LEQVIO 284 mg Roztwór Do Wstrzykiwań

Treść ulotki

1. Leqvio 284 mg injectable solution in pre-filled syringe
   1. What is Leqvio and what is it 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
2. Leqvio 284 mg injectable solution in pre-filled syringe
3. Leqvio 284 mg injectable solution in pre-filled syringe
   1. What is Leqvio and what is it 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. Package contents and other information
4. Leqvio 284 mg injectable solution in pre-filled syringe

Leqvio 284 mg injectable solution in pre-filled syringe

inclisiran

Read this leaflet carefully before you are given this medicine, as 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, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. 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 given
• 4. Possible side effects
• 5. How to store Leqvio
• 6. Contents of the pack and other information

1. What is Leqvio and what is it used for

What is Leqvio and how does it work
Leqvio contains the active substance inclisiran. Inclisiran lowers levels of LDL cholesterol (cholesterol
"bad" cholesterol), which can cause problems with the heart and blood circulation when levels are
elevated.
Inclisiran works by interfering with RNA (the genetic material of body cells) to limit the
production of a protein called PCSK9. This protein can increase LDL cholesterol levels and preventing its production helps to lower LDL cholesterol levels.

What is Leqvio used for
Leqvio is used in addition to diet to lower cholesterol if you are an adult with high levels of
cholesterol in the blood (primary hypercholesterolemia, including heterozygous and non-familial, or
mixed dyslipidemia).
Leqvio is used:

• together with a statin (a type of medicine for treating high cholesterol), sometimes in combination with other treatments to lower cholesterol, if the maximum dose of the statin does not work adequately, or
• alone or with other medicines to lower cholesterol when statins do not work well or cannot be used.

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 undergoing dialysis
• if you have a severe liver disease
• if you have a severe kidney disease

Children and adolescents
This medicine should not be used in children and young people under 18 years of age, as
there is no experience with the 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, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor, pharmacist or nurse for advice before you are given 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 start treatment with Leqvio. The doctor will consider the potential benefits of
treatment for you and the benefits to health and risks of breastfeeding for your baby.

Driving and operating machinery
Leqvio is not expected to affect your ability to drive or operate machinery.

Leqvio contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium
free’.

3. How Leqvio is administered

The recommended dose of Leqvio is 284 mg administered via an injection under the skin (subcutaneous
injection). The next dose is administered after 3 months and is followed by further doses every
6 months.
Before starting treatment with Leqvio, you should follow a diet to lower cholesterol and you are
likely to need to take a statin. You should continue this diet to lower cholesterol and
continue to take the statin for as long as you receive Leqvio.
Leqvio must 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 a
nurse (healthcare professional).

If you are given too much Leqvio
This medicine will be administered to you by the doctor, pharmacist or nurse (healthcare
professional). In the extremely unlikely event that you are given an excessive amount
(overdose), the doctor or another healthcare professional will check for unwanted 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 arrange 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 get any side effect, even if not listed in this leaflet, please tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system indicated in Annex V. By reporting side effects you can help to 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 the packaging after
“Expiry/EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions. Do not freeze.
The doctor, pharmacist or nurse will check this medicine and dispose of it if it contains
particles.
Do not dispose of any medicine in 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 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 concentrated phosphoric acid (E338).

Description of Leqvio and contents of the pack
Leqvio 284 mg solution for injection in a pre-filled syringe is a transparent solution, from colourless to
slightly yellow, essentially particle-free.
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 on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf.: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel: +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
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 injectable solution in pre-filled syringe

inclisiran
Healthcare professionals must 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 (heterozygous familial or non-familial) hypercholesterolemia or mixed dyslipidemia, in addition 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 statins, or
• in monotherapy or in combination with other lipid-lowering therapies in patients intolerant to statins or for whom a statin is contraindicated.

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

Missed doses
If a planned dose is missed by less than 3 months, inclisiran should be administered and the dosage continued as per the patient’s initial treatment schedule.
If a planned dose is missed by more than 3 months, a new treatment schedule should be started – inclisiran should be administered initially, again at 3 months, and subsequently every 6 months.

Transition from proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor monoclonal antibodies

Inclisirancan be administered immediately after the last dose of a PCSK9 inhibitor monoclonal antibody. To maintain low-density lipoprotein cholesterol (LDL-C) lowering, it is recommended to administer inclisiran within 2 weeks after the last dose of a PCSK9 inhibitor monoclonal antibody.

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). There is limited experience with inclisiran in patients with severe renal impairment. Inclisiran should be used with caution in these patients. See section 4.4 of the SmPC for precautions to be taken in case of 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 SmPC)
Subcutaneous use.
Inclisiran is administered via subcutaneous injection in the abdomen; alternative injection sites include the arm or thigh. Injections should not be made in areas of skin that exhibit 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)
Hemodialysis
The effect of hemodialysis on the pharmacokinetics of inclisiran has not been studied. Considering that inclisiran is renally eliminated, hemodialysis should not be performed for at least 72 hours after the 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 notuse the pre-filled syringe if any seal on the outer carton or the plastic tray seal is damaged.
• Do notremove the needle cap until you are ready to inject.
• Do notuse if the pre-filled syringe has been dropped after removing the needle cap.
• Do notattempt 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 nottry to remove the air.

• Do notuse 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
Firmly pull to remove the needle cap
from the pre-filled syringe. You may see a drop
of liquid on the tip of the needle. This is normal.

Do notreplace the needle cap. Throw it away.

Do notremove the needle cap until you are
ready to inject. Removing the cap well
before the injection can lead to drying of the
medicine inside the needle, causing the needle
to become blocked.

Step 3. Insert the needle
Gently pinch the skin at the injection site and
keep the pinch during the injection. With the other hand
insert the needle into the skin at an approximate angle
of 45 degrees as illustrated.

Step 4. Inject
Maintain the pinch. Slowly press the plunger

all the way down. This will ensure that the entire
dose is injected.
Note: if you are unable to depress the plunger after inserting the needle, 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 in accordance with local regulations.

Leqvio 284 mg injectable solution in pre-filled syringe

Pre-filled syringe with needle protection device
inclisiran

Read this leaflet carefully before this medicine is administered to you, as 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 any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Leqvio is and what it is used for
• 2. What you need to know before Leqvio is administered to you
• 3. How Leqvio is administered
• 4. Possible side effects
• 5. How to store Leqvio
• 6. Contents of the pack and other information

1. What is Leqvio and what is it used for

What is Leqvio and how does it work
Leqvio contains the active substance inclisiran. Inclisiran lowers levels of LDL cholesterol ( "bad" cholesterol), which can cause problems with the heart and blood circulation when levels are
increased.
Inclisiran works by interfering with RNA (the genetic material of body cells) to limit the
production of a protein called PCSK9. This protein can increase levels of LDL cholesterol and preventing its production helps to lower LDL cholesterol levels.

What is Leqvio used for
Leqvio is used in addition to diet to lower cholesterol if you are an adult with high levels of
cholesterol in the blood (primary hypercholesterolemia, including heterozygous and non-familial, or
mixed dyslipidemia).
Leqvio is used:

• together with a statin (a type of medicine for treating high cholesterol), sometimes in combination with other treatments to lower cholesterol, if the maximum dose of the statin does not work adequately, or
• alone or together with other medicines to lower cholesterol when statins do not work well or cannot be used.

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 undergoing dialysis
• if you have a severe liver disease
• if you have a severe kidney disease

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age, as there is no experience with the 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, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor, pharmacist or nurse for advice before you are given 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. The doctor will consider the potential benefits of treatment for you and the benefits to health and risks of breastfeeding for your baby.

Driving and operating machinery
Leqvio is not expected to affect your ability to drive or operate machinery.

Leqvio contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

3. How Leqvio is administered

The recommended dose of Leqvio is 284 mg administered via an injection under the skin (subcutaneous
injection). The next dose is administered after 3 months and is followed by further doses every
6 months.
Before starting treatment with Leqvio, you should follow a diet to lower cholesterol and you will
likely need to take a statin. You should continue this cholesterol-lowering diet and
continue taking the statin for as long as you receive Leqvio.
Leqvio must 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 too much Leqvio
This medicine will be administered to you by the doctor, pharmacist or nurse (healthcare
professional). In the extremely unlikely event that you are given an excessive amount
(overdose), the doctor or another healthcare professional will check for undesirable 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 arrange 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 get any side effects, 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
to 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 the packaging after
“Expiry Date/EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions. Do not freeze.
The doctor, pharmacist or nurse will check this medicine and dispose of it if it contains
particles.
Do not dispose of any medicine in wastewater or household waste. The doctor, pharmacist or
nurse will dispose of medicines you no longer use. 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 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 concentrated phosphoric acid (E338).

Description of Leqvio and package contents
Leqvio 284 mg solution for injection in a pre-filled syringe is a transparent solution, from colourless to
slightly yellow, essentially free from particles.
Each pack contains 1 pre-filled syringe with a 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 on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf.: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel: +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
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 injectable solution in pre-filled syringe

Pre-filled syringe with needle protection device
inclisiran
Healthcare professionals must 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 (heterozygous familial or non-familial) hypercholesterolaemia or mixed dyslipidaemia, in addition 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 statins, or
• in monotherapy or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated.

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

Missed doses
If a planned dose is missed by less than 3 months, inclisiran should be administered and the dosage continued as per the patient’s initial treatment schedule.
If a planned dose is missed by more than 3 months, a new treatment schedule should be started – inclisiran should be administered initially, again at 3 months, and subsequently every 6 months.

Transition from proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor monoclonal antibodies

Inclisirancan be administered immediately after the last dose of a PCSK9 inhibitor monoclonal antibody. To maintain the lowering of low-density lipoprotein cholesterol (LDL-C), it is recommended to administer inclisiran within 2 weeks after the last dose of a PCSK9 inhibitor monoclonal antibody.

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). There is limited experience with inclisiran in patients with severe renal impairment. Inclisiran should be used with caution in these patients. See section 4.4 of the SmPC for precautions to be taken in case of 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.

Route of administration (see section 4.2 of the SmPC)
Subcutaneous use.
Inclisiran is administered via subcutaneous injection in the abdomen; alternative injection sites include the arm or thigh. Injections should not be made in areas of skin that exhibit active skin disease or lesions such as sunburn, rash, inflammation or skin infections.
Each 284 mg dose is delivered 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. Considering that inclisiran is renally eliminated, haemodialysis should not be performed for at least 72 hours after the 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 useAfter use
Important information you need to know before injecting Leqvio

• Do notuse the pre-filled syringe if any seal on the outer carton or the plastic tray seal is damaged.
• 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 disassemble the pre-filled syringe.
• The pre-filled syringe has a needle protection device that will activate to cover the needle after you have finished the injection. The needle protection device will help prevent needle stick 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 try to remove the air.

• Do notuse 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
Firmly pull to remove the needle cap
from the pre-filled syringe. You may see a drop
of liquid on the tip of the needle. This is normal.
Do not put the needle cap back on. Throw it away.

Do notremove the needle cap until you are
ready to inject. Removing the cap too
early before the injection can lead to drying of
the medicine inside the needle, causing the
needle to become blocked.

Step 3. Insert the needle
Gently pinch the skin at the injection site and
keep the pinch during the injection. With your other hand
insert the needle into the skin at an approximate angle
of 45 degrees as illustrated.

Step 4. Start the injection
Maintain the pinch. Slowly press the plunger

all the way down. This will ensure that the entire
dose is injected.
Note: if you are unable to depress the plunger after inserting the needle, use a new pre-filled syringe.

Step 5. Complete the injection
Make sure as illustrated 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 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.