Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Evkeeza 150 mg/ml concentrate for solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Evinacumab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 6 months 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 LDLcholesterol levels.
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What you need to know before you take it
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 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 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 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.
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 to take it
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 (asthenia) infusion reaction, such as itching where the drip is given.
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
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 oC to 8 oC). 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
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: Ultragenyx Germany GmbH, DE Tel: + 49 30 20179810 This leaflet was last revised in September 2025
Evkeeza has been authorised under 'exceptional circumstances'. This means that due to the rarity of the disease it has been impossible to get complete information on this medicine. Any new information on Evkeeza will be reviewed every year and this leaflet will be updated as necessary. Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: 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 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 patient's 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 solution by gentle inversion.
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For patients weighing 45 kg and above, the IV 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 IV 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 IV 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: • or •
under refrigeration at 2 oC to 8 oC for no more than 24 hours from the time of infusion preparation to the end of the infusion at room temperature up to 25 oC 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 oC) 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.
Frequently asked questions about Evkeeza 150 mg/ml concentrate for solution for infusion
How do I take Evkeeza 150 mg/ml concentrate for solution for infusion?
Evkeeza 150 mg/ml concentrate for solution for infusion comes as infusion containing 150mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Evkeeza 150 mg/ml concentrate for solution for infusion?
The active substance in Evkeeza 150 mg/ml concentrate for solution for infusion is evinacumab.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Evkeeza 150 mg/ml concentrate for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Evkeeza 150 mg/ml concentrate for solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: evinacumab
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and paediatric patients aged 6 months and older with homozygous familial hypercholesterolaemia (HoFH).
4.2. Posology and method of administration
Before treatment initiation of evinacumab the patient should be on an optimal LDL-C lowering regimen.
Treatment with evinacumab should be initiated and monitored by a physician experienced in the treatment of lipid disorders.
Posology
The recommended dose is 15 mg/kg body weight (bw) administered by intravenous infusion over 60 minutes once monthly (every 4 weeks).
If a dose is missed, it should be administered as soon as possible. Thereafter, treatment with evinacumab should be scheduled monthly from the date of the last dose.
The rate of infusion may be slowed, interrupted, or discontinued if the patient develops any signs of adverse reactions, including infusion-associated symptoms.
Evkeeza can be administered without regard to lipoprotein apheresis.
Elderly
No dosage adjustment is required for elderly patients (see sections 5.1 and 5.2).
Renal impairment
No dose adjustment is required in patients with renal impairment (see section 5.2).
Hepatic impairment
No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Paediatric population
No dose adjustment is required for paediatric patients aged 6 months to 17 years (see sections 4.8, 5.1 and 5.2). The safety and efficacy of Evkeeza in children aged less than 6 months have not been established. No data are available.
Method of administration
Evkeeza is for intravenous infusion use only.
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.
For instructions on dilution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
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.
Hypersensitivity and infusion reactions
Hypersensitivity reactions, including anaphylaxis, and infusion reactions have been reported with evinacumab (see section 4.8). If signs or symptoms of serious hypersensitivity or serious infusion reactions occur, discontinue treatment with evinacumab, treat according to the standard-of-care, and monitor until signs and symptoms resolve.
Excipients
This medicinal product contains 30 mg of proline in each ml. Proline may be harmful for patients with hyperprolinaemia type I or type II.
This medicinal product contains 1 mg of polysorbate 80 in each ml. Polysorbates may cause allergic reactions.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. No interacting mechanisms between evinacumab and other lipid-lowering medications have been observed.
4.6. Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential should use effective contraception during treatment with evinacumab and for at least 5 months after the last dose of evinacumab.
Pregnancy
There is a limited amount of data from the use of evinacumab in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Human IgG antibodies are known to cross the placenta barrier; therefore, evinacumab has the potential to be transmitted from the mother to the developing foetus. Evinacumab may cause foetal harm when administered to a pregnant woman and it is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the expected benefit to the patient outweighs the potential risk to the foetus.
Breast-feeding
It is unknown whether evinacumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which decrease to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. Afterwards, Evkeeza could be used during breast-feeding if clinically needed.
Fertility
No human data on the effect of evinacumab on fertility are available. Animal studies do not indicate harmful effects with respect to male and female fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
Evkeeza may have a minor influence on the ability to cycle, drive and use machines. Dizziness, fatigue and asthenia may occur following administration of Evkeeza (see section 4.8).
4.8. Undesirable effects
Summary of the safety profile
The most frequently occurring adverse reactions are nasopharyngitis (13.7%), influenza like illness (7.7%), dizziness (6.0%), back pain (5.1%) and nausea (5.1%). The most serious adverse reaction is anaphylaxis (0.9%).
Tabulated list of adverse reactions
Table 1 lists the incidence of adverse reactions in clinical trials of evinacumab therapy involving 137 treated patients (117 adult and adolescent patients with HoFH and persistent hypercholesterolaemia from pooled controlled clinical trials and 20 paediatric patients aged >5 to 11 years with HoFH from Study R1500-CL-17100). Adverse reactions are listed by system organ class (SOC) and by frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Table 1: Adverse reactions
MedDRA System organ class
Preferred term
Frequency categories
Infections and infestations
Nasopharyngitis
Very Common
Upper respiratory tract infection
Common
Immune system disorders
Anaphylaxis
Uncommon
Nervous system disorders
Dizziness
Common
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
Common
Gastrointestinal disorders
Nausea
Common
Abdominal pain
Common
Constipation
Common
Musculoskeletal and connective tissue disorders
Back pain
Common
Pain in extremity
Common
General disorders and administration site conditions
Fatigue*
Very Common
Influenza like illness
Common
Asthenia
Common
Infusion related reaction
Common
Infusion site reactions
Common
* See section Paediatric population, below.
Description of selected adverse reactions
Hypersensitivity reactions
Anaphylaxis was reported in 1 (0.9%) patient treated with evinacumab (see section 4.4).
Infusion reactions
Infusion reactions (e.g., infusion site pruritus) were reported in 9 (7.7%) patients treated with evinacumab and in 2 (3.7%) patients treated with placebo.
Paediatric population
The safety profile observed in 14 adolescent patients with HoFH aged 12 to 17 years treated with evinacumab 15 mg/kg IV every 4 weeks was consistent with the safety profile of adult patients with HoFH.
The safety of evinacumab was assessed in 20 paediatric patients aged ≥ 5 to 11 years. The safety profile of evinacumab observed in these patients was consistent with the safety profile observed in adult and adolescent patients aged 12 years and older, with the additional adverse reaction of fatigue. Fatigue was reported in 3 (15%) patients (see section 5.1).
Data are available for 5 patients aged ≥1 to 5 years old treated with evinacumab via compassionate use. The treatment duration was between 12 weeks and 90 weeks. Based on safety data received, no new safety concern has been identified (see section 5.1).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There is no specific treatment for evinacumab overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- EVKEEZA 150 mg/ml prescriptionEVINACUMABUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- EvkeezaEvinacumabum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Evkeeza 150 mg/ml concentrate for solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.