Patient leaflet - Evkeeza
B. PACKAGE LEAFLET
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.
What is in this leaflet:
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1. What Evkeeza is and what it is used for
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2. What you need to know before you are given Evkeeza
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3. How Evkeeza is given
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4. Possible side effects
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5. How to store Evkeeza
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6. 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 attach to other substances in the body.
What Evkeeza is used for
Evkeeza is used to treat adults and children aged 12 years and older with very high cholesterol caused by a condition called ‘homozygous familial hypercholesterolaemia’. 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 (‘bad cholesterol’) 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.
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
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 “Serious side effects” in section 4.
Children
Evkeeza is not recommended for children below the age of 12 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 contraception 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
Evkeeza is not likely to affect you being able to drive, use any tools or machines.
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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 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 (‘intravenous infusion’)
over 60 minutes.
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.
4. Possible 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 medicines to control the reaction:
- swelling – 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 (nasopharyngitis).
Common (may affect up to 1 in 10 people)
- feeling dizzy
- sore throat or sinus infection (upper respiratory tract infection)
- feeling sick (nausea)
- stomach pain
- constipation
- back pain
- pain in your hands or feet (pain in extremity)
- symptoms of flu
- feeling tired or weary
- infusion reaction, such as itching where the drip is given.
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 By reporting side effects you can help provide more information on the safety of this medicine.
5. How 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 °C to 8 °C).
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 re-used and should be disposed in accordance with local requirements.
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.
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 concentrate or 1 glass vial of 8 ml of concentrate.
Marketing Authorisation Holder
Regeneron Ireland Designated Activity Company (DAC)
One Warrington Place,
Dublin 2,
D02 HH27
Ireland
Manufacturer
Regeneron Ireland DAC
Raheen Business Park
Limerick
Ireland
This leaflet was last revised in <month year>
This medicine has been authorised under ‘exceptional circumstances’. 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 SmPC will be updated as necessary.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
http: //www.ema. europa. eu
The following information is 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 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 patient’s 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 solution by gentle inversion.
- The final concentration of the diluted solution should be between 0.5 mg/ml to 20 mg/ml.
- 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 °C to 8 °C for no more than 24 hours from the time of infusion
preparation to the end of the infusion
or
- at room temperature up to 25 °C 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 °C) 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 symptoms.
ANNEX IV
CONCLUSIONS ON THE GRANTING OF THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Conclusions presented by the European Medicines Agency on:
- Marketing authorisation under exceptional circumstances
The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.
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