Praluent 300 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Praluent 75 mg solution for injection in a pre-filled pen

Praluent 150 mg solution for injection in a pre-filled pen

Praluent 300 mg solution for injection in a pre-filled pen

alirocumab

Read all of this leaflet carefully before you start using 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.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse, including any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Praluent is and what it is used for

What Praluent is

• The active substance in Praluent is alirocumab.

• Praluent is a monoclonal antibody (a type of specialized protein designed to bind to a specific target substance in the body). Monoclonal antibodies are proteins that recognize and bind to specific other proteins. Alirocumab binds to PCSK9.

How Praluent works

Praluent helps lower your levels of "bad" cholesterol (also called "LDL cholesterol"). Praluent blocks a protein called PCSK9.

• PCSK9 is a protein secreted by liver cells.
• Normally, "bad" cholesterol is removed from the blood by binding to specific "receptors" (docking stations) in the liver.
• PCSK9 reduces the number of these receptors in the liver, resulting in higher-than-normal levels of "bad" cholesterol.
• By blocking PCSK9, Praluent increases the number of available receptors to help remove "bad" cholesterol, thereby lowering levels of "bad" cholesterol.

What Praluent is used for

• In adults with high blood cholesterol levels (hypercholesterolemia [heterozygous familial and non-familial] or mixed dyslipidemia) and in children and adolescents aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
• To reduce cardiovascular risk in adults with high blood cholesterol levels and established cardiovascular disease.

It is administered:

• in combination with a statin (a medicine commonly used to treat high cholesterol) or with other cholesterol-lowering medicines, when the maximum dose of a statin does not sufficiently reduce cholesterol levels, or

• alone or with another cholesterol-lowering medicine when statins are not tolerated or cannot be used.

• Continue your cholesterol-lowering diet while taking this medicine.

2. What you need to know before using Praluent

Do not use Praluent

• if you are allergic to alirocumab 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 starting to use Praluent.

If you experience a severe allergic reaction, stop treatment with Praluent and contact your doctor immediately. Serious allergic reactions have sometimes occurred, such as hypersensitivity, including angioedema (difficulty breathing, or swelling of the face, lips, throat, or tongue), nummular eczema (reddish patches on the skin, sometimes with blisters), and hypersensitivity vasculitis (a specific type of hypersensitivity reaction with symptoms such as diarrhea, skin rash, or purple-colored skin spots). For information on allergic reactions that may occur while taking Praluent, see section 4.

Tell your doctor before using this medicine if you have any kidney or liver disease, as Praluent has been studied in only a small number of patients with severe kidney disease and in no patients with severe liver disease.

Children and adolescents

Praluent must not be given to children under 8 years of age, as there is no experience with the use of this medicine in this age group.

Use of Praluent with other medicines

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 or pharmacist before using this medicine.

The use of Praluent is not recommended during pregnancy or breastfeeding.

Driving and using machines

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

3. How to use Praluent

Follow exactly the administration instructions for this medicine given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

What dose to inject

Your doctor will tell you the appropriate dose for you and how often you should inject (75 mg or 150 mg once every 2 weeks, or 300 mg once every 4 weeks/monthly). Your doctor will monitor your cholesterol levels and may adjust the dose (either increasing or decreasing it) during treatment.

Always check the name and concentration of the medicine on the pen label.

When to inject

Adults

Inject Praluent once every 2 weeks (for the 75 mg or 150 mg doses) or once every 4 weeks/monthly (for the 300 mg dose). To administer the 300 mg dose, either one 300 mg injection or two consecutive 150 mg injections at two different injection sites must be given.

Children and adolescents aged 8 years and older with HoFH:

Inject Praluent once every 2 weeks (for the 75 mg or 150 mg doses), or once every 4 weeks/monthly (for the 150 mg or 300 mg doses).

In adolescents aged 12 years and older, Praluent should be administered by an adult or under adult supervision.

In children under 12 years of age, Praluent should be administered by a caregiver.

Before injecting

Praluent must be allowed to reach room temperature before use.

Read the detailed instructions for use in the package leaflet before injecting Praluent.

Where to inject

Praluent is injected under the skin in the thigh, abdomen, or upper arm.

Refer to the detailed instructions for use in the package leaflet for information on injection sites.

How to use the pre-filled pen

Before using the pen for the first time, your doctor, pharmacist, or nurse will show you how to inject Praluent.

• Always read the “Instructions for Use” included in the package.
• Always use the pen as described in the “Instructions for Use.”

If you use more Praluent than you should

If you use more Praluent than you should, consult your doctor, pharmacist, or nurse.

If you forget to use Praluent

If you missed a dose of Praluent, inject the missed dose as soon as possible. Then take the next dose according to your regular schedule. This way, you will maintain the original dosing regimen. If you are unsure about when to inject Praluent, consult your doctor, pharmacist, or nurse.

If you stop using Praluent

Do not stop treatment with Praluent without first talking to your doctor. If you stop treatment with Praluent, your cholesterol levels may increase.

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 can cause adverse effects, although not everyone will experience them.

If you have a serious allergic reaction, stop treatment with Praluent and contact your doctor immediately. Serious allergic reactions have sometimes occurred, such as hypersensitivity (difficulty breathing), nummular eczema (reddish patches on the skin, sometimes with blisters), and hypersensitivity vasculitis (a specific type of hypersensitivity reaction with symptoms such as diarrhea, skin rash, or purple-colored spots on the skin) (may affect up to 1 in 1,000 people).

Other adverse effects are:

Common (may affect up to 1 in 10 people)

• redness, itching, swelling, pain/soreness at the injection site (local injection site reactions)
• signs or symptoms of upper respiratory tract infection, such as sore throat, runny nose, sneezing
• itching (pruritus).

Rare (may affect up to 1 in 1,000 people)

• raised, red, itchy welts (urticaria).

Frequency not known

The following adverse effects have been reported since Praluent has been marketed, with frequency not known:

• flu-like illness
• difficulty breathing, or swelling of the face, lips, throat, or tongue (angioedema).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Praluent

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, following EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

Keep the pen in the outer carton to protect it from light.

If necessary, individual pre-filled pens may be kept outside the refrigerator below 25°C for up to 30 days. Protect from light. After removal from the refrigerator, Praluent must be used within 30 days or must be discarded.

Do not use this medicine if it has changed colour, is cloudy, or contains visible particles.

After use, place the pen in a sharps container. Ask your doctor, pharmacist, or nurse how to dispose of the container. Do not recycle the container.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Praluent

• The active substance is alirocumab.

Praluent 75 mg solution for injection in a pre-filled pen

Each pre-filled pen contains 75 milligrams of alirocumab.

Praluent 150 mg solution for injection in a pre-filled pen

Each pre-filled pen contains 150 milligrams of alirocumab.

Praluent 300 mg solution for injection in a pre-filled pen

Each pre-filled pen contains 300 milligrams of alirocumab.

• The other components are histidine, sucrose, polysorbate 20, and water for injections.

Nature of the product and contents of the pack

Praluent is a clear, colourless to pale yellow injectable solution presented in a pre-filled pen.

Praluent 75 mg solution for injection in a pre-filled pen

Each pre-filled pen with a green push-button contains 1 ml of solution delivering a single dose of 75 milligrams of alirocumab.

Available in packs of 1, 2 or 6 pre-filled pens.

Each pre-filled pen without an activation button contains 1 ml of solution delivering a single dose of 75 milligrams of alirocumab.

Available in packs of 1, 2, or 3 pre-filled pens without activation button, or a multiple pack containing 6 (2 packs of 3) pre-filled pens without activation button.

Praluent 150 mg solution for injection in a pre-filled pen

Each pre-filled pen with a grey push-button contains 1 ml of solution delivering a single dose of 150 milligrams of alirocumab.

Available in packs of 1, 2 or 6 pre-filled pens.

Each pre-filled pen without an activation button contains 1 ml of solution delivering a single dose of 150 milligrams of alirocumab.

Available in packs of 1, 2, or 3 pre-filled pens without activation button, or a multiple pack containing 6 (2 packs of 3) pre-filled pens without activation button.

Praluent 300 mg solution for injection in a pre-filled pen

Each pre-filled pen without an activation button contains 2 ml of solution delivering a single dose of 300 milligrams of alirocumab.

Available in packs of 1 or 3 pre-filled pens without activation button.

Only certain presentations and pack sizes may be marketed.

Marketing Authorisation Holder

Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer

Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
Brüningstraße 50
65926 Frankfurt am Main
Germany

Genzyme Ireland Ltd
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland

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

Belgium/Belgium/Belgium Sanofi Belgium Tel/Tel: +32 (0)2 710 54 00	Lithuania Swixx Biopharma UAB Tel: +370 5 236 91 40
	Luxembourg/Luxembourg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgium/Belgium)
Czech Republic Sanofi s.r.o. Tel: +420 233 086 111	Hungary SANOFI-AVENTIS Zrt., Hungary Tel.: +36 1 505 0050
Denmark Sanofi A/S Tlf: +45 45 16 70 00	Malta Sanofi S.r.l. Tel: +39 02 39394275
Germany Sanofi-Aventis Deutschland GmbH Tel.: 0800 52 52 010 Tel. from abroad: +49 69 305 21 131	Netherlands Sanofi B.V. Tel: +31 20 245 4000
Estonia Swixx Biopharma OÜ Tel: +372 640 10 30	Norway sanofi-aventis Norge AS Tlf: +47 67 10 71 00
Greece Sanofi-Aventis Monoprosopiki EPE Tel: +30 210 900 16 00	Austria sanofi-aventis GmbH Tel: +43 1 80 185 – 0
Spain sanofi-aventis, S.A Tel: +34 93 485 94 00	Poland Sanofi Sp. z o.o. Tel.: +48 22 280 00 00
France Sanofi Winthrop Industrie Tél: 0 800 222 555 Call from abroad: +33 1 57 63 23 23	Portugal Sanofi - Produtos Farmacêuticos, Lda. Tel: +351 21 35 89 400
Croatia Swixx Biopharma d.o.o. Tel: +385 1 2078 500	Romania Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00	Slovenia Swixx Biopharma d.o.o. Tel: +386 1 235 51 00
Iceland Vistor ehf. Sími: +354 535 7000	Slovakia Swixx Biopharma s.r.o. Tel: +421 2 208 33 600
Italy Sanofi S.r.l. Tel: 800 536389	Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300
Cyprus C.A. Papaellinas Ltd. Tel: +357 22 741741	Sweden Sanofi AB Tel: +46 (0)8 634 50 00
Latvia Swixx Biopharma SIA Tel: +371 6 616 47 50

Date of the most recent review of this leaflet:

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

Praluent pre-filled pen

Instructions for use

The following image shows the parts of the Praluent pen.

Important information

• The medicine is injected under the skin and may be administered by you or another person (caregiver).
• This pen must be used for only one injection and then must be discarded.
• In adolescents aged 12 years and older, Praluent should be administered by an adult or under their supervision.
• In children under 12 years of age, Praluent must be administered by a caregiver.

What you should do

• Keep the Praluent pen out of the sight and reach of children.
• Read all instructions carefully before using the Praluent pen.
• Follow these instructions every time you use a Praluent pen.

What you should not do

• Do not touch the yellow safety shield.
• Do not use the pen if it has been dropped on the floor or is damaged.
• Do not use the pen if the blue cap is missing or not firmly attached.
• Do not reuse the pen.
• Do not shake the pen.
• Do not freeze the pen.
• Do not expose the pen to direct sunlight.

Keep this leaflet. If you have any questions, consult your doctor, pharmacist, or nurse or contact the local representative of the Marketing Authorisation Holder listed in the leaflet.

STEP A: Preparing the injection

Before you begin you will need:

• the Praluent pen
• alcohol wipes
• cotton ball or gauze
• a sharps container (see step B, 8).

1. Check the label on the pen.

• Check that it contains the correct medicine and correct dose.

• Check the expiry date of the pen; do not use if expired.

2. Check the inspection window.

• Check that the liquid is clear, colourless to pale yellow, and free from particles; do not use the pen if not (see image A).
• You may see air bubble(s). This is normal.
• Do not use the pen if the inspection window is solid yellow (see image B).

3. Allow the pen to reach room temperature for 30 to 40 minutes.

• Allow the pen to warm up on its own; do not attempt to heat it.
• Do not put the pen back into the refrigerator.

4. Prepare the injection site.

• Wash your hands with soap and water and dry them with a towel.
• You may inject into:
  • the thigh
  • the abdomen (except for the area within 5 cm around the navel)
  • the outer upper arm

(See image).

• You may stand or sit when injecting.
• Clean the skin at the injection site with an alcohol wipe.
• Do not choose an area of skin that is painful, hardened, red, or inflamed.
• Do not choose an area close to a visible vein.
• Inject in a different area each time.
• Do not inject Praluent together with other injectable medicines in the same area.

STEP B: How to inject yourself

1. After completing all steps in “Step A: Preparing the injection”, remove the blue cap.

• Do not remove the cap until you are ready to inject.
• Do not replace the blue cap.

2. Hold the Praluent pen as follows.

• Do not touch the yellow safety shield.
• Make sure the inspection window is visible.

3. Press the yellow safety shield against the skin at an approximate angle of 90 degrees.

• In children under 12 years of age, it is necessary to pinch the skin before and during the injection.

• In adolescents over 12 years of age and adults, pinching the skin may be necessary to ensure the injection site is firm.

• Press and hold the pen firmly against the body until the yellow safety shield is no longer visible. The pen will not work if the yellow safety shield is not fully pressed.

4. Press and immediately release the green push-button with your thumb.

• You will hear a click. The injection will start at this point.
• The inspection window will begin to turn yellow.

5. Keep the pen pressed against the skin after releasing the push-button.

• The injection may last up to 20 seconds.

6. Check that the inspection window is yellow before removing the pen.

• Do not remove the pen until the entire inspection window is yellow.
• The injection is complete when the inspection window has turned completely yellow, and you may hear a second click.
• If the inspection window does not turn completely yellow, contact the local representative of the Marketing Authorisation Holder for assistance. Do not administer a second dose without first speaking to your doctor, pharmacist, or nurse.

7. Remove the pen from the skin.

• Do not rub the skin surface after the injection.
• If bleeding occurs, press the injection site with a cotton ball or gauze until bleeding stops.

8. Dispose of the pen and cap.

• Do not replace the blue cap.
• Immediately after use, dispose of the pen and cap in a sharps container.
• Ask your doctor, pharmacist, or nurse how to dispose of the container.
• Always keep the container out of the sight and reach of children.

Praluent pre-filled pen

Instructions for use

The following image shows the parts of the Praluent pen.

Important information

• The medicine is injected under the skin and may be administered by you or another person (caregiver).
• This pen must be used for only one injection and then must be discarded.
• In adolescents aged 12 years and older, Praluent should be administered by an adult or under their supervision.
• In children under 12 years of age, Praluent must be administered by a caregiver.

What you should do

• Keep the Praluent pen out of the sight and reach of children.
• Read all instructions carefully before using the Praluent pen.
• Follow these instructions every time you use a Praluent pen.

What you should not do

• Do not touch the yellow safety shield.
• Do not use the pen if it has been dropped on the floor or is damaged.
• Do not use the pen if the blue cap is missing or not firmly attached.
• Do not reuse the pen.
• Do not shake the pen.
• Do not freeze the pen.
• Do not expose the pen to direct sunlight.

Keep this leaflet. If you have any questions, consult your doctor, pharmacist, or nurse or contact the local representative of the Marketing Authorisation Holder listed in the leaflet.

STEP A: Preparing the injection

Before you begin you will need:

• the Praluent pen
• alcohol wipes
• cotton ball or gauze
• a sharps container (see step B, 8).

1. Check the label on the pen.

• Check that it contains the correct medicine and correct dose.

• Check the expiry date of the pen; do not use if expired.

2. Check the inspection window.

• Check that the liquid is clear, colourless to pale yellow, and free from particles; do not use the pen if not (see image A).
• You may see air bubble(s). This is normal.
• Do not use the pen if the inspection window is solid yellow (see image B).

3. Allow the pen to reach room temperature for 30 to 40 minutes.

• Allow the pen to warm up on its own; do not attempt to heat it.
• Do not put the pen back into the refrigerator.

4. Prepare the injection site.

• Wash your hands with soap and water and dry them with a towel.
• You may inject into:
  • the thigh
  • the abdomen (except for the area within 5 cm around the navel)
  • the outer upper arm

(See image).

• You may stand or sit when injecting.
• Clean the skin at the injection site with an alcohol wipe.
• Do not choose an area of skin that is painful, hardened, red, or inflamed.
• Do not choose an area close to a visible vein.
• Inject in a different area each time.
• Do not inject Praluent together with other injectable medicines in the same area.

STEP B: How to inject yourself

1. After completing all steps in “Step A: Preparing the injection”, remove the blue cap.

• Do not remove the cap until you are ready to inject.
• Do not replace the blue cap.

2. Hold the Praluent pen as follows.

• Do not touch the yellow safety shield.
• Make sure the inspection window is visible.

3. Press the yellow safety shield against the skin at an approximate angle of 90 degrees.

• In children under 12 years of age, it is necessary to pinch the skin before and during the injection.

• In adolescents over 12 years of age and adults, pinching the skin may be necessary to ensure the injection site is firm.

• Press and hold the pen firmly against the body until the yellow safety shield is no longer visible. The pen will not work if the yellow safety shield is not fully pressed.

4. Press and immediately release the grey push-button with your thumb.

• You will hear a click. The injection will start at this point.
• The inspection window will begin to turn yellow.

5. Keep the pen pressed against the skin after releasing the push-button.

• The injection may last up to 20 seconds.

6. Check that the inspection window is yellow before removing the pen.

• Do not remove the pen until the entire inspection window is yellow.
• The injection is complete when the inspection window has turned completely yellow, and you may hear a second click.
• If the inspection window does not turn completely yellow, contact the local representative of the Marketing Authorisation Holder for assistance. Do not administer a second dose without first speaking to your doctor, pharmacist, or nurse.

7. Remove the pen from the skin.

• Do not rub the skin surface after the injection.
• If bleeding occurs, press the injection site with a cotton ball or gauze until bleeding stops.

8. Dispose of the pen and cap.

• Do not replace the blue cap.
• Immediately after use, dispose of the pen and cap in a sharps container.
• Ask your doctor, pharmacist, or nurse how to dispose of the container.
• Always keep the container out of the sight and reach of children.

Praluent pre-filled pen

Instructions for use

The following image shows the parts of the Praluent pen.

Important information

• This device is a disposable single-use pre-filled pen. It contains 75 mg of Praluent (alirocumab) in 1 ml. The Praluent pen contains the medicine prescribed by your doctor.
• The medicine is injected under the skin and may be administered by you or another person (caregiver).
• It is important that you or another person do not attempt to administer it unless trained by a healthcare professional.
• This pen must be used for only one injection and then must be discarded.

What you should do

• Keep the Praluent pen out of the sight and reach of children.
• Read all instructions carefully before using the Praluent pen.
• Follow these instructions every time you use a Praluent pen.
• Store in the refrigerator (2°C to 8°C).
• Keep the pen in the outer packaging to protect it from light.

What you should not do

• Do not touch the orange needle shield.
• Do not use the pen if it has been dropped on the floor or is damaged.
• Do not use the pen if the blue cap is missing or not firmly attached.
• Do not reuse the pen.
• Do not shake the pen.
• Do not freeze the pen.
• Do not expose the pen to extreme heat.
• Do not expose the pen to direct sunlight.

Keep this leaflet. If you have any questions, consult your doctor, pharmacist, or nurse or contact the local representative of the Marketing Authorisation Holder listed in the leaflet.

STEP A: Preparing the injection

1. Check the label on the pen.

2. Check that it contains the correct medicine and correct dose.

2. Check the expiry date of the pen; do not use if expired.

Do not use the Praluent pen if it has been dropped on a hard surface or is damaged.

2. Check the window

1. Check that the liquid is clear, colourless to pale yellow, and free from particles.

Air bubble(s) may be visible. This is normal.

Do not use this medicine if the solution is discoloured or cloudy, or if it contains flakes or visible particles.

Do not use if the window appears solid yellow.

Solid yellow in the window means the device has already been used.

3. Allow the pen and other items to reach room temperature

1. Allow the pen to reach room temperature for 45 minutes.

Do not heat the pen. Allow the pen to warm up on its own.

Do not place the pen in direct sunlight.

Do not put the pen back into the refrigerator.

1. While waiting for the pen to reach room temperature, gather the following items:

• Alcohol wipes
• Cotton ball or gauze
• A sharps container (see Step B9 Disposal).

1. Prepare the injection site

2. Wash your hands with soap and water and dry them with a towel.

3. You may inject into (see IMAGE):

   • the upper part of your thighs
   • the abdomen (except for the area within 5 cm around the navel)
   • the outer upper arm (only for administration by a caregiver)

4. Clean the skin at the injection site with an alcohol wipe.

• You may stand or sit when injecting.
• Use a different area each time you inject.
• Do not choose an area of skin that is painful, hardened, red, or inflamed.
• Do not choose an area close to a visible vein.
• Do not inject Praluent together with other injectable medicines in the same area.

STEP B: How to inject

1. Remove the blue cap

2. Pull off the blue cap and discard it.

Do not twist the blue cap.

Do not remove the blue cap until you are ready to inject.

Do not touch the orange needle shield. The needle is inside the orange needle shield.

Do not replace the blue cap.

Do not use the pen if the blue cap is missing or not firmly attached.

1. Pinch the skin and position the pen

2. Pinch the skin to ensure the injection site is firm. This is necessary for children under 12 years of age.

3. When placing the orange needle shield on your skin, hold the pen so that you can see the window.

4. Place the orange needle shield on your skin at an approximate angle of 90 degrees.

Do not press the pen against your skin until you are ready to inject.

Do not touch the orange needle shield. The needle is inside the orange shield.

1. Administer the injection (press ? hold ? check)

2. Press the pen down against the skin until the orange needle shield is fully inside the pen and keep it pressed.

The injection will not start until the orange needle shield is fully pressed.

You will hear a click when the injection starts. The window will begin to turn yellow.

1. Keep the pen pressed against your skin. You may hear a second click.
2. Check that the window is completely yellow.

If the window does not turn completely yellow, remove the pen and contact the local representative of the Marketing Authorisation Holder listed in the leaflet.

Do not administer a second dose without first speaking to your doctor, pharmacist, or nurse.

1. Remove

2. Remove the pen from your skin

Do not rub the skin surface after the injection.

1. If bleeding occurs, press the injection site with a cotton ball or gauze until bleeding stops.

9. Dispose

1. Immediately after use, dispose of the pen and cap in a sharps container.

Do not replace the blue cap

1. Ask your doctor, pharmacist, or nurse how to dispose of the container.
2. Always keep the container out of the sight and reach of children.

Praluent pre-filled pen

Instructions for use

The following image shows the parts of the Praluent pen.

Important information

• This device is a disposable single-use pre-filled pen. It contains 150 mg of Praluent (alirocumab) in 1 ml. The Praluent pen contains the medicine prescribed by your doctor.
• The medicine is injected under the skin and may be administered by you or another person (caregiver).
• It is important that you or another person do not attempt to administer it unless trained by a healthcare professional.
• This pen must be used for only one injection and then must be discarded.

What you should do

• Keep the Praluent pen out of the sight and reach of children.
• Read all instructions carefully before using the Praluent pen.
• Follow these instructions every time you use a Praluent pen.
• Store in the refrigerator (2°C to 8°C).
• Keep the pen in the outer packaging to protect it from light.

What you should not do

• Do not touch the orange needle shield.
• Do not use the pen if it has been dropped on the floor or is damaged.
• Do not use the pen if the blue cap is missing or not firmly attached.
• Do not reuse the pen.
• Do not shake the pen.
• Do not freeze the pen.
• Do not expose the pen to extreme heat.
• Do not expose the pen to direct sunlight.

Keep this leaflet. If you have any questions, consult your doctor, pharmacist, or nurse or contact the local representative of the Marketing Authorisation Holder listed in the leaflet.

STEP A: Preparing the injection

1. Check the label on the pen.

2. Check that it contains the correct medicine and correct dose.

2. Check the expiry date of the pen; do not use if expired.

Do not use the Praluent pen if it has been dropped on a hard surface or is damaged.

1. Check the window

2. Check that the liquid is clear, colourless to pale yellow, and free from particles.

Air bubble(s) may be visible. This is normal.

Do not use this medicine if the solution is discoloured or cloudy, or if it contains flakes or visible particles.

Do not use if the window appears solid yellow.

Solid yellow in the window means the device has already been used.

1. Allow the pen and other items to reach room temperature

2. Allow the pen to reach room temperature for 45 minutes.

Do not heat the pen. Allow the pen to warm up on its own.

Do not place the pen in direct sunlight.

Do not put the pen back into the refrigerator.

1. While waiting for the pen to reach room temperature, gather the following items:

• Alcohol wipes
• Cotton ball or gauze
• A sharps container (see Step B9 Disposal).

1. Prepare the injection site

2. Wash your hands with soap and water and dry them with a towel.

3. You may inject into (see IMAGE):

   • the upper part of your thighs
   • the abdomen (except for the area within 5 cm around the navel)
   • the outer upper arm (only for administration by a caregiver)

4. Clean the skin at the injection site with an alcohol wipe.

• You may stand or sit when injecting.
• Use a different area each time you inject.
• Do not choose an area of skin that is painful, hardened, red, or inflamed.
• Do not choose an area close to a visible vein.
• Do not inject Praluent together with other injectable medicines in the same area.

STEP B: How to inject

1. Remove the blue cap

2. Pull off the blue cap and discard it.

Do not twist the blue cap.

Do not remove the blue cap until you are ready to inject.

Do not touch the orange needle shield. The needle is inside the orange needle shield.

Do not replace the blue cap.

Do not use the pen if the blue cap is missing or not firmly attached.

1. Pinch the skin and position the pen

2. Pinch the skin to ensure the injection site is firm. This is necessary for children under 12 years of age.

3. When placing the orange needle shield on your skin, hold the pen so that you can see the window.

4. Place the orange needle shield on your skin at an approximate angle of 90 degrees.

Do not press the pen against your skin until you are ready to inject.

Do not touch the orange needle shield. The needle is inside the orange shield.

1. Administer the injection (press ? hold ? check)

2. Press the pen down against the skin until the orange needle shield is fully inside the pen and keep it pressed.

The injection will not start until the orange needle shield is fully pressed.

You will hear a click when the injection starts. The window will begin to turn yellow.

1. Keep the pen pressed against your skin. You may hear a second click.
2. Check that the window is completely yellow.

If the window does not turn completely yellow, remove the pen and contact the local representative of the Marketing Authorisation Holder listed in the leaflet.

Do not administer a second dose without first speaking to your doctor, pharmacist, or nurse.

8. Remove

1. Remove the pen from your skin

Do not rub the skin surface after the injection.

1. If bleeding occurs, press the injection site with a cotton ball or gauze until bleeding stops.

9. Dispose

a. Immediately after use, dispose of the pen and cap in a sharps container.

Do not replace the blue cap

1. Ask your doctor, pharmacist, or nurse how to dispose of the container.
2. Always keep the container out of the sight and reach of children.

Praluent pre-filled pen

Instructions for use

The following image shows the parts of the Praluent pen.

Important information

• The medicine is injected under the skin and may be administered by you or another person (caregiver).
• It is important that you or another person do not attempt to administer it unless trained by a healthcare professional.
• This pen must be used for only one injection and then must be discarded.

What you should do

• Keep the Praluent pen out of the sight and reach of children.
• Read all instructions carefully before using the Praluent pen.
• Follow these instructions every time you use a Praluent pen.

What you should not do

• Do not touch the yellow safety shield.
• Do not use the pen if it has been dropped on the floor or is damaged.
• Do not use the pen if the blue cap is missing or not firmly attached.
• Do not reuse the pen.
• Do not shake the pen.
• Do not expose the pen to extreme heat.
• Do not expose the pen to direct sunlight.

Keep this leaflet. If you have any questions, consult your doctor, pharmacist, or nurse or contact the local representative of the Marketing Authorisation Holder listed in the leaflet.

STEP A: Preparing the injection

Before you begin you will need:

• the Praluent pen
• alcohol wipes
• cotton ball or gauze
• a sharps container (see step B7).

1. Check the label on the pen.

• Check that it contains the correct medicine and correct dose.

• Check the expiry date of the pen; do not use if expired.

• Do not use the Praluent pen if it has been dropped on a hard surface or is damaged.

2. Check the inspection window.

• Check that the liquid is clear, colourless to pale yellow, and free from particles (see image A).
• Do not use this medicine if the solution is discoloured or cloudy, or if it contains flakes or visible particles.
• You may see air bubble(s). This is normal.
• Do not use the pen if the inspection window is solid yellow (see image B).

3. Allow the pen to reach room temperature for 45 minutes.

• This is important to deliver the full dose and help minimise discomfort.

• Allow the pen to warm up on its own; do not attempt to heat it.

• Do not put the pen back into the refrigerator.

4. Prepare the injection site.

• Wash your hands with soap and water and dry them with a towel.

• You may inject into (see IMAGE):

  • the upper part of your thighs
  • the abdomen (except for the area within 5 cm around the navel)
  • the outer upper arm (only for administration by a caregiver)

• You may stand or sit when injecting.

• Clean the skin at the injection site with an alcohol wipe.

• Do not choose an area of skin that is painful, hardened, red, or inflamed.

• Do not choose an area close to a visible vein.

• Change (rotate) your injection site, ensuring it is not the same area on the side you used last time.

• Do not inject Praluent together with other injectable medicines in the same area.

STEP B: How to inject yourself

1. After completing all steps in “Step A: Preparing the injection”, remove the blue cap.

• Do not remove the cap until you are ready to inject.
• Do not replace the blue cap.
• Do not use the pen if the blue cap is missing or not firmly attached.

2. Hold the Praluent pen as follows.

• Do not touch the yellow safety shield. The needle is inside the yellow safety shield.
• Make sure the inspection window is visible.
• Do not press the pen against the skin until you are ready to inject.

3. Press the yellow safety shield against the skin at an approximate angle of 90 degrees.

• Pinch the skin to ensure the injection site is firm.
• Press the pen down against the skin until the yellow safety shield is fully inside the pen and keep it pressed (see image).
• The injection will not start until the yellow safety shield is fully pressed.
• You will hear a click when the injection starts. The window will begin to turn yellow.

? Keep the pen pressed against the skin

• You may hear a second click.
• Check that the window is completely yellow.
• Then, slowly count to 5.

4. Check again that the inspection window is yellow before removing the pen.

• If the inspection window does not turn completely yellow, contact the local representative of the Marketing Authorisation Holder for assistance.
• Do not administer a second dose without first speaking to your doctor, pharmacist, or nurse.

5. Remove the pen from the skin.

• Do not rub the skin surface after the injection.
• If bleeding occurs, press the injection site with a cotton ball or gauze until bleeding stops.

7. Dispose of the pen and cap.

• Do not replace the blue cap.
• Immediately after use, dispose of the pen and cap in a sharps container.
• Ask your doctor, pharmacist, or nurse how to dispose of the container.
• Always keep the container out of the sight and reach of children.

Praluent pre-filled pen

Instructions for use

The following image shows the parts of the Praluent pen.

Important information

• This device is a disposable single-use pre-filled pen. It contains 300 mg of Praluent (alirocumab) in 2 ml. The Praluent pen contains the medicine prescribed by your doctor.
• The medicine is injected under the skin and may be administered by you or another person (caregiver).
• It is important that you or another person do not attempt to administer it unless trained by a healthcare professional.
• This pen must be used for only one injection and then must be discarded.

What you should do

• Keep the Praluent pen out of the sight and reach of children.
• Read all instructions carefully before using the Praluent pen.
• Follow these instructions every time you use a Praluent pen.
• Store in the refrigerator (2°C to 8°C).
• Keep the pen in the outer packaging to protect it from light.

What you should not do

• Do not touch the yellow needle shield.
• Do not use the pen if it has been dropped on the floor or is damaged.
• Do not use the pen if the blue cap is missing or not firmly attached.
• Do not reuse the pen.
• Do not shake the pen.
• Do not freeze the pen.
• Do not expose the pen to extreme heat.
• Do not expose the pen to direct sunlight.

Keep this leaflet. If you have any questions, consult your doctor, pharmacist, or nurse or contact the local representative of the Marketing Authorisation Holder listed in the leaflet.

STEP A: Preparing the injection

1. Check the label on the pen.

2. Check that it contains the correct medicine and correct dose.

2. Check the expiry date of the pen; do not use if expired.

Do not use the Praluent pen if it has been dropped on a hard surface or is damaged.

2. Check the window

1. Check that the liquid is clear, colourless to pale yellow, and free from particles.

Air bubble(s) may be visible. This is normal.

Do not use this medicine if the solution is discoloured or cloudy, or if it contains flakes or visible particles.

Do not use if the window appears solid yellow.

Solid yellow in the window means the device has already been used.

1. Allow the pen and other items to reach room temperature

2. Allow the pen to reach room temperature for 45 minutes.

Do not heat the pen. Allow the pen to warm up on its own.

Do not place the pen in direct sunlight.

Do not put the pen back into the refrigerator.

1. While waiting for the pen to reach room temperature, gather the following items:

• Alcohol wipes
• Cotton ball or gauze
• A sharps container (see Step B9 Disposal).

4. Prepare the injection site

1. Wash your hands with soap and water and dry them with a towel.

2. You may inject into (see IMAGE):

• the upper part of your thighs
• the abdomen (except for the area within 5 cm around the navel)
• the outer upper arm (only for administration by a caregiver)

1. Clean the skin at the injection site with an alcohol wipe.

• You may stand or sit when injecting.
• Use a different area each time you inject.
• Do not choose an area of skin that is painful, hardened, red, or inflamed.
• Do not choose an area close to a visible vein.
• Do not inject Praluent together with other injectable medicines in the same area.

STEP B: How to inject

1. Remove the blue cap

2. Pull off the blue cap and discard it.

Do not twist the blue cap.

Do not remove the blue cap until you are ready to inject.

Do not touch the yellow needle shield. The needle is inside the yellow needle shield.

Do not replace the blue cap.

Do not use the pen if the blue cap is missing or not firmly attached.

1. Pinch the skin and position the pen

2. Pinch the skin to ensure the injection site is firm. This is necessary for children under 12 years of age.

3. When placing the yellow needle shield on your skin, hold the pen so that you can see the window.

4. Place the yellow needle shield on your skin at an approximate angle of 90 degrees.

Do not press the pen against your skin until you are ready to inject.

Do not touch the yellow needle shield. The needle is inside the yellow shield.

1. Administer the injection (press ? hold ? check)

2. Press the pen down against the skin until the yellow needle shield is fully inside the pen and keep it pressed.

The injection will not start until the yellow needle shield is fully pressed.

You will hear a click when the injection starts. The window will begin to turn yellow.

1. Keep the pen pressed against your skin. You may hear a second click.
2. Check that the window is completely yellow.

If the window does not turn completely yellow, remove the pen and contact the local representative of the Marketing Authorisation Holder listed in the leaflet.

Do not administer a second dose without first speaking to your doctor, pharmacist, or nurse.

1. Remove

2. Remove the pen from your skin

Do not rub the skin surface after the injection.

1. If bleeding occurs, press the injection site with a cotton ball or gauze until bleeding stops.

2. Dispose

3. Immediately after use, dispose of the pen and cap in a sharps container.

Do not replace the blue cap

1. Ask your doctor, pharmacist, or nurse how to dispose of the container.
2. Always keep the container out of the sight and reach of children.