Leqvio 284 mg solucion inyectable en jeringa precargada

Patient Information Leaflet

Leqvio 284mg pre-filled syringe

Pre-filled syringe with needle guard

inclisirán

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this leaflet carefully before you receive this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

1.What Leqvio is and what it is used for

2.What you need to know before you receive Leqvio

3.How to administer Leqvio

4.Possible side effects

5.Storage of Leqvio

6.Contents of the pack and additional information

What is Leqvio and how it works

Leqvio contains the active ingredient inclisiran. Inclisiran reduces levels of LDL cholesterol (bad cholesterol), which can cause heart and blood circulation problems when levels are high.

Inclisiran acts by interfering with RNA (responsible for transferring genetic information from cells in the body) to limit the production of a protein called PCSK9. This protein can increase levels of LDL cholesterol, and by limiting its production, it helps to reduce LDL cholesterol levels.

What is Leqvio used for

Leqvio is used in combination with a cholesterol-lowering diet if you are an adult with high cholesterol in your blood (primary hypercholesterolemia, including familial and non-familial heterozygous and non-familial or mixed dyslipidemia).

Leqvio is given:

You should not be given Leqvio

‑if you are allergic to inclisiran or to any of the other components of this medicine (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist or nurse before they give you Leqvio:

• if you are receiving dialysis
• if you have severe liver disease
• if you have severe kidney disease

Children and adolescents

Do not use this medicine in children and adolescents under 18years of age, because there is no experience with the use of this medicine in this age group.

Other medicines and Leqvio

Inform your doctor, pharmacist or nurse if you are taking, have taken recently or may have to take any other medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor, pharmacist or nurse before using this medicine.

Leqvio should be avoided during pregnancy.

It is not yet known whether Leqvio can pass into breast milk. Your doctor will help you decide whether to continue breastfeeding or start treatment with Leqvio. Your doctor will consider the potential benefits of treatment for you, compared with the benefits for your health and risks to your baby's breastfeeding.

Driving and operating machines

Leqvio is not expected to affect your ability to drive or use machines.

Leqvio contains sodium

This medicine contains less than 1mmol of sodium (23mg)per dose; this is essentially “sodium-free”.

The recommended dose of Leqvioes 284mg administered via a subcutaneous injection under the skin. The next dose is administered at 3months and subsequent doses are administered every 6months.

Before starting Leqvio, you should be following a cholesterol-lowering diet and may be taking a statin. You should continue to follow the cholesterol-lowering diet and take the statin throughout the time you receive Leqvio.

Leqvio is administered as a subcutaneous injection in the abdomen, alternative administration sites are the upper arm or thigh. Leqvio will be administered by a doctor, pharmacist, or nurse (healthcare professional).

If you have been given too much Leqvio

This medication will be administered by a doctor, pharmacist, or nurse (healthcare professional). In the unlikely event of an overdose, the doctor or other healthcare professional will monitor your adverse effects.

If you forgot that Leqvio was administered

If you forgot a scheduled injection of Leqvio, contact your doctor, pharmacist, or nurse as soon as possible to arrange your next injection.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent(may affect up to 1 in 10people)

• Reactions at the injection site, such as pain, redness, or rash.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the box after CAD/EXP.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Do not freeze.

Your doctor, pharmacist, or nurse will check this medication and dispose of it if it contains particles.

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

Composition of Leqvio

• The active ingredient is inclisiran. Each pre-filled syringe contains inclisiran sodium equivalent to 284 mg of inclisiran in 1.5 ml of solution. Each ml contains inclisiran sodium equivalent to 189 mg of inclisiran.
• The other components are water for injection, sodium hydroxide (see section 2 “Leqvio contains sodium”) and concentrated phosphoric acid.

Appearance of the product and contents of the pack

Leqvio is a clear, colourless to slightly yellowish solution, practically free of particles.

Each pack contains a pre-filled syringe with a single-use needle guard.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible Person

Sandoz GmbH

Biochemiestrasse 10

6336 Langkampfen

Austria

Novartis Pharmaceutical Manufacturing GmbH

Biochemiestrasse 10

6336 Langkampfen

Austria

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Leqvio 284 mg solution for injection in a pre-filled syringe

Pre-filled syringe with needle guard

inclisiran

Healthcare professionals should refer to the SmPC for complete 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 a statin and other lipid-lowering treatments in patients who do not achieve their LDL-C targets with the maximum dose of a statin or,
• alone or in combination with other lipid-lowering treatments in patients who are intolerant to statins, or for whom statins are contraindicated.

Dosage and administration (see section 4.2 of the SmPC)

Dosage

The recommended dose is 284 mg of inclisiran in a single subcutaneous injection administered at the initial dose, another at 3 months and subsequently every 6 months.

Missed doses

If a planned dose is delayed by less than 3 months, inclisiran should be administered and the dosing schedule maintained according to the patient's initial dosing calendar.

If a planned dose is delayed by more than 3 months, a new dosing calendar should be initiated – inclisiran should be administered at the initial dose, another at 3 months and subsequently every 6 months.

Transition from PCSK9 monoclonal antibody inhibitors

Inclisiran can be administered immediately after the last dose of a PCSK9 monoclonal antibody inhibitor. To maintain LDL-C reduction, inclisiran should be administered 2 weeks after the last dose of the PCSK9 monoclonal antibody inhibitor.

Special populations

Geriatric population (≥65 years)

No dose adjustment is required in elderly patients.

Renal impairment

No dose adjustment is required in patients with mild, moderate or severe renal impairment or patients with end-stage renal disease. The experience with inclisiran is limited in patients with severe renal impairment. Inclisiran should be used with caution in these patients. See section 4.4 of the SmPC for precautions in haemodialysis.

Pediatric population

The safety and efficacy of inclisiran have not been established in children under 18 years. No data are available.

Method of administration (see section 4.2 of the SmPC)

Subcutaneous route.

Inclisiran is administered subcutaneously in the abdomen, some alternative injection sites are the upper arm or thigh. Injections should not be made in areas with active skin disease or with wounds such as sunburn, skin rash, inflammation or skin infections.

Each dose of 284 mg is administered via a pre-filled syringe. Each pre-filled syringe is for single use.

Inclisiran is intended to be administered by a healthcare professional.

Contraindications (see section 4.3 of the SmPC)

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use (see section 4.4 of the SmPC)

Haemodialysis

The effect of haemodialysis on the pharmacokinetics of inclisiran has not been studied. Given that inclisiran is eliminated by the kidneys, haemodialysis should not be performed until at least 72 hours after administration of Leqvio.

Storage (see section 6.4 of the SmPC)

No special storage conditions are required. Do not freeze.

Instructions for use of Leqvio pre-filled syringe with needle guard

This section contains information on how to inject Leqvio.

Important information you need to know before injecting Leqvio

• Do not use the pre-filled syringe if any of the outer pack or plastic tray seals are broken.
• Do not remove the needle cap until you are ready to inject.
• Do not use if the pre-filled syringe has fallen onto a hard surface or has been dropped after the needle cap has been removed.
• Do not attempt to re-use or disassemble the pre-filled syringe.
• The pre-filled syringe has a needle guard that will activate to cover the needle when the injection is complete. The needle guard will help prevent needlestick injuries to anyone handling the pre-filled syringe after the injection.

Step 1. Inspect the pre-filled syringe

You may see air bubbles in the liquid, which is normal.Do not attemptto remove the air.

• Do not use the pre-filled syringe if it appears damaged or if part of the injectable solution has leaked out of the pre-filled syringe.