LYUMJEV 100 units/ml INJECTABLE SOLUTION IN VIAL

Introduction

Package Leaflet: Information for the User

Lyumjev 100 units/ml solution for injection in vial

insulin lispro

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on 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 is Lyumjev and what is it used for
2. What you need to know before you use Lyumjev
3. How to use Lyumjev
4. Possible side effects
5. Storing Lyumjev
6. Contents of the pack and other information

1. What is Lyumjev and what is it used for

Lyumjev 100 units/ml solution for injection in vial 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 speed up 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.

2. What you need to know before you use Lyumjev

Do not use Lyumjev

• 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 levels (see section 3 "If you use more Lyumjev than you should").
• if you are allergic to insulin lispro or any of the other components of this medicinal product (listed in section 6).

Warnings and precautions

Talk to 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 inject.

• Low blood sugar level(hypoglycemia).

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

Lyumjev starts to lower blood sugar more quickly than other insulins administered at mealtimes. If you experience hypoglycemia, you may notice it soon after a Lyumjev injection. If you frequently experience 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 perceive the warning symptoms that alert you to the fact that your blood sugar 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 strictly monitor your blood sugar levels by performing frequent blood sugar tests.

Making changes in the type of insulin you use can cause your blood sugar to rise or fall too much.

You may need to increase the frequency of 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 could cause high blood sugar levels (hyperglycemia) and diabetic ketoacidosis, which are serious disorders that can even cause death. For more information on symptoms, please consult "Common problems of diabetes".

• If you use an insulin pump and it stops working, you will need to fix the problem immediately, as this can cause high blood sugar levels. If your pump stops working, you may need to inject Lyumjev using an insulin pen or syringe.
• 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 abnormal difficulty breathing, rapid weight gain, or localized swelling caused by fluid retention (edema).
• If you experience a severe allergic reaction to insulin or any of the components of Lyumjev, stop using this medicinal product 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 blockage. If the needle becomes blocked, replace it with a new needle.

• Changes in the skin at the injection site.

You should rotate the injection site 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"). 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 medicinal product 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 levels, which may require a change in 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 mild fever, and to prevent blood clots)
• certain antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors)
• certain angiotensin-converting enzyme inhibitors (ACE inhibitors) (such as 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)

Beta-blockers (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 check your blood sugar levels more frequently than usual.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, nurse, or pharmacist before using this medicinal product. The amount of insulin you need usually decreases during the first 3 months of pregnancy and increases in the following 6 months. Once you have had your baby, 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 experience 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 convenience of driving if you:

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

Lyumjev contains sodium

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

3. How to use Lyumjev

Follow the instructions for administration of the medicinal product contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. If you are in doubt, ask your doctor, pharmacist, or nurse.

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

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

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

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

When to inject Lyumjev

Lyumjev is an insulin that is administered at mealtimes. You should use Lyumjev when you start eating, or 1-2 minutes before eating; you also have the option of injecting up to 20 minutes after starting a meal.

How much insulin to use

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

• 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 in your diet, exercise, or if you are sick or using other medicines.
• 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 necessary for the first injection or may require a gradual change that lasts several weeks or months.

Do not use Lyumjev

• If it does not look like water. Lyumjev must be transparent, colorless, and free of solid particles. Check it every time you inject.
• If Lyumjev has not been stored correctly (see section 5 "Storing Lyumjev").
• If the plastic cap of the vial is damaged, do not use it.

Where to inject Lyumjev

• Inject Lyumjev under the skin (subcutaneous injection).
• Do not inject directly into a vein. Only your doctor can administer Lyumjev intravenously. Your doctor will only do this in special circumstances, such as surgery or if you are sick and your blood sugar levels are too high.
• 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), as you have been instructed.
• 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 injecting, clean the skin as you have been taught. Clean the rubber stopper of the vial, but do not remove it.
• Use a new syringe and needle, and insert the needle into the rubber stopper to withdraw the amount of Lyumjev you need. Your doctor, nurse, or medical staff will teach you how to do this. Do not share needles or syringes.
• Inject under the skin, as you have been taught. After the injection, leave the needle in the skin for 5 seconds to ensure you have injected the full dose.

Using Lyumjev in an insulin pump

• Only certain insulin infusion pumps can be used to infuse Lyumjev.
• Follow the instructions that come with the infusion pump carefully.
• Make sure to use the reservoir and catheter suitable for your pump. It is important to use the needle of the correct length for the filling system to avoid damaging the pump.
• Change the infusion set (catheter and needle) according to the instructions provided with the infusion set.
• If you experience repeated or severe low blood sugar levels, inform your doctor or nurse.
• Pump failure or blockage of the infusion set can cause a rapid increase in blood sugar levels. If you think the insulin flow may have been interrupted, follow the pump's instructions and, if necessary, inform your doctor or nurse.
• You may need an injection of Lyumjev if your pump is not working correctly.

After injection

If you are unsure how much you have injected, check your blood sugar level before deciding whether you need another injection.

If you use more Lyumjev than you should

If you inject too much Lyumjev, or are unsure how much you have injected, you may experience 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, biscuits, 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 it 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 a person 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 the 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 you from choking, seek immediate medical attention, and do not give you anything to eat or drink, as you may choke.

If you forget to use Lyumjev

If you forget to use your insulin or use less than you should, or are unsure 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 stop using Lyumjev

Do not stop treatment or change your insulin unless your doctor tells you to. If you use less Lyumjev than you should, you may experience high blood sugar levels.

If high blood sugar levels (hyperglycemia) are not treated properly, they 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 syringe and a spare vial of Lyumjev.
• Always carry some form of identification that indicates you have diabetes.
• Always carry some sugar with you.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Low blood sugar level (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 medicine and contact emergency medical services immediately.

Other adverse effects include

Very common

Reactions at the infusion site. In some people, redness, pain, inflammation, or itching appears at the insulin infusion site. If you have reactions at the infusion site, talk to your doctor.

Common

Reactions at the injection site. In some people, redness, pain, inflammation, or itching appears at the insulin injection site. These reactions usually disappear within a few minutes to a few weeks without the need 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 insulin is injected 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 well if injected into a lumpy area. Change the injection site to help avoid these skin changes.

Other possible adverse effects

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

Reporting adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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 too much just 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 the 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 signs, avoid situations like driving a car, where you or others could be in danger if hypoglycemia occurs.

High blood sugar level(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, get medical help immediately.

See the section "If you forget to use Lyumjev".

Illness

If you are ill, 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.Have your urine or blood checked, follow the instructions given to you for these cases, and inform your doctor.

5. Storage of Lyumjev

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

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

Do not freeze.

Store in the outer packaging to protect from light.

Before first use

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

After first use

Do not store above 30°C.

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 medicines no longer required. This will help protect the environment.

6. Package contents and additional information

Composition of Lyumjev 100 units/ml solution for injection in vial

• The active substance is insulin lispro. Each ml of solution contains 100 units of insulin lispro. One vial contains 1000 units of insulin lispro in 10 ml of 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 "Lyumjev contains sodium").

Appearance and package contents of the product

Lyumjev 100 units/ml solution for injection is a clear, colorless, aqueous solution in a vial. Each vial contains 1000 units (10 milliliters). It is available in packs of 1 vial, 2 vials, or a multipack of 5 packs of 1 vial. Not all presentations may be marketed.

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 medicine by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

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

This information is intended only for healthcare professionals:

Lyumjev 100 units/ml is available in vials for intravenous administration if needed.

For intravenous use, Lyumjev should be diluted to concentrations of 0.1 to 1.0 units/ml in a 5% glucose solution or a 9 mg/ml (0.9%) sodium chloride solution. It is recommended to purge the system before starting the infusion to the patient. Compatibility has been demonstrated with ethylene/propylene copolymer bags and polyolefin bags with polyvinyl chloride.

Chemical and physical stability has been demonstrated for 14 days at 2-8°C and 20 hours at 20-25°C protected from light. From a microbiological point of view, the medicine should be used immediately. If not used immediately, the storage times during use and the conditions before use are the responsibility of the user and normally will not exceed 24 hours at 2-8°C, unless the dilution is made under controlled and validated aseptic conditions.