Evkeeza 150 mg/ml concentrate for solution for infusion

• 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.

1. What Evkeeza is and what it is used for
2. What you need to know before you are given Evkeeza
3. How Evkeeza is given
4. Possible side effects
5. How to store Evkeeza
6. Contents of the pack and other information

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.

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.

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.

• you are allergic to evinacumab or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or nurse before you are given Evkeeza.

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.

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.

Tell your doctor if you are taking, have recently taken or might take any other medicines.

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.

• 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.

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).

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.

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.

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.

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 have missed an appointment to receive Evkeeza, talk to your doctor or nurse as soon as possible.

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.

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.

Very common (may affect more than 1 in 10 people)

• feeling tired (fatigue).

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.

• 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.

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.