Patient leaflet - Leqvio
B. PACKAGE LEAFLET
Package leaflet: Information for the patient
Leqvio 284 mg solution for injection in pre-filled syringe inclisiran
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, pharmacist or nurse.
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– If you get any side effects, talk to your doctor, pharmacist 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 Leqvio is and what it is used for
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2. What you need to know before you are given Leqvio
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3. How Leqvio is given
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4. Possible side effects
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5. How to store Leqvio
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6. Contents of the pack and other information
1. What Leqvio is and what it is used for
What Leqvio is and how it works
Leqvio contains the active substance inclisiran. Inclisiran lowers levels of LDL-cholesterol (“bad” cholesterol), which can cause heart and blood circulation problems when levels are raised.
Inclisiran works by interfering with RNA (genetic material in body cells) to limit the production of a protein called PCSK9. This protein can increase LDL-cholesterol levels and preventing its production helps to lower your LDL-cholesterol levels.
What Leqvio is used for
Leqvio is used in addition to your cholesterol-lowering diet if you are an adult with a high cholesterol level in your blood (primary hypercholesterolaemia, including heterozygous familial and non-familial, or mixed dyslipidaemia).
Leqvio is given:
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– together with a statin (a type of medicine that treats high cholesterol), sometimes combined with
another cholesterol-lowering treatment if the maximum dose of the statin does not work well enough, or
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– alone or together with other cholesterol-lowering medicines when statins do not work well or
cannot be used.
2. What you need to know before you are given Leqvio
You must not be given Leqvio
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– if you are allergic to inclisiran or any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Leqvio:
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– if you are receiving dialysis
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– if you have severe liver disease
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– if you have severe kidney disease
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because there is no experience of using the medicine in this age group.
Other medicines and Leqvio
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before you are given this medicine.
The use of Leqvio should be avoided during pregnancy.
It is not yet known whether Leqvio passes into human breast milk. Your doctor will help you to decide whether to continue breast-feeding or to start treatment with Leqvio. Your doctor will consider the potential benefits of treatment for you, compared with the health benefits and risks of breast-feeding for your baby.
Driving and using machines
Leqvio is not expected to affect your ability to drive or use machines.
Leqvio contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
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3. How Leqvio is given
The recommended dose of Leqvio is 284 mg given by injection under the skin (subcutaneous injection). The next dose is given after 3 months, followed by further doses every 6 months.
Before starting Leqvio you should be on a diet to lower your cholesterol and it is likely that you will be taking a statin. You should stay on this cholesterol-lowering diet and keep taking the statin all the time you receive Leqvio.
Leqvio is for injection under the skin of the abdomen; alternative injection sites include the upper arm or thigh. Leqvio will be given to you by a doctor, pharmacist or nurse (healthcare professional).
If you receive more Leqvio than you should
This medicine will be given to you by your doctor, pharmacist or nurse (healthcare professional). In the highly unlikely event that you are given too much (an overdose) the doctor or other healthcare professional will check you for side effects.
If you miss your dose of Leqvio
If you miss your appointment for your Leqvio injection, contact your doctor, pharmacist or nurse as soon as you can to arrange your next injection.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people)
- Injection site reactions, such as pain, redness or rash.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist 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 Leqvio
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 label and carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Do not freeze.
The doctor, pharmacist or nurse will check this medicine and will discard it if it contains particles.
Medicines should not be disposed of via wastewater or household waste. Your doctor, pharmacist or nurse will throw away medicines no longer being used. These measures will help protect the environment.
6. Contents of the pack and other information
What Leqvio contains
- The active substance is inclisiran. Each pre-filled syringe contains inclisiran sodium equivalent
to 284 mg inclisiran in 1.5 ml solution. Each ml contains inclisiran sodium equivalent to 189 mg inclisiran.
- The other ingredients are water for injections, sodium hydroxide (see section 2 “Leqvio contains
sodium”) and concentrated phosphoric acid.
What Leqvio looks like and contents of the pack
Leqvio is a clear, colourless to pale yellow solution, essentially free of particulates.
Each pack contains one single-use pre-filled syringe.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Sandoz GmbH
Biochemiestrasse 10 6336 Langkampfen Austria
Novartis Pharma GmbH
Roonstrasse 25 90429 Nuremberg Germany
For any information about this medicine, please Authorisation Holder:
België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11
Efc^rapufl
Novartis Bulgaria EOOD
Ten.: +359 2 489 98 28
Česká republika
Novartis s.r.o.
Tel: +420 225 775 111
Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00
Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0
Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810
EÀÀàôa
Novartis (Hellas) A.E.B.E.
Tql: +30 210 281 17 12
España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00
contact the local representative of the Marketing
Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50
Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11
Magyarorszag
Novartis Hungaria Kft.
Tel.: +36 1 457 65 00
Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872
Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111
Norge
Novartis Norge AS
Tlf: +47 23 05 20 00
Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570
Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888
| France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00 | Portugal Novartis Farma – Produtos Farmacêuticos, S.A Tel: +351 21 000 8600 |
| Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 220 | România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01 |
| Ireland Novartis Ireland Limited Tel: +353 1 260 12 55 | Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 50 |
| Island Vistor hf. Simi: +354 535 7000 | Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439 |
| Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 | Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200 |
| Knnpoç Novartis Pharma Services Inc. Tql: +357 22 690 690 | Sverige Novartis Sverige AB Tel: +46 8 732 32 00 |
| Latvija SIA Novartis Baltics Tel: +371 67 887 070 | United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698370 |
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
The following information is intended for healthcare professionals only:
Leqvio 284 mg solution for injection in pre-filled syringe inclisiran
Healthcare professionals should refer to the Summary of Product Characteristics for full prescribing information.
Indication (see section 4.1 of the SmPC)
Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- in combination with a statin or statin with other lipid-lowering therapies in patients unable to
reach LDL-C goals with the maximum tolerated dose of a statin, or
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant,