LYUMJEV 100 units/ml JUNIOR KWIKPEN PRE-FILLED PEN INJECTABLE SOLUTION

Introduction

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 Increments of 0.5 Units.

This medicinal product is subject to additional monitoring, which 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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. Storage of 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 substance insulin lispro. Lyumjev is used to treat diabetes mellitus in adults, adolescents, and children from 1 year of age. It is an insulin that is administered at mealtimes and acts more quickly than other medicines that contain insulin lispro. Lyumjev has components that accelerate the absorption of insulin lispro by the body.

Diabetes is a disease in which the body does not produce enough insulin or does not use insulin effectively, resulting in effects such as high blood sugar levels. Lyumjev is an insulin used to treat diabetes by controlling blood sugar levels. Effective treatment of diabetes, with good blood sugar control, prevents long-term complications of diabetes.

Treatment with Lyumjev helps control blood sugar levels in the long term and prevents complications of diabetes. Lyumjev reaches its maximum effect between 1 and 3 hours after injection and lasts up to 5 hours. You should use Lyumjev when you start eating, or up to 20 minutes after starting a meal.

Your doctor may recommend using Lyumjev in addition to a long-acting 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 that contains 3 ml (300 units, 100 units/ml) of insulin lispro. A KwikPen contains multiple doses of insulin. The KwikPen marks half units (0.5 units) at a time. The number of units is shown in the dosing window, always check it before your injection.You can inject from 0.5 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.

2. What you need to know before you use Lyumjev Junior KwikPen

DO NOT use Lyumjev Junior KwikPen

• if you think your blood sugar level is low (hypoglycemia). Later in this leaflet, it is indicated how to act in case of low blood sugar level (see section 3 “If you use more Lyumjev than you should”).
• if you are allergicto insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Lyumjev.

If you have vision problems, you will need the help of a trained person to give injections.

• Low blood sugar level(hypoglycemia).

A low blood sugar level can be serious and untreated hypoglycemia can even lead to death.

Lyumjev starts to lower blood sugar more quickly than other insulins administered at mealtimes. If you suffer from hypoglycemia, you may notice it soon after a Lyumjev injection. If you have frequent episodes of hypoglycemia or have difficulty recognizing the symptoms, please discuss this with your doctor or nurse. If your blood sugar levels are well controlled with your current insulin therapy or if you have had diabetes for a long time, you may not notice the warning symptoms that alert you to the fact that your blood sugar level is dropping too low. Later in this leaflet, the warning symptoms are listed. For more information on symptoms, please consult “Common problems of diabetes”.

You must carefully plan when to eat, when to exercise, and how much you can do. You must also closely monitor your blood sugar levels by doing frequent blood sugar tests.

Making changes in the type of insulin you use may cause your blood sugar level to increase or decrease too much.

You may need to increase the frequency of your blood sugar tests if you are at risk of having low blood sugar levels. Your doctor may consider it necessary to make changes in the doses of other medicines you use to treat your diabetes.

• High blood sugar level(hyperglycemia).

Stopping insulin administration or not using enough insulin may cause a high blood sugar level (hyperglycemia) and diabetic ketoacidosis, which are serious disorders that can even lead to death. For more information on symptoms, please consult “Common problems of diabetes”.

• If you combine your insulin treatment with a type of diabetes medicine called thiazolidinediones or glitazones, such as pioglitazone, inform your doctor as soon as possible if you have signs of heart failure such as unusual difficulty breathing, rapid weight gain, or localized swelling caused by fluid retention (edema).
• If you have a severe allergic reaction to insulin or any of the components of Lyumjev, stop using this medicine and contact the emergency medical service immediately.
• Always check the name and type of insulin that appears on the packaging and label when you receive it at the pharmacy. Make sure you are carrying the Lyumjev that your doctor has prescribed for you.
• Keep the box or note the batch number that appears on the box. This way, if you experience a side effect, you can provide that number when reporting the side effect, see “Reporting side effects”.
• Always use a new needle for each injection to prevent infections and needle obstruction. If the needle becomes obstructed, replace it with a new needle.

• Changes in the skin at the injection site.

The injection site should be rotated to avoid changes in the skin, such as lumps under the skin. Insulin may not work as well if it is injected into a swollen area (see How to use Lyumjev Junior KwikPen). Contact your doctor if you are currently injecting into a swollen area before starting to inject into a different area. Your doctor may instruct you to check your blood sugar levels more closely and adjust your insulin or the dose of your other diabetes medications.

Children and adolescents

This medicine is not recommended for use in children under 1 year 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, and you may need to change your insulin dose.

Your blood sugar level may decrease (hypoglycemia) if you take:

• other diabetes medicines (oral and injectable)
• sulphonamide-type antibiotics (to treat infections)
• acetylsalicylic acid (to relieve pain and lower fever, and to prevent blood clots)
• certain antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors)
• certain angiotensin-converting enzyme (ACE) inhibitors (e.g., captopril, enalapril) (to treat certain heart problems or high blood pressure)
• angiotensin II receptor blockers (to treat high blood pressure or heart problems)
• somatostatin analogues (such as octreotide, used to treat a rare disease characterized by excessive production of growth hormone)

Your blood sugar level may increase (hyperglycemia) if you take:

• danazol (to treat endometriosis)
• oral contraceptives (birth control pills)
• thyroid hormone replacement therapy (to treat thyroid problems)
• human growth hormone (to treat growth hormone deficiency)
• diuretics (to treat high blood pressure or if your body retains too much fluid)
• sympathomimetics (to treat severe allergic reactions or used in some cold medicines)
• corticosteroids (to treat asthma or autoimmune diseases)

Betablockers (used for high blood pressure, arrhythmias, or angina) may make it harder to recognize the warning signs of low blood sugar levels.

Using Lyumjev with alcohol

If you drink alcohol, your blood sugar levels may increase or decrease. Therefore, you may need to change the amount of insulin you use. You should monitor your blood sugar level more frequently than usual.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, nurse, or pharmacist for advice before using this medicine. The amount of insulin you need usually decreases during the first three months of pregnancy and increases during the last six months. After you have given birth, your insulin requirements will probably return to what they were before pregnancy.

During breastfeeding, there are no restrictions on treatment with Lyumjev. If you are breastfeeding, you may need to adjust your insulin dose or diet.

Driving and using machines

Your ability to concentrate and react may be reduced if you suffer from hypoglycemia. Please consider this possible problem, taking into account all situations that may be a risk for you or others (e.g., driving a car or using machines). You should consult your doctor about the suitability of driving if you:

• have frequent episodes of hypoglycemia
• have difficulty recognizing the warning signs of a hypoglycemia or do not recognize them

Lyumjev Junior KwikPen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; i.e., it is essentially “sodium-free”.

3. How to use Lyumjev Junior KwikPen

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

They will have indicated exactly how much Lyumjev to use, when to use it, and how often. They will also indicate how often you should visit your doctor.

To prevent the possible transmission of diseases, each pen should be used only by you, even if you change the needle.

You should always carry a spare insulin and another injection device in case you need to use it.

If you are blind or have reduced vision, you will need the help of a person to administer the injections.

Your doctor may indicate that you use Lyumjev as well as a long-acting or intermediate-acting insulin. Inject them separately. Lyumjev should not be mixed with any other insulin.

When to inject Lyumjev

Lyumjev is an insulin that is administered at mealtime. You should use Lyumjev when you start eating, or one or two minutes before eating; you also have the option of injecting up to 20 minutes after starting the meal.

How much insulin to use

Your doctor will determine the dose based on your blood sugar level and body weight and will explain

• How much Lyumjev you need at each meal.
• How and when to check your blood sugar level.
• How to change your insulin dose based on your blood sugar levels.
• What to do if you make changes to your diet, exercise, or if you are sick or using other medications.
• If you change the type of insulin you use, you may need to use a larger or smaller amount than before. This may only be the case for the first injection or may require a gradual change that lasts several weeks or months.

Do not use Lyumjev

• If it does not have the appearance of water. Lyumjev should be transparent, colorless, and free of solid particles. Check it every time you inject.
• If Lyumjev has not been stored correctly (see section 5 "Storage of Lyumjev Junior KwikPen").
• If the pen is damaged in any way, do not use it.

How to prepare the Lyumjev Junior KwikPen (please consult the instructions for use)

• First, wash your hands.
• Read the instructions on how to use your pre-filled insulin pen. Follow the instructions carefully. Below are some reminders.
• Use a new needle. (Needles are not included).
• Purge your Lyumjev Junior KwikPen before each use. This verifies that the insulin comes out and that air bubbles are removed from your Lyumjev Junior KwikPen. There may still be some small air bubbles in your pen. Small air bubbles are normal and will not affect your dose.
• The number of units is shown in the dosing window, always check it before injecting.

How to inject Lyumjev

• Before injecting, clean your skin.
• Inject under the skin (subcutaneous injection), as your doctor or nurse has taught you.
• After the injection, leave the needle in the skin for 5 seconds to ensure you have injected the full dose. Make sure you have injected at least 1 cm away from where you last injected and "alternate" the injection sites (upper arm, thigh, buttocks, or abdomen).
• If you do not have enough insulin in the pen to complete your dose, note how much you still need to use. Purge 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 the injection

• As soon as you finish injecting, unscrew the needle from the Lyumjev Junior KwikPen using the outer needle protector. This will maintain the sterility of the insulin and prevent losses. It will also prevent air from entering the pen and the needle from becoming clogged. Do not share needles. Do not share your pen. Put the cap back on the pen.
• If you are not sure how much you have injected, check your blood sugar level before deciding if you need another injection.

Subsequent injections

• Each time you use a Lyumjev Junior KwikPen, use a new needle. Before each injection, remove air bubbles. You can see how much insulin is left by holding your Lyumjev Junior KwikPen with the needle pointing upwards.
• Once the Lyumjev Junior KwikPen is empty, do not use it again.

If you use more Lyumjev than you should

If you inject too much Lyumjev, or are not sure how much you have injected, you may have low blood sugar. Check your blood sugar level.

If your blood sugar level is low (hypoglycemia) and you can treat yourself, take glucose tablets, sugar, or drink a sugary drink. Then eat fruit, cookies, or a snack, as your doctor or nurse has indicated, and take a rest. This usually helps to overcome a low blood sugar level or a mild insulin overdose. Check your blood sugar level again after 15-20 minutes until your blood sugar level stabilizes.

If you are unable to treat yourself (severe hypoglycemia) because you feel too dizzy, weak, confused, have difficulty speaking, loss of consciousness, or have a seizure, you may need treatment with glucagon. This can be administered by someone who knows how to use it. After being treated with glucagon, take glucose or sugar. If you do not respond to glucagon, you should go to the hospital or call emergency services. Ask your doctor to inform you about glucagon.

Tell the people around you that you have diabetes. Tell them what the consequences of low blood sugar levels could be, including the risk of losing consciousness.

Tell them that if you become unconscious, they should do the following: lay you on your side to prevent choking, seek immediate medical attention, and do not give you anything to eat or drink, as you could choke.

If you forget to use Lyumjev

If you forget to use your insulin or use less than you should, or are not sure how much you have injected, your blood sugar level may become very high (hyperglycemia). Check your blood sugar level to decide if an insulin dose is needed. Resume your usual dosing schedule at the next meal.

If you interrupt treatment with Lyumjev

Do not interrupt treatment or change insulin unless your doctor indicates it. If you use less Lyumjev than you should, you may have high blood sugar.

If high blood sugar (hyperglycemia) is not treated properly, it can be very serious and cause headache, nausea, vomiting, abdominal pain, dehydration, loss of consciousness, coma, and even death (see section 4).

Three simple measuresto reduce the risk of hypoglycemia or hyperglycemia are:

• Always carry a spare pen in case you lose your Lyumjev Junior KwikPen or it breaks.
• Always carry some identification that indicates you have diabetes.
• Always carry something sugary with you.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

Low blood sugar (hypoglycemia)is very common with insulin treatment (it can affect more than 1 in 10 people). It can be very serious. If your blood sugar level drops too low, you may lose consciousness. Severe hypoglycemia can cause brain damage and put your life at risk. If you have symptoms of low blood sugar, act immediatelyto increase your blood sugar level. See section 3 "If you use more Lyumjev than you should".

Allergic reactionsare common (they can affect up to 1 in 10 people). They can be serious and include the following symptoms:

If you have a severe allergic reaction(including anaphylactic shock) to insulin or any of the components of Lyumjev, stop using this medication and contact emergency medical services immediately.

Other side effects include

Common

Reactions at the injection site. In some people, redness, pain, inflammation, or itching may appear at the insulin injection site. These reactions usually disappear within a few minutes to a few weeks without needing to interrupt Lyumjev. If you have reactions at the injection site, talk to your doctor.

Uncommon(can affect up to 1 in 100 people)

Skin changes at the injection site: If you inject insulin too frequently in the same spot, the fatty tissue can shrink (lipoatrophy) or become thicker (lipohypertrophy). Lumps under the skin can also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis). Insulin may not work very well if injected into a lumpy area. Change the injection site to help avoid these skin changes.

Other possible side effects

Swelling in the arms or legs due to fluid retention (edema), especially at the start of insulin treatment or during a change in your diabetes medications.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

Common diabetes problems

Low blood sugar

Low blood sugar (hypoglycemia) means you do not have enough sugar in your blood.

This can happen if:

• you use too much Lyumjev or other insulin;
• you skip or delay meals, or change your diet;
• you exercise or work hard immediately before or after a meal;
• you have an infection or illness (especially diarrhea or vomiting);
• there is a change in your insulin needs, for example, if you lose weight; or you have kidney or liver problems that worsen.

See section "If you use more Lyumjev than you should".

The first symptoms of low blood sugar usually appear quickly and include:

• fatigue
• rapid heartbeat
• nervousness or tremors
• nausea
• headache
• cold sweat

If you are not sure how to recognize the warning symptoms, avoid situations like driving a car, where you or others could be in danger if hypoglycemia occurs.

High blood sugar (hyperglycemia)and diabetic ketoacidosis

Hyperglycemia (too much sugar in the blood) means that the glucose levels in your body are too high. Hyperglycemia can be caused by:

• not using your insulin;
• using less insulin than your body needs;
• an imbalance between the amount of carbohydrates you eat and the insulin you use; or
• fever, infection, or emotional stress.

The first symptoms of hyperglycemia are:

• feeling very thirsty
• headache
• drowsiness
• increased need to urinate

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms appear slowly, over many hours or several days. These symptoms include:

• nausea and/or vomiting
• abdominal pain
• rapid pulse
• rapid breathing
• moderate or large amounts of ketones in the urine. Ketones are produced when your body uses fat instead of glucose for energy.

If you have any of these symptoms and high blood sugar, seek medical attention immediately.

See section "If you forget to use Lyumjev".

Illness

If you are sick, especially if you have nausea or vomiting, the amount of insulin you need may vary. Even if you are not eating as usual, you still need to receive insulin.Perform urine or blood tests, follow the instructions you have been given for these cases, and inform your doctor.

5. Storage of Lyumjev Junior KwikPen

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the label and carton. The expiration date is the last day of the month indicated.

Before first use

Store in the refrigerator (between 2°C - 8°C).

Do not freeze.

Keep in the outer packaging to protect from light.

After first use

Do not store above 30°C.

Do not freeze.

Do not refrigerate.

The Lyumjev Junior KwikPen should not be stored with the needle attached. Keep the cap on the pen to protect it from light.

Discard after 28 days even if some solution remains.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Lyumjev 100 units/ml Junior KwikPen injectable solution

• The active ingredient is insulin lispro. Each ml of solution contains 100 units of insulin lispro. Each Lyumjev Junior KwikPen pen contains 300 units of insulin lispro in 3 ml of solution.
• The other components are metacresol, glycerol, magnesium chloride hexahydrate, sodium citrate dihydrate, treprostinil sodium, zinc oxide, and water for injectable preparations. Sodium hydroxide or hydrochloric acid may have been used to adjust the pH (see the end of section 2 "Lyumjev Junior KwikPen contains sodium").

Appearance of the Product and Container Contents

Lyumjev 100 units/ml Junior KwikPen injectable solution is a clear, colorless, aqueous solution in a pre-filled pen. Each pre-filled pen contains 300 units (3 milliliters).

It is available in packs of 2, 5, or a multipack of 2 packs of 5 pre-filled pens. Not all presentations may be marketed.

The Lyumjev Junior KwikPen pen is gray-brown in color. The dosing button is peach-colored with raised markings at the end and on the side. The label is white with a peach-colored bar and a peach-colored, light blue, and dark blue band. Each Lyumjev Junior KwikPen administers from 0.5 to 30 units in increments of 0.5 units.

Marketing Authorization Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

Manufacturer

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.

Instructions for Use

Lyumjev 100 units/ml Junior KwikPen injectable solution in a pre-filled pen

insulin lispro

PLEASE READ THESE INSTRUCTIONS BEFORE USE

Read the instructions for use before starting to use Lyumjev and each time you start another Lyumjev Junior KwikPen. There may be new information. This information does not replace a direct conversation with your healthcare professional about your disease or 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 transmit a serious infection or those people may transmit a serious infection to you.

Lyumjev 100 units/ml Junior KwikPen ("pen") is a pre-filled pen that contains 3 ml (300 units, 100 units/ml) of insulin lispro injectable solution.

• Your healthcare professional will tell you how many units you should use for your dose and how you should inject the prescribed dose of insulin.
• You can administer more than 1 dose with your pen.
• Each turn of the dosing button marks half a unit (0.5 units) of insulin. You can administer from half (0.5 units) to 30 units in a single injection.
• If your dose is more than 30 units, you will need to administer more than 1 injection. Always check the number shown in the dosing window to make sure you have dialed the correct dose.
• With each injection, the plunger moves only a little, so you may not notice the movement. The plunger will reach the end of the cartridge only when you have used the 300 units of the pen.

Blind or visually impaired people should not use the pen without the help of a person trained in the use of the pen.

Parts of Lyumjev Junior KwikPen

How to Recognize Your Lyumjev Junior KwikPen

• Pen Color: Gray-brown

• Dosing Button: Peach-colored, with raised markings at the end and on the side

• Label: White with a peach-colored bar and a peach-colored, light blue, and dark blue band

Materials Needed to Inject

• Lyumjev Junior KwikPen

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

• Cotton or gauze

Preparing Your Pen

• Wash your hands with water and soap.

• Check the pen to make sure you are using the correct type of insulin. This is especially important if you use more than 1 type of insulin.

• Do notuse your pen after the expiration date printed on the label or more than 28 days after you first start using your pen.

• Always use a new needlefor each injection to help prevent infections and clogged needles.

Purging Your Pen

Purge before each injection.

• Purging your pen means removing the air that may be in the needle and cartridge during normal use and ensuring that the pen works correctly.

• If you do notpurge before each injection, you may receive too much or too little insulin.

Selecting Your Dose

• You can administer from half a unit (0.5 units) to 30 units in each injection.

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

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

• Use a new needle for each injection and repeat the purging steps.

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

• The pen will not allow you to dial more units than are left in the pen.

• If you need to inject a number of units greater than what is left in the pen, you can:

• inject the amount left in your pen and then use a new pen to inject the rest of the dose,

or

• use a new pen and inject the full dose.

• It is normal to see a small amount of insulin in the pen that cannot be injected.

Injecting Your Dose

• Inject your insulin as your healthcare professional has shown you.

• Change (rotate) the injection site each time you inject.

• Do nottry to change your dose while you are injecting.

After Your Injection

Disposal of Pens and Needles

• Put used needles in a sharps container or a hard plastic container with a tight-fitting lid. Do notthrow the needles away in your household trash.

• Do notrecycle the filled sharps container.

• Ask your healthcare professional about the options available for properly disposing of your used pen and needle.

• needle and the container for sharp objects.

• The instructions for handling needles are not intended to replace local, institutional, or professional healthcare guidelines.

Troubleshooting

• If you are unable to remove the pen cap, gently turn the cap from side to side and then pull the cap outward.

• If it is difficult to press the dosing button:

• it will be easier to inject if you press the dosing button more slowly.

• your needle may be clogged. Put on a new needle and purge the pen.

• dust, food residue, or liquid may have entered the pen. Discard the pen and get a new one.

If you have any questions or problems with Lyumjev 100 units/ml Junior KwikPen, consult your healthcare professional or contact Lilly in Spain.

Date of last revision of this document: