Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Insulin lispro may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 mellitus in adults, adolescents and children aged 1 year and above. It is a mealtime insulin that works more quickly than other medicines 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. 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.
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What you need to know before you take it
e 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 use more Lyumjev than you should"). • 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 medicines. • 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 medicines 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 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.
• Skin changes at the injection site. The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work well if you inject into a lumpy area (see "How to use Lyumjev KwikPen"). Contact your doctor if you are currently injecting into a lumpy area before you start injecting into a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose. Children and adolescents This medicine is not recommended for use in children below the age of 1 year. 2
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
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Lyumjev KwikPen contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodiumfree'. 3.
How to take it
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. 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. 4
• • • •
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 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. • If you are unsure how much you have injected then check your blood sugar levels before deciding if you need another injection. 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 use more Lyumjev than you should If you inject too much Lyumjev, or are unsure how much you have injected, 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 use less than you should, or are unsure how much you have injected, 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 use less Lyumjev than you should, 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. 5
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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 use more Lyumjev than you should'. Allergic reactions are common (may affect up to 1 in 10 people). They may be severe and they may include the following symptoms:
- rash and itching 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 (may affect up to 1 in 10 people) 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) Skin changes at the injection site: If you inject insulin too often at the same place, the fatty tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes. 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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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: 6
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 use more Lyumjev than you should".
• • • • •
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. 5.
How to store it
Lyumjev KwikPen
Keep this medicine out of the sight and reach of children. 7
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 – 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. 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 on side. The label is blue and white. Each Lyumjev KwikPen delivers 1 to 60 units in steps of 1 unit in a single injection. Marketing Authorisation Holder Eli Lilly Nederland B.V. Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands Manufacturer Lilly France Rue du Colonel Lilly 67640 Fegersheim France 8
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000 This leaflet was last revised in March 2026.
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Frequently asked questions about Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen
How do I take Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen?
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen comes as injection containing 100iu. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen?
The active substance in Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen is insulin lispro.
Are there equivalent medicines to Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen?
Medicines with the same active substance, strength and form include: Admelog 100 units/ml solution for injection in cartridge, Admelog 100 units/ml solution for injection in pre filled pen, Admelog 100 units/ml solution for injection in vial. In total there are 10 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: insulin lispro
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
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 dose 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
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
Lyumjev can be used in adolescents and children from the age of 1 year (see section 5.1). There is no clinical experience with the use of Lyumjev in children below the age of 3 years. Similar to adults, dosage should be adjusted individually. Lyumjev is recommended to 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 when needed.
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.
• Injection or infusion sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8).
• 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 and Lyumjev Tempo Pen
The KwikPen, Junior KwikPen and Tempo Pen are only suitable for subcutaneous injections.
Lyumjev KwikPens are 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 Lyumjev 100 units/ml Tempo Pen 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.
Lyumjev 100 units/mL Junior KwikPen is suitable for patients who may benefit from finer insulin dose adjustments.
The Tempo Pen can be used with the optional transfer module Tempo Smart Button (see section 6.6).
As with any insulin injection, when using the Tempo Pen, Tempo Smart Button and the mobile application, the patient should be instructed to check their blood sugar levels when considering or making decisions about another injection if they are unsure how much they have injected.
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 (see section 4.8). 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.
Patients should be educated to recognize the signs and symptoms of ketoacidosis and to get immediate help when ketoacidosis is suspected.
Injection technique
Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.
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, dose 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 dose adjusted on an individual basis (see section 4.2).
Insulin requirements may be increased during illness or emotional disturbances.
Adjustment of dose 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 (see section 4.8). 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.
Tempo Pen
The Tempo Pen contains a magnet (see section 6.5) that may interfere with the functions of an implantable electronic medical device, such as a pacemaker. The magnetic field extends to approximately 1.5 cm.
Excipients
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say 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).
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 reactions during treatment are hypoglycaemia (very common) and infusion site reactions in patients using CSII system (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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1. Adverse reactions
MedDRA system organ class
Very common
Common
Uncommon
Not known
Metabolism and nutrition disorders
Hypoglycaemia
General disorders and administration site conditions
Infusion site reactionsa
Allergic reactions b
Oedema
Injection site reactions c
Skin and subcutaneous tissue disorders
Lipodystrophy
Cutaneous amyloidosis
Rash
Pruritus
aReported in PRONTO-Pump-2
bSee section 4.8 Description of selected adverse reactions
cReported in PRONTO-T1D, PRONTO-T2D and PRONTO-Peds
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 adult 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). In study PRONTO-Peds, severe hypoglycaemia was reported in 0.7% of paediatric patients treated with Lyumjev.
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/Infusion site reactions
As with other insulin therapy, patients may experience rash, redness, inflammation, pain, bruising or itching at the site of Lyumjev injection or infusion.
In studies PRONTO-T1D and PRONTO-T2D (multiple-dose injection [MDI] administration), injection site reactions occurred in 2.7% of adult patients treated with Lyumjev. These reactions were usually mild and normally disappeared during continued treatment. Of the 1 116 patients who received Lyumjev, 1 discontinued treatment due to injection site reactions (< 0.1%).
In study PRONTO-Peds, injection site reactions occurred in 6.2% of paediatric patients treated with Lyumjev. These events were mild or moderate. Of the 418 patients treated with Lyumjev, 2 discontinued treatment due to injection site reactions (< 0.5%).
In study PRONTO-Pump-2, infusion site reactions were reported in 38% of patients treated with Lyumjev. The majority of these events were mild. Of the 215 patients treated with Lyumjev, 7 discontinued treatment due to infusion site reactions (3.3%).
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.
Skin and subcutaneous tissue disorders
Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions (see section 4.4).
Oedema
Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.
Paediatric population
Safety and efficacy have been investigated in a therapeutic confirmatory trial in children with type 1 diabetes aged 3 to < 18 years. In the trial, 418 patients were treated with Lyumjev. The frequency, type and severity of adverse reactions observed in the paediatric population is consistent with the safety profile in adult patients.
Other 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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 medicinal product dose, meal patterns, or exercise may be needed.
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