Evkeeza – Package Leaflet: InfoCons â Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Evkeeza, 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 or nurse.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
âčïž 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 âmonoclonal antibodyâ. Monoclonal antibodies are proteins that attach to other substances in the body.
What Evkeeza is used for
Evkeeza is used to treat adults and children aged 6 months and older with very high cholesterol caused by a condition called âhomozygous familial hypercholesterolaemiaâ. Evkeeza is used with a low- fat diet and other medicines to bring down cholesterol levels.
Homozygous familial hypercholesterolaemia runs in families and it is usually passed down by both father and mother.
People with this condition have extremely high levels of LDL-cholesterol (âbad cholesterolâ) from birth. Such high levels can lead to heart attacks, heart valve disease or other problems at an early age.
How does Evkeeza work?
Evinacumab, the active substance in Evkeeza, attaches to a protein in the body called ANGPTL3 and blocks its effects. ANGPTL3 is involved in controlling the production of cholesterol, and blocking its effect reduces the production of cholesterol. In this way, Evkeeza can lower blood levels of LDL -cholesterol and so prevent problems caused by high LDL-cholesterol levels.
â ïž 2. What you need to know before you are given Evkeeza
You should not be given Evkeeza
- if you are allergic to evinacumab or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
25 Talk to your doctor or nurse before you are given Evkeeza.
Look out for serious side effects Evkeeza can cause serious allergic reactions.
- Tell your doctor or nurse immediately if you get any symptoms of a severe allergic reaction. The symptoms are listed in âSerious side effectsâ in section 4.
Children
Evkeeza is not recommended for children below the age of 6 months because there is not yet enough information on its use in this group of patients.
Other medicines and Evkeeza
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Pregnancy and contraception If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
- Evkeeza may harm your unborn baby.
- Tell your doctor immediately if you become pregnant while you are being treated with Evkeeza.
If you are able to become pregnant, you should use effective contraception to avoid becoming pregnant.
- Use effective contraception while you are being treated with Evkeeza and
- Use effective cont raception for at least 5 months after the last dose of Evkeeza.
Talk to your doctor about the best contraception method for you during this time.
Breast -feeding
- If you are breast-feeding or plan to breast-feed, ask your doctor for advice before you are given this medicine.
- It is not known if Evkeeza passes into the breast milk.
Driving and using machines
It is possible that Evkeeza could make you feel dizzy and tired and may affect your ability to ride a bike, drive, or use any tools or machines. If you think you are affected, do not ride a bike, drive, or use machines and tools, and tell your doctor (see section 4).
Evkeeza contains proline
This medicine contains 30 mg of proline in each ml. Proline may be harmful for patients with hyperprolinaemia, a rare genetic disorder in which proline builds up in the body. If you (or your child) have hyperprolinaemia, do not use this medicine unless your doctor has recommended it.
Evkeeza contains polysorbate 80
This medicine contains 1 mg of polysorbate 80 in each ml. Polysorbates may cause allergic reactions.
Tell your doctor if you (or your child) have any known allergies.
đ 3. How Evkeeza is given
How much Evkeeza is given Your doctor will work out how much of the medicine to give you. The amount will depend on your body weight.
- The recommended dose is 15 milligrams for every kilogram you weigh.
- You will be given the medicine around once a month.
How Evkeeza is given Evkeeza is usually given by a doctor or nurse. It is given as a drip into a vein (âintravenous infusion (IV)â) over 60 minutes.
26 If you miss your dose of Evkeeza If you have missed an appointment to receive Evkeeza, talk to your doctor or nurse as soon as possible.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
â 4. P ossible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Severe allergic reactions (uncommon: may affect up to 1 in 100 people) Tell your doctor or nurse immediately if you get any of the following symptoms of a severe allergic reaction (anaphylactic reaction). The drip will be stopped immediately and you may need to take other medicine s to control the reaction:
- swelling â mainly of the lips, tongue or throat, which makes it difficult to swallow or breathe
- breathing problems or wheezing
- feeling dizzy or fainting
- rash, hives
- itching.
Other side effects
Tell your doctor or nurse if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people)
- symptoms of the common cold, such as runny nose, sore throa t, and coughing (nasopharyngitis).
Common (may affect up to 1 in 10 people)
- sore throat or sinus infection (upper respiratory tract infection)
- feeling dizzy
- feeling sick (nausea)
- stomach pain
- constipation
- back pain
- pain in your hands or feet (pain in extremity)
- symptoms of flu
- feeling tired or weary (asthenia)
- infusion reaction, such as itching where the drip is given, flushing, rash or chill s.
Additional side effects in children aged 5 to 11 years Very common (may affect more than 1 in 10 people)
- feeling tired (fatigue).
Reporting of side effects
If you get any side effects, talk to your doctor 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.
đĄïž 5. H ow to store Evkeeza
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 and vial after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ÂșC to 8 ÂșC).
Do not freeze. Do not shake. Store in the original carton to protect from light.
Do not use this medicine if you notice it is cloudy, discoloured or contains particulate matter.
Do not store any unused portion of the infusion solution for re use. Any unused portion of the infusion solution should not be reused and should be disposed in accordance with local requirements.
đŠ 6. Contents of the pack and other information
What Evkeeza contains
- The active substance is evinacumab.
Each 1 ml of concentrate for solution for infusion contains 150 mg of evinacumab.
Each vial contains either 345 mg of evinacumab in 2.3 ml of concentrate or 1 200 mg of evinacumab in 8 ml of concentrate.
- The other ingredients are proline, arginine hydrochloride, histidine hydrochloride monohydrate,
polysorbate 80, histidine and water for injections. See section 2 âEvkeeza contains prolineâ and âEvkeeza contains polysorba te 80â.
What Evkeeza looks like and contents of the pack
Evkeeza concentrate for solution for infusion is a clear to slightly opalescent, colourless to pale yellow solution.
It is available in packs containing either 1 glass vial of 2.3 ml of concentrat e or 1 glass vial of 8 ml of concentrate.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ultragenyx Germany GmbH Rahel -Hirsch -Str. 10 10557 Berlin Germany
Manufacturer
Ultragenyx Netherlands B. V.
Evert van de Beekstraat 1, Unit 104 1118 CL Schiphol Netherlands For any information about this medicine, please contact 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/TĂ©l/TeĐ»./Tlf/Puh/SĂmi : + 49 30 20179810 EL Medison Pharma Greece Single Member Societe Anonyme, EL ΀ηλ: +30 210 0100 188 28 FR Ultragenyx France SAS, FR TĂ©l: + 33 1 85 65 37 61 ou 0800 91 79 24 (numĂ©ro vert) This leaflet was last revised i n .
This medicine has been authorised under âexceptional circumstancesâ. This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
The European Medicines Agency will review any new information which may become available every year and this leaflet will be updated as necessary.
Other sources of information Detailed information on this medicine is available on the E uropean Medicines Agency website: https://www.ema.europa.eu/ ————————————————————————————————————————
đ©ș Information intended for healthcare professionals only
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Instructions for use Preparation of solution Evkeeza is supplied as a single use vial only. During preparation and reconstitution a strictly aseptic technique should be used.
- Visually inspect the medicinal product for cloudiness, discolouration or particulate matter prior to administration.
- Discard the vial if the solution is cloudy or discoloured or contains particulate matter.
- Do not shake the vial.
- Withdraw the required volume of evinacumab from the vial(s) based on patientâs body weight and transfer into an intravenous infusion bag containing sodium chloride 9 mg/ml (0.9%) or dextrose 50 mg/ml (5%) for infusion. Mix the diluted solu tion by gentle inversion.
- For patients weighing 45 kg and above, the intravenous infusion bag should contain a maximum volume of 250 ml of 9 mg/ml (0.9%) sodium chloride, or 50 mg/ml (5%) dextrose.
- For patients weighing between 26 kg and 44 kg, the intravenous infusion bag should contain a maximum volume of 150 ml of 9 mg/ml (0.9%) sodium chloride, or 50 mg/ml (5%) dextrose.
- For 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 range from 15 ml to 125 ml of 9 mg/ml (0.9%) sodium chloride, or 50 mg/ml (5%) dextrose administered at a maximum rate of 5 ml/kg/hour.
- Do not freeze or shake the solution.
- Discard any unused portion left in the vial.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
After dilution Once prepared, administer the diluted solution immediately. If the diluted solution is not administered immediately, it may be stored temporarily either:
- under refrigeration at 2 ÂșC to 8 ÂșC for no more than 24 hours from the time of infusion preparation to the end of the infusion or âą at room temperature up to 25 ÂșC for no more than 6 hours from the time of infusion preparation to the end of the infusion.
Administration
- If refrigerated, allow the solution to come to room temperature (up to 25 ÂșC) prior to administration.
- Evinacumab should be administered over 60 minutes by intravenous infusion through an intravenous line containing a sterile, in- line or add-on 0.2- micron to 5-micron filter. Do not administer evinacumab as an intravenous push or bolus.
- Do not mix other medicinal products with evinacumab or administer concomitantly via the same infusion line.
The rate of infusion may be slowed, interrupted or discontinued if the patient develops any signs of adverse reactions, including infusion- associated sy mptoms.
đ Package Leaflet â 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 Evkeeza (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/21/1551).
â ïž 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.