284 mg solution for injection in pre-filled syringe
inclisirane
What Leqvio is and what it is used for
What Leqvio is and how it works
Leqvio contains the active substance inklisiran, which lowers the levels of LDL – cholesterol (“bad” cholesterol ). Elevated levels of LDL – cholesterol can cause heart problems and blood circulation.
Inklisiran works by affecting RNA (the genetic material in the body’s cells) so that the production of a protein called PCSK9 is limited. This protein can increase levels of LDL – cholesterol. When protein production is prevented, it helps lower your LDL cholesterol levels.
What Leqvio is used for
Leqvio is used as a supplement to the cholesterol-lowering diet in adults with high blood cholesterol levels (primary hypercholesterolemia, including heterozygous familial and non-familial, or mixed dyslipidemia).
Leqvio ges:
- together with a statin (a type of high- cholesterol treatment drug ), and sometimes together with additional cholesterol-lowering treatment (s) if the highest statin dose does not work well enough, or
- alone or in combination with other cholesterol-lowering drugs, when statins cannot be used or when the patient is intolerant to statins.
What you need to know before you get Leqvio
You should not get Leqvio
- if you are allergic to inklisiran or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving Leqvio:
- if you receive dialysis
- if you have severe liver disease
- if you have severe kidney disease
Children and young people
Do not give this medicine to children and adolescents under 18 years of age. There is no experience of using the drug in this age group.
Other medicines and Leqvio
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Leqvio should not be used during pregnancy.
It is not yet known if Leqvio passes into human breast milk. Your doctor will help you decide if you should continue breastfeeding or start treatment with Leqvio. Your doctor will weigh the possible benefits of the treatment for you against the health benefits and risks of breastfeeding your baby.
Driving and using machines
Leqvio is not expected to affect the ability to drive or use machines.
Leqvio contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per unit dose, ie essentially ‘sodium-free’.
How to get Leqvio
The recommended dose of Leqvio is 284 mg, which is given as an injection under the skin ( subcutaneous injection ). The next dose is given after 3 months and then an additional dose is given every 6 months.
Before you start with Leqvio, you should have switched to a cholesterol-lowering diet and you will probably also take a statin. You should continue with the cholesterol-lowering diet and continue to take the statin at all times while you are receiving Leqvio.
Leqvio is for injection under the skin of the abdomen; alternative injection sites are the upper arm or thigh. Leqvio will be given to you by a doctor, pharmacist, or nurse (healthcare professional).
If you take more Leqvio than you should
You will receive the medicine from a doctor, pharmacist, or nurse (healthcare professional). It is very unlikely, but if you get too much (an overdose), your doctor or other healthcare professional will check to see if you get any side effects.
If you have missed a dose of Leqvio
If you have missed your visit to get your Leqvio injection, contact your doctor, pharmacist or nurse as soon as you can and make an appointment for your next injection.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
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)
- Reactions at the injection site, including pain, redness or rash.
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 expiration date is the last day of the specified month.
No special storage instructions. Do not freeze.
Your doctor, pharmacist, or nurse will check this medicine and discard it if it contains particles.
Medicines should not be disposed of via wastewater or household waste. The doctor, pharmacist, or nurse discards medicines that are no longer used. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is inklisiran. Each pre-filled syringe contains the sodium inclisiran equivalent to 284 mg inclisiran in 1.5 ml solution. Each ml contains sodium inclisiran 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 the medicine looks like and contents of the pack
Leqvio is a clear, colorless the light yellow solution that is essentially free of particles.
Each pack contains a pre-filled syringe for single use.
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
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
| Czech RepublicNovartis sroTel: +420 225 775 111 | HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872 |
| GermanyNovartis Pharma GmbHTel: +49 911 273 0 | The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111 |
| EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 | NorwayNovartis Norge ASTel: +47 23 05 20 00 |
| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600 |
| CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 | SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439 |
| ItalyNovartis Farma SpATel: +39 02 96 54 1 | Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200 |
| .ΠροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 | SwedenNovartis Sverige ABTel: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsTel: +371 67 887 070 | United Kingdom (Northern Ireland)Novartis Ireland LimitedTel: +44 1276 698370 |