Lyumjev U100 100 units Solution

LYUMJEV U100, 100 units/ml KwikPen solution for injection in pre-filled pen contains the active ingredient insulin lispro. LYUMJEV U100 is used to treat diabetes in adults. It is a mealtime insulin that works more quickly than other medicine containing insulin lispro. LYUMJEV U100 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 U100 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 U100 helps to control blood sugar in the long term and prevent complications from your diabetes. LYUMJEV U100 has its maximum effect 1 to 3 hours after injection and the effect lasts for up to 5 hours. You should use LYUMJEV U100 at the start of the meal, or up to 20 minutes after starting the meal. Your doctor may tell you to use LYUMJEV U100 as well as a longer- or intermediate-acting insulin. Do not change your insulin unless your doctor tells you to. The LYUMJEV U100, 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.

Do not use LYUMJEV U100 KWIKPEN:

• if you think your blood sugar is dropping (hypoglycaemia). Further on, this leaflet tells you how to deal with low blood sugar (see section 3 under “If you take more LYUMJEV U100 than you need”).
• if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using LYUMJEV U100. 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 U100 starts to lower blood sugar faster than some other mealtime insulins. If hypoglycaemia occurs, you may experience it earlier after an injection of LYUMJEV U100. 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.
• 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 medicine called thiazolidinediones or glitazones, such as pioglitazone, tell your doctor as soon as possible if you get signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling caused by fluid retention (oedema).
• If you have a serious allergic reaction to insulin or any of the ingredients in LYUMJEV U100, 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 U100 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 adverse 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 U100 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 should not be used in children or adolescents, since there is no experience with this medicine in children and adolescents under 18 years of age.

Other medicines and LYUMJEV U100

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.

Always use LYUMJEV U100 exactly 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 U100 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 U100 as well as a longer- or intermediate-acting insulin. Inject them separately. LYUMJEV U100 should not be mixed with any other insulin.

When to inject LYUMJEV U100

LYUMJEV U100 is a mealtime insulin. You should use LYUMJEV U100 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 U100 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 U100:

• If it does not look like water. LYUMJEV U100 must be clear, have no colour and no solid pieces in it. Check each time you inject yourself.
• If LYUMJEV U100 has not been stored correctly (see section 5 “How to store LYUMJEV U100”).
• 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 U100

Before you make an injection, clean your skin. Inject under the skin (subcutaneous injection), as you were taught by your physician or nurse. After your injection, leave the needle in the skin for 5 seconds to make sure you receive the full dose. Make sure you inject at least 1 cm from the last injection and that you ‘rotate’ the places you inject (upper arm, thigh, buttocks or abdomen).

If you do not have enough insulin in the pen to complete your dose, make a note of how much you still need to take. Prime a new pen and inject the remaining dose. If you need to inject another insulin at the same time as LYUMJEV U100, 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.

Like all medicines, LYUMJEV U100 can cause side effects, although not everybody gets them. Low blood sugar (hypoglycaemia) is very common with insulin treatment (may affect more than 1 in 10 people). It can be very serious. If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you have symptoms of low blood sugar, act immediately to increase your blood sugar level. See section 3 under ‘If you take more LYUMJEV U100 than you need’.

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

• rash over the whole body,
• difficulty in breathing,
• wheezing,
• blood pressure dropping,
• heart beating fast,
• sweating.

If you have a serious allergic reaction (including an anaphylactic attack) to insulin or any of the ingredients in LYUMJEV U100, stop using this medicine and contact emergency medical service straight away.

Other side effects include:

Common

Injection site reactions. Some people get redness, pain, swelling or itching around the area of the insulin injection. This usually clears up in a few minutes to a few weeks without needing to stop LYUMJEV U100. 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 side effects, talk to your doctor or, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of LYUMJEV U100. Alternately, report suspected adverse events to the company at: [email protected]

Store all medicines out of reach of children. Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Before first use Store in a refrigerator (2 °C to 8 °C). Do not freeze. Keep in the outer carton in order to protect from light.

After first use Store at or below 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.