Leqvio 284 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Leqvio 284 mg solution for injection in pre-filled syringe

Pre-filled syringe with needle guard

inclisiran

Read the entire leaflet carefully before you are given 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, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Leqvio is and what it is used for
2. What you need to know before you are given Leqvio
3. How Leqvio is administered
4. Possible side effects
5. How to store Leqvio
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 reduces levels of LDL cholesterol (so-called "bad" cholesterol), which can cause heart and circulatory problems when levels are high.

Inclisiran works by interfering with RNA (responsible for carrying genetic information in the body's cells) to limit the production of a protein called PCSK9. This protein can increase LDL cholesterol levels, and by preventing its production, inclisiran helps reduce LDL cholesterol levels.

What Leqvio is used for

Leqvio is used together with a cholesterol-lowering diet in adults who have high cholesterol levels in the blood (primary hypercholesterolaemia, including heterozygous familial and non-familial forms, or mixed dyslipidaemia).

Leqvio is given:

• in combination with a statin (a type of medicine used to treat high cholesterol), sometimes together with another cholesterol-lowering treatment, when the maximum dose of statin is not effective enough, or
• alone or in combination with other cholesterol-lowering medicines when statins are not effective enough or cannot be used.

2. What you need to know before you are given Leqvio

Do not administer Leqvio to you

• if you are allergic to inclisiran or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given Leqvio:

• if you are undergoing 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 18 years of age, as there is no experience with the use of this medicine in this age group.

Other medicines and Leqvio

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

Pregnancy and breastfeeding

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

The use of Leqvio should be avoided during pregnancy.

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

Driving and using machines

Leqvio is not expected to have any effect on your ability to drive or use machines.

Leqvio contains sodium

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

3. How Leqvio is administered

The recommended dose of Leqvio is 284 mg administered as an injection under the skin (subcutaneous injection). The next dose is given after 3 months, followed by subsequent doses every 6 months.

Before starting Leqvio, you should already be following a cholesterol-lowering diet and are likely taking a statin. You should continue the cholesterol-lowering diet and keep taking the statin throughout the time you receive Leqvio.

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

If more Leqvio has been administered than you should receive

This medicine will be administered by a doctor, pharmacist, or nurse (healthcare professional). In the unlikely event that you are given too much (an overdose), the doctor or other healthcare professional will monitor you for any adverse effects.

If you miss a dose of Leqvio

If you miss an appointment for your Leqvio injection, contact your doctor, pharmacist, or nurse as soon as possible to reschedule your next injection.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Frequent (may affect up to 1 in 10 people)

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

Reporting of 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 leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Leqvio

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

Do not use this medicine after the expiry date stated on the label and the carton after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions. Do not freeze.

Your doctor, pharmacist, or nurse will check this medicine and discard it if it contains particles.

Medicines must not be disposed of via wastewater or household waste. Your doctor, pharmacist, or nurse will dispose of any medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Leqvio

• The active substance 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 injections, sodium hydroxide (E524) (see section 2 “Leqvio contains sodium”), and concentrated phosphoric acid (E338).

Nature of the product and pack contents

Leqvio 284 mg solution for injection in pre-filled syringe is a clear, colourless to slightly yellow solution, practically free from particles.

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

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharmaceutical Manufacturing GmbH

Biochemiestrasse 10

6336 Langkampfen

Austria

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Leqvio 284 mg solution for injection in pre-filled syringe

Pre-filled syringe with needle guard

inclisiran

Healthcare professionals should refer to the Summary of Product Characteristics for complete prescribing information.

Indication (see section 4.1 of the Summary of Product Characteristics)

Leqvio is indicated in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet:

• in combination with a statin or a statin and other lipid-lowering therapies in patients who do not achieve LDL-C (low-density lipoprotein cholesterol) goals with the maximum dose of a statin, or
• alone or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom statins are contraindicated.

Dosage (see section 4.2 of the Summary of Product Characteristics)

The recommended dose is 284 mg of inclisiran administered as a single subcutaneous injection given at initiation, again at 3 months, and thereafter every 6 months.

Missed doses

If administration of a scheduled dose is delayed by less than 3 months, inclisiran should be administered and the original dosing schedule maintained.

If administration of a scheduled dose is delayed by more than 3 months, a new dosing schedule should be initiated – inclisiran should be administered as an initial dose, another at 3 months, and thereafter every 6 months.

Transition from monoclonal antibody inhibitors of proprotein convertase subtilisin/kexin type 9 (PCSK9)

Inclisiran may be administered immediately after the last dose of a monoclonal antibody inhibitor of PCSK9. To maintain LDL-C reduction, it is recommended to administer inclisiran 2 weeks after the last dose of the monoclonal antibody inhibitor of PCSK9.

Special populations

Elderly

Dose adjustment is not required in elderly patients (see section 5.2 of the Summary of Product Characteristics).

Hepatic impairment

Dose adjustment is not required in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. No data are available in patients with severe hepatic impairment (Child-Pugh class C) (see section 5.2 of the Summary of Product Characteristics). Inclisiran should be used with caution in patients with severe hepatic impairment.

Renal impairment

Dose adjustment is not required in patients with mild, moderate, or severe renal impairment or in patients with end-stage renal disease (see section 5.2 of the Summary of Product Characteristics). 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 Summary of Product Characteristics for precautions regarding hemodialysis.

Paediatric population

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

Method of administration (see section 4.2 of the Summary of Product Characteristics)

For subcutaneous use.

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

Each 284 mg dose is administered using a pre-filled syringe. Each pre-filled syringe is for single use only.

Inclisiran is intended to be administered by a healthcare professional.

Contraindications (see section 4.3 of the Summary of Product Characteristics)

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

Special warnings and precautions for use (see section 4.4 of the Summary of Product Characteristics)

Hemodialysis

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

Storage (see section 6.4 of the Summary of Product Characteristics)

No special storage conditions 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 the seals on the outer packaging or the seal on the plastic tray are broken.
• Do not remove the needle cap until you are ready to inject.
• Do not use if the pre-filled syringe has been dropped onto a hard surface or has been dropped after removing the needle cap.
• Do not attempt to reuse or disassemble the pre-filled syringe.
• The pre-filled syringe has an activated needle guard that will cover the needle once the injection is complete. The needle guard will help prevent needle-stick injuries to anyone handling the pre-filled syringe after injection.

Step 1. Inspect the pre-filled syringe

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

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