adults 
 
PRONTO-T1D was a 26 week, treat-to-target, trial that evaluated the efficacy of Lyumjev in 
1222 patients on multiple daily injection therapy. Patients were randomized to either blinded 
mealtime Lyumjev, blinded mealtime Humalog , or open-label postmeal Lyumjev , all in combination 
with either insulin glargine  or insulin degludec.Mealtime Lyumjev or Humalog was injected 0 to 
2 minutes before the meal and postmeal Lyumjev was injected 20 minutes after the start of the meal. 
Efficacy results are provided in Table 2 and Figure 2. 
 
37.4 % of patients treated with mealtime Lyumjev, 33.6 % of patients treated with mealtime Humalog 
and 25.6 % of patients treated with postmeal Lyumjev reached a target HbA1c of < 7 %. 
 
Basal, bolus and total insulin doses were similar among study arms at 26 weeks. 
 
Following the 26 week period, the two blinded treatment arms continued to 52 weeks. HbA1c was not 
statistically significantly different between treatments at the 52 week endpoint. 
 



30 
 

Table 2 Results from 26 week basal-bolus clinical trial in patients with type 1 diabetes  
 
 Mealtime Lyumjev 

+ basal insulin 
Mealtime 

Humalog + 
basal insulin 

Postmeal Lyumjev 
+ basal insulin 

Number of randomized subjects (N) 451 442 329 
HbA1c (%) 
 Baseline  week 26  7.34  7.21 7.337.29 7.367.42 
 Change from baseline -0.13 -0.05 0.08 
 Treatment difference  -0.08 [-0.16, -0.00]C  0.13 [0.04, 0.22]D 
HbA1c (mmol/mol) 
 Baseline  week 26 56.755.3 56.756.1 56.957.6 
 Change from baseline -1.4 -0.6 0.8 
 Treatment difference  -0.8 [-1.7, 0.00]C  1.4 [0.5, 2.4]D 
1 hour postprandial glucose excursion (mg/dL) A 
 Baseline  week 26  77.3 46.4 71.5 74.3 76.387.5 
 Change from baseline  -28.6 -0.7 12.5 
 Treatment difference -27.9 [-35.3, -20.6]C,E  13.2 [5.0, 21.4]D 
1 hour postprandial glucose excursion (mmol/L) A 
 Baseline  week 26  4.292.57 3.97 4.13 4.244.86 
 Change from baseline  -1.59 -0.04 0.70 
 Treatment difference -1.55[-1.96, -1.14]C,E  0.73 [0.28,1.19]D 
2 hour postprandial glucose excursion (mg/dL) A 
 Baseline  week 26  112.772.7 101.6 103.9 108.0 97.2 
 Change from baseline  -34.7 -3.5 -10.2 
 Treatment difference -31.2 [-41.1, -21.2]C,E  -6.7 [-17.6, 4.3] D.   
2 hour postprandial glucose excursion (mmol/L) A 
 Baseline  week 26  6.264.04 5.645.77 5.995.40 
 Change from baseline  -1.93 -0.20 -0.56 
 Treatment difference -1.73 [-2.28, -1.18]C,E  -0.37 [-0.98, -0.24]D 
Body weight (Kg)    
 Baseline  week 26 77.377.9 77.378.2 77.678.1 
 Change from baseline  0.6 0.8 0.7 
 Treatment difference -0.2 [-0.6, 0.1]A  -0.1[-0.5, 0.3]D 
Severe hypoglycaemia B (% of patients) 5.5 % 5.7 % 4.6 % 

Week 26 and change from baseline values are based on the least-squares means (adjusted means).  
The 95 % confidence interval is stated in ‘[ ]’.   
A Meal test  
B Severe hypoglycaemia is defined as episode requiring assistance of another person due to patient’s 
neurological impairment. 
C The difference is for mealtime Lyumjev – mealtime Humalog.  
D The difference is for postmeal Lyumjev – mealtime Humalog. 
E Statistically significant in favour of mealtime Lyumjev. 



31 
 

 
Figure 2. Time course of blood glucose excursion during mixed-meal tolerance test at week 26 in 
patients with type 1 diabetes 
 

 
 

PPG = Postprandial glucose 
Lyumjev and Humalog administered at mealtime 
Lyumjev + 20 = Lyumjev was injected 20 minutes after the start of the meal. 
*p < 0.05 for pairwise comparison on Lyumjev versus Humalog 
^p < 0.05 for pairwise comparison on Lyumjev +20 versus Humalog 
#p < 0.05 for pairwise comparison on Lyumjev +20 versus Lyumjev 
 
Continuous glucose monitoring (CGM) in Type 1 Diabetes – Adults 
 
A subset of patients (N = 269) participated in an evaluation of the 24 hour ambulatory glucose profiles 
captured with blinded CGM. At the 26 week assessment, patients treated with mealtime Lyumjev 
demonstrated statistically significant improvement in PPG control during CGM assessment of glucose 
excursions or incremental area under the curve (AUC) 0 - 2 hours, 0 - 3 hours, and 0 - 4 hours after 
meals compared to patients treated with Humalog. Patients treated with mealtime Lyumjev reported 
statistically significantly longer time in range (6 am to midnight) with 603 minutes in range, (3.9 to 
10 mmol/L, 71 – 180 mg/dL), and 396 minutes in range (3.9 to 7.8 mmol/L, 71 to 140  mg/dL), 44 and 
41 minutes longer than Humalog patients respectively.  
 
Type 2 Diabetes – Adults 
 
PRONTO-T2D was a 26 week, treat-to-target trial that evaluated the efficacy of Lyumjev in 
673 patients randomized to either blinded mealtime Lyumjev or to blinded mealtime Humalog, both 
in combination with a basal insulin (insulin glargine or insulin degludec) in a basal-bolus regimen. . 
Mealtime Lyumjev or mealtime Humalog was injected 0 - 2 minutes before the meal. 
Efficacy results are provided in Table 3 and Figure 3. 
 
58.2 % of patients treated with mealtime Lyumjev and 52.5 % of patients treated with mealtime 
Humalog reached a target HbA1c of < 7 %.  
 
Basal, bolus and total insulin doses were similar among study arms at the end of the trial.  
 



32 
 

Table 3 Results from 26 week basal-bolus clinical trial in patients with type 2 diabetes  
 
 Mealtime Lyumjev 

+ basal insulin 
Mealtime Humalog 

+ basal insulin 

Number of randomized subjects (N) 336 337 
HbA1c (%) 
 Baseline  week 26 7.286.92 7.316.86 
 Change from baseline -0.38 -0.43 
 Treatment difference  0.06 [-0.05, 0.16]  
HbA1c (mmol/mol) 
 Baseline  week 26 56.052.1 56.451.5 
 Change from baseline -4.1 -4.7 
 Treatment difference  0.6 [-0.6, 1.8]  
1 hour postprandial glucose excursion (mg/dL)A 

 Baseline  week 26 76.663.1 77.174.9 
 Change from baseline  -13.8 -2.0 
 Treatment difference -11.8 [-18.1, -5.5]C 

1 hour postprandial glucose excursion (mmol/L)A   
 Baseline  week 26 4.253.50 4.284.16 
 Change from baseline  -0.77 -0.11 
 Treatment difference -0.66 [-1.01, -0.30]C 
2 hour postprandial glucose excursion (mg/dL)A 
 Baseline  week 26 99.380.4 99.697.8 
 Change from baseline  -19.0 -1.6 
 Treatment difference -17.4 [-25.3, -9.5]C 
2 hour postprandial glucose excursion (mmol/L)A 
 Baseline  week 26 5.514.47 5.535.43 
 Change from baseline  -1.06 -0.09 
 Treatment difference -0.96 [-1.41, -0.52]C 
Body weight (Kg)   
 Baseline  week 26 89.891.3 90.0 91.6 
 Change from baseline  1.4 1.7 
 Treatment difference -0.2 [-0.7, 0.3] 
Severe hypoglycaemia (% of patients)B 0.9 % 1.8 % 

Week 26 and change from baseline values are based on the least-squares means (adjusted means).  
The 95 % confidence interval is stated in ‘[ ]’. The difference is for mealtime Lyumjev – mealtime 
Humalog.  
A Meal test  
B Severe hypoglycaemia is defined as episode requiring assistance of another person due to patient’s 
neurological impairment. 
C Statistically significant in favour of mealtime Lyumjev. 
 
 



33 
 

Figure 3. Time course of blood glucose excursion during mixed-meal tolerance test at week 26 in 
patients with type 2 diabetes 
 

 
 

PPG = Postprandial glucose 
Lyumjev and Humalog administered at mealtime 
Data are LSM (SE), *p < 0.05  
 
Elderly  
 
In the two 26 week clinical studies, 187 of 1,116 (17 %) Lyumjev treated patients with type 1 diabetes 
or type 2 diabetes were ≥ 65 years of age and 18 of 1,116 (2 %) were ≥ 75 years of age. No overall 
differences in safety or effectiveness were observed between elderly patients and younger patients. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Absorption of insulin lispro was accelerated and the duration of exposure was shorter in healthy 
subjects and patients with diabetes following injection of Lyumjev compared to Humalog. In patients 
with type 1 diabetes: 
• Insulin lispro appeared in circulation approximately 1 minute after injection of Lyumjev, which 

was five minutes faster than Humalog . 
• Time to 50 % maximum concentration was 14 minutes shorter with Lyumjev compared to 

Humalog. 
• Following injection of Lyumjev, there was seven times more insulin lispro in circulation during 

the first 15 minutes compared to Humalog and three times more insulin lispro during the first 
30 minutes compared to Humalog. 

• After administration of Lyumjev the time to maximum insulin lispro concentration was 
achieved at 57 minutes.  

• Following injection of Lyumjev there was 41 % less insulin lispro in circulation after 3 hours 
following injection compared to Humalog.  

• The duration of insulin lispro exposure for Lyumjev was 60 minutes shorter compared to 
Humalog. 



34 
 

• The total insulin lispro exposure (ratio and 95 % CI of 1.03 (0.973, 1.09) and maximum 
concentration (ratio and 95 % CI of 1.06 (0.97, 1.16) were comparable between Lyumjev and 
Humalog. 

 
In type 1 patients, the day-to-day variability [CV %] of Lyumjev was 13 % for total insulin lispro 
exposure (AUC, 0 - 10h) and 23 % for maximum insulin lispro concentration (Cmax).The absolute 
bioavailability of insulin lispro after subcutaneous administration of Lyumjev in the abdomen, upper 
arm and thigh was approximately 65 %. The accelerated absorption of insulin lispro is maintained 
regardless of injection site (abdomen, upper arm and thigh). No exposure data are available following 
injection in the buttocks.  
 
Maximum concentration and time to maximum concentration were comparable for the abdomen and 
upper arm regions; time to maximum concentration was longer and maximum concentration lower for 
the thigh. 
 
Total insulin lispro exposure and maximum insulin lispro concentration increased proportionally with 
increasing subcutaneous doses of Lyumjev within the dose range from 7U to 30U. 
 
Comparison of Lyumjev 200 units/mL and Lyumjev 100 units/mL 
 
The results of a study in healthy subjects demonstrated that Lyumjev 200 units/mL is bioequivalent to 
Lyumjev 100 units/mL following administration of a single 15 unit dose for the area under serum 
insulin lispro concentration-time curve from time zero to infinity and maximum insulin lispro 
concentration. The accelerated insulin lispro absorption after administration of 200 units/mL was 
similar to that observed with Lyumjev 100 units/mL. No dose conversion is required if transferring a 
patient between the strengths.  
 
Distribution 
 
The geometric mean (% coefficient of variation [CV %]) volume of distribution of insulin lispro (Vd) 
was 34 L (30 %) after intravenous administration of Lyumjev as a bolus injection of a 15 unit dose in 
healthy subjects. 
 
Elimination 
 
The geometric mean (CV %) clearance of insulin lispro was 32 L/hour (22 %) and the median half-life 
of insulin lispro was 44 minutes after intravenous administration of Lyumjev as a bolus injection of a 
15 unit dose in healthy subjects. 
 
Special populations 
 
In adult subjects, age, gender, and race did not affect the pharmacokinetics and pharmacodynamics of 
Lyumjev. No data are available on children and adolescents below 18 years of age. 
 
Patients with renal and hepatic impairment 
 
Renal and hepatic impairment is not known to impact the pharmacokinetics of insulin lispro.  
 
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 
and development after exposure to insulin lispro. 
 
 
 
 



35 
 

6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Glycerol 
Magnesium chloride hexahydrate 
Metacresol 
Sodium citrate dihydrate 
Treprostinil sodium 
Zinc oxide 
Water for injections 
Hydrochloric acid and sodium hydroxide (for pH adjustment)  
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with any other insulin or any other medicinal product. 
 
6.3 Shelf life 
 
Before use 
 
2 years 
 
After first use 
 
28 days 
 
6.4 Special precautions for storage 
 
Before use 
 
Store in the refrigerator (2 °C - 8 °C). 
Do not freeze. 
Store in the original package in order to protect from light. 
 
After first use  
 
Do not refrigerate. 
Do not store above 30 °C.  
Do not freeze.  
Keep the cap on the pen in order to protect from light. 
 
6.5 Nature and contents of container  
 
Type I clear glass cartridges, sealed with disc seals secured with aluminium seals and halobutyl 
plungers.  
 
The 3 mL cartridges are sealed in a disposable pen injector KwikPen   
 
The medicinal product is packed in a white carton with dark blue bands and dark blue and light blue 
checked bands and an image of the pen. On the carton and label the insulin strength is highlighted in a 
box with a yellow background. There is a yellow warning label on the cartridge holder “Use only in 
this pen, or severe overdose can result”. The KwikPen is taupe, the dose knob is taupe with raised 
edges.  
 
3 mL KwikPen: Packs of 2 pre-filled pens, 5 pre-filled pens or a multipack of 10 (2 packs of 5) pre-
filled pens.  



36 
 

 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Lyumjev should look clear and colourless. It should not be used if it is cloudy, coloured, or has 
particles or clumps in it. 
 
Lyumjev should not be used if it has been frozen. 
 
A new needle must always be attached before each use. Needles must not be re-used. Needles are not 
included. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1422/013 
EU/1/20/1422/014 
EU/1/20/1422/015 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 24 March 2020 
 
 
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 
 
 



37 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

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



38 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer(s) of the biological active substance 
 
Eli Lilly and Company, Indianapolis, Indiana, 46285, USA. 
Lilly del Caribe, Inc., 12.3 KM 65th Infantry Road, Carolina, Puerto Rico 00985. 
 
Name and address of the manufacturer responsible for batch release 
 
Lilly France S.A.S, Rue du Colonel Lilly, 67640 Fegersheim, France. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
• Risk management plan (RMP) 

 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 
marketing authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 



39 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



40 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



41 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – Vial 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 100 units/mL solution for injection in vial 
insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL solution contains 100 units of insulin lispro (equivalent to 3.5 mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, 
zinc oxide, metacresol, sodium hydroxide, hydrochloric acid, water for injections.  
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
1 vial of 10 mL 
2 vials of 10 mL 
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and intravenous 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, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze.  



42 
 

Store in original package in order to protect from light.  
 
Before use: Store in a refrigerator.  
 
After first use: Do not store above 30 °C. Discard after 28 days.  
 
 
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  
 
EU/1/20/1422/001 1vial 
EU/1/20/1422/002 2 vials 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lyumjev 100 units/mL 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  



43 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (with blue box) multipack – Vial 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 100 units/mL solution for injection in vial 
insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL solution contains 100 units of insulin lispro (equivalent to 3.5 mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, 
zinc oxide, metacresol, sodium hydroxide, hydrochloric acid, water for injections. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
Multipack: 5 (5 packs of 1) vials of 10 mL.  
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and intravenous 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, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze.  
Store in original package in order to protect from light.  



44 
 

 
Before use: Store in a refrigerator.  
 
After first use: Do not store above 30 °C. Discard after 28 days.  
 
 
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  
 
EU/1/20/1422/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lyumjev 100 units/mL 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN  
NN  



45 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE CARTON (without blue box) component of a multipack – Vial  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 100 units/mL solution for injection in vial 
insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL solution contains 100 units of insulin lispro (equivalent to 3.5 mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, 
zinc oxide, metacresol, sodium hydroxide, hydrochloric acid, water for injections. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
1 vial of 10 mL. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and intravenous 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, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze.  



46 
 

Store in original package in order to protect from light.  
 
Before use: Store in a refrigerator.  
 
After first use: Do not store above 30 °C. Discard after 28 days.  
 
 
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  
 
EU/1/20/1422/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lyumjev 100 units/mL 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 



47 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT - Vial 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION 
 
Lyumjev 100 units/mL solution for injection  
insulin lispro 
Subcutaneous and intravenous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP   
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
10 mL  
 
6. OTHER 
 



48 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON - Cartridges 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 100 units/mL solution for injection in cartridge 
insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL solution contains 100 units of insulin lispro (equivalent to 3.5 mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, 
zinc oxide, metacresol, sodium hydroxide, hydrochloric acid, water for injections. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
2 cartridges of 3 mL  
5 cartridges of 3 mL  
10 cartridges of 3 mL 
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Use these cartridges 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 WARNINGS, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



49 
 

9. SPECIAL STORAGE CONDITIONS 
 
Before use:  
Store in a refrigerator.  
Do not freeze.  
Store in original package in order to protect from light.  
 
After first use:  
Do not store above 30 °C.  
Do not refrigerate or freeze.  
Recap the pen after use in order to protect from light.  
Discard after 28 days. 
 
 
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  
 
EU/1/20/1422/004  2 cartridges 
EU/1/20/1422/005 5 cartridges 
EU/1/20/1422/006 10 cartridges 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lyumjev 100 units/mL  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



50 
 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  



51 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT - Cartridges 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION 
 
Lyumjev 100 units/mL solution for injection in cartridge  
insulin lispro 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 mL  
 
 
6. OTHER 



52 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – KwikPen.  
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen. 
insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL solution contains 100 units of insulin lispro (equivalent to 3.5 mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, 
zinc oxide, metacresol, sodium hydroxide, hydrochloric acid, water for injections. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
2 pens of 3 mL  
5 pens of 3 mL  
 
 
5. METHOD AND ROUTES 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, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Before use:  
Store in a refrigerator.  



53 
 

Do not freeze. 
Store in original package in order to protect from light.  
 
After first use:  
Do not store above 30 °C.  
Do not refrigerate or freeze.  
Recap the pen after use in order to protect from light.  
Discard after 28 days. 
 
 
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  
 
EU/1/20/1422/007  2 pens 
EU/1/20/1422/008  5 pens 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lyumjev 100 units/mL KwikPen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  



54 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (with blue box) multipack – KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen 
insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL solution contains 100 units of insulin lispro (equivalent to 3.5 mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, 
zinc oxide, metacresol, sodium hydroxide, hydrochloric acid, water for injections. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. 
 
Multipack: 10 (2 packs of 5) pre-filled pens of 3 mL.  
 
 
5. METHOD AND ROUTES 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, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Before use:  
Store in a refrigerator.  



55 
 

Do not freeze. 
Store in original package in order to protect from light.  
 
After first use:  
Do not store above 30 °C.  
Do not refrigerate or freeze.  
Recap the pen after use in order to protect from light.  
Discard after 28 days 
 
 
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  
 
EU/1/20/1422/009  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lyumjev 100 units/mL KwikPen  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



56 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE CARTON (without blue box) component of a multipack – KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen 
insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL solution contains 100 units of insulin lispro (equivalent to 3.5 mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, 
zinc oxide, metacresol, sodium hydroxide, hydrochloric acid, water for injections. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. 
 
5 pens of 3 mL. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTES 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, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Before use:  
Store in a refrigerator.  



57 
 

Do not freeze.  
Store in original package in order to protect from light.  
 
After first use:  
Do not store above 30 °C.  
Do not refrigerate or freeze.  
Recap the pen after use in order to protect from light.  
Discard after 28 days. 
 
 
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  
 
EU/1/20/1422/009  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lyumjev 100 units/mL KwikPen  
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



58 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT - KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION 
 
Lyumjev 100 units/mL KwikPen solution for injection 
insulin lispro 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 mL  
 
 
6. OTHER 



59 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – Junior KwikPen  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen. 
insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL solution contains 100 units of insulin lispro (equivalent to 3.5 mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, 
zinc oxide, metacresol, sodium hydroxide, hydrochloric acid, water for injections. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
2 pen of 3 mL. 
5 pens of 3 mL. 
 
 
5. METHOD AND ROUTES 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, IF NECESSARY 
 
The pen delivers 0.5 - 30 units in steps of 0.5 units. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



60 
 

9. SPECIAL STORAGE CONDITIONS 
 
Before use:  
Store in a refrigerator.  
Do not freeze. 
Store in original package in order to protect from light.  
 
After first use:  
Do not store above 30 °C.  
Do not refrigerate or freeze..  
Recap the pen after use in order to protect from light.  
Discard after 28 days. 
 
 
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  
 
EU/1/20/1422/010  2 pen 
EU/1/20/1422/011  5 pens 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lyumjev 100 units/mL Junior KwikPen  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



61 
 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



62 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (with blue box) multipack – Junior KwikPen  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen. 
insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL solution contains 100 units of insulin lispro (equivalent to 3.5 mg).  
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, 
zinc oxide, metacresol, sodium hydroxide, hydrochloric acid, water for injections. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
Multipack: 10 (2 packs of 5) pre-filled pens of 3 mL.  
 
 
5. METHOD AND ROUTES 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, IF NECESSARY 
 
The pen delivers 0.5 - 30 units in steps of 0.5 units. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



63 
 

9. SPECIAL STORAGE CONDITIONS 
 
Before use:  
Store in a refrigerator.  
Do not freeze. 
Store in original package in order to protect from light.  
 
After first use:  
Do not store above 30 °C.  
Do not refrigerate or freeze. 
Recap the pen after use in order to protect from light. 
Discard after 28 days. 
 
 
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  
 
EU/1/20/1422/012  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lyumjev 100 units/mL Junior KwikPen   
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



64 
 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



65 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE CARTON (without blue box) component of a multipack – Junior KwikPen  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen. 
insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL solution contains 100 units of insulin lispro (equivalent to 3.5 mg).  
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, 
zinc oxide, metacresol, sodium hydroxide, hydrochloric acid, water for injections. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.   
 
5 pens of 3 mL. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTES 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, IF NECESSARY 
 
The pen delivers 0.5 - 30 units in steps of 0.5 units. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



66 
 

9. SPECIAL STORAGE CONDITIONS 
 
Before use:  
Store in a refrigerator.  
Do not freeze. 
Store in original package in order to protect from light.  
 
After first use: 
Do not store above 30 °C.  
Do not refrigerate or freeze.  
Recap the pen after use in order to protect from light.  
Discard after 28 days 
 
 
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  
 
EU/1/20/1422/012  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lyumjev 100 units/mL Junior KwikPen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 



67 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT - Junior KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION 
 
Lyumjev 100 units/mL Junior KwikPen solution for injection 
insulin lispro 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 mL 
 
 
6. OTHER 
 
 
 



68 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON – KwikPen. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 200 units/mL KwikPen solution for injection in pre-filled pen 
insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL solution contains 200 units of insulin lispro (equivalent to 6.9 mg)  
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, 
zinc oxide, metacresol, sodium hydroxide, hydrochloric acid, water for injections. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
2 pens of 3 mL. 
5 pens of 3 mL. 
 
 
5. METHOD AND ROUTES 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, IF NECESSARY 
 
Use only in this pen, or severe overdose can result. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



69 
 

9. SPECIAL STORAGE CONDITIONS 
 
Before use:  
Store in a refrigerator.  
Do not freeze. 
Store in original package in order to protect from light.  
 
After first use:  
Do not store above 30 °C.  
Do not refrigerate or freeze..  
Recap the pen after use in order to protect from light.  
Discard after 28 days 
 
 
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  
 
EU/1/20/1422/013  2 pens 
EU/1/20/1422/014  5 pens 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lyumjev 200 units/mL KwikPen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



70 
 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 



71 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (with blue box) multipack – KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 200 units/mL KwikPen solution for injection in pre-filled pen 
insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL solution contains 200 units of insulin lispro (equivalent to 6.9 mg) 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, 
zinc oxide, metacresol, sodium hydroxide, hydrochloric acid, water for injections. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
Multipack: 10 (2 packs of 5) pre-filled pens of 3 mL.  
 
 
5. METHOD AND ROUTES 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, IF NECESSARY 
 
Use only in this pen, or severe overdose can result. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



72 
 

9. SPECIAL STORAGE CONDITIONS 
 
Before use:  
Store in a refrigerator.  
Do not freeze. 
Store in original package in order to protect from light.  
 
After first use:  
Do not store above 30 °C.  
Do not refrigerate or freeze.  
Recap the pen after use in order to protect from light. 
Discard after 28 days. 
 
 
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  
 
EU/1/20/1422/015  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lyumjev 200 units/mL KwikPen  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



73 
 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN 



74 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE CARTON (without blue box) component of a multipack – KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Lyumjev 200 units/mL KwikPen solution for injection in pre-filled pen 
insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each mL solution contains 200 units of insulin lispro (equivalent to 6.9 mg)  
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, 
zinc oxide, metacresol, sodium hydroxide, hydrochloric acid, water for injections. 
 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
5 pens of 3 mL. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTES 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, IF NECESSARY 
 
Use only in this pen, or severe overdose can result. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



75 
 

9. SPECIAL STORAGE CONDITIONS 
 
Before use:  
Store in a refrigerator.  
Do not freeze. 
Store in original package in order to protect from light.  
 
After first use:  
Do not store above 30 °C.  
Do not refrigerate or freeze.  
Recap the pen after use in order to protect from light.  
Discard after 28 days. 
 
 
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  
 
EU/1/20/1422/015  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Lyumjev 200 units/mL KwikPen  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 



76 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT - KwikPen 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION 
 
Lyumjev 200 units/mL KwikPen solution for injection 
insulin lispro 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 mL 
 
 
6. OTHER 
 
Use only in this pen, or severe overdose can result. 
 



77 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



78 
 

 
Package leaflet: Information for the user 

 
Lyumjev 100 units/ml solution for injection in vial 

insulin lispro 
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, nurse or pharmacist. 
- 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, nurse or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Lyumjev is and what it is used for 
2. What you need to know before you use Lyumjev 
3. How to use Lyumjev 
4. Possible side effects 
5. How to store Lyumjev 
6. Contents of the pack and other information 
 
 
1. What Lyumjev is and what it is used for  

 
Lyumjev 100 units/ml solution for injection in vial contains the active ingredient insulin lispro. 
Lyumjev is used to treat diabetes in adults. It is a mealtime insulin that works more quickly than other 
medicine containing insulin lispro. Lyumjev contains ingredients that speed up absorption of insulin 
lispro into the body. 
 
Diabetes is a condition in which your body does not make enough insulin or does not use insulin 
effectively, which results in effects such as high levels of sugar in the blood. Lyumjev is an insulin 
medicine that is used in the treatment of diabetes and so controls blood sugar. Effective treatment of 
diabetes, with good control of blood sugar, prevents long-term complications from your diabetes. 
 
Treatment with Lyumjev helps to control blood sugar in the long term and prevent complications from 
your diabetes. Lyumjev has its maximum effect 1 to 3 hours after injection and the effect lasts for up 
to 5 hours. You should use Lyumjev at the start of the meal, or up to 20 minutes after starting the 
meal. 
 
Your doctor may tell you to use Lyumjev as well as a longer- or intermediate-acting insulin. Do not 
change your insulin unless your doctor tells you to.  
 
2. What you need to know before you use Lyumjev  
 
Do NOT use Lyumjev 
• if you think your blood sugar is dropping (hypoglycaemia). Further on, this leaflet tells you 

how to deal with low blood sugar (see section 3 under “If you take more Lyumjev than you 
need”). 

• if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in 
section 6).  



79 
 

 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before using Lyumjev. 
 
If you cannot see very well you will need help from someone who has been trained to give injections. 
 
• Low blood sugar (hypoglycaemia).  
Low blood sugar can be serious and untreated hypoglycaemia may even lead to death.  
Lyumjev starts to lower blood sugar faster than some other mealtime insulins. If hypoglycaemia 
occurs, you may experience it earlier after an injection of Lyumjev. If you often have hypoglycaemia 
or have difficulty recognising it, please discuss this with your doctor or nurse. If your blood sugar 
levels are well controlled by your current insulin therapy or after long duration of diabetes, you may 
not feel the warning symptoms when your blood sugar is falling too low.Warning signs are listed later 
in this leaflet. For symptoms please see “Common problems of diabetes”. 

 
You must think carefully about when to have your meals, how often to exercise and how much to do. 
You must also keep a close watch on your blood sugar levels by testing your blood sugar often. 
Making changes to the types of  insulin you use may cause your blood sugar to rise or fall too much.  
It may be necessary to increase the frequency of blood sugar testing if you are at risk of low blood 
sugars. Your doctor may need to change the doses of your other diabetes medicine.  
 
• High blood sugar (hyperglycaemia).   
Stopping or not taking enough insulin may lead to high blood sugar (hyperglycaemia) and diabetic 
ketoacidosis, serious conditions that can even lead to death. For symptoms please see “Common 
problems of diabetes”. 
 
• If you are using an insulin pump and it stops working you will need to fix the problem 

immediately as this can lead to high blood sugar. You may need to take an injection of Lyumjev 
using an insulin pen or a syringe if your pump stops working. 

• If your insulin treatment is being combined with one of a class of diabetes medicine called 
thiazolidinediones or glitazones, such as pioglitazone, tell your doctor as soon as possible if you 
get signs of heart failure such as unusual shortness of breath or rapid increase in weight or 
localised swelling caused by fluid retention (oedema). 

• If you have a serious allergic reaction to insulin or any of the ingredients in Lyumjev, stop using 
this medicine and contact emergency medical services straight away. 

• Always check the pack and the label for the name and type of the insulin when you get it from 
your pharmacy. Make sure you get the Lyumjev that your doctor has told you to use. 

• Keep the carton, or keep a note of the batch number on the carton.  If you have a side effect you 
can then provide that number when you report the advere side effect, see “reporting of side 
effects”. 

• Always use a new needle for each injection to prevent infections and blocked needles.  If a 
needle is blocked replace it with a new needle. 

 
Children and adolescents 
This medicine should not be used in children or adolescents, since there is no experience with this 
medicine in children and adolescents under 18 years of age. 
 
Other medicines and Lyumjev 
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other 
medicines. Some medicines affect your blood sugar level - this may mean your insulin dose has to 
change. 
 
Your blood sugar levels may fall (hypoglycaemia) if you take:   
 
• other medicines for diabetes (oral and injectable)  
• sulphonamide antibiotics (for infections) 



80 
 

• acetylsalicylic acid (for pain and mild fever and to prevent blood clotting) 
• some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors) 
• some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril) (for 

some heart problems or high blood pressure) 
• angiotensin II receptor blockers (for high blood pressure or heart problems) 
• somatostatin analogues (such as octreotide, which are used to treat a rare condition involving 

too much growth hormone) 
 
Your blood sugar levels may rise (hyperglycaemia) if you take: 
 
• danazol (for endometriosis) 
• the contraceptive pill (birth control pills) 
• thyroid hormone replacement therapy (for thyroid problems) 
• human growth hormone  (for growth hormone deficiency) 
• diuretics (for high blood pressure or if you have a build-up of water in your body)  
• sympathomimetic agents (for serious allergic reactions or used in some cold remedies)  
• corticosteroids (to treat asthma or autoimmune conditions) 
 
Beta-blockers (used for high blood pressure, arrhythmia or angina) make it harder to recognise the 
warning signs of low blood sugar.  
 
Lyumjev with alcohol 
Your blood sugar levels may either rise or fall if you drink alcohol. Therefore the amount of insulin 
needed may change. You should therefore monitor your blood sugar level more often than usual. 
 
Pregnancy and breast-feeding 
If you are planning to have a baby, think you may be pregnant, are pregnant or breast-feeding, ask 
your doctor, nurse or pharmacist for advice before taking this medicine. The amount of insulin you 
need usually falls during the first 3 months of pregnancy and increases for the remaining 6 months. 
After you have had your baby your insulin requirements will likely return to how much you needed 
before your pregnancy.  
 
There are no restrictions on treatment with Lyumjev during breast-feeding. If you are breast-feeding, 
you may need to alter your insulin intake or diet. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or using machines). You should contact your doctor about driving if you have: 
• frequent episodes of hypoglycaemia 
• reduced or absent warning signs of hypoglycaemia 
 
Lyumjev contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Lyumjev 
 
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has 
told you. Check with them if you are not sure.  
 
They will have told you exactly how much Lyumjev to use, when to use it, and how often. They will 
also tell you how often to visit your diabetes clinic.  
 
You should always have spare insulin and another injection device in case you need them. 



81 
 

 
If you are blind or visually impaired you will need help from someone to make your injections.  
 
Your doctor may tell you to use Lyumjev as well as a longer- or intermediate-acting insulin. Inject 
them separately. Lyumjev should not be mixed with any other insulin. 
 
When to inject Lyumjev 
Lyumjev is a mealtime insulin. You should use Lyumjev when you start to eat, or a minute or two 
before the meal; you also have the option to inject up to 20 minutes after starting the meal.  
 
How much insulin to use 
Your doctor will work out your dose based on your blood sugar and body weight and explain  
• How much Lyumjev you need at each meal. 
• How and when to check your blood sugar level.  
• How to change your insulin dose depending on your blood sugar levels. 
• What to do if you change your diet, or change how much you exercise, if you are ill or if you are 

using other medicines. 
• If you change the type of insulin you use, you may have to take more or less than before. This 

might just be for the first injection or it may be a gradual change over several weeks or months.  
 
Do not use Lyumjev 
• If it does not look like water. Lyumjev must be clear, have no colour and no solid pieces in it. 

Check each time you inject yourself. 
• If Lyumjev has not been stored correctly (see section 5 “How to store Lyumjev”). 
• If the plastic cap of the vial is damaged, do not use.  
 
Where to inject Lyumjev 
• Inject Lyumjev under the skin (subcutaneous injection). 
• Do not inject yourself directly into a vein. Only your physician can administer Lyumjev by the 

intravenous use. He will only do this under special circumstances such as surgery or if you are 
ill and your sugar levels are too high. 

• Make sure you inject at least 1 cm from the last injection and that you ‘rotate’ the places you 
inject (upper arm, thigh, buttocks or abdomen), as you have been taught.  

• If you need to inject another insulin at the same time as Lyumjev, use a different injection site. 
 
How to inject Lyumjev from a vial 
• First wash your hands. 
• Before you make an injection, clean your skin as you have been instructed. Clean the rubber 

stopper on the vial, but do not remove the stopper. 
• Use a new, sterile syringe and needle to pierce the rubber stopper and draw in the amount of 

Lyumjev you want. Your doctor, nurse or clinic will tell you how to do this. Do not share your 
needles and syringes. 

• Inject under the skin, as you were taught. After your injection, leave the needle in the skin for 5 
seconds to make sure you receive the full dose.   

 
Using Lyumjev in an insulin pump  
• Only certain insulin infusion pumps may be used to infuse Lyumjev.  
• Carefully follow the instructions supplied with your infusion pump. 
• Be sure to use the correct reservoir and catheter for your pump. It is important to use the correct 

needle length on the filling system to avoid damaging the pump. 
• Change the infusion set (tubing and needle) according to the instructions supplied with the 

infusion set.  
• If repeated or severe low blood sugar levels occur, tell your doctor or nurse. 



82 
 

• A pump malfunction or obstruction of the infusion set can result in a rapid rise in sugar levels. 
If you think Lyumjev is not flowing, follow the pump instructions and if appropriate, notify 
your doctor or nurse.  

• You may need to take an injection of Lyumjev if your pump does not work properly. 
 
If you take more Lyumjev than you need 
If you inject too much Lyumjev, a low blood sugar may occur. Check your blood sugar. 
 
If your blood sugar is low (hypoglycaemia) and you can treat yourself, eat glucose tablets, sugar or 
drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor or nurse has advised you 
and have some rest. This will often get you over a low blood sugar or a minor insulin overdose. Check 
your blood sugar again after 15-20 mins until blood sugar is stabilised. 
 
If you are unable to treat yourself (severe hypoglycaemia) because you feel too dizzy, weak, confused, 
have difficulty talking, lose consciousness or have a seizure you may need to be treated with glucagon. 
This can be given by someone who knows how to use it. Eat glucose or sugar after the glucagon. If 
glucagon does not work, you will have to go to hospital or call emergency services. Ask your doctor to 
tell you about glucagon. 
 
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood 
sugar gets too low, including the risk of passing out. 
 
Let them know that if you pass out, they must: turn you on your side to avoid choking, get medical 
help straight away and not give you any food or drink because you may choke.  
 
If you forget to use Lyumjev 
If you forget to use your insulin or you take less than you need, your blood sugar may get too high 
(hyperglycaemia). Check your blood sugar level to decide if an insulin dose is needed. Resume your 
usual dosing schedule at your next meal. 
 
If you stop using Lyumjev 
Do not stop or change your insulin unless your doctor tells you to. If you take less Lyumjev than you 
need, a high blood sugar may occur. 
 
If high blood sugar (hyperglycaemia) is not treated it can be very serious and cause headaches, nausea, 
vomiting, abdominal pain, dehydration, unconsciousness, coma or even death (see section 4 ).  
 
Three simple steps to reduce your risk of hypoglycaemia or hyperglycaemia are: 
• Always keep spare syringes and a spare vial of Lyumjev. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Low blood sugar (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 
10 people). It can be very serious. If your blood sugar level falls too much you may become 
unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you 
have symptoms of low blood sugar, act immediately to increase your blood sugar level. See section 3 
under ‘If you take more Lyumjev than you need’. 
 



83 
 

Allergic reactions are common (may affect up to 1 in 10 people). They may be severe and they may 
include the following symptoms: 
 

• rash over the whole body  
• difficulty in breathing  
• wheezing 

• blood pressure dropping  
• heart beating fast  
• sweating 

 
If you have a serious allergic reaction (including an anaphylactic attack) to insulin or any of the 
ingredients in Lyumjev, stop using this medicine and contact emergency medical service straight 
away. 
 
Other side effects include: 
 
Common  
Injection site reactions. Some people get redness, pain, swelling or itching around the area of the 
insulin injection. This usually clears up in a few minutes to a few weeks without needing to stop 
Lyumjev. If you have injection site reactions, tell your doctor. 
 
Uncommon (may affect up to 1 in 100 people) 
There are several skin changes that can happen if you inject insulin too often at the same place called 
lipodystrophy which is where skin can shrink (lipoatrophy), thicken (lipohypertrophy) or get lumps 
under the skin caused by a build-up of a protein called amyloid (cutaneous amyloidosis). Tell your 
doctor if you get lipodystrophy at the injection site, rash or very itchy skin. Change the injection site 
with each injection to help prevent skin changes. 
 
Other potential side effects 
Swelling in arms or ankles due to fluid retention (oedema), particularly at the start of insulin therapy 
or during a change in your diabetes medicines. 
 
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. 
 
Common problems of diabetes 
 
Low blood sugar  
Low blood sugar (hypoglycaemia) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Lyumjev or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin for example if you lose weight; or you have trouble 

with your kidneys or liver which gets worse. 
See section ‘If you take more Lyumjev than you need.’ 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
• tiredness 
• rapid heart beat 
• nervousness or shakiness 
• feeling sick 
• headache 
• cold sweat 
 



84 
 

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. 
 
High blood sugar (hyperglycaemia) and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that the levels of glucose in your body are too 
high. Hyperglycaemia can be brought about by: 
• not taking your insulin; 
• using less insulin than your body needs;   
• an imbalance between the amount of carbohydrates you eat and the insulin you take; or 
• fever, infection or emotional stress. 
 
The early symptoms of hyperglycaemia are;  
• being very thirsty  
• headache  
• feeling sleepy 
• urinating more often 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. Additional symptoms include the following: 
• nausea and/or vomiting 
• abdominal pain 
• rapid pulse 
• heavy breathing 
• moderate or large amounts of urine ketones. Ketones are produced when your body burns fat for 

energy instead of glucose. 
 
If you have any of these symptoms and high sugars get medical help immediately. 
See section ‘If you forget to use Lyumjev’. 
 
Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 
5. How to store Lyumjev 
 
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 label and the carton. The expiry 
date refers to the last day of that month.  
 
Do not freeze.  
Keep in the outer carton in order to protect from light. 
 
Before first use 
Store in a refrigerator (2 °C to 8 °C).  
 
After first use  
Do not store above 30 °C. 
Discard after 28 days even if some of the solution remains. 
 
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 to protect the environment. 
 
 



85 
 

6. Contents of the pack and other information  
 
What Lyumjev 100 units/ml solution for injection in vial contains 
• The active substance is insulin lispro. Each ml solution contains 100 units of insulin lispro. One 

vial contains 1,000 units of insulin lispro in 10 ml solution.  
• The other ingredients are metacresol, glycerol, magnesium chloride hexahydrate, sodium citrate 

dihydrate, treprostinil sodium, zinc oxide, water for injections. Sodium hydroxide or 
hydrochloric acid may have been used to adjust the pH  (see the end of section 2 under 
‘Lyumjev contains sodium’). 

 
What Lyumjev looks like and contents of the pack 
Lyumjev 100 units/ml, solution for injection is a clear, colourless, aqueous solution in a vial. Each vial 
contains 1,000 units (10 millilitres). Pack sizes of 1 , 2 or a multipack of 5 × 1 vials. 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, 67640 Fegersheim, France. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
Belgique/België/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 6000 
 

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

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

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

Eesti 
Eli Lilly Nederland B.V.  
Tel: +372 6817 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 
 

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



86 
 

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

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 
 

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 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

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 

 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 
 
--------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for heath care professionals only: 
 
Lyumjev 100 units /mL is available in vials if administration of intravenous injection is necessary.  
 
For intravenous use, Lyumjev should be diluted to concentrations of 0.1 to 1.0 unit/mL in 5 % glucose 
solution for injection or sodium chloride 9 mg/mL (0.9 %) solution for injection. It is recommended 
that the system is primed before starting the infusion to the patient.Compatibility has been 
demonstrated in ethylene-propylene copolymer and polyolefin with polyvinyl chloride bags. 
 
Chemical and physical in-use stability has been demonstrated for 14 days at 2–8 °C and 20 hours at 
20–25 °C when protected from light. From a microbiological point of view, the medicinal product 
should be used immediately. If not used immediately, in-use storage times and conditions prior to use 
are the responsibility of the user and would not normally be longer than 24 hours at 2–8 °C, unless 
dilution has taken place in controlled and validated aseptic conditions.  



87 
 

Package leaflet: Information for the user 
 

Lyumjev 100 units/ml solution for injection in cartridge 
insulin lispro 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor, nurse or pharmacist. 
• 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, nurse or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Lyumjev is and what it is used for 
2. What you need to know before you use Lyumjev 
3. How to use Lyumjev 
4. Possible side effects 
5. How to store Lyumjev 
6. Contents of the pack and other information 
 
 
1. What Lyumjev is and what it is used for 
 
Lyumjev 100 units/ml solution for injection in a cartridge contains the active ingredient insulin lispro. 
Lyumjev is used to treat diabetes in adults. It is a mealtime insulin that works more quickly than other 
medicine containing insulin lispro. Lyumjev contains ingredients that speed up absorption of insulin 
lispro into the body. 
 
Diabetes is a condition in which your body does not make enough insulin or does not use insulin 
effectively, which results in effects such as high levels of sugar in the blood. Lyumjev is an insulin 
medicinethat is used in the treatment of diabetes and so controls blood sugar. Effective treatment of 
diabetes, with good control of blood sugar, prevents long-term complications from your diabetes. 
 
Treatment with Lyumjev helps to control blood sugar in the long term and prevent complications from 
your diabetes. Lyumjev has its maximum effect 1 to 3 hours after injection and the effect lasts for up 
to 5 hours. You should use Lyumjev at the start of the meal, or up to 20 minutes after starting the 
meal. 
 
Your doctor may tell you to use Lyumjev as well as a longer- or intermediate-acting insulin. Do not 
change your insulin unless your doctor tells you to.  
 
 
2. What you need to know before you use Lyumjev  
 
Do NOT use Lyumjev 
• if you think your blood sugar is dropping (hypoglycaemia). Further on, this leaflet tells you 

how to deal with low blood sugar (see section 3 under “If you take more Lyumjev than you 
need”). 

• if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in 
section 6). 

 



88 
 

Warnings and precautions  
Talk to your doctor, pharmacist or nurse before using Lyumjev. 
 
If you cannot see very well you will need help from someone who has been trained to give injections. 
 
• Low blood sugar (hypoglycaemia).  
Low blood sugar can be serious and untreated hypoglycaemia may even lead to death.  
Lyumjev starts to lower blood sugar faster than some other mealtime insulins. If hypoglycaemia 
occurs, you may experience it earlier after an injection of Lyumjev. If you often have hypoglycaemia 
or have difficulty recognising it, please discuss this with your doctor or nurse. If your blood sugar 
levels are well controlled by your current insulin therapy or after long duration of diabetes, you may 
not feel the warning symptoms when your blood sugar is falling too low.Warning signs are listed later 
in this leaflet. For symptoms please see “Common problems of diabetes”. 

 
You must think carefully about when to have your meals, how often to exercise and how much to do. 
You must also keep a close watch on your blood sugar levels by testing your blood sugar often. 
Making changes to the types of  insulin you use may cause your blood sugar to rise or fall too much.  
It may be necessary to increase the frequency of blood sugar testing if you are at risk of low blood 
sugars. Your doctor may need to change the doses of your other diabetes medicine.  
 
• High blood sugar (hyperglycaemia).   
Stopping or not taking enough insulin may lead to high blood sugar (hyperglycaemia) and diabetic 
ketoacidosis, serious conditions that can even lead to death. For symptoms please see “Common 
problems of diabetes”. 
 
• If your insulin treatment is being combined with one of a class of diabetes medicinecalled 

thiazolidinediones or glitazones, such as pioglitazone, tell your doctor as soon as possible if you 
get signs of heart failure such as unusual shortness of breath or rapid increase in weight or 
localised swelling caused by fluid retention (oedema). 

• If you have a serious allergic reaction to insulin or any of the ingredients in Lyumjev, stop using 
this medicine and contact emergency medical services straight away. 

• Always check the pack and the label for the name and type of the insulin when you get it from 
your pharmacy. Make sure you get the Lyumjev that your doctor has told you to use.  

• Keep the carton, or keep a note of the batch number on the carton.  If you have a side effect you 
can then provide that number when you report the advere side effect, see “reporting of side 
effects”. 

• Always use a new needle for each injection to prevent infections and blocked needles.  If a 
needle is blocked replace it with a new needle. 

 
Children and adolescents 
This medicine should not be used in children or adolescents, since there is no experience with this 
medicine in children and adolescents under 18 years of age. 
 
Other medicines and Lyumjev 
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other 
medicines. Some medicines affect your blood sugar level - this may mean your insulin dose has to 
change. 
 
Your blood sugar levels may fall (hypoglycaemia) if you take:   
 
• other medicines for diabetes (oral and injectable)  
• sulphonamide antibiotics (for infections) 
• acetylsalicylic acid (for pain and mild fever and to prevent blood clotting) 
• some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors) 
• some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril) (for 

some heart problems or high blood pressure) 



89 
 

• angiotensin II receptor blockers (for high blood pressure or heart problems) 
• somatostatin analogues (such as octreotide, which are used to treat a rare condition involving 

too much growth hormone) 
 
Your blood sugar levels may rise (hyperglycaemia) if you take: 
 
• danazol (for endometriosis)  
• the contraceptive pill (birth control pills) 
• thyroid hormone replacement therapy (for thyroid problems) 
• human growth hormone (for growth hormone deficiency) 
• diuretics (for high blood pressure or if you have a build-up of water in your body)  
• sympathomimetic agents (for serious allergic reactions or used in some cold remedies)  
• corticosteroids (to treat asthma or autoimmune conditions) 

 
Beta-blockers (used for high blood pressure, arrhythmia or angina) make it harder to recognise the 
warning signs of low blood sugar. 
 
Lyumjev with alcohol 
Your blood sugar levels may either rise or fall if you drink alcohol. Therefore the amount of insulin 
needed may change. You should therefore monitor your blood sugar level more often than usual. 
  
Pregnancy and breast-feeding 
If you are planning to have a baby, think you may be pregnant, are pregnant or breast-feeding, ask 
your doctor, nurse or pharmacist for advice before taking this medicine. The amount of insulin you 
need usually falls during the first 3 months of pregnancy and increases for the remaining 6 months. 
After you have had your baby your insulin requirements will likely return to how much you needed 
before your pregnancy.  
 
There are no restrictions on treatment with Lyumjev during breast-feeding. If you are breast-feeding, 
you may need to alter your insulin intake or diet. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or using machines). You should contact your doctor about driving if you have: 
• frequent episodes of hypoglycaemia 
• reduced or absent warning signs of hypoglycaemia 
 
Lyumjev contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Lyumjev 
 
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has 
told you. Check with them if you are not sure.  
 
They will have told you exactly how much Lyumjev to use, when to use it, and how often. They will 
also tell you how often to visit your diabetes clinic.  
 
To prevent the possible transmission of disease, each cartridge must be used by you only, even if the 
needle on the pen is changed. 
 
You should always have spare insulin and another injection device in case you need them. 
 



90 
 

If you are blind or visually impaired you will need help from someone to make your injections. 
 
Your doctor may tell you to use Lyumjev as well as a longer- or intermediate-acting insulin. Inject 
them separately. Lyumjev should not be mixed with any other insulin. 
 
When to inject Lyumjev 
Lyumjev is a mealtime insulin. You should use Lyumjev when you start to eat, or a minute or two 
before the meal; you also have the option to inject  up to 20 minutes after starting the meal.  
 
How much insulin to use 
Your doctor will work out your dose based on your blood sugar and body weight and explain  
• How much Lyumjev you need at each meal. 
• How and when to check your blood sugar level.  
• How to change your insulin dose depending on your blood sugar levels. 
• What to do if you change your diet, or change how much you exercise, if you are ill or if you are 

using other medicines. 
• If you change the type of insulin you use, you may have to take more or less than before. This 

might just be for the first injection or it may be a gradual change over several weeks or months.  
 
Do not use Lyumjev 
• If it does not look like water. Lyumjev must be clear, have no colour and no solid pieces in it. 

Check each time you inject yourself. 
• If Lyumjev has not been stored correctly (see section 5 “How to store Lyumjev”). 
• If the cartridge is damaged in any way, do not use.  
 
Getting the pen ready to use 
• First wash your hands. Disinfect the rubber membrane of the cartridge. 
• You must only use Lyumjev cartridges in Lilly insulin pens. Please make sure that 

Lyumjev or Lilly cartridges are mentioned in the leaflet accompanying your pen. The 3 ml 
cartridge only fits the 3 ml pen. 

• Follow the instructions that come with the pen. Put the cartridge into the pen.  
• Use a new needle. (Needles are not included). 
• Prime every time. The pen must be primed until you see insulin at the needle tip before each 

injection to make sure the pen is ready to dose. If you do not prime, you may get the wrong 
dose. 
 

Injecting Lyumjev 
• Before you make an injection, clean your skin.  
• Inject under the skin (subcutaneous injection), as you were taught by your physician or nurse.  
• After your injection, leave the needle in the skin for 5 seconds to make sure you receive the full 

dose. Make sure you inject at least 1 cm from the last injection and that you ‘rotate’ the places 
you inject (upper arm, thigh, buttocks or abdomen). 

• If you do not have enough insulin in the pen to complete your dose, make a note of how much 
you still need to take. Prime a new pen and inject the remaining dose. 

• If you need to inject another insulin at the same time as Lyumjev, use a different injection site. 
• Do not inject directly into a vein.  
 
After injecting 
• As soon as you have done the injection, take the needle off the pen using the outer needle cap. 

This will keep the Lyumjev sterile and prevent leaking. It will also stop air going back into the 
pen and the needle clogging up. Do not share your needles. Do not share your pen. Replace 
the cap on your pen. Leave the cartridge in the pen. 

  



91 
 

Further injections 
• Every time you plan to make an injection use a new needle. Before every injection, prime the 

pen to clear any large air bubbles.  
• Once the cartridge is empty, do not use it again.  
 
If you take more Lyumjev than you need 
If you inject too much Lyumjev, a low blood sugar may occur. Check your blood sugar.  
 
If your blood sugar is low (hypoglycaemia) and you can treat yourself, eat glucose tablets, sugar or 
drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor or nurse has advised you 
and have some rest. This will often get you over a low blood sugar or a minor insulin overdose. Check 
your blood sugar again after 15-20 mins until blood sugar is stabilised. 
 
If you are unable to treat yourself (severe hypoglycaemia) because you feel too dizzy, weak, confused, 
have difficulty talking, lose consciousness or have a seizure you may need to be treated with glucagon. 
This can be given by someone who knows how to use it. Eat glucose or sugar after the glucagon. If 
glucagon does not work, you will have to go to hospital or call emergency services. Ask your doctor to 
tell you about glucagon. 
 
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood 
sugar gets too low, including the risk of passing out. 
Let them know that if you pass out, they must: turn you on your side to avoid choking, get medical 
help straight away and not give you any food or drink because you may choke.  
 
If you forget to use Lyumjev 
If you forget to use your insulin or you take less than you need, your blood sugar may get too high 
(hyperglycaemia). Check your blood sugar level to decide if an insulin dose is needed. Resume your 
usual dosing schedule at your next meal. 
 
If you stop using Lyumjev 
Do not stop or change your insulin unless your doctor tells you to. If you take less Lyumjev than you 
need, a high blood sugar may occur. 
 
If high blood sugar (hyperglycaemia) is not treated it can be very serious and cause headaches, nausea, 
vomiting, abdominal pain, dehydration, unconsciousness, coma or even death (see section 4).  
 
Three simple steps to reduce your risk of hypoglycaemia or hyperglycaemia are: 
• Always keep a spare pen and cartridges, in case you lose your pen or cartridges or they get 

damaged. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
  
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Low blood sugar (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 
10 people). It can be very serious. If your blood sugar level falls too much you may become 
unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you 
have symptoms of low blood sugar, act immediately to increase your blood sugar level. See section 3 
under ‘If you take more Lyumjev than you need’. 
 



92 
 

Allergic reactions are common (may affect up to 1 in 10 people). They may be severe and they may 
include the following symptoms: 
 

• rash over the whole body  
• difficulty in breathing  
• wheezing 

• blood pressure dropping  
• heart beating fast  
• sweating 

 
If you have a serious allergic reaction (including an anaphylactic attack) to insulin or any of the 
ingredients in Lyumjev, stop using this medicine and contact emergency medical service straight 
away. 
 
Other side effects include: 
 
Common  
Injection site reactions. Some people get redness, pain, swelling or itching around the area of the 
insulin injection. This usually clears up in a few minutes to a few weeks without needing to stop 
Lyumjev. If you have injection site reactions, tell your doctor. 
 
Uncommon (may affect up to 1 in 100 people) 
There are several skin changes that can happen if you inject insulin too often at the same place called 
lipodystrophy which is where skin can shrink (lipoatrophy), thicken (lipohypertrophy) or get lumps 
under the skin caused by a build-up of a protein called amyloid (cutaneous amyloidosis). Tell your 
doctor if you get lipodystrophy at the injection site, rash or very itchy skin. Change the injection site 
with each injection to help prevent skin changes. 
 
Other potential side effects 
Swelling in arms or ankles due to fluid retention (oedema) particularly at the start of insulin therapy or 
during a change in your diabetes medicines. 
 
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. 
 
Common problems of diabetes 
 
Low blood sugar  
Low blood sugar (hypoglycaemia) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Lyumjev or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin for example if you lose weight; or you have trouble 

with your kidneys or liver which gets worse. 
See section “If you take more Lyumjev than you need”. 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
 
• tiredness 
• rapid heart beat 
• nervousness or shakiness 
• feeling sick 
• headache 
• cold sweat 
 



93 
 

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. 
 
High blood sugar (hyperglycaemia) and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that the levels of glucose in your body are too 
high. Hyperglycaemia can be brought about by: 
• not taking your insulin; 
• using less insulin than your body needs; 
• an imbalance between the amount of carbohydrates you eat and the insulin you take; or 
• fever, infection or emotional stress. 
 
The early symptoms of hyperglycaemia are;  
• being very thirsty  
• headache  
• feeling sleepy 
• urinating more often 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. Additional symptoms include the following: 
• nausea and/or vomiting 
• abdominal pain 
• rapid pulse 
• heavy breathing 
• moderate or large amounts of urine ketones. Ketones are produced when your body burns fat for 

energy instead of glucose. 
 
If you have any of these symptoms and high sugars get medical help immediately. 
See section ‘If you forget to use Lyumjev’. 
 
Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 
5. How to store Lyumjev 
 
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 label and the carton. The expiry 
date refers to the last day of that month.  
 
Before first use 
Store in a refrigerator (2 °C to 8 °C).  
Do not freeze.  
Keep in the outer carton in order to protect from light. 
 
After first use (after cartridge insertion into the pen) 
Do not store above 30 °C.  
Do not freeze.  
Do not refrigerate.  
 
The pen with the inserted cartridge should not be stored with the needle attached.  
Keep the cap on the pen in order to protect from light. 
Discard after 28 days even if some of the solution remains. 
 



94 
 

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 to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Lyumjev 100 units/ml solution for injection in cartridge contains 
• The active substance is insulin lispro. Each ml solution contains 100 units of insulin lispro. One 

cartridge contains 300 units of insulin lispro in 3 ml solution.  
• The other ingredients are metacresol, glycerol, magnesium chloride hexahydrate, sodium citrate 

dihydrate, treprostinil sodium, zinc oxide, water for injections. Sodium hydroxide or 
hydrochloric acid may have been used to adjust the pH (see the end of section 2 under ‘Lyumjev 
contains sodium’). 

 
What Lyumjev looks like and contents of the pack 
Lyumjev 100 units/ml, solution for injection is a clear, colourless, aqueous solution in a cartridge. 
Each cartridge contains 300 units (3 millilitres). Pack sizes of 2, 5 or 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, 67640 Fegersheim, France. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
Belgique/België/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 6000 
 

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

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

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

Eesti 
Eli Lilly Nederland B.V.  
Tel: +372 6817 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 



95 
 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 

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

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

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 
 

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 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

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 

 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 

 
 



96 
 

Package leaflet: Information for the user 
 

Lyumjev 100 units/ml KwikPen solution for injection in pre-filled pen 
insulin lispro 

 
Each KwikPen delivers 1 to 60 units in steps of 1 units. 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor, nurse or pharmacist. 
• 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, nurse or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Lyumjev KwikPen is and what it is used for 
2. What you need to know before you use Lyumjev KwikPen 
3. How to use Lyumjev KwikPen 
4. Possible side effects 
5. How to store Lyumjev KwikPen 
6. Contents of the pack and other information 
 
 
1. What Lyumjev KwikPen is and what it is used for 
 
Lyumjev 100 units/ml KwikPen solution for injection in pre-filled pen contains the active ingredient 
insulin lispro. Lyumjev is used to treat diabetes in adults. It is a mealtime insulin that works more 
quickly than other medicinecontaining insulin lispro. Lyumjev contains ingredients that speed up 
absorption of insulin lispro into the body. 
 
Diabetes is a condition in which your body does not make enough insulin or does not use insulin 
effectively, which results in effects such as high levels of sugar in the blood. Lyumjev is an insulin 
medicinethat is used in the treatment of diabetes and so controls blood sugar. Effective treatment of 
diabetes, with good control of blood sugar, prevents long-term complications from your diabetes. 
 
Treatment with Lyumjev helps to control blood sugar in the long term and prevent complications from 
your diabetes. Lyumjev has its maximum effect 1 to 3 hours after injection and the effect lasts for up 
to 5 hours. You should use Lyumjev at the start of the meal, or up to 20 minutes after starting the 
meal. 
 
Your doctor may tell you to use Lyumjev as well as a longer- or intermediate-acting insulin. Do not 
change your insulin unless your doctor tells you to.  
 
The Lyumjev 100 units/ml KwikPen is a disposable pre-filled pen containing 3 ml (300 units, 
100 units/ml) of insulin lispro.  One KwikPen contains multiple doses of insulin. The KwikPen dials 
1 unit at a time. The number of units are displayed in the dose window, always check this before 
your injection. You can give from 1 to 60 units in a single injection. If your dose is more than 
60 units, you will need to give yourself more than one injection.  
 
 



97 
 

2. What you need to know before you use Lyumjev KwikPen 
 
Do NOT use Lyumjev KwikPen  
• if you think your blood sugar is dropping (hypoglycaemia). Further on, this leaflet tells you 

how to deal with low blood sugar (see section 3 under “If you take more Lyumjev than you 
need”). 

• if you are allergic to insulin lispro 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 Lyumjev. 
 
If you cannot see very well you will need help from someone who has been trained to give injections. 
 
• Low blood sugar (hypoglycaemia).  
Low blood sugar can be serious and untreated hypoglycaemia may even lead to death.  
Lyumjev starts to lower blood sugar faster than some other mealtime insulins. If hypoglycaemia 
occurs, you may experience it earlier after an injection of Lyumjev. If you often have hypoglycaemia 
or have difficulty recognising it, please discuss this with your doctor or nurse. If your blood sugar 
levels are well controlled by your current insulin therapy or after long duration of diabetes, you may 
not feel the warning symptoms when your blood sugar is falling too low.Warning signs are listed later 
in this leaflet. For symptoms please see “Common problems of diabetes”. 

 
You must think carefully about when to have your meals, how often to exercise and how much to do. 
You must also keep a close watch on your blood sugar levels by testing your blood sugar often. 
Making changes to the types of  insulin you use may cause your blood sugar to rise or fall too much.  
It may be necessary to increase the frequency of blood sugar testing if you are at risk of low blood 
sugars. Your doctor may need to change the doses of your other diabetes medicine.  
 
• High blood sugar (hyperglycaemia).   
Stopping or not taking enough insulin may lead to high blood sugar (hyperglycaemia) and diabetic 
ketoacidosis, serious conditions that can even lead to death. For symptoms please see “Common 
problems of diabetes”. 
 
• If your insulin treatment is being combined with one of a class of diabetes medicinecalled 

thiazolidinediones or glitazones, such as pioglitazone, tell your doctor as soon as possible if you 
get signs of heart failure such as unusual shortness of breath or rapid increase in weight or 
localised swelling caused by fluid retention (oedema). 

• If you have a serious allergic reaction to insulin or any of the ingredients in Lyumjev, stop using 
this medicine and contact emergency medical services straight away. 

• Always check the pack and the label for the name and type of the insulin when you get it from 
your pharmacy. Make sure you get the Lyumjev that your doctor has told you to use. 

• Keep the carton, or keep a note of the batch number on the carton.  If you have a side effect you 
can then provide that number when you report the advere side effect, see “reporting of side 
effects”. 

• Always use a new needle for each injection to prevent infections and blocked needles.  If a 
needle is blocked replace it with a new needle. 

 
Children and adolescents 
This medicine should not be used in children or adolescents, since there is no experience with this 
medicine in children and adolescents under 18 years of age. 
 
Other medicines and Lyumjev 
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other 
medicines. Some medicines affect your blood sugar level - this may mean your insulin dose has to 
change. 



98 
 

 
Your blood sugar levels may fall (hypoglycaemia) if you take:   
 
• other medicines for diabetes (oral and injectable)  
• sulphonamide antibiotics (for infections) 
• acetylsalicylic acid (for pain and mild fever and to prevent blood clotting) 
• some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors) 
• some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril) (for 

some heart problems or high blood pressure) 
• angiotensin II receptor blockers (for high blood pressure or heart problems) 
• somatostatin analogues (such as octreotide, which are used to treat a rare condition involving 

too much growth hormone) 
 
Your blood sugar levels may rise (hyperglycaemia) if you take: 
 
• danazol (for endometriosis)  
• the contraceptive pill (birth control pills) 
• thyroid hormone replacement therapy (for thyroid problems) 
• human growth hormone (for growth hormone deficiency) 
• diuretics (for high blood pressure or if you have a build-up of water in your body)  
• sympathomimetic agents (for serious allergic reactions or used in some cold remedies)  
• corticosteroids (to treat asthma or autoimmune conditions) 
 
Beta-blockers (used for high blood pressure, arrhythmia or angina) make it harder to recognise the 
warning signs of low blood sugar.  
 
Lyumjev with alcohol 
Your blood sugar levels may either rise or fall if you drink alcohol. Therefore the amount of insulin 
needed may change. You should therefore monitor your blood sugar level more often than usual. 
 
Pregnancy and breast-feeding 
If you are planning to have a baby, think you may be pregnant, are pregnant or breast-feeding, ask 
your doctor, nurse or pharmacist for advice before taking this medicine. The amount of insulin you 
need usually falls during the first 3 months of pregnancy and increases for the remaining 6 months. 
After you have had your baby your insulin requirements will likely return to how much you needed 
before your pregnancy.  
 
There are no restrictions on treatment with Lyumjev during breast-feeding. If you are breast-feeding, 
you may need to alter your insulin intake or diet. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or using machines). You should contact your doctor about driving if you have: 
• frequent episodes of hypoglycaemia 
• reduced or absent warning signs of hypoglycaemia 
 
Lyumjev KwikPen contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Lyumjev KwikPen 
 
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has 
told you. Check with them if you are not sure.  



99 
 

 
They will have told you exactly how much Lyumjev to use, when to use it, and how often. They will 
also tell you how often to visit your diabetes clinic.  
 
To prevent the possible transmission of disease, each pen must be used by you only, even if the needle 
is changed. 
 
You should always have spare insulin and another injection device in case you need them. 
 
If you are blind or visually impaired you will need help from someone to make your injections. 
 
Your doctor may tell you to use Lyumjev as well as a longer- or intermediate-acting insulin. Inject 
them separately. Lyumjev should not be mixed with any other insulin. 
 
When to inject Lyumjev 
Lyumjev is a mealtime insulin. You should use Lyumjev when you start to eat, or a minute or two 
before the meal; you also have the option to inject up to 20 minutes after starting the meal. 
 
 How much insulin to use 
Your doctor will work out your dose based on your blood sugar and body weight and explain  
• How much Lyumjev you need at each meal. 
• How and when to check your blood sugar level.  
• How to change your insulin dose depending on your blood sugar levels. 
• What to do if you change your diet, or change how much you exercise, if you are ill or if you are 

using other medicines. 
• If you change the type of insulin you use, you may have to take more or less than before. This 

might just be for the first injection or it may be a gradual change over several weeks or months.  
 
Do not use Lyumjev 
• If it does not look like water. Lyumjev must be clear, have no colour and no solid pieces in it. 

Check each time you inject yourself. 
• If Lyumjev has not been stored correctly (see section 5 “How to store Lyumjev”). 
• If the pen is damaged in any way, do not use.  
 
Getting the KwikPen ready to use (Please see instructions for use) 
• First wash your hands. 
• Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions 

carefully. Here are some reminders. 
• Use a new needle. (Needles are not included). 
• Prime your KwikPen before each use. This checks that insulin comes out and clears the air 

bubbles from your KwikPen. There may still be some small air bubbles left in the pen. Small air 
bubbles are normal and will not affect your dose. 

• The number of units are displayed in the dose window, always check this before your injection. 
 

Injecting Lyumjev  
• Before you make an injection, clean your skin.  
• Inject under the skin (subcutaneous injection), as you were taught by your physician or nurse.  
• After your injection, leave the needle in the skin for 5 seconds to make sure you receive the full 

dose. Make sure you inject at least 1 cm from the last injection and that you ‘rotate’ the places 
you inject (upper arm, thigh, buttocks or abdomen). 

• If you do not have enough insulin in the pen to complete your dose, make a note of how much 
you still need to take. Prime a new pen and inject the remaining dose. 

• If you need to inject another insulin at the same time as Lyumjev, use a different injection site. 
• Do not inject directly into a vein.  
  



100 
 

After injecting 
• As soon as you have done the injection, unscrew the needle from the KwikPen using the outer 

needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering the pen 
and your needle clogging. Do not share your needles. Do not share your pen. Replace the cap 
on your pen. 

 
Further injections 
• Every time you use a KwikPen you must use a new needle. Before every injection, clear any air 

bubbles. You can see how much insulin is left by holding the KwikPen with the needle pointing 
up.  

• Once the KwikPen is empty, do not use it again. 
 
If you take more Lyumjev than you need 
If you inject too much Lyumjev, a low blood sugar may occur. Check your blood sugar.  
 
If your blood sugar is low (hypoglycaemia) and you can treat yourself, eat glucose tablets, sugar or 
drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor or nurse has advised you 
and have some rest. This will often get you over a low blood sugar or a minor insulin overdose. Check 
your blood sugar again after 15-20 mins until blood sugar is stabilised. 
 
If you are unable to treat yourself (severe hypoglycaemia) because you feel too dizzy, weak, confused, 
have difficulty talking, lose consciousness or have a seizure you may need to be treated with glucagon. 
This can be given by someone who knows how to use it. Eat glucose or sugar after the glucagon. If 
glucagon does not work, you will have to go to hospital or call emergency services. Ask your doctor to 
tell you about glucagon. 
 
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood 
sugar gets too low, including the risk of passing out. 
Let them know that if you pass out, they must: turn you on your side to avoid choking, get medical 
help straight away and not give you any food or drink because you may choke.  
 
If you forget to use Lyumjev 
If you forget to use your insulin or you take less than you need, your blood sugar may get too high 
(hyperglycaemia). Check your blood sugar level to decide if an insulin dose is needed. Resume your 
usual dosing schedule at your next meal. 
 
If you stop using Lyumjev 
Do not stop or change your insulin unless your doctor tells you to. If you take less Lyumjev than you 
need, a high blood sugar may occur. 
 
If high blood sugar (hyperglycaemia) is not treated it can be very serious and cause headaches, nausea, 
vomiting, abdominal pain, dehydration, unconsciousness, coma or even death (see section 4).  
 
Three simple steps to reduce your risk of hypoglycaemia or hyperglycaemia are: 
• Always keep a spare pen in case you lose your KwikPen or it gets damaged. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 



101 
 

Low blood sugar (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 
10 people). It can be very serious. If your blood sugar level falls too much you may become 
unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you 
have symptoms of low blood sugar, act immediately to increase your blood sugar level. See section 3 
under ‘If you take more Lyumjev than you need’. 
 
Allergic reactions are common (may affect up to 1 in 10 people). They may be severe and they may 
include the following symptoms: 
 

• rash over the whole body  
• difficulty in breathing  
• wheezing 

• blood pressure dropping  
• heart beating fast  
• sweating 

 
If you have a serious allergic reaction (including an anaphylactic attack) to insulin or any of the 
ingredients in Lyumjev, stop using this medicine and contact emergency medical service straight 
away. 
 
Other side effects include: 
 
Common  
Injection site reactions. Some people get redness, pain, swelling or itching around the area of the 
insulin injection. This usually clears up in a few minutes to a few weeks without needing to stop 
Lyumjev. If you have injection site reactions, tell your doctor. 
 
Uncommon (may affect up to 1 in 100 people) 
There are several skin changes that can happen if you inject insulin too often at the same place called 
lipodystrophy which is where skin can shrink (lipoatrophy), thicken (lipohypertrophy) or get lumps 
under the skin caused by a build-up of a protein called amyloid (cutaneous amyloidosis). Tell your 
doctor if you get lipodystrophy at the injection site, rash or very itchy skin. Change the injection site 
with each injection to help prevent skin changes. 
 
Other potential side effects 
Swelling in arms or ankles due to fluid retention (oedema) particularly at the start of insulin therapy or 
during a change in your diabetes medicines. 
 
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. 
 
Common problems of diabetes 
 
Low blood sugar  
Low blood sugar (hypoglycaemia) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Lyumjev or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin for example if you lose weight; or you have trouble 

with your kidneys or liver which gets worse. 
See section “If you take more Lyumjev than you need”. 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
 
• tiredness 



102 
 

• rapid heart beat 
• nervousness or shakiness 
• feeling sick 
• headache 
• cold sweat 
 
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. 
 
High blood sugar (hyperglycaemia) and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that the levels of glucose in your body are too 
high. Hyperglycaemia can be brought about by: 
• not taking your insulin; 
• using less insulin than your body needs; 
• an imbalance between the amount of carbohydrates you eat and the insulin you take; or 
• fever, infection or emotional stress. 
 
The early symptoms of hyperglycaemia are;  
• being very thirsty  
• headache  
• feeling sleepy 
• urinating more often 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. Additional symptoms include the following: 
• nausea and/or vomiting 
• abdominal pain 
• rapid pulse 
• heavy breathing 
• moderate or large amounts of urine ketones. Ketones are produced when your body burns fat for 

energy instead of glucose. 
 
If you have any of these symptoms and high sugars get medical help immediately. 
See section ‘If you forget to use Lyumjev’. 
 
Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 
5. How to store Lyumjev KwikPen 
 
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 label and the carton. The expiry 
date refers to the last day of that month.  
 
Before first use 
Store in a refrigerator (2 °C to 8 °C).  
Do not freeze.  
Keep in the outer carton in order to protect from light. 
 
After first use  
Do not store above 30 °C.  



103 
 

Do not freeze.  
Do not refrigerate.  
 
The KwikPen should not be stored with the needle attached. Keep the cap on the pen in order to 
protect from light. 
Discard after 28 days even if some of the solution remains. 
 
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 to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Lyumjev 100 units/ml KwikPen solution for injection contains 
• The active substance is insulin lispro. Each ml solution contains 100 units of insulin lispro. One 

KwikPen contains 300 units of insulin lispro in 3 ml solution.  
• The other ingredients are metacresol, glycerol, magnesium chloride hexahydrate, sodium citrate 

dihydrate, treprostinil sodium, zinc oxide, water for injections. Sodium hydroxide or 
hydrochloric acid may have been used to adjust the pH (see the end of section 2 under ‘Lyumjev 
KwikPen contains sodium’). 

 
What Lyumjev KwikPen looks like and contents of the pack 
Lyumjev KwikPen solution for injection is a clear, colourless, aqueous solution in a pre-filled pen. 
Each pre-filled pen contains 300 units (3 millilitres).  
 
Pack sizes of 2, 5 or a multipack of 2 x 5 pre-filled pens. Not all pack sizes may be marketed.  
 
The Lyumjev KwikPen is taupe. The dose knob is blue with raised ridges. The label is blue and white. 
Each Lyumjev KwikPen delivers 1 to 60 units in steps of 1 unit.  
 
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, 67640 Fegersheim, France. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
Belgique/België/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 6000 
 

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

Deutschland Nederland 



104 
 

Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

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

Eesti 
Eli Lilly Nederland B.V.  
Tel: +372 6817 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 
 

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

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

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 
 

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 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

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 

 
This leaflet was last revised in {MM/YYYY}. 
 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 



105 
 

Instructions for Use 

Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen  
insulin lispro 

 
PLEASE READ THESE INSTRUCTIONS BEFORE USE 

Read the instructions for use before you start taking Lyumjev and each time you get another Lyumjev 
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. 
 
Do not share your Lyumjev KwikPen with other people, even if the needle has been changed. Do 
not reuse or share needles with other people. You may give other people a serious infection or 
get a serious infection from them. 
 
Lyumjev 100 units/mL KwikPen (“Pen”) is a disposable pre-filled pen containing 3 mL (300 units, 
100 units/mL) of insulin lispro solution for injection.  
• Your healthcare professional will tell you how many units to give as your dose and how to 

inject your prescribed dose of insulin. 
• You can give yourself more than 1 dose from the Pen.  
• Each turn of the dose knob dials 1 unit of insulin. You can give from 1 to 60 units in a single 

injection. 
• If your dose is more than 60 units, you will need to give yourself more than 1 injection. Always 

check the number in the dose window to make sure you dialed the correct dose. 
• 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. 
 
People who are blind or have vision problems should not use the Pen without help from a person 
trained to use the Pen. 
 

Lyumjev KwikPen Parts 
 

 Pen Cap       Cartridge Holder    Label Dose Indicator 

 

 Cap Clip Rubber Seal Plunger Pen Body Dose 
Window 

Dose 
Knob 

 
 

Pen Needle Parts 
(Needles Not Included) 

Dose Knob 
 

 

 
 

 Outer Needle 
Shield 

Inner 
Needle 

Needle Paper Tab   



106 
 

Shield 
 

How to recognize your Lyumjev KwikPen 
• Pen colour:  Taupe 

• Dose Knob:  Blue, with raised ridges on side 

• Label:  Blue and white 
 
 
Supplies needed to give your injection 
• Lyumjev KwikPen 

• KwikPen compatible needle (BD [Becton, Dickinson and Company] Pen needles 
recommended) 

• Swab or gauze 
 
 
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 expiry 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. 

 
 

Step 2: 
• Check the liquid in the Pen. 

• Lyumjev should look clear and colourless. Do 
not use if it is cloudy, coloured, or has 
particles or clumps in it. 

 

Step 3: 
• Select a new needle. 

• Pull off the paper tab from the outer needle 
shield. 

 

Step 4: 
• Push the capped needle straight onto the Pen 

and twist the needle on until it is tight. 

 



107 
 

Step 5: 
• 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 your Pen is working correctly. 

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

 
Step 6: 
• To prime your Pen, turn the dose knob to select 

2 units. 

 

 

 
 

Step 7: 
• Hold your Pen with the needle pointing up. Tap 

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

 

Step 8: 
• Continue holding your Pen with the 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 priming 
steps 6 to 8, but not more than 4 times. 

– If you still do not see insulin, change the 
needle and repeat priming steps 6 to 8. 

Small air bubbles are normal and will not affect your 
dose. 

 

 
 

 
 
 
Selecting your dose 
• You can give from 1 to 60 units in a single injection. 

• If your dose is more than 60 units, you will need to give more than 1 injection. 

– If you need help with dividing up your dose the right way, ask your healthcare professional. 

Keep 
Throw 
Away 



108 
 

– Use a new needle for each injection and repeat the priming steps. 

 
Step 9: 
• 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. You may dial the wrong dose. This 
may lead to getting too much insulin or not 
enough insulin. 

– 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 example to the right shows 12 units. 

– The odd numbers, after the number 1, are 
shown as full lines between the numbers. 
The example to the right shows 25 units. 

• Always check the number in the dose window 
to make sure you have dialed the correct 
dose. 

 

 
 
 

  
Example: 12 units 
shown in the dose 
window 

 

  
Example: 25 units 
shown in the dose 
window 

 
• 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. 



109 
 

 
Step 10: 
• Choose your injection site. 

 Lyumjev is injected under the skin 
(subcutaneously) of your stomach area, 
buttocks, upper legs or upper arms. 

• Wipe your skin with a swab, and let your 
skin dry before you inject your dose. 

 

 

Step 11: 
• 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. 

 

 

5 sec 



110 
 

Step 12: 
• 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 dialed. 

– If you do not see “0” in the dose window, 
you did not receive your full dose. 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 dialed 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 a swab. Do not rub the area. 

 

 

 
 
After your injection 
Step 13: 
• Carefully replace the outer needle shield. 

 

 

  

Step 14: 
• Unscrew the capped needle and dispose of it as 

described below (see Disposing of Pens and 
needles section). 

• Do not store the Pen with the needle attached to 
prevent leaking, blocking the needle, and air 
from entering the Pen.  

Step 15: 
• Replace the Pen cap by lining up the cap clip 

with the dose indicator and pushing straight on. 
 

 



111 
 

 
Disposing of Pens and needles 
•  Put used needles in a sharps container or a hard plastic container with a secure lid. Do not throw 

needles directly into your household waste. 

•  Do not recycle the filled sharps container. 

•  Ask your healthcare professional about options to dispose of the Pen and the sharps container 
properly. 

•  The directions regarding needle handling are not intended to replace local, healthcare 
professional or institutional policies. 

 
 
 
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 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 Lyumjev 100 units/mL KwikPen, call your 
healthcare professional for help or contact your local Lilly affiliate.  
 
Document Revision Date:  
 
 



112 
 

Package leaflet: Information for the user 
 

Lyumjev 100 units/ml Junior KwikPen solution for injection in pre-filled pen 
insulin lispro 

 
Each Junior KwikPen delivers 0.5 to 30 units in steps of 0.5 units. 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor, nurse or pharmacist. 
• 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, nurse or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Lyumjev Junior KwikPen is and what it is used for 
2. What you need to know before you use Lyumjev Junior KwikPen 
3. How to use Lyumjev Junior KwikPen 
4. Possible side effects 
5. How to store Lyumjev Junior KwikPen 
6. Contents of the pack and other information 
 
 
1. What Lyumjev Junior KwikPen is and what it is used for 
 
Lyumjev 100 units/ml Junior KwikPen solution for injection in pre-filled pen contains the active 
ingredient insulin lispro. Lyumjev is used to treat diabetes in adults. It is a mealtime insulin that works 
more quickly than other medicinecontaining insulin lispro. Lyumjev contains ingredients that speed up 
absorption of insulin lispro into the body. 
 
Diabetes is a condition in which your body does not make enough insulin or does not use insulin 
effectively, which results in effects such as high levels of sugar in the blood. Lyumjev is an insulin 
medicinethat is used in the treatment of diabetes and so controls blood sugar. Effective treatment of 
diabetes, with good control of blood sugar, prevents long-term complications from your diabetes. 
 
Treatment with Lyumjev helps to control blood sugar in the long term and prevent complications from 
your diabetes. Lyumjev has its maximum effect 1 to 3 hours after injection and the effect lasts for up 
to 5 hours. You should use Lyumjev at the start of the meal, or up to 20 minutes after starting the 
meal. 
 
Your doctor may tell you to use Lyumjev as well as a longer- or intermediate-acting insulin. Do not 
change your insulin unless your doctor tells you to.  
 
Lyumjev 100 units/ml Junior KwikPen is a disposable pre-filled pen containing 3 ml (300 units, 
100 units/ml) of insulin lispro. One KwikPen contains multiple doses of insulin. The KwikPen dials 
half unit (0.5 unit) at a time. The number of units are displayed in the dose window, always check 
this before your injection. You can give from 0.5 unit to 30 units in a single injection. If your dose is 
more than 30 units, you will need to give yourself more than one injection.  
 
 



113 
 

2. What you need to know before you use Lyumjev Junior KwikPen   
 
Do NOT use Lyumjev Junior KwikPen  
• if you think your blood sugar is dropping (hypoglycaemia). Further on this leaflet tells you how 

to deal with low blood sugar (see section 3 under “If you take more Lyumjev than you need”). 
• if you are allergic to insulin lispro 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 Lyumjev. 
 
If you cannot see very well you will need help from someone who has been trained to give injections. 
 
• Low blood sugar (hypoglycaemia).  
Low blood sugar can be serious and untreated hypoglycaemia may even lead to death.  
Lyumjev starts to lower blood sugar faster than some other mealtime insulins. If hypoglycaemia 
occurs, you may experience it earlier after an injection of Lyumjev. If you often have hypoglycaemia 
or have difficulty recognising it, please discuss this with your doctor or nurse. If your blood sugar 
levels are well controlled by your current insulin therapy or after long duration of diabetes, you may 
not feel the warning symptoms when your blood sugar is falling too low.Warning signs are listed later 
in this leaflet. For symptoms please see “Common problems of diabetes”. 

 
You must think carefully about when to have your meals, how often to exercise and how much to do. 
You must also keep a close watch on your blood sugar levels by testing your blood sugar often. 
Making changes to the types of  insulin you use may cause your blood sugar to rise or fall too much.  
It may be necessary to increase the frequency of blood sugar testing if you are at risk of low blood 
sugars. Your doctor may need to change the doses of your other diabetes medicine.  
 
• High blood sugar (hyperglycaemia).   
Stopping or not taking enough insulin may lead to high blood sugar (hyperglycaemia) and diabetic 
ketoacidosis, serious conditions that can even lead to death. For symptoms please see “Common 
problems of diabetes”. 
 
• If your insulin treatment is being combined with one of a class of diabetes medicinecalled 

thiazolidinediones or glitazones, such as pioglitazone, tell your doctor as soon as possible if you 
get signs of heart failure such as unusual shortness of breath or rapid increase in weight or 
localised swelling caused by fluid retention (oedema). 

• If you have a serious allergic reaction to insulin or any of the ingredients in Lyumjev, stop using 
this medicine and contact emergency medical services straight away. 

• Always check the pack and the label for the name and type of the insulin when you get it from 
your pharmacy. Make sure you get the Lyumjev that your doctor has told you to use. 

• Keep the carton, or keep a note of the batch number on the carton.  If you have a side effect you 
can then provide that number when you report the advere side effect, see “reporting of side 
effects”. 

• Always use a new needle for each injection to prevent infections and blocked needles.  If a 
needle is blocked replace it with a new needle. 

 
Children and adolescents 
This medicine should not be used in children or adolescents, since there is no experience with this 
medicine in children and adolescents under 18 years of age. 
 
Other medicines and Lyumjev 
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other 
medicines. Some medicines affect your blood sugar level - this may mean your insulin dose has to 
change. 
 



114 
 

Your blood sugar levels may fall (hypoglycaemia) if you take:   
 
• other medicines for diabetes (oral and injectable)  
• sulphonamide antibiotics (for infections) 
• acetylsalicylic acid (for pain and mild fever and to prevent blood clotting) 
• some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors) 
• some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril) (for 

some heart problems or high blood pressure) 
• angiotensin II receptor blockers (for high blood pressure or heart problems) 
• somatostatin analogues (such as octreotide, which are used to treat a rare condition involving 

too much growth hormone) 
 
Your blood sugar levels may rise (hyperglycaemia) if you take: 
 
• danazol (for endometriosis)  
• the contraceptive pill (birth control pills) 
• thyroid hormone replacement therapy (for thyroid problems) 
• human growth hormone (for growth hormone deficiency) 
• diuretics (for high blood pressure or if you have a build-up of water in your body) 

sympathomimetic agents (for serious allergic reactions or used in some cold remedies)  
• corticosteroids (to treat asthma or autoimmune conditions) 

 
Beta-blockers (used for high blood pressure, arrhythmia or angina) make it harder to recognise the 
warning signs of low blood sugar.  
 
Lyumjev with alcohol 
Your blood sugar levels may either rise or fall if you drink alcohol. Therefore the amount of insulin 
needed may change. You should therefore monitor your blood sugar level more often than usual. 
 
Pregnancy and breast-feeding 
If you are planning to have a baby, think you may be pregnant, are pregnant or breast-feeding, ask 
your doctor, nurse or pharmacist for advice before taking this medicine. The amount of insulin you 
need usually falls during the first 3 months of pregnancy and increases for the remaining 6 months. 
After you have had your baby your insulin requirements will likely return to how much you needed 
before your pregnancy.  
 
There are no restrictions on treatment with Lyumjev during breast-feeding. If you are breast-feeding, 
you may need to alter your insulin intake or diet. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or using machines). You should contact your doctor about driving if you have: 
• frequent episodes of hypoglycaemia 
• reduced or absent warning signs of hypoglycaemia 
 
Lyumjev Junior KwikPen contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Lyumjev Junior KwikPen  
 
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has 
told you. Check with them if you are not sure.  
 



115 
 

They will have told you exactly how much Lyumjev to use, when to use it, and how often. They will 
also tell you how often to visit your diabetes clinic.  
 
To prevent the possible transmission of disease, each pen must be used by you only, even if the needle 
is changed. 
 
You should always have spare insulin and another injection device in case you need them. 
 
If you are blind or visually impaired you will need help from someone to make your injections. 
 
Your doctor may tell you to use Lyumjev as well as a longer- or intermediate-acting insulin. Inject 
them separately. Lyumjev should not be mixed with any other insulin. 
 
When to inject Lyumjev 
Lyumjev is a mealtime insulin. You should use Lyumjev when you start to eat, or a minute or two 
before the meal; you also have the option to inject  up to 20 minutes after starting the meal.  
 
How much insulin to use 
Your doctor will work out your dose based on your blood sugar and body weight and explain  
• How much Lyumjev you need at each meal. 
• How and when to check your blood sugar level. 
• How to change your insulin dose depending on your blood sugar levels. 
• What to do if you change your diet, or change how much you exercise, if you are ill or if you are 

using other medicines. 
• If you change the type of insulin you use, you may have to take more or less than before. This 

might just be for the first injection or it may be a gradual change over several weeks or months.  
 
Do not use Lyumjev 
• If it does not look like water. Lyumjev must be clear, have no colour and no solid pieces in it. 

Check each time you inject yourself. 
• If Lyumjev has not been stored correctly (see section 5 “How to store Lyumjev”). 
• If the pen is damaged in any way, do not use.  
 
Getting the Lyumjev Junior KwikPen ready to use (Please see instructions for use) 
• First wash your hands. 
• Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions 

carefully. Here are some reminders. 
• Use a new needle. (Needles are not included). 
• Prime your Lyumjev Junior KwikPen before each use. This checks that insulin comes out and 

clears the air bubbles from your Lyumjev Junior KwikPen. There may still be some small air 
bubbles left in the pen. Small air bubbles are normal and will not affect your dose. 

• The number of units are displayed in the dose window, always check this before your injection. 
 
Injecting Lyumjev  
• Before you make an injection, clean your skin.  
• Inject under the skin (subcutaneous injection), as you were taught by your physician or nurse.  
• After your injection, leave the needle in the skin for 5 seconds to make sure you receive the full 

dose. Make sure you inject at least 1 cm from the last injection and that you ‘rotate’ the places 
you inject (upper arm, thigh, buttocks or abdomen).  

• If you do not have enough insulin in the pen to complete your dose, make a note of how much 
you still need to take.  Prime a new pen and inject the remaining dose. 

• If you need to inject another insulin at the same time as Lyumjev, use a different injection site. 
• Do not inject directly into a vein.  



116 
 

 
After injecting 
• As soon as you have done the injection, unscrew the needle from the Lyumjev Junior KwikPen 

using the outer needle cap. This will keep the insulin sterile and stop it leaking. It also stops air 
entering the pen and your needle clogging. Do not share your needles. Do not share your 
pen. Replace the cap on your pen. 

 
Further injections 
• Every time you use a Lyumjev Junior KwikPen you must use a new needle. Before every 

injection, clear any air bubbles. You can see how much insulin is left by holding the Lyumjev 
Junior KwikPen with the needle pointing up.  

• Once the Lyumjev Junior KwikPen is empty, do not use it again.  
 
If you take more Lyumjev than you need 
If you inject too much Lyumjev, a low blood sugar may occur. Check your blood sugar.  
 
If your blood sugar is low (hypoglycaemia) and you can treat yourself, eat glucose tablets, sugar or 
drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor or nurse has advised you 
and have some rest. This will often get you over a low blood sugar or a minor insulin overdose. Check 
your blood sugar again after 15-20 mins until blood sugar is stabilised. 
 
If you are unable to treat yourself (severe hypoglycaemia) because you feel too dizzy, weak, confused, 
have difficulty talking, lose consciousness or have a seizure you may need to be treated with glucagon. 
This can be given by someone who knows how to use it. Eat glucose or sugar after the glucagon. If 
glucagon does not work, you will have to go to hospital or call emergency services. Ask your doctor to 
tell you about glucagon. 
 
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood 
sugar gets too low, including the risk of passing out. 
Let them know that if you pass out, they must: turn you on your side to avoid choking, get medical 
help straight away and not give you any food or drink because you may choke.  
 
If you forget to use Lyumjev 
If you forget to use your insulin or you take less than you need, your blood sugar may get too high 
(hyperglycaemia). Check your blood sugar level to decide if an insulin dose is needed. Resume your 
usual dosing schedule at your next meal. 
 
If you stop using Lyumjev 
Do not stop or change your insulin unless your doctor tells you to. If you take less Lyumjev than you 
need, a high blood sugar may occur. 
 
If high blood sugar (hyperglycaemia) is not treated it can be very serious and cause headaches, nausea, 
vomiting, abdominal pain, dehydration, unconsciousness, coma or even death (see section 4).  
 
Three simple steps to reduce your risk of hypoglycaemia or hyperglycaemia are: 
• Always keep a spare pen in case you lose your Lyumjev Junior KwikPen or it gets damaged. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 



117 
 

Low blood sugar (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 
10 people). It can be very serious. If your blood sugar level falls too much you may become 
unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you 
have symptoms of low blood sugar, act immediately to increase your blood sugar level. See section 3 
under ‘If you take more Lyumjev than you need’. 
 
Allergic reactions are common (may affect up to 1 in 10 people). They may be severe and they may 
include the following symptoms: 
 

• rash over the whole body  
• difficulty in breathing  
• wheezing 

• blood pressure dropping  
• heart beating fast  
• sweating 

 
If you have a serious allergic reaction (including an anaphylactic attack) to insulin or any of the 
ingredients in Lyumjev, stop using this medicine and contact emergency medical service straight 
away. 
 
Other side effects include: 
 
Common  
Injection site reactions. Some people get redness, pain, swelling or itching around the area of the 
insulin injection. This usually clears up in a few minutes to a few weeks without needing to stop 
Lyumjev. If you have injection site reactions, tell your doctor. 
 
Uncommon (may affect up to 1 in 100 people) 
There are several skin changes that can happen if you inject insulin too often at the same place called 
lipodystrophy which is where skin can shrink (lipoatrophy), thicken (lipohypertrophy) or get lumps 
under the skin caused by a build-up of a protein called amyloid (cutaneous amyloidosis). Tell your 
doctor if you get lipodystrophy at the injection site, rash or very itchy skin. Change the injection site 
with each injection to help prevent skin changes. 
 
Other potential side effects 
Swelling in arms or ankles due to fluid retention (oedema) particularly at the start of insulin therapy or 
during a change in your diabetes medicines. 
 
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. 
 
Common problems of diabetes 
 
Low blood sugar  
Low blood sugar (hypoglycaemia) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Lyumjev or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin for example if you lose weight; or you have trouble 

with your kidneys or liver which gets worse. 
 See section ‘If you take more Lyumjev than you need.’ 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
 
• tiredness 



118 
 

• rapid heart beat 
• nervousness or shakiness 
• feeling sick 
• headache 
• cold sweat 
 
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. 
 
High blood sugar (hyperglycaemia) and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that the levels of glucose in your body are too 
high. Hyperglycaemia can be brought about by: 
• not taking your insulin; 
• using less insulin than your body needs; 
• an imbalance between the amount of carbohydrates you eat and the insulin you take; or 
• fever, infection or emotional stress. 
 
The early symptoms of hyperglycaemia are;  
• being very thirsty  
• headache  
• feeling sleepy 
• urinating more often 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. Additional symptoms include the following: 
• nausea and/or vomiting 
• abdominal pain 
• rapid pulse 
• heavy breathing 
• moderate or large amounts of urine ketones. Ketones are produced when your body burns fat for 

energy instead of glucose. 
 
If you have any of these symptoms and high sugars get medical help immediately. 
See section ‘If you forget to use Lyumjev’. 
 
Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 
5. How to store Lyumjev Junior KwikPen 
 
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 label and the carton. The expiry 
date refers to the last day of that month.  
 
Before first use 
Store in a refrigerator (2 °C to 8 °C).  
Do not freeze.  
Keep in the outer carton in order to protect from light. 
 
After first use  
Do not store above 30 °C.  



119 
 

Do not freeze.  
Do not refrigerate.  
 
The Lyumjev Junior KwikPen should not be stored with the needle attached. Keep the cap on the pen 
in order to protect from light. 
Discard after 28 days even if some of the solution remains. 
 
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 to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Lyumjev 100 units/ml Junior KwikPen solution for injection contains 
• The active substance is insulin lispro. Each ml solution contains 100 units of insulin lispro. One 

Lyumjev Junior KwikPen contains 300 units of insulin lispro in 3 ml solution.  
• The other ingredients are metacresol, glycerol, magnesium chloride hexahydrate, sodium citrate 

dihydrate, treprostinil sodium, zinc oxide, water for injections. Sodium hydroxide or 
hydrochloric acid may have been used to adjust the pH (see the end of section 2 under ‘Lyumjev 
Junior KwikPen contains sodium’). 

 
What Lyumjev 100 units/ml Junior KwikPen looks like and contents of the pack 
Lyumjev 100 units/ml Junior KwikPen solution for injection is a clear, colourless, aqueous solution in 
a pre-filled pen. Each pre-filled pen contains 300 units (3 millilitres).  
 
Pack sizes of 2, 5 or a multipack of 2 x 5 pre-filled pens. Not all pack sizes may be marketed.  
 
The Lyumjev Junior KwikPen is taupe. The dose knob is peach with raised ridges. The label is white 
with a peach colour bar, and peach, light blue and dark blue colour band Each Lyumjev Junior 
KwikPen delivers 0.5 to 30 units in steps of 0.5 units. 
 
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, 67640 Fegersheim, France. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
Belgique/België/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 



120 
 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 6000 
 

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

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

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

Eesti 
Eli Lilly Nederland B.V.  
Tel: +372 6817 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 
 

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

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

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 
 

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 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

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 

 
This leaflet was last revised in {MM/YYYY}. 
 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 



121 
 

Instructions for Use 
 

Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen  
insulin lispro 

 
 
 
 
 
 
 

PLEASE READ THESE INSTRUCTIONS BEFORE USE 
 

Read the instructions for use before you start taking Lyumjev and each time you get another Lyumjev 
Junior 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. 
 
Do not share your Lyumjev Junior KwikPen with other people, even if the needle has been 
changed. Do not reuse or share needles with other people. You may give other people a serious 
infection or get a serious infection from them. 
 
Lyumjev 100 units/mL Junior KwikPen (“Pen”) is a disposable pre-filled pen containing 3 mL 
(300 units, 100 units/mL) of insulin lispro solution for injection.  
• Your healthcare professional will tell you how many units to give as your dose and how to 

inject your prescribed dose of insulin. 
• You can give yourself more than 1 dose from the Pen.  
• Each turn of the dose knob dials half (0.5 unit) of insulin. You can give from half (0.5 unit) to 

30 units in a single injection. 
• If your dose is more than 30 units, you will need to give yourself more than 1 injection. Always 

check the number in the dose window to make sure you dialed the correct dose. 
• 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. 
 
People who are blind or have vision problems should not use the Pen without help from a person 
trained to use the Pen. 
 

Lyumjev Junior KwikPen Parts 
 

 Pen Cap  Cartridge Holder     Label Dose Indicator 

 

 Cap Clip Rubber Seal Plunger       Pen Body Dose 
Window 

Dose 
Knob 

 
 

Pen Needle Parts 
(Needles Not Included) 

Dose Knob 
 

 

  
 Outer Needle Inner Needle Needle Paper Tab   



122 
 

Shield Shield 
 
How to recognize your Lyumjev Junior KwikPen 
• Pen colour:  Taupe 

• Dose knob:  Peach, with raised ridges on end and side 

• Label:  White with a peach colour bar, and peach, light blue and dark blue 
   colour band 
 
 
Supplies needed to give your injection 
• Lyumjev Junior KwikPen 

• KwikPen compatible needle (BD [Becton, Dickinson and Company] Pen needles 
recommended) 

• Swab or gauze 
 
 
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 expiry 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. 

 
 

Step 2: 
• Check the liquid in the Pen. 

• Lyumjev should look clear and colourless. Do 
not use if it is cloudy, coloured, or has particles 
or clumps in it. 

 

Step 3: 
• Select a new needle. 

• Pull off the paper tab from the outer needle 
shield. 

 

Step 4: 
• Push the capped needle straight onto the Pen 

and twist the needle on until it is tight. 

 



123 
 

Step 5: 
• 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 your Pen is working correctly.  

• If you do not prime before each injection, you may get too much or too little insulin. 
 
Step 6: 
• To prime your Pen, turn the dose knob to select 

2 units. 

 

 

 
 

Step 7: 
• Hold your Pen with the needle pointing up. Tap 

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

 

Step 8: 
• Continue holding your Pen with the 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 priming steps 6 
to 8, but not more than 4 times. 

– If you still do not see insulin, change the needle 
and repeat priming steps 6 to 8. 

Small air bubbles are normal and will not affect your 
dose. 

 

 

 
 
 
Selecting your dose 
• You can give from half unit (0.5 unit) to 30 units in a single injection. 

• If your dose is more than 30 units, you will need to give more than 1 injection. 

– If you need help with dividing up your dose the right way, ask your healthcare professional. 

Keep Throw Away 



124 
 

– Use a new needle for each injection and repeat the priming steps. 

– If you usually need more than 30 units, ask your healthcare professional if a different 
Lyumjev KwikPen would be better for you. 

 
Step 9: 
• 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 half unit (0.5 unit) at a time. 

– The dose knob clicks as you turn it. 

– Do not dial your dose by counting the 
clicks. You may dial the wrong dose. This 
may lead to getting too much insulin or not 
enough insulin. 

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

– The whole unit numbers are printed on the 
dial. The example to the right shows 4 units. 

– The half units are shown as lines between 
the whole unit numbers. The example to the 
right shows 10.5 units. 

• Always check the number in the dose window 
to make sure you have dialed the correct 
dose. 

 

 

 
Example: 4 units 
shown in the dose 
window 

 
Example: 10 ½ (10.5) 
units shown in the dose 
window 

 
• 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. 



125 
 

 
Step 10: 
• Choose your injection site. 

 Lyumjev is injected under the skin 
(subcutaneously) of your stomach area, 
buttocks, upper legs or upper arms. 

• Wipe your skin with a swab, and let your 
skin dry before you inject your dose. 

 
 

Step 11: 
• 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. 

 

 

5 sec 



126 
 

Step 12: 
• 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 dialed. 

– If you do not see “0” in the dose 
window, you did not receive your 
full dose. 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 dialed 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 a swab. Do not rub the 
area. 

 

 

 
 



127 
 

After your injection 
Step 13: 
• Carefully replace the outer needle shield. 

 

Step 14: 
• Unscrew the capped needle and dispose of it as 

described below (see Disposing of Pens and 
needles section). 

• Do not store the Pen with the needle attached to 
prevent leaking, blocking the needle, and air 
from entering the Pen. 

 

Step 15: 
• 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 sharps container or a hard plastic container with a secure lid. Do not throw 

needles directly into your household waste. 

•  Do not recycle the filled sharps container. 

•  Ask your healthcare professional about options to dispose of the Pen and the sharps container 
properly. 

•  The directions regarding needle handling are not intended to replace local, healthcare 
professional or institutional policies. 

 
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 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 Lyumjev 100 units/mL Junior KwikPen, call your 
healthcare professional for help or contact your local Lilly affiliate.  
 
Document Revision Date:  
 
 
 



128 
 

Package leaflet: Information for the user 
 

Lyumjev 200 units/ml KwikPen solution for injection in pre-filled pen 
insulin lispro 

 
Each KwikPen delivers 1 to 60 units in steps of 1 units 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor, nurse or pharmacist. 
• 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, nurse or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Lyumjev 200 units/ml KwikPen is and what it is used for 
2. What you need to know before you use Lyumjev 200 units/ml KwikPen 
3. How to use Lyumjev 200 units/ml KwikPen 
4. Possible side effects 
5. How to store Lyumjev 200 units/ml KwikPen 
6. Contents of the pack and other information 
 
 
1. What Lyumjev 200 units/ml KwikPen is and what it is used for 
 
Lyumjev 200 units/ml KwikPen solution for injection in pre-filled pen contains the active ingredient 
insulin lispro. Lyumjev is used to treat diabetes in adults. It is a mealtime insulin that works more 
quickly than other medicinecontaining insulin lispro. Lyumjev contains ingredients that speed up 
absorption of insulin lispro into the body. 
 
Diabetes is a condition in which your body does not make enough insulin or does not use insulin 
effectively, which results in effects such as high levels of sugar in the blood. Lyumjev is an insulin 
medicinethat is used in the treatment of diabetes and so controls blood sugar. Effective treatment of 
diabetes, with good control of blood sugar, prevents long-term complications from your diabetes. 
 
Treatment with Lyumjev helps to control blood sugar in the long term and prevent complications from 
your diabetes. Lyumjev has its maximum effect 1 to 3 hours after injection and the effect lasts for up 
to 5 hours. You should use Lyumjev at the start of the meal, or up to 20 minutes after starting the 
meal. 
 
Your doctor may tell you to use Lyumjev as well as a longer- or intermediate-acting insulin. Do not 
change your insulin unless your doctor tells you to.  
 
Lyumjev 200 units/ml KwikPen is a disposable pre-filled pen containing 3 ml (600 units, 
200 units/ml) of insulin lispro. One KwikPen contains multiple doses of insulin. The KwikPen dials 
1 unit at a time. The number of units are displayed in the dose window, always check this before 
your injection. You can give from 1 to 60 units in a single injection. If your dose is more than 
60 units, you will need to give yourself more than one injection.  
 
 



129 
 

2. What you need to know before you use Lyumjev 200 units/ml KwikPen 
 
Do NOT use Lyumjev 200 units/ml KwikPen  
• if you think your blood sugar is dropping (hypoglycaemia). Further on this leaflet tells you how 

to deal with low blood sugar (see section 3 under “If you take more Lyumjev than you need”). 
• if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions  
• The Lyumjev 200 units/ml solution for injection in your pre-filled pen (the KwikPen) 

should ONLY be injected with this pre-filled pen. Do not transfer the insulin lispro from 
your Lyumjev 200 units/ml KwikPen to a syringe. The markings on the insulin syringe will 
not measure your dose correctly. A severe overdose can result, causing low blood sugar which 
may put your life in danger. Do not transfer insulin from your Lyumjev 200 units/ml KwikPen 
to any other insulin delivery devices like insulin infusion pumps. 

 
Talk to your doctor, pharmacist or nurse before using Lyumjev. 
 
If you cannot see very well you will need help from someone who has been trained to give injections. 
 
• Low blood sugar (hypoglycaemia).  
Low blood sugar can be serious and untreated hypoglycaemia may even lead to death.  
Lyumjev starts to lower blood sugar faster than some other mealtime insulins. If hypoglycaemia 
occurs, you may experience it earlier after an injection of Lyumjev. If you often have hypoglycaemia 
or have difficulty recognising it, please discuss this with your doctor or nurse. If your blood sugar 
levels are well controlled by your current insulin therapy or after long duration of diabetes, you may 
not feel the warning symptoms when your blood sugar is falling too low.Warning signs are listed later 
in this leaflet. For symptoms please see “Common problems of diabetes”. 

 
You must think carefully about when to have your meals, how often to exercise and how much to do. 
You must also keep a close watch on your blood sugar levels by testing your blood sugar often. 
Making changes to the types of  insulin you use may cause your blood sugar to rise or fall too much.  
It may be necessary to increase the frequency of blood sugar testing if you are at risk of low blood 
sugars. Your doctor may need to change the doses of your other diabetes medicine.  
 
• High blood sugar (hyperglycaemia).   
Stopping or not taking enough insulin may lead to high blood sugar (hyperglycaemia) and diabetic 
ketoacidosis, serious conditions that can even lead to death. For symptoms please see “Common 
problems of diabetes”. 
 
• If your insulin treatment is being combined with one of a class of diabetes medicinecalled 

thiazolidinediones or glitazones, such as pioglitazone, tell your doctor as soon as possible if you 
get signs of heart failure such as unusual shortness of breath or rapid increase in weight or 
localised swelling caused by fluid retention (oedema). 

• If you have a serious allergic reaction to insulin or any of the ingredients in Lyumjev, stop using 
this medicine and contact emergency medical services straight away. 

• Always check the pack and the label for the name and type of the insulin when you get it from 
your pharmacy. Make sure you get the Lyumjev that your doctor has told you to use. 

• Keep the carton, or keep a note of the batch number on the carton.  If you have a side effect you 
can then provide that number when you report the advere side effect, see “reporting of side 
effects”. 

• Always use a new needle for each injection to prevent infections and blocked needles.  If a 
needle is blocked replace it with a new needle. 

 



130 
 

Children and adolescents 
This medicine should not be used in children or adolescents, since there is no experience with this 
medicine in children and adolescents under 18 years of age. 
 
Other medicines and Lyumjev 
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other 
medicines. Some medicines affect your blood sugar level - this may mean your insulin dose has to 
change. 
 
Your blood sugar levels may fall (hypoglycaemia) if you take:   
 
• other medicines for diabetes (oral and injectable)  
• sulphonamide antibiotics (for infections) 
• acetylsalicylic acid (for pain and mild fever and to prevent blood clotting) 
• some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors) 
• some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril) (for 

some heart problems or high blood pressure) 
• angiotensin II receptor blockers (for high blood pressure or heart problems) 
• somatostatin analogues (such as octreotide, which are used to treat a rare condition involving 

too much growth hormone) 
 
Your blood sugar levels may rise (hyperglycaemia) if you take: 
 
• danazol (for endometriosis)  
• the contraceptive pill (birth control pills) 
• thyroid hormone replacement therapy (for thyroid problems) 
• human growth hormone (for growth hormone deficiency) 
• diuretics (for high blood pressure or if you have a build-up of water in your body) 

sympathomimetic agents (for serious allergic reactions or used in some cold remedies)  
• corticosteroids (to treat asthma or autoimmune conditions) 
 
Beta-blockers (used for high blood pressure, arrhythmia or angina) make it harder to recognise the 
warning signs of low blood sugar.  
 
Lyumjev with alcohol 
Your blood sugar levels may either rise or fall if you drink alcohol. Therefore the amount of insulin 
needed may change. You should therefore monitor your blood sugar level more often than usual. 
 
Pregnancy and breast-feeding 
If you are planning to have a baby, think you may be pregnant, are pregnant or breast-feeding, ask 
your doctor, nurse or pharmacist for advice before taking this medicine. The amount of insulin you 
need usually falls during the first 3 months of pregnancy and increases for the remaining 6 months. 
After you have had your baby your insulin requirements will likely return to how much you needed 
before your pregnancy.  
 
There are no restrictions on treatment with Lyumjev during breast-feeding. If you are breast-feeding, 
you may need to alter your insulin intake or diet. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or using machines). You should contact your doctor about driving if you have: 
• frequent episodes of hypoglycaemia 
• reduced or absent warning signs of hypoglycaemia 
 



131 
 

Lyumjev 200 units/ml KwikPen contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Lyumjev 200 units/ml KwikPen 
 
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has 
told you. Check with them if you are not sure.  
 
They will have told you exactly how much Lyumjev to use, when to use it, and how often. They will 
also tell you how often to visit your diabetes clinic.  
 
To prevent the possible transmission of disease, each pen must be used by you only, even if the needle 
is changed. 
 
Do not use Lyumjev 200 units/ml KwikPen solution for injection in an insulin infusion pump. 
 
You should always have spare insulin and another injection device in case you need them. 
 
If you are blind or visually impaired you will need help from someone to make your injections. 
 
Your doctor may tell you to use Lyumjev as well as a longer- or intermediate-acting insulin. Inject 
them separately. Lyumjev should not be mixed with any other insulin. 
 
When to inject Lyumjev 
Lyumjev is a mealtime insulin. You should use Lyumjev when you start to eat, or a minute or two 
before the meal; you also have the option to inject  up to 20 minutes after starting the meal.  
 
How much insulin to use 
Your doctor will work out your dose based on your blood sugar and body weight and explain  
• How much Lyumjev you need at each meal. 
• How and when to check your blood sugar level. 
• How to change your insulin dose depending on your blood sugar levels. 
• What to do if you change your diet, or change how much you exercise, if you are ill or if you are 

using other medicines. 
• If you change the type of insulin you use, you may have to take more or less than before. This 

might just be for the first injection or it may be a gradual change over several weeks or months.  
 
Do not use Lyumjev 
• If it does not look like water. Lyumjev must be clear, have no colour and no solid pieces in it. 

Check each time you inject yourself. 
• If Lyumjev has not been stored correctly (see section 5 “How to store Lyumjev”). 
• If the pen is damaged in any way, do not use.  
 
Getting the Lyumjev 200 units/ml KwikPen ready to use (Please see instructions for use) 
• First wash your hands. 
• Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions 

carefully. Here are some reminders. 
• Use a new needle. (Needles are not included). 
• Prime your Lyumjev 200 units/ml KwikPen before each use. This checks that insulin comes out 

and clears the air bubbles from your Lyumjev 200 units/ml KwikPen. There may still be some 
small air bubbles left in the pen. Small air bubbles are normal and will not affect your dose. 

• The number of units are displayed in the dose window, always check this before your injection. 
 



132 
 

Injecting Lyumjev  
• Before you make an injection, clean your skin.  
• Inject under the skin (subcutaneous injection), as you were taught by your physician or nurse.  
• After your injection, leave the needle in the skin for 5 seconds to make sure you receive the full 

dose. Make sure you inject at least 1 cm from the last injection and that you ‘rotate’ the places 
you inject (upper arm, thigh, buttocks or abdomen).  

• If you do not have enough insulin in the pen to complete your dose, make a note of how much 
you still need to take.  Prime a new pen and inject the remaining dose. 

• If you need to inject another insulin at the same time as Lyumjev, use a different injection site. 
• Do not inject directly into a vein.  
 
After injecting 
• As soon as you have done the injection, unscrew the needle from the Lyumjev 200 units/ml 

KwikPen using the outer needle cap. This will keep the insulin sterile and stop it leaking. It also 
stops air entering the pen and your needle clogging. Do not share your needles. Do not share 
your pen. Replace the cap on your pen. 

 
Further injections 
• Every time you use a Lyumjev 200 units/ml KwikPen you must use a new needle. Before every 

injection, clear any air bubbles. You can see how much insulin is left by holding the Lyumjev 
200 units/ml KwikPen with the needle pointing up.  

• Once the Lyumjev 200 units/ml KwikPen is empty, do not use it again.  
 
If you take more Lyumjev than you need 
If you inject too much Lyumjev, a low blood sugar may occur. Check your blood sugar.  
 
If your blood sugar is low (hypoglycaemia) and you can treat yourself, eat glucose tablets, sugar or 
drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor or nurse has advised you 
and have some rest. This will often get you over a low blood sugar or a minor insulin overdose. Check 
your blood sugar again after 15-20 mins until blood sugar is stabilised. 
 
If you are unable to treat yourself (severe hypoglycaemia) because you feel too dizzy, weak, confused, 
have difficulty talking, lose consciousness or have a seizure you may need to be treated with glucagon. 
This can be given by someone who knows how to use it. Eat glucose or sugar after the glucagon. If 
glucagon does not work, you will have to go to hospital or call emergency services. Ask your doctor to 
tell you about glucagon. 
 
Tell everyone you spend time with that you have diabetes. Tell them what could happen if your blood 
sugar gets too low, including the risk of passing out. 
Let them know that if you pass out, they must: turn you on your side to avoid choking, get medical 
help straight away and not give you any food or drink because you may choke.  
 
If you forget to use Lyumjev 
If you forget to use your insulin or you take less than you need, your blood sugar may get too high 
(hyperglycaemia). Check your blood sugar level to decide if an insulin dose is needed. Resume your 
usual dosing schedule at your next meal. 
 
If you stop using Lyumjev 
Do not stop or change your insulin unless your doctor tells you to. If you take less Lyumjev than you 
need, a high blood sugar may occur. 
 
If high blood sugar (hyperglycaemia) is not treated it can be very serious and cause headaches, nausea, 
vomiting, abdominal pain, dehydration, unconsciousness, coma or even death (see section 4).  
 
Three simple steps to reduce your risk of hypoglycaemia or hyperglycaemia are: 



133 
 

• Always keep a spare pen in case you lose your Lyumjev 200 units/ml KwikPen or it gets 
damaged. 

• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Low blood sugar (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 
10 people). It can be very serious. If your blood sugar level falls too much you may become 
unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you 
have symptoms of low blood sugar, act immediately to increase your blood sugar level. See section 3 
under ‘If you take more Lyumjev than you need’. 
 
Allergic reactions are common (may affect up to 1 in 10 people). They may be severe and they may 
include the following symptoms: 
 

• rash over the whole body  
• difficulty in breathing  
• wheezing 

• blood pressure dropping  
• heart beating fast  
• sweating 

 
If you have a serious allergic reaction (including an anaphylactic attack) to insulin or any of the 
ingredients in Lyumjev, stop using this medicine and contact emergency medical service straight 
away. 
 
Other side effects include: 
 
Common  
Injection site reactions. Some people get redness, pain, swelling or itching around the area of the 
insulin injection. This usually clears up in a few minutes to a few weeks without needing to stop 
Lyumjev. If you have injection site reactions, tell your doctor. 
 
Uncommon (may affect up to 1 in 100 people) 
There are several skin changes that can happen if you inject insulin too often at the same place called 
lipodystrophy which is where skin can shrink (lipoatrophy), thicken (lipohypertrophy) or get lumps 
under the skin caused by a build-up of a protein called amyloid (cutaneous amyloidosis). Tell your 
doctor if you get lipodystrophy at the injection site, rash or very itchy skin. Change the injection site 
with each injection to help prevent skin changes. 
 
Other potential side effects 
Swelling in arms or ankles due to fluid retention (oedema) particularly at the start of insulin therapy or 
during a change in your diabetes medicines. 
 
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. 
 



134 
 

Common problems of diabetes 
 
Low blood sugar  
Low blood sugar (hypoglycaemia) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Lyumjev or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin for example if you lose weight; or you have trouble 

with your kidneys or liver which gets worse. 
 See section ‘If you take more Lyumjev than you need.’ 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
 
• tiredness 
• rapid heart beat 
• nervousness or shakiness 
• feeling sick 
• headache 
• cold sweat 
 
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. 
 
High blood sugar (hyperglycaemia) and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that the levels of glucose in your body are too 
high. Hyperglycaemia can be brought about by: 
• not taking your insulin; 
• using less insulin than your body needs; 
• an imbalance between the amount of carbohydrates you eat and the insulin you take; or 
• fever, infection or emotional stress. 
 
The early symptoms of hyperglycaemia are;  
• being very thirsty  
• headache  
• feeling sleepy 
• urinating more often 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. Additional symptoms include the following: 
• nausea and/or vomiting 
• abdominal pain 
• rapid pulse 
• heavy breathing 
• moderate or large amounts of urine ketones. Ketones are produced when your body burns fat for 

energy instead of glucose. 
 
If you have any of these symptoms and high sugars get medical help immediately. 
See section ‘If you forget to use Lyumjev’. 
 
Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 



135 
 

 
5. How to store Lyumjev 200 units/ml KwikPen 
 
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 label and the carton. The expiry 
date refers to the last day of that month.  
 
Keep in the outer carton in order to protect from light. 
 
Before first use 
Store in a refrigerator (2 °C to 8 °C).  
Do not freeze.  
 
After first use  
Do not store above 30 °C. 
Do not freeze.  
Do not refrigerate.  
 
The Lyumjev 200 units/ml KwikPen should not be stored with the needle attached. Keep the cap on 
the pen in order to protect from light 
Discard after 28 days even if some of the solution remains. 
 
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 to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Lyumjev 200 units/ml KwikPen solution for injection contains 
• The active substance is insulin lispro. Each ml solution contains 200 units of insulin lispro. One 

Lyumjev 200 units/ml KwikPen contains 600 units of insulin lispro in 3 ml solution.  
• The other ingredients are metacresol, glycerol, magnesium chloride hexahydrate, sodium citrate 

dihydrate, treprostinil sodium, zinc oxide, water for injections. Sodium hydroxide or 
hydrochloric acid may have been used to adjust the pH (see the end of section 2 under ‘Lyumjev 
200 units/ml KwikPen contains sodium’). 

 
What Lyumjev 200 units/ml KwikPen looks like and contents of the pack 
Lyumjev 200 units/ml KwikPen solution for injection is a clear, colourless, aqueous solution in a pre-
filled pen. Each pre-filled pen contains 600 units (3 millilitres). Pack sizes of 2 or 5 or a multipack of 
10 (2 x 5) pre-filled pens. Not all pack sizes may be marketed.  
 
The Lyumjev 200 units/ml KwikPen is taupe. The dose knob is taupe with raised ridges. The label is 
white with a blue colour bar and checkerboard design. On the carton and label the insulin strength is 
highlighted in a box with a yellow background. 
 
The yellow warning label on cartridge holder reminds you to “Use only in this pen, or severe overdose 
can result.”  
 
Each Lyumjev 200 units/ml KwikPen delivers 1 to 60 units in steps of 1 unit. 
 
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, 67640 Fegersheim, France.  



136 
 

 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
Belgique/België/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 6000 
 

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

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

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

Eesti 
Eli Lilly Nederland B.V.  
Tel: +372 6817 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 
 

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

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

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 
 

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 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

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

Κύπρος Sverige 



137 
 

Phadisco Ltd  
Τηλ: +357 22 715000 
 

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 

 
This leaflet was last revised in {MM/YYYY}. 
 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 
 

 



138 
 

Instructions for Use 
 

Lyumjev 200 units/mL KwikPen solution for injection in pre-filled pen 
 insulin lispro 

 

 
PLEASE READ THESE INSTRUCTIONS BEFORE USE 

 

 
 

Read the instructions for use before you start taking Lyumjev and each time you get another Lyumjev 
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. 
 
Do not share your Lyumjev KwikPen with other people, even if the needle has been changed. Do 
not reuse or share needles with other people. You may give other people a serious infection or 
get a serious infection from them. 
 
Lyumjev 200 units/mL KwikPen (“Pen”) is a disposable pre-filled pen containing 3 mL (600 units, 
200 units/mL) of insulin lispro solution for injection.  
• Your healthcare professional will tell you how many units to give as your dose and how to 

inject your prescribed dose of insulin. 
• You can give yourself more than 1 dose from the Pen.  
• Each turn of the dose knob dials 1 unit of insulin. You can give from 1 to 60 units in a single 

injection. 
• If your dose is more than 60 units, you will need to give yourself more than 1 injection. Always 

check the number in the dose window to make sure you dialed the correct dose. 
• 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 600 units in the Pen. 
 
This Pen is designed to allow you to give more doses than other pens you may have used in the 
past. Dial your usual dose as instructed by your healthcare professional. 
 
Lyumjev KwikPen is available in two strengths, 100 units/mL and 200 units/mL. Inject Lyumjev 
200 units/mL only with your Pen. Do not transfer insulin from your Pen to another insulin 
delivery device. Syringes and insulin pumps will not measure 200 units/mL of insulin correctly. 
A severe overdose can result, causing very low blood sugar which may put your life in danger. 
 
People who are blind or have vision problems should not use the Pen without help from a person 
trained to use the Pen. 
 

USE ONLY IN THIS PEN, OR SEVERE 
OVERDOSE CAN RESULT 



139 
 

Lyumjev KwikPen Parts 
 

 Pen Cap Cartridge Holder Label Dose Indicator 

 

 Cap Clip Rubber Seal Plunger Pen Body Dose 
Window 

Dose  
Knob 

     
   

Pen Needle Parts 
(Needles Not Included) 

Dose Knob 
  

 

 
 

 
 

 Outer Needle 
Shield 

Inner 
Needle 
Shield 

Needle Paper Tab    

 
 
How to recognize your Lyumjev KwikPen 
• Pen colour:  Taupe 
• Dose Knob:  Taupe, with raised ridges on side 
• Label:   White with a blue colour bar and checkerboard design. Yellow warning on 

 
cartridge holder.  

 
 
Supplies needed to give your injection 
• Lyumjev KwikPen   

• KwikPen compatible needle (BD [Becton, Dickinson and Company] Pen needles 
recommended) 

• Swab or gauze 
 
 
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 expiry 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.  

 



140 
 

Step 1: 
• Pull the Pen cap straight off. 

– Do not remove the Pen label. 

• Wipe the rubber seal with a swab. 

   

 
Step 2: 
• Check the liquid in the Pen.  

• Lyumjev should look clear and colourless. Do 
not use if it is cloudy, coloured, or has 
particles or clumps in it. 

 

Step 3: 
• Select a new needle. 

• Pull off the paper tab from the outer needle 
shield. 

 

Step 4: 
• Push the capped needle straight onto the Pen 

and twist the needle on until it is tight. 

 

Step 5: 
• 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 your Pen is working correctly. 

• If you do not prime before each injection, you may get too much or too little insulin. 
 
Step 6: 
• To prime your Pen, turn the dose knob to select 

2 units. 

 

Keep Throw 
Away 

USE ONLY IN THIS PEN, OR 
SEVERE OVERDOSE CAN RESULT 



141 
 

Step 7: 
• Hold your Pen with the needle pointing up. Tap 

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

 
 

Step 8: 
• Continue holding your Pen with the 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 priming 
steps 6 to 8, but not more than 8 times. 

– If you still do not see insulin, change the 
needle and repeat priming steps 6 to 8. 

Small air bubbles are normal and will not affect your 
dose. 

 
 

 
 

 
 
Selecting your dose 
This Pen has been designed to deliver the dose that is shown in the dose window. Dial your usual 
dose as instructed by your healthcare professional. 

• You can give from 1 to 60 units in a single injection. 

• If your dose is more than 60 units, you will need to give more than 1 injection. 

– If you need help dividing up your dose the right way, ask your healthcare professional. 

– Use a new needle for each injection and repeat the priming steps. 



142 
 

 
Step 9: 
• 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. You may dial the wrong dose. This 
may lead to getting too much insulin or not 
enough insulin. 

– 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 example to the right shows 12 units. 

– The odd numbers, after the number 1, are 
shown as full lines between the numbers. 
The example to the right shows 25 units. 

• Always check the number in the dose 
window to make sure you have dialed the 
correct dose. 

 

 
 
 

 
Example: 12 units 
shown in the dose 
window 

 

 
Example: 25 units 
shown in the dose 
window 

 
• 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. Do not 
transfer this to a syringe. Severe overdose can result. 

 
 
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. 



143 
 

 
Step 10: 
• Choose your injection site. 

 Lyumjev is injected under the skin 
(subcutaneously) of your stomach area, 
buttocks, upper legs or upper arms. 

• Wipe your skin with a swab, and let your 
skin dry before you inject your dose. 

 
 

Step 11: 
• 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. 

 

 

5 sec 



144 
 

Step 12: 
• 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 dialed. 

– If you do not see “0” in the dose window, 
you did not receive your full dose. 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 dialed 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 a swab. Do not rub the area. 

 

 

 
 
After your injection 
Step 13: 
• Carefully replace the outer needle shield. 

 

 

 
 

Step 14: 
• Unscrew the capped needle and dispose of it as 

described below (see Disposing of Pens and 
needles section). 

• Do not store the Pen with the needle attached to 
prevent leaking, blocking the needle, and air 
from entering the Pen.  



145 
 

Step 15: 
• 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 sharps container or a hard plastic container with a secure lid. Do not throw 

needles directly into your household waste. 

•  Do not recycle the filled sharps container. 

•  Ask your healthcare professional about options to dispose of the Pen and the sharps container 
properly. 

•  The directions regarding needle handling are not intended to replace local, healthcare 
professional or institutional policies. 

 
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 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 Lyumjev 200 units/mL KwikPen, call your 
healthcare professional for help or contact your local Lilly affiliate.  
 
Document Revision Date:  
 


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