Leqvio

Package leaflet: Information for the patient

Leqvio 284 mg solution for injection in pre-filled syringe

inclisiran
Please read this leaflet carefully before you are given this medicine because it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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.

Contents of this 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 lowers levels of LDL cholesterol ("bad" cholesterol), which can cause heart and circulatory problems when levels are elevated.
Inclisiran works by interfering with RNA (genetic material in the body's cells) to reduce the production of a protein called PCSK9. This protein can increase LDL cholesterol levels, and reducing its production helps lower LDL cholesterol levels.

What Leqvio is used for
Leqvio is used in addition to diet to lower cholesterol in adults who have high cholesterol levels in the blood (primary hypercholesterolemia, including heterozygous familial and non-familial forms, or mixed dyslipidemia).
Leqvio is used:

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

2. What you should know before you are given Leqvio

Do not take Leqvio

• if you are allergic to inclisiran or to 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 on dialysis
• if you have severe liver disease
• if you have severe kidney disease

Children and adolescents
This medicine must not be used in children and young people under 18 years of age, as there is no experience with use of the 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, think you might be pregnant, are planning to become pregnant, or are breastfeeding, please consult your doctor, pharmacist or nurse before you are given this medicine.
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 and the benefits to your baby's health and the risks of breastfeeding for your baby.
Driving and using machines
Leqvio is not expected to affect your ability to drive vehicles or operate machinery.
Leqvio contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How Leqvio is administered

The recommended dose of Leqvio is 284 mg given as an injection under the skin (subcutaneous injection). The next dose is given after 3 months, followed by further doses every 6 months.
Before starting treatment with Leqvio, you must follow a cholesterol-lowering diet and you will likely need to take a statin. You must continue this cholesterol-lowering diet and keep taking the statin for as long as you are receiving Leqvio.
Leqvio should be injected under the skin of the abdomen; alternative injection sites include the upper arm or thigh. Leqvio will be administered to you by a doctor, pharmacist, or nurse (healthcare professional).
If you are given more Leqvio than you should have
This medicine will be administered to you by a doctor, pharmacist, or nurse (healthcare professional). In the extremely unlikely event that you are given too much medicine (overdose), the doctor or another healthcare professional will monitor you for any adverse effects.
If you miss a dose of Leqvio
If you miss your appointment for the Leqvio injection, contact your doctor, pharmacist, or nurse as soon as possible to reschedule the next injection.
If you have any doubts about how to use this medicine, consult 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)

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system detailed in Annex V. 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./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 discard it if it contains particles.
Do not dispose of any medicine via wastewater or household waste. Unused or expired medicines will be disposed of by the doctor, pharmacist, or nurse. This will help protect the environment.

6. Package contents and other information

What Leqvio contains

• The active substance is inclisiran. Each pre-filled syringe contains sodium inclisiran equivalent to 284 mg of inclisiran in 1.5 mL of solution. Each mL contains sodium inclisiran equivalent to 189 mg of inclisiran.
• The other ingredients are: water for injections, sodium hydroxide (E524) (see section 2 “Leqvio contains sodium”), and concentrated phosphoric acid (E338).

Description of the appearance of Leqvio and contents of the pack
Leqvio 284 mg solution for injection in pre-filled syringe is a clear, colourless to slightly yellow solution, essentially free from particles.
Each pack contains 1 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 Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50
България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11
Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00
Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872
Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111
Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00
Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570
España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888
France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600
Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel: +385 1 6274 220 Tel: +40 21 31299 01
Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50
Ísland Slovenská republika
Vistor ehf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439
Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200
Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00
Latvija
SIA Novartis Baltics
Tel: +371 67 887 070
Other sources of information
More detailed information about this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu/
The following information is intended exclusively for healthcare professionals:
Leqvio 284 mg solution for injection in pre-filled syringe
inclisiran
Healthcare professionals should refer to the Summary of Product Characteristics 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 therapies in patients who cannot reach LDL-C goals with the maximum tolerated dose of a statin, or
• as monotherapy or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated.

Dosage ( see section 4.2 of the SmPC )
The recommended dose of inclisiran is 284 mg administered as a single subcutaneous injection: at initiation, again at 3 months, and thereafter every 6 months.
Missed doses
If a scheduled dose is missed by less than 3 months, inclisiran should be administered and the dosing schedule continued as per the patient’s initial treatment regimen.
If a scheduled dose is missed by more than 3 months, a new treatment regimen should be initiated – inclisiran should be administered at initiation, again 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 low-density lipoprotein cholesterol (LDL-C) reduction, it is recommended to administer inclisiran within 2 weeks after the last dose of a monoclonal antibody inhibitor of PCSK9.
Special populations
Elderly
No dose adjustments are required for elderly patients (see section 5.2 of the SmPC).
Hepatic impairment
No dose adjustments are required for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. Data are not available in patients with severe hepatic impairment (Child-Pugh class C) (see section 5.2 of the SmPC). Inclisiran should be used with caution in patients with severe hepatic impairment.
Renal impairment
No dose adjustments are required for patients with mild, moderate or severe renal impairment or patients with end-stage renal disease (see section 5.2 of the SmPC). Experience with inclisiran in patients with severe renal impairment is limited. Inclisiran should be used with caution in these patients. See section 4.4 of the SmPC for precautions related to haemodialysis.
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 SmPC )
For subcutaneous use.
Inclisiran is administered by subcutaneous injection into the abdomen; alternative injection sites include the arm or thigh. Injections must not be administered into areas of skin with active skin disease or skin lesions such as sunburn, rashes, inflammation, or skin infections.
Each 284 mg dose is administered using a single pre-filled syringe. Each pre-filled syringe is for single use only.
Inclisiran is intended for administration 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 renally, haemodialysis should not be performed for at least 72 hours after administration of inclisiran.
Storage ( see section 6.4 of the SmPC)
This medicinal product does not require any special storage conditions. Do not freeze.
Instructions for use of Leqvio pre-filled syringe
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 seal on the outer carton or the seal of the plastic tray is damaged.
• Do not remove the needle cap until you are ready to inject.
• Do not use if the pre-filled syringe has been dropped after removing the needle cap.
• Do not attempt to reuse or disassemble the pre-filled syringe.

Step 1. Inspect the pre-filled syringe
You may see air bubbles in the liquid, which is normal. Do not try to remove the air.

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

Step 2. Remove the needle cap

Pull firmly to remove the needle cap from the pre-filled syringe. You may see a drop of liquid at the tip of the needle. This is normal.
Do not replace the needle cap. Discard it.
Do not remove the needle cap until you are ready to inject. Removing the cap too early may lead to drying of the medicine inside the needle, causing needle blockage.

Step 3. Insert the needle
Gently pinch the skin at the injection site and maintain the pinch during the injection. With the other hand, insert the needle into the skin at an approximate angle of 45 degrees as shown.
Step 4. Inject

Maintain the pinch. Slowly push the plunger all the way down. This will ensure the full dose is injected.
Note: If after inserting the needle you are unable to push the plunger down, use a new pre-filled syringe.
Step 5. Complete the injection and dispose of the pre-filled syringe
Remove the pre-filled syringe from the injection site. Do not replace the needle cap.
Dispose of the pre-filled syringe according to local regulations.

Package leaflet: information for the patient

Leqvio 284 mg solution for injection in pre-filled syringe

Pre-filled syringe with needle safety device
inclisiran

Please read this leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this 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 lowers LDL cholesterol (so-called "bad" cholesterol) levels, which can cause heart and blood circulation problems when elevated.
Inclisiran works by interfering with RNA (the genetic material of the body's cells) to limit the production of a protein called PCSK9. This protein can increase LDL cholesterol levels, and reducing its production helps lower LDL cholesterol levels.

What Leqvio is used for
Leqvio is used in addition to diet to lower cholesterol in adults who have high cholesterol levels in the blood (primary hypercholesterolaemia, including heterozygous familial and non-familial forms, or mixed dyslipidaemia).
Leqvio is used:

• in combination with a statin (a type of medicine used to treat high cholesterol), sometimes together with other cholesterol-lowering treatments, when the maximum tolerated dose of statin does not provide adequate control, or
• alone or together with other cholesterol-lowering medicines when statins are ineffective or cannot be used.

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

Do not use Leqvio

• if you are allergic to inclisiran or to 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 on dialysis
• if you have severe liver disease
• if you have severe kidney disease

Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age, as there is no experience with use of the 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, think you might be pregnant, are planning to become pregnant, or are breastfeeding, please consult your doctor, pharmacist, or nurse before being given this medicine.
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 and the benefits to your baby's health and the risks of breastfeeding for your baby.
Driving and using machines
Leqvio is not expected to affect your ability to drive or use machinery.
Leqvio contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How Leqvio is administered

The recommended dose of Leqvio is 284 mg given as an injection under the skin (subcutaneous injection). The next dose is administered after 3 months, followed by further doses every 6 months.
Before starting treatment with Leqvio, you must follow a cholesterol-lowering diet and you will likely need to take a statin. You must continue this cholesterol-lowering diet and keep taking the statin for as long as you receive Leqvio.
Leqvio should be injected under the skin of the abdomen; alternative injection sites include the upper arm or thigh. Leqvio will be administered to you by a doctor, pharmacist, or nurse (healthcare professional).
If you are given more Leqvio than you should
This medicine will be administered to you by a doctor, pharmacist, or nurse (healthcare professional). In the extremely unlikely event that you are given too much medicine (overdose), your doctor or another healthcare professional will monitor you for any adverse effects.
If you miss a dose of Leqvio
If you miss your appointment for the Leqvio injection, contact your doctor, pharmacist, or nurse as soon as possible to schedule the next injection.
If you have any questions about 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)

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly through the national reporting system referred to in Annex V. 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 stated on the label and the carton after "Exp./EXP". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions. Do not freeze.
The doctor, pharmacist or nurse will check this medicine and discard it if it contains particles.
Do not dispose of any medicine via wastewater or household waste. The doctor, pharmacist or nurse will dispose of medicines you no longer use. This 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 sodium inclisiran equivalent to 284 mg of inclisiran in 1.5 mL of solution. Each mL contains sodium inclisiran 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).

Description of the appearance of Leqvio and contents of the pack
Leqvio 284 mg solution for injection in pre-filled syringe is a clear, colourless to slightly yellow solution, essentially free from particles.
Each pack contains 1 pre-filled syringe with needle protection device.

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 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel: +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor ehf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/

The following information is intended exclusively for healthcare professionals:

Leqvio 284 mg solution for injection in pre-filled syringe
Pre-filled syringe with needle protection device
inclisiran
Healthcare professionals should refer to the Summary of Product Characteristics 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 with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
• as monotherapy or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated.

Dosage (see section 4.2 of the SmPC)
The recommended dose of inclisiran is 284 mg administered as a single subcutaneous injection: at initiation, again at 3 months, and thereafter every 6 months.

Missed doses
If a scheduled dose is missed for less than 3 months, inclisiran should be administered and dosing continued according to the patient’s initial treatment schedule.
If a scheduled dose is missed for more than 3 months, a new treatment schedule should be initiated – inclisiran should be administered at initiation, again at 3 months, and thereafter every 6 months.

Transition from monoclonal antibodies inhibiting proprotein convertase subtilisin/kexin type 9 (PCSK9)
Inclisiran may be administered immediately after the last dose of a monoclonal antibody PCSK9 inhibitor. To maintain LDL-C lowering, inclisiran should be administered within 2 weeks after the last dose of a monoclonal antibody PCSK9 inhibitor.

Special populations
Elderly
No dose adjustments are required for elderly patients (see section 5.2 of the SmPC).

Hepatic impairment
No dose adjustments are required for 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 SmPC). Inclisiran should be used with caution in patients with severe hepatic impairment.

Renal impairment
No dose adjustments are required for patients with mild, moderate or severe renal impairment or patients with end-stage renal disease (see section 5.2 of the SmPC). Experience with inclisiran in patients with severe renal impairment is limited. Inclisiran should be used with caution in these patients. See section 4.4 of the SmPC for precautions regarding 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 SmPC)
For subcutaneous use.
Inclisiran is administered via subcutaneous injection into the abdomen; alternative injection sites include the arm or thigh. Injections must not be administered into areas of skin with active skin disease or lesions such as sunburn, rashes, inflammation, or skin infections.
Each 284 mg dose is administered using a single pre-filled syringe. Each pre-filled syringe is for single use only.
Inclisiran is intended for administration 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. Since inclisiran is eliminated renally, haemodialysis should not be performed for at least 72 hours after administration of inclisiran.

Storage (see section 6.4 of the SmPC)
This medicinal product does not require any special storage conditions. Do not freeze.

Instructions for use of Leqvio pre-filled syringe with needle protection device
This section contains information on how to inject Leqvio.

Before use After use
Important information you need to know before injecting Leqvio

• Do not use the pre-filled syringe if any seal on the outer carton or the seal of the plastic tray is damaged.
• Do not remove the needle cap until you are ready to inject.
• Do not use if the pre-filled syringe has been dropped on a hard surface or dropped after removing the needle cap.
• Do not attempt to reuse or disassemble the pre-filled syringe.
• The pre-filled syringe has a needle protection device which will activate to cover the needle after the injection is completed. The needle protection device 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 not try to remove the air.

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

Step 2. Remove the needle cap

Pull firmly to remove the needle cap from the pre-filled syringe. You may see a drop of liquid at the tip of the needle. This is normal.
Do not replace the needle cap. Dispose of it.
Do not remove the needle cap until you are ready to inject. Removing the cap well before injection may lead to drying of the medicine inside the needle, causing needle blockage.

Step 3. Insert the needle

Gently pinch the skin at the injection site and maintain the pinch during injection. With the other hand, insert the needle into the skin at an approximate angle of 45 degrees as shown.

Step 4. Begin injection

Maintain the skin pinch. Slowly push the plunger all the way down. This will ensure the full dose is injected.
Note: If after inserting the needle you are unable to depress the plunger, use a new pre-filled syringe.

Step 5. Complete the injection
Ensure as shown that the end of the plunger is between the wings of the needle protection device. This will ensure that the needle protection device has activated and will cover the needle after the injection is completed.

Step 6. Release the plunger

While keeping the pre-filled syringe at the injection site, slowly release the plunger until the needle is covered by the needle protection device. Remove the pre-filled syringe from the injection site.

Step 7. Dispose of the pre-filled syringe
Dispose of the pre-filled syringe in accordance with local regulations.