Evkeeza 150 mg/ml concentrate for solution for infusion
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Evkeeza 150 mg/ml concentrate for solution for infusion
evinacumab
This medicinal product is subject to additional monitoring, which will allow rapid identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end 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, as you may need to read it again.
- If you have any questions, ask your doctor or nurse.
- If you experience any side effects, consult your doctor or nurse, even if they are possible side effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Evkeeza is and what it is used for
- What you need to know before Evkeeza is administered
- How Evkeeza is administered
- Possible side effects
- How to store Evkeeza
- Contents of the pack and other information
1. What Evkeeza is and what it is used for
What Evkeeza is
Evkeeza contains the active substance evinacumab. It is a type of medicine called a "monoclonal antibody." Monoclonal antibodies are proteins that bind to other substances in the body.
What Evkeeza is used for
Evkeeza is used to treat adults and children from 6 months of age with very high cholesterol caused by a condition called homozygous familial hypercholesterolemia. Evkeeza is used together with a low-fat diet and other cholesterol-lowering medicines.
Homozygous familial hypercholesterolemia is an inherited condition, usually passed down from both the mother and the father.
People with this condition have extremely high levels of LDL cholesterol ("bad cholesterol") from birth. Such high levels can lead to heart attacks, heart valve disease, or other problems at an early age.
How Evkeeza works
Evinacumab, the active substance in Evkeeza, binds to a protein in the body called ANGPTL3 and blocks its effects. ANGPTL3 is involved in regulating cholesterol production, and by blocking its action, cholesterol production is reduced. In this way, Evkeeza can lower LDL cholesterol levels in the blood, helping to prevent complications caused by high LDL cholesterol levels.
2. What you need to know before Evkeeza is administered to you
Do not receive Evkeeza
- if you are allergic to evinacumab or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or nurse before you are given Evkeeza.
Be alert for serious adverse reactions
Evkeeza may cause severe allergic reactions.
- Immediately inform your doctor or nurse if you experience any symptoms of a severe allergic reaction. Symptoms are listed under "Serious adverse reactions" in section 4.
Children
Evkeeza is not recommended for children under 6 months of age, as there is insufficient information on its use in this patient group.
Other medicines and Evkeeza
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and contraception
If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
- Evkeeza may harm the fetus.
- Inform your doctor immediately if you become pregnant while being treated with Evkeeza.
If you are capable of becoming pregnant, you must use effective contraceptive methods to prevent pregnancy.
- Use effective contraception during treatment with Evkeeza and
- continue using effective contraception for at least 5 months after the last dose of Evkeeza.
Discuss with your doctor the most suitable contraceptive method for you during this time.
Breast-feeding
- If you are breast-feeding or plan to breast-feed, consult your doctor before receiving this medicine.
- It is unknown whether Evkeeza passes into breast milk.
Driving and using machines
Evkeeza may make you feel dizzy and tired and could affect your ability to ride a bicycle, drive, or operate tools or machinery. If you feel affected, do not ride a bicycle, drive, or use tools or machinery, and inform your doctor (see section 4).
Evkeeza contains proline
This medicine contains 30 mg of proline per ml. Proline may be harmful in patients with hyperprolinemia, a rare genetic disorder in which proline accumulates in the body. If you (or your child) have hyperprolinemia, do not use this medicine unless your doctor has specifically recommended it.
Evkeeza contains polysorbate 80
This medicine contains 1 mg of polysorbate 80 per ml. Polysorbates may cause allergic reactions. Inform your doctor if you (or your child) have any known allergies.
3. How Evkeeza is administered
How much Evkeeza is administered
Your doctor will calculate the amount of medicine you should be given. The amount will depend on your body weight.
- The recommended dose is 15 milligrams per kilogram of body weight.
- You will be given the medicine approximately once a month.
How Evkeeza is administered
Evkeeza is generally administered by a doctor or nurse. It is given as an intravenous infusion ("i.v. infusion") over 60 minutes.
If you miss a dose of Evkeeza
If you have missed an appointment to receive Evkeeza, consult your doctor or nurse as soon as possible.
If you have any further questions about the use of this medicine, ask your doctor or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Reporting of adverse effects
Severe allergic reactions (uncommon: may affect up to 1 in 100 people)
Inform your doctor or nurse if you experience any of the following symptoms of a severe allergic reaction (anaphylactic reaction). The infusion will be stopped immediately, and you may need to take other medicines to manage the reaction:
- swelling, mainly of the lips, tongue, or throat, making it difficult to swallow or breathe
- breathing problems or wheezing
- feeling dizzy or fainting
- rash, hives
- itching.
Other adverse effects
Consult your doctor or nurse if you experience any of the following adverse effects:
Very common (may affect more than 1 in 10 people)
- symptoms of common cold, such as runny nose, sore throat, and cough (nasopharyngitis).
Common (may affect up to 1 in 10 people)
- sore throat or sinus infection (upper respiratory tract infection)
- feeling dizzy
- feeling unwell (nausea)
- stomach pain
- constipation
- back pain
- pain in hands or feet (limb pain)
- flu-like symptoms
- feeling tired or exhausted (asthenia)
- infusion site reaction, such as itching at the site where the infusion is given, redness, rash, or chills.
Other adverse effects in children aged 5 to 11 years
Very common (may affect more than 1 in 10 people)
- Feeling of tiredness (fatigue).
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Evkeeza
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after EXP. The expiry date refers to the last day of the stated month.
Store in a refrigerator (between 2 °C and 8 °C).
Do not freeze. Do not shake.
Keep in the original packaging to protect from light.
Do not use this medicine if it appears cloudy, shows changes in colour, or contains visible particles.
Do not store any unused portion of the infusion solution for reuse. Any unused portion of the infusion solution must not be reused and should be disposed of according to local requirements.
6. Package contents and other information
Composition of Evkeeza
- The active substance is evinacumab.
Each ml of concentrate for solution for infusion contains 150 mg of evinacumab.
Each vial contains 345 mg of evinacumab in 2.3 ml of concentrate or 1,200 mg of evinacumab in 8 ml of concentrate.
- The other components are proline, arginine hydrochloride, monohydrate histidine hydrochloride, polysorbate 80, histidine and water for injections. See section 2 "Evkeeza contains proline" and "Evkeeza contains polysorbate 80".
Appearance of the product and contents of the pack
Evkeeza concentrate for solution for infusion is a solution ranging from clear to slightly opalescent, colourless to pale yellow.
It is available in packs containing 1 glass vial of 2.3 ml concentrate or 1 glass vial of 8 ml concentrate.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder
Ultragenyx Germany GmbH
Rahel-Hirsch-Str. 10
10557 Berlin
Germany
Manufacturer responsible for manufacturing
Ultragenyx Netherlands B.V.
Evert van de Beekstraat 1, Unit 104
1118 CL Schiphol
The Netherlands
Further information on this medicinal product is available by contacting the local representative of the Marketing Authorisation Holder:
BE, BG, CZ, DK, DE, EE, ES, HR, IE, IS, IT, CY, LI, LV, LT, LU, HU, MT, NL, NO, AT, PL, PT, RO, SI, SK, FI, SE
Ultragenyx Germany GmbH, DE
Tel/Tél/Teλ./Tlf/Τηλ/Puh/Sími: +49 30 20179810
EL
Medison Pharma Greece Single Member Societe Anonyme, EL
Τηλ: +30 210 0100 188
FR
Ultragenyx France SAS, FR
Tél: +33 1 85 65 37 61 or 0800 917 924 (toll-free number)
Date of the most recent review of this leaflet:
This medicinal product has been authorised under "exceptional circumstances". This type of approval means that, due to the rarity of the disease, it has not been possible to obtain complete information about this medicinal product. The European Medicines Agency will review any new information about this medicinal product annually, and this leaflet will be updated as necessary.
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
This information is intended for healthcare professionals only:
Traceability
In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product should be clearly documented.
Instructions for use
Preparation of the solution
Evkeeza is supplied exclusively as a single-use vial. A strict aseptic technique must be used during preparation and reconstitution.
- Visually inspect the medicinal product for turbidity, colour changes or particles before administration.
- Discard the vial if the solution is turbid, discoloured or contains particles.
- Do not shake the vial.
- Withdraw the required volume of evinacumab from the vial(s) according to the patient's body weight and transfer it to an intravenous infusion bag containing sodium chloride 9 mg/ml (0.9%) or dextrose 50 mg/ml (5%) for infusion. Mix the diluted solution by gentle inversion.
- In patients weighing 45 kg or more, the intravenous infusion bag should contain a maximum volume of 250 ml of sodium chloride 9 mg/ml (0.9%) or dextrose 50 mg/ml (5%).
- In patients weighing between 26 kg and 44 kg, the intravenous infusion bag should contain a maximum volume of 150 ml of sodium chloride 9 mg/ml (0.9%) or dextrose 50 mg/ml (5%).
- In patients weighing between 3 kg and 25 kg, the intravenous infusion bag should contain a maximum volume of 5 ml/kg. The corresponding volume for patients weighing between 3 kg and 25 kg should be between 15 ml and 125 ml of sodium chloride 9 mg/ml (0.9%) or dextrose 50 mg/ml (5%), administered at a maximum rate of 5 ml/kg/hour.
- Do not freeze or shake the solution.
- Discard any unused portion remaining in the vial.
Disposal of unused medicinal product and of materials that have come into contact with it must be carried out in accordance with local regulations.
After dilution
Once prepared, administer the diluted solution immediately. If immediate administration is not possible, the diluted solution may be stored temporarily:
- refrigerated at 2°C to 8°C for no more than 24 hours from the time of infusion preparation until completion of infusion
or
- at room temperature up to 25°C for no more than 6 hours from the time of infusion preparation until completion of infusion.
Administration
- If refrigerated, allow the solution to reach room temperature (up to 25°C) before administration.
- Evinacumab must be administered over 60 minutes by intravenous infusion through an intravenous line containing a sterile in-line or add-on filter of 0.2 micrometres to 5 micrometres. Do not administer evinacumab as a bolus or rapid intravenous injection.
- Do not mix other medicinal products with evinacumab or administer concomitantly through the same infusion line.
The infusion rate may be slowed, interrupted or discontinued if the patient experiences any signs of adverse reactions, including infusion-related symptoms.