LEQVIO 284 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

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

Leqvio must not be given to you

• 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:

• 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 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 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 using this medicine.

Leqvio should be avoided during pregnancy.

It is not known whether Leqvio passes 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 to the benefits and risks for your baby's health and breastfeeding.

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 of sodium (23 mg) per dose; it is essentially "sodium-free".

3. How Leqvio is given

The recommended dose of Leqvio is 284 mg administered via a subcutaneous injection (under the skin). The next dose is given 3 months later, and additional doses are given every 6 months.

Before starting Leqvio, you should be following a cholesterol-reducing diet and may be taking a statin. You should maintain the cholesterol-reducing diet and continue taking the statin while receiving Leqvio.

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

If you are given too much Leqvio

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

If you miss a dose of Leqvio

If you miss an appointment to receive your Leqvio injection, contact your doctor, pharmacist, or nurse as soon as possible 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 experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side 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 which is stated on the label and carton after EXP. The expiry date refers to the last day of the month shown.

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

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

Medicines should not be disposed of via wastewater or household waste. Your doctor, pharmacist, or nurse will dispose of any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Leqvio Composition

• 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 ingredients are water for injections, sodium hydroxide (E524) (see section 2 "Leqvio contains sodium") and phosphoric acid concentrated (E338).

Appearance and Container Contents of the Product

Leqvio 284 mg solution for injection in pre-filled syringe is a clear, colorless to slightly yellowish solution, practically free of particles.

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

You can request more information about this medicinal product from the local representative of the marketing authorisation holder:

Date of Last Revision of this Prospectus:

Other Sources of Information

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

This information is intended only for healthcare professionals:

Leqvio 284 mg solution for injection in pre-filled syringe

Pre-filled syringe with needle protector

Inclisiran

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

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

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 goals 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.

Posology (see section 4.2 of the Summary of Product Characteristics).

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

Missed Doses

If administration of a planned dose is delayed by less than 3 months, inclisiran should be administered and the patient's original schedule maintained.

If administration of a planned dose is delayed by more than 3 months, a new dosing schedule should be initiated – inclisiran should be administered at initiation, again at 3 months, and then every 6 months.

Transition from Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Monoclonal Antibody Treatment

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

Special Populations

Elderly

No dose adjustments are necessary in elderly patients (see section 5.2 of the Summary of Product Characteristics).

Hepatic Impairment

No dose adjustments are necessary in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. There are no data available in patients with severe (Child-Pugh C) hepatic impairment (see section 5.2 of the Summary of Product Characteristics). Inclisiran should be used with caution in patients with severe hepatic impairment.

Renal Impairment

No dose adjustments are necessary in patients with mild, moderate, or severe renal impairment or 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 in case of haemodialysis.

Paediatric Population

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

Method of Administration (see section 4.2 of the Summary of Product Characteristics).

Subcutaneous use.

Inclisiran is administered subcutaneously in the abdomen; alternative injection sites include 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 284 mg dose is administered via a pre-filled syringe. Each pre-filled syringe is for single use.

Inclisiran is intended for administration 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).

Haemodialysis

The effect of haemodialysis on the pharmacokinetics of inclisiran has not been studied. Given that inclisiran is eliminated via the kidneys, haemodialysis 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 are required. Do not freeze.

Instructions for Use of Leqvio Pre-filled Syringe with Needle Protector

This section contains information on how to inject Leqvio.

Important Information You Need to Know Before Injecting Leqvio

• Do notuse the pre-filled syringe if any of the seals of the outer packaging or the seal of the plastic tray are broken.
• Do notremove the needle cap until you are ready to inject.
• Do notuse if the pre-filled syringe has been dropped onto a hard surface or dropped after removing the needle cap.
• Do notattempt to reuse or dismantle the pre-filled syringe.
• The pre-filled syringe has a needle protector that will activate to cover the needle when the injection is complete. The needle protector will help prevent needlestick 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 notattempt to remove the air.

• Do notuse the pre-filled syringe if it appears damaged or if part of the injectable solution has leaked out of the pre-filled syringe.