LYROKAUL – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine LYROKAUL, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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.
- The warnings and instructions in this document are intended for the person taking the medicine.
If you are a parent or carer responsible for giving the medicine to someone else, such as a child, you will need to apply the information accordingly.
ℹ️ 1. What LYROKAUL is and what it is used for
LYROKAUL contains the active substance lerodalcibep which belongs to a group of medicines known as lipid modifying agents.
LYROKAUL is used with diet to reduce LDL -cholesterol (‘bad’ cholesterol) in adults with primary hypercholesterolaemia (high blood cholesterol levels often caused by a genetic abnormality) and mixed dyslipidaemia (abnormal levels of different lipids , including LDL -cholesterol). It is given:
- together with a statin or other LDL -cholesterol – lowering treatments, if the maximum dose of a statin does not lower levels of LDL -cholesterol sufficiently, or;
- alone or together with other LDL -cholesterol -lowering treatments when statins do not work well or cannot be used.
LDL -cholesterol (‘b ad’ cholesterol ) is normally removed from your body by binding to targets (receptors) in your liver called LDL-cholesterol receptors. A protein known as PCSK9 can lower the number of these targets available in your liver, thereby reducing your liver’s ability to remove ‘bad’ cholesterol from your body. This may result in you having too much ‘bad’ cholesterol.
The active substance in LYROKAUL, lerodalcibep, works by blocking PCSK9 from binding to the LDL -cholesterol receptors in your liver. This increases the number of LDL- cholesterol receptors in the liver which can attach to bad cholesterol and remove it from the body. This helps to reduce the amount of ‘bad’ cholesterol in your blood.
⚠️ 2. What you need to know before you use LYROKAUL
Do not use LYROKAUL
25 If you are allergic to lerodalcibep 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 LYROKAUL .
Tell your doctor if you have kidney or liver disease before using this medicine, as LYROKAUL has not been studied in patients with severe kidney or liver disease.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age . The safety and efficacy of this medicine have not been established in this age group.
Other medicines and LYROKAUL
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
LYROKAUL is not recommended during pregnancy.
It is important to tell your doctor if you are breast- feeding or plan to do so. Your doctor will help you decide whether to stop breast -feeding, or whether to stop taking LYROKAUL considering the benefit of breast -feeding to the baby and the benefit of LYR OKAUL to the mother.
Driving and using machines
LYROKAUL is not expected to affect your ability to drive or use machines.
LYROKAUL contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium – free’.
LYROKAUL contains polysorbate 80 This medicine contains 0.24 mg of polysorbate 80 (E 433) per dose. Polysorbates may cause allergic reactions. Tell your doctor if you or your child has any known allergies.
💊 3. How to use LYROKAUL
Always use this medicine exactly as your doctor, pharmacist or nurse ha s told you. Check with your doctor, pharmacist or nurse if you are not sure.
Before you use the pre -filled syringe for the first time, your doctor, pharmacist or nurse will show you how to inject LYROKAUL .
- Always read the ‘Instructions for Use’ provided at the end of this leaflet.
- Always use the pre- filled syringe as described in the ‘Instruction s for Use ’.
How much to inject The recommended dose of LYROKAUL is 300 mg given by subcutaneous (under the skin) injection.
Each pre- filled syringe can only be used once (single use) .
When to inject Once a month.
Before you inject 26 If LYROKAUL is refrigerated, remove it from the refrigerator, keep it in its original package, and allow to warm to room temperature (15 °C – 25 °C ) for 30 minutes . This will make the injection more comfortable. Do not try to warm it up by shaking or rolling the LYROKAUL pre- filled syringe between your hands. Do not expose the LYROKAUL pre-filled syringe to a heat source such as boiling water or microwave.
Visually inspect the medicine before giving the injection. The solution should be clear to slightly opalescent, brownish-yellow to amber.
Do not use this medicine if you notice that the solution is cloudy, discoloured or contains particles.
Do not shake or drop the pre -filled syringe .
Where to inject If you are injecting yourself, use the abdomen or thigh. If injected by a doctor, nurse or caregiver, the back of the upper arm can also be used.
Avoid using the same injection area for consecutive months . Do not inject into areas of damaged skin such as sunburns, skin rashes, inflammation or skin infections.
If you forget to use LYROKAUL
Do not take a double dose to make up for a forgotten dose.
- If a planned dose is missed by less than 7 days , inject your missed dose as soon as you can.
Then take your next dose at your regular scheduled time. This will keep you on the original schedule.
- If a planned dose is missed by 7 or more days, inject your missed dose as soon as you can.
Your next dose will be due 1 month after this injection and this will become your new monthly schedule.
If you use more LYROKAUL than you should
Contact your doctor or pharmacist immediately.
If you stop using LYROKAUL
Do not stop using LYROKAUL without talking to your doctor. If you stop using LYROKAUL , your cholesterol levels may increase.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people)
Injection site reactions, such as pain, redness, itching or bruising Children and adolescents are expected to get the same side effects as adults.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store LYROKAUL
27 Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
Store in a refrigerator ( 2° C – 8° C). Do not freeze.
LYROKAUL may also be stored at room temperature ( 15 °C – 25 °C) in the outer carton for up to 6 months. Once removed from the refrigerator, LYROKAUL can remain at room temperature ( 15 °C – 25 °C) for up to 6 months. The ‘Use by date ’ should be written on the outer carton (up to 6 months from the date removed from the refrigerator).
If the medicine is not used within 6 months of being stored at room temperature or by the original expiry date, whichever is earlier, it should be discarded appropriately.
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 protect the environment.
📦 6. Contents of the pack and other information
What LYROKAUL contains
- The active substance is lerodalcibep. Each pre- filled syringe contains 300 mg of lerodalcibep in 1.2 mL solution.
- The other ingredients are : histidine, histidine monohydrochloride, sodium chloride, polysorbate 80 (E 433), water for injection s. See section 2 for further information.
What LYROKAUL looks like and contents of the pack
LYROKAUL is a clear to slightly opalescent, brownish yellow to amber solution.
Each pack of LYROKAUL contains 1 pre -filled syringe.
Marketing Authori sation Holder LIB Therapeutics B.V.
Eurogate III 3e Verdieping Watermanweg 32 3067 GG Rotterdam The Netherlands
Manufacturer
MIAS Pharma Limited Suite 1, Stafford House Strand Road, Portmarnock, Dublin D13 WC83 Ireland Tel: +353 1 846 3605 e-mail: [email protected]
This leaflet was last revised i n
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu . ———————————————————————————————————————— 28 INSTRUCTIONS FOR USE Read the package leaflet first before reading this ‘ Instructions for Use’.
LYROKAUL 300 mg solution for injection in pre -filled syringe Important information
- The medicine is injected under your skin and can be given by yourself or a caregiver.
- The pre -filled syringe can only be used once and must be thrown away immediately after it is used.
Do Keep LYROKAUL out of the sight and reach of children. Have your doctor, pharmacist or nurse instruct you how to use LYROKAUL. Read carefully all the instructions before using LYROKAUL. Follow these instructions every time you use LYROKAUL. Remove from the refrigerator 30 minutes before use. Handle the LYROKAUL pre -filled syringe by the barrel only.
Do not Do not remove the air bubble in the syringe. This will not harm you. Do not remove the needle cap until you are ready to use LYROKAUL pre -filled syringe. Do not touch the needle. Do not use the syringe if the needle cap is missing or not securely attached. Do not re-use the syringe. Do not shake or drop the syringe. Do not freeze the syringe or use it if it has been frozen. Do not expose the syringe to direct sunlight. Do not use if the expiry date has passed.
Keep this leaflet. If you have questions, ask your doctor, pharmacist, or nurse.
Step 1: Remove LYROKAUL from refrigerator.
A. Remove LYROKAUL from the refrigerator and allow it to warm up for 30 minutes at room temperature (15 °C – 25 °C).
- Keep LYROKAUL in its original package in order to protect from light.
- Do not expose the LYROKAUL pre -filled syringe to a heat source such as boiling water or microwave.
- Do not try to warm it up by shaking or rolling the LYROKAUL pre -filled syringe between your hands.
If the carton containing the LYROKAUL pre -filled syringe has been stored at room temperature (15 °C – 25 °C) it must be used within 6 months of being removed from the refrigerator or by the original expiry date, whichever is earlier.
Solution Syringe label with expiry date Needle cap Before use After use Plunger Barrel Needle 29 The Use by date should be written on the outer carton (up to 6 months from the date removed from the refrigerator).
B. Wash hands with soap and gather all materials needed for your injection.
On a clean, flat, well -lit surface, gather together:
- One (1) carton LYROKAUL 300 mg solution for injection in pre -filled syringe
- Alcohol wipes
- Cotton balls or gauze pads
- A plaster
- A sharps disposal container C. Choose your injection site.
Caregiver and Doctor ONLY = Self-injection and Caregiver/Doctor = WAIT minutes 30 Appropriate injection sites include:
- Thigh
- Abdomen, except for the 5 c m around the belly button (navel) .
- Upper arm for a caregiver or doctor.
- Do not choose an area of damaged skin such as sunburns, skin rashes, inflammation or skin infections. Avoid using the same injection area for consecutive months.
- Do not inject through clothing.
D. Clean your injection site.
Clean your injection site with an alcohol wipe. Let your skin dry before injecting.
- Do not touch the cleaned area again before injecting.
E. Open the outer carton and remove the LYROKAUL pre -filled syringe tray.
F. Remove the LYROKAUL pre -filled syringe from the tray.
- Place the tray in the palm of your hand.
- Peel the paper off the tray.
- Turn the tray over, if needed, gently press the middle of the tray to release the syringe into the palm of your hand.
- Always hold the LYROKAUL pre -filled syringe by the barrel.
G. Inspect the syringe and medicine.
Check the following:
- The name on the syringe label is LYROKAUL.
- The solution in the syringe is clear to slightly opalescent, brownish- yellow to amber.
- Do not use the syringe if it is cracked or broken.
- Do not use the syringe if the needle cap is missing or is not securely fastened.
- Do not use if the solution is cloudy, discoloured or contains particles.
- Do not use if the expir y date has passed.
Step 2: Give the injection.
A. Carefully pull the needle cap off the syringe. Immediately place the needle cap in the sharps container.
- Do not twist or bend the needle cap. This can damage the needle.
- Do not put the needle cap back on the syringe.
B. Pinch the selected injection site to create a firm surface.
- Pinch the skin firmly between your thumb and fingers.
- Insert the syringe needle into the skin at 45 ° to 90 ° angle.
32 • Do not touch the plunger rod while inserting the syringe needle.
C. Using constant pressure, PUSH the plunger rod all the way down until the syringe is empty.
D. When the syringe is empty, remove the needle from the injection site.
- Do not replace the needle cap.
Step 3. Complete injection.
A. Immediately place the used syringe in a sharps disposal container.
- Keep the sharps disposal container out of sight and reach of children.
- Do not reuse the syringe.
- Do not recycle the used syringe.
B. Examine the injection site.
- There may be a small amount of blood. Use a cotton ball or alcohol wipe to clean the area and apply a plaster if necessary.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information LYROKAUL (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/26/2061).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.