Praluent (Sanofi-Aventis Canada, 75 mg, 150 mg, 300 mg): Uses, Side Effects and Dosage

What PRALUENT is used for:

• To reduce the risk of heart attack, stroke, and certain types of heart procedures (to restore blood flow to the heart) in adults with cardiovascular disease.
• To reduce low density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol levels (hypercholesterolemia, heterozygous familial and non-familial).

PRALUENT can be used along with lifestyle changes, by itself or with other medicines (such as statins or ezetimibe) to treat patients with high cholesterol. Continue to follow your cholesterol-lowering diet while taking this medicine.

It is not known if PRALUENT is safe and effective in children.

How PRALUENT works:

PRALUENT is an injectable medicine that belongs to a type of medicines called PCSK9 inhibitors.

• PRALUENT is a fully human monoclonal antibody that blocks a protein called PCSK9 (proprotein convertase subtilisin kexin type 9).
• PCSK9 is a protein secreted by liver cells.
• LDL (“bad”) cholesterol is normally removed from the blood by binding to specific receptors (docking stations) on liver cells. PCSK9 lowers the number of LDL receptors available to remove LDL cholesterol from the blood.
• PRALUENT blocks PCSK9 and thereby increases the number of receptors available to remove LDL cholesterol from the blood. This results in lower LDL cholesterol levels.

The ingredients in PRALUENT are:

Medicinal ingredient(s): alirocumab.

Non-medicinal ingredients: histidine, polysorbate 20, sucrose and water for injection.

PRALUENT comes in the following dosage form(s):

• Pre-filled pen with an activation button, which contains a solution of 75 mg/mL or 150 mg/mL of PRALUENT.
• Pre-filled pen without an activation button, which contain a solution of 75 mg/mL, 150 mg/mL, or 300 mg/mL of PRALUENT.

Do not use PRALUENT if:

• You are allergic to alirocumab or to any of the other ingredients in this medicine.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PRALUENT. Talk about any health conditions or problems you may have, including if you:

• Have allergies. If you have a serious allergic reaction, stop using PRALUENT and tell your doctor or pharmacist.

• Are pregnant or intend to get pregnant. Tell your doctor or pharmacist before using this medicine. The use of PRALUENT is not recommended during pregnancy.

• Are breastfeeding or plan to breastfeed. Tell your doctor or pharmacist before using this medicine. The use of PRALUENT is not recommended during breast-feeding.

Other warnings you should know about:

• The safety and efficacy have not been established in children and adolescents less than 18 years of age. Therefore, the use of PRALUENT is not recommended in this age group.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take PRALUENT:

• Before starting PRALUENT, you should be on a diet to lower your cholesterol. You should stay on this cholesterol lowering diet while taking PRALUENT.
• If your doctor has prescribed PRALUENT along with a statin or other cholesterol lowering medicine, follow your doctor’s instructions on how to take these medicines together. In this case, please read the dosage instructions in the package leaflet of the other medicines.
• Before you use the pre-filled pen for the first time, your doctor, pharmacist or nurse will show you how to inject PRALUENT.
• Do not use this medicine if the solution is discoloured or cloudy, or if it contains visible flakes or particles.
• PRALUENT is injected under the skin (subcutaneous use) of your upper leg (thigh), stomach area (abdomen), or upper arm.
• Always check the label of your pre-filled pen to make sure you have the correct product and the correct strength of PRALUENT before each injection.
• For the pre-filled pen with activation button (75 mg or 150 mg pen), remove from the refrigerator approximately 30 to 40 minutes before the injection to allow the solution to warm up to room temperature.
• For the pre-filled pen without activation button (75mg, 150mg, or 300 mg pen), remove from the refrigerator approximately 45 minutes before the injection to allow the solution to warm up to room temperature.
• Choose a different spot each time you inject (e.g. right thigh then left thigh, or right abdomen then left abdomen).
• Do not inject into areas where the skin is injured, tender, hard, red or hot.
• Do not inject PRALUENT together with other injectable medicines at the same injection site.
• PRALUENT comes as a single-dose (1 time) pre-filled pen (autoinjector). Your healthcare provider will prescribe the dose that is best for you.
• Ask your doctor if you have any further questions on how to use PRALUENT.

Usual dose:

PRALUENT is available as 75 mg, 150 mg, or 300 mg for subcutaneous administration. Your doctor will tell you which dosage (75 mg or 150 mg every 2 weeks or 300 mg every 4 weeks) is right for you.

To give the 300 mg dose, give either one 300 mg injection, or two 150 mg injections in a row at two different injection sites.

Do not stop using PRALUENT without talking with your doctor. If you stop using PRALUENT, your cholesterol levels can increase.

Overdose:

Missed dose:

If you miss a dose of PRALUENT, inject your missed dose as soon as you are able to do so, within 7 days. Then take your next dose at your regular scheduled time:

• If you take PRALUENT every 2 weeks, take your next dose 2 weeks from the day you missed your dose.
• If you take PRALUENT every 4 weeks, take your next dose 4 weeks from the day you missed your dose.

If you miss a dose by more than 7 days:

• If you take PRALUENT every 2 weeks, wait until your next dose scheduled to re-start.

• If you take PRALUENT every 4 weeks, start a new schedule from the time you remember to

  • take your dose.

In case you are not sure when to inject PRALUENT, call your doctor, nurse or pharmacist.

Possible side effects from using PRALUENT:

These are not all the possible side effects you may have when taking PRALUENT. If you experience any side effects not listed here, contact your healthcare professional.

PRALUENT may cause allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction, including a severe rash, redness, severe itching, swelling of the face, lips, throat or tongue, or trouble breathing.

Common (may affect up to 1 in 10 people)

• Redness, swelling, pain, tenderness, or bruising (hematoma) where the injection is given (local injection site reactions)
• Symptoms of the common cold
• Itching (pruritus)

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

• Allergic reactions
• Hypersensitivity vasculitis: a specific form of allergic reaction, with symptoms such as rash or purple-coloured spots on the skin, diarrhea.
• Hives (urticaria)
• Reddish skin spots, sometimes with blisters (nummular eczema)

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting side effects

Storage:

Keep out of reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and carton.

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

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

Do not expose to extreme heat.

PRALUENT should be allowed to warm to room temperature prior to use. PRALUENT should be used as soon as possible after it has warmed up. When taken out of the refrigerator to warm up the pen, do not put near a heat source or in direct sunlight. Do not keep PRALUENT for more than 30 days at room temperature.

After use, put the pen into a puncture-resistant container. Always keep the container out of the reach of children. Ask your health care provider or pharmacist how to throw away the container. Do not recycle the container.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

If you want more information about PRALUENT:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.sanofi.com/en/canada, or by calling 1-800-265-7927.

Date of Authorization: 2026-07-20

INSTRUCTIONS FOR USE

PRALUENT (alirocumab) 75 mg solution for injection in a pre-filled pen with activation button

IMPORTANT INFORMATION

• The device is a single use disposable pen. It contains 75 mg of PRALUENT (alirocumab) in 1 mL.
• The PRALUENT pen contains medicine prescribed by your doctor.
• The medicine is injected under your skin and can be given by yourself or someone else (caregiver).
• This pen can only be used for one single injection, and must be discarded after use.

Keep this leaflet. If you have questions, ask your doctor, pharmacist or nurse or call the sanofi-aventis number on the patient leaflet.

The parts of the PRALUENT pen are shown in this picture.

STEP A: GETTING READY FOR AN INJECTION

Before you start you will need:

• the PRALUENT pen,

• alcohol wipes,

• cotton ball or gauze,
• a puncture-resistant container (see STEP B-8).

• Look at the label on the pen.

  1. • Check that you have the correct product and the correct dose.
  2. •

     Check the use by date: do not use if this date has passed.

     Green button

     Body

     Window

     Yellow safety cover

     Needle inside

     Blue cap

     For single use only

1. 2.

   Look at the window.

   1. • Check the liquid is clear, colourless to pale yellow and free from particles - if not, do not use (see picture A).
   2. • You may see an air bubble. This is normal.
   3. • Do not use if the window appears solid yellow (see picture B).
   4. • Do not use this medicine if the solution is discoloured or cloudy, or if it contains visible flakes or particles.

1. 3.

   Let the pen warm up at room temperature for 30 to 40 minutes.

   1. • This is important for administering the entire dose and helps minimize discomfort.
   2. • Take PRALUENT out of the refrigerator to warm up before using.
   3. • Do not heat the pen; let it warm up on its own.
   4. • Use the pen as soon as possible after it has warmed up.
   5. • Do not put the pen back in the refrigerator.

30-40

minutes

1. 4.

   Prepare the injection site.

   1. • Wash your hands with soap and water and dry with a towel.
   2. • Clean skin in the injection area with an alcohol wipe.
   3. •

      You can inject into your (see below picture):

      • thigh
      • belly (except for the 5 cm/2 inch area around your navel)
      • upper arm
   4. • You can stand or sit to give yourself an injection.

Important:

• Change (rotate) your injection site each time you give yourself an injection. If you need to use the same injection area, make sure it is not the same spot on the site you used last time.
• Do not inject into areas where the skin is injured, tender, hard, red, or hot. Do not inject PRALUENT into areas with visible veins, scars or stretch marks

STEP B: HOW TO INJECT

1. 1.

   After completing all steps in “STEP A: GETTING READY FOR AN INJECTION”, pull off the blue cap

   1. • Do not pull off the cap until you are ready to inject.
   2. • Do not put the blue cap back on.

1. 2. Hold the PRALUENT pen like this.
2. • Do not touch the yellow safety cover.
3. • Make sure you can see the window.

1. 3.

   Press the yellow safety cover on your skin at roughly a 90° angle.

   1. • Press and firmly hold the pen against your body until the yellow safety cover is no longer visible. The pen will not work if the yellow safety cover is not depressed fully.
   2. • If needed, pinch the skin to make sure the injection site is firm.

1. 4.

   Push and immediately release the green button with your thumb.

   1. • You will hear a click. Your injection has now started.
   2. • The window will start to turn yellow.

1. 5.

   Keep holding the pen against your skin after releasing the button

   • The injection may take up to 20 seconds.

1. 6.

   Check the window has turned yellow, before removing the pen.

   1. • Do not remove the pen until the entire window has turned yellow.
   2. • Your injection is complete, when the window has turned completely yellow, you may hear a second click.
   3. • If the window does not turn completely yellow, call 1-800-265-7927 for help. Do not give yourself a second dose without speaking to your doctor, pharmacist or nurse.

1. 7.

   Pull pen away from your skin.

   • Do not rub the skin after the injection.
   • If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.

1. 8.

   Discard pen and cap

   • Do not put the blue cap back on.
   • Throw away the pen in a puncture-resistant container immediately after they have been used
   • Dispose of used container according to your local regulations.
   • Always keep the container out of the reach of children.

PRALUENT (alirocumab) 75 mg solution for injection in a pre-filled pen without activation button

IMPORTANT INFORMATION

• The device is a single use disposable pen. It contains 75 mg of PRALUENT (alirocumab) in 1 mL.
• The PRALUENT pen contains medicine prescribed by your doctor.
• The medicine is injected under your skin and can be given by yourself or someone else (caregiver).
• This pen can only be used for one single injection, and must be discarded after use.

Keep this leaflet. If you have questions, ask your doctor, pharmacist or nurse or call the sanofi-aventis number on the patient leaflet.

The parts of the PRALUENT pen are shown in this picture.

STEP A: GETTING READY FOR AN INJECTION

Before you start you will need:

• the PRALUENT pen,
• alcohol wipes,
• cotton ball or gauze,
• a puncture-resistant container (see STEP B-8).

• Look at the label on the pen.

  1. •

     Check that you have the correct product and the correct dose.

     For single use only

     Medication Label

     Body

     Window

     Orange needle cover

     Needle inside

     Blue cap

• Check the use by date: do not use if this date has passed.

  

• Look at the window.
• Check the liquid is clear, colourless to pale yellow and free from particles.
• You may see an air bubble. This is normal.

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

  

  • flakes or particles.

• Do not use if the window appears solid yellow.

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

  Look at the label

  • Expiration date
  1. Check window
• Let the pen warm up at room temperature for 45 minutes.
• This is important for administering the entire dose and helps minimize discomfort.
• Take PRALUENT out of the refrigerator to warm up before using.
• Do not heat the pen; let it warm up on its own.
• Use the pen as soon as possible after it has warmed up.
• Do not put the pen back in the refrigerator.

1. 4.

   Prepare the injection site.

   1. • Wash your hands with soap and water and dry with a towel.
   2. • Clean skin in the injection area with an alcohol wipe.
   3. •

      You can inject into your (see below picture):

      • thigh
      • belly (except for the 5 cm/2 inch area around your navel)
      • upper arm
   4. • You can stand or sit to give yourself an injection.

Important:

• Change (rotate) your injection site each time you give yourself an injection. If you need to use the same injection area, make sure it is not the same spot on the site you used last time.
• Do not inject into areas where the skin is injured, tender, hard, red, or hot. Do not inject PRALUENT into areas with visible veins, scars or stretch marks

Injection by caregiver only

Self-injection or by caregiver

STEP B: HOW TO INJECT

1. 5.

   After completing all steps in “STEP A: GETTING READY FOR AN INJECTION”, pull off the blue cap

   1. • Do not pull off the cap until you are ready to inject.
   2. • Do not put the blue cap back on.

1. 6.

   Hold the PRALUENT pen.

   1. • Do not touch the orange safety cover. The needle is inside.
   2. • Make sure you can see the window.
2. 7.

   Press the orange safety cover on your skin at roughly a 90° angle.

   1. • Press and firmly hold the pen against your body until the orange safety cover is no longer visible. The pen will not work if the orange safety cover is not depressed fully.
   2. •

      If needed, pinch the skin to make sure the injection site is firm.

      Pull the blue cap straight off

      Needle inside

      DO not touch the orange needle cover

DO not touch the orange needle cover

1. 8.

   Deliver injection (press → hold → check)

   1. • You will hear a click. Your injection has now started.
   2. • The window will start to turn yellow.

1. 9.

   Keep holding the pen firmly against your skin.

   • The injection may take up to 20 seconds.

1. 10.

   Check the window has turned yellow, before removing the pen.

   1. •

      Do not remove the pen until the entire window has turned yellow.

      Correct

      Incorrect

      Check Yellow Window

   2. • Your injection is complete, when the window has turned completely yellow, you may hear a second click.
   3. • If the window does not turn completely yellow, call 1-800-265-7927 for help. Do not give yourself a second dose without speaking to your doctor, pharmacist or nurse.

1. 11.

   Pull pen away from your skin.

   • Do not rub the skin after the injection.
   • If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.

1. 12.

   Discard pen and cap

   • Do not put the blue cap back on.
   • Throw away the pen in a puncture-resistant container immediately after they have been used
   • Dispose of used container according to your local regulations.
   • Always keep the container out of the reach of children.

PRALUENT (alirocumab) 150 mg solution for injection in a pre-filled pen with activation button

IMPORTANT INFORMATION

• The device is a single use disposable pen. It contains 150 mg of PRALUENT (alirocumab) in 1 mL.
• The PRALUENT pen contains medicine prescribed by your doctor.
• The medicine is injected under your skin and can be given by yourself or someone else (caregiver).
• This pen can only be used for one single injection, and must be discarded after use.

Keep this leaflet. If you have questions, ask your doctor, pharmacist or nurse or call the sanofi-aventis number on the patient leaflet.

The parts of the PRALUENT pen are shown in this picture.

STEP A: GETTING READY FOR AN INJECTION

Before you start you will need:

• the PRALUENT pen,
• alcohol wipes,
• cotton ball or gauze,
• a puncture-resistant container (see STEP B-8).

• Look at the label on the pen.

  1. • Check that you have the correct product and the correct dose.
  2. •

     Check the use by date: do not use if this date has passed.

     Grey button

     Body

     Window

     Yellow safety cover

     Needle inside

     Blue cap

     For single use only

1. 2.

   Look at the window.

   1. • Check the liquid is clear, colourless to pale yellow and free from particles - if not, do not use (see picture A).
   2. • You may see an air bubble. This is normal.
   3. • Do not use if the window appears solid yellow (see picture B).
   4. • Do not use this medicine if the solution is discoloured or cloudy, or if it contains visible flakes or particles.

1. 3.

   Let the pen warm up at room temperature for 30 to 40 minutes.

   1. • This is important for administering the entire dose and helps minimize discomfort.
   2. • Take PRALUENT out of the refrigerator to warm up before using.
   3. • Do not heat the pen, let it warm up on its own.
   4. • Use the pen as soon as possible after it has warmed up.
   5. • Do not put the pen back in the refrigerator.

1. 4.

   Prepare the injection site.

   1. • Wash your hands with soap and water and dry with a towel.
   2. • Clean skin in the injection area with an alcohol wipe.
   3. •

      You can inject into your (see below picture):

      30-40

      minutes

      • thigh
      • belly (except for the 5 cm/2 inch area around your navel)
      • upper arm
   4. • You can stand or sit to give yourself an injection.

Important:

• Change (rotate) your injection site each time you give yourself an injection. If you need to use the same injection area, make sure it is not the same spot on the site you used last time.
• Do not inject into areas where the skin is injured, tender, hard, red, or hot. Do not inject PRALUENT into areas with visible veins, scars or stretch marks.

STEP B: HOW TO INJECT

1. 1.

   After completing all steps in “STEP A: GETTING READY FOR AN INJECTION”, pull off the blue cap

   1. • Do not pull off the cap until you are ready to inject.
   2. • Do not put the blue cap back on.

1. 2.

   Hold the PRALUENT pen like this.

   1. • Do not touch the yellow safety cover.
   2. • Make sure you can see the window.

1. 3.

   Press the yellow safety cover on your skin at roughly a 90° angle.

   1. • Press and firmly hold the pen against your body until the yellow safety cover is no longer visible. The pen will not work if the yellow safety cover is not depressed fully.
   2. • If needed, pinch the skin to make sure the injection site is firm.

1. 4.

   Push and immediately release the grey button with your thumb.

   1. • You will hear a click. Your injection has now started.
   2. • The window will start to turn yellow.

1. 5.

   Keep holding the pen against your skin after releasing the button

   • The injection may take up to 20 seconds.

1. 6.

   Check the window has turned yellow, before removing the pen.

   1. • Do not remove the pen until the entire window has turned yellow.
   2. • Your injection is complete, when the window has turned completely yellow, you may hear a second click.
   3. • If the window does not turn completely yellow, call 1-800-265-7927 for help. Do not give yourself a second dose without speaking to your doctor, pharmacist or nurse.

1. 7.

   Pull pen away from your skin.

   • Do not rub the skin after the injection.
   • If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.

1. 8.

   Discard pen and cap

   • Do not put the blue cap back on.
   • Throw away the pen in a puncture-resistant container immediately after they have been used
   • Dispose of used container according to your local regulations.
   • Always keep the container out of the reach of children.

PRALUENT (alirocumab) 150 mg solution for injection in a pre-filled pen without activation button

IMPORTANT INFORMATION

• The device is a single use disposable pen. It contains 150 mg of PRALUENT (alirocumab) in 1 mL.
• The PRALUENT pen contains medicine prescribed by your doctor.
• The medicine is injected under your skin and can be given by yourself or someone else (caregiver).
• This pen can only be used for one single injection, and must be discarded after use.

Keep this leaflet. If you have questions, ask your doctor, pharmacist or nurse or call the sanofi-aventis number on the patient leaflet.

The parts of the PRALUENT pen are shown in this picture.

STEP A: GETTING READY FOR AN INJECTION

Before you start you will need:

• the PRALUENT pen,
• alcohol wipes,
• cotton ball or gauze,
• a puncture-resistant container (see STEP B-8).

• Look at the label on the pen.

  1. •

     Check that you have the correct product and the correct dose.

     Medication Label

     Body

     Window

     Orange safety cover

     Needle inside

     Blue cap

     For single use only

• Check the use by date: do not use if this date has passed.

1. 2.

   Look at the window.

   1. • Check the liquid is clear, colourless to pale yellow and free from particles. You may see an air bubble. This is normal.

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

• flakes or particles.

• Do not use if the window appears solid yellow.

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

  Look at the label

  Expiration date

  Check window

• Let the pen warm up at room temperature for 45 minutes.
• This is important for administering the entire dose and helps minimize discomfort.
• Take PRALUENT out of the refrigerator to warm up before using.
• Do not heat the pen, let it warm up on its own.
• Use the pen as soon as possible after it has warmed up.
• Do not put the pen back in the refrigerator.

1. 4.

   Prepare the injection site.

   1. • Wash your hands with soap and water and dry with a towel.
   2. • Clean skin in the injection area with an alcohol wipe.
   3. •

      You can inject into your (see below picture):

      • thigh
      • belly (except for the 5 cm/2 inch area around your navel)
      • upper arm
   4. • You can stand or sit to give yourself an injection.

Important:

• Change (rotate) your injection site each time you give yourself an injection. If you need to use the same injection area, make sure it is not the same spot on the site you used last time.
• Do not inject into areas where the skin is injured, tender, hard, red, or hot. Do not inject PRALUENT into areas with visible veins, scars or stretch marks.

STEP B: HOW TO INJECT

1. 5.

   After completing all steps in “STEP A: GETTING READY FOR AN INJECTION”, pull off the blue cap

   1. • Do not pull off the cap until you are ready to inject.
   2. • Do not put the blue cap back on.

1. 6.

   Hold the PRALUENT pen.

   1. • Do not touch the orange safety cover. The needle is inside.
   2. •

      Make sure you can see the window.

      Injection by caregiver only

      Self-injection or by caregiver

      Pull the blue cap straight up

      Needle inside

      Do not touch the orange needle cover

2. 7.

   Press the orange safety cover on your skin at roughly a 90° angle.

   1. • Press and firmly hold the pen against your body until the orange safety cover is no longer visible. The pen will not work if the orange safety cover is not depressed fully.
   2. • If needed, pinch the skin to make sure the injection site is firm.

1. 8.

   Deliver injection (press → hold → check)

   1. • You will hear a click. Your injection has now started.
   2. •

      The window will start to turn yellow.

      Do not touch the orange needle cover

1. 9.

   Keep holding the pen firmly against your skin

   • The injection may take up to 20 seconds.

1. 10.

   Check the window has turned yellow, before removing the pen.

   1. • Do not remove the pen until the entire window has turned yellow.
   2. • Your injection is complete, when the window has turned completely yellow, you may hear a second click.
   3. •

      If the window does not turn completely yellow, call 1-800-265-7927 for help. Do not give yourself a second dose without speaking to your doctor, pharmacist or nurse.

      Correct

      Incorrect

      Check Yellow Window

1. 11.

   Pull pen away from your skin.

   • Do not rub the skin after the injection.
   • If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.

1. 12.

   Discard pen and cap

   • Do not put the blue cap back on.
   • Throw away the pen in a puncture-resistant container immediately after they have been used
   • Dispose of used container according to your local regulations.
   • Always keep the container out of the reach of children.

PRALUENT (alirocumab) 300 mg solution for injection in a pre-filled pen without activation button

IMPORTANT INFORMATION

• The device is a single use disposable pre-filled pen. It contains 300 mg of PRALUENT (alirocumab) in 2 mL.
• The PRALUENT pen contains medicine prescribed by your doctor.
• The medicine is injected under your skin and can be given by yourself or someone else (caregiver).
• It is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider.
• This pen can only be used for one single injection, and must be discarded after use.

Keep this leaflet. If you have questions, ask your doctor, pharmacist or nurse or call the sanofi-aventis number on the patient leaflet.

The parts of the PRALUENT pen are shown in this picture.

STEP A: GETTING READY FOR AN INJECTION

Before you start you will need:

• the PRALUENT pen,
• alcohol wipes,
• cotton ball or gauze,
• a puncture-resistant container.

• Look at the label on the pen.

  1. •

     Check that you have the correct product and the correct dose.

     For single use only

     Medication label

     Body

     Window

     Blue cap

     Yellow safety cover

     Needle inside

• Check the expiration date: do not use if this date has passed.
• Do not use the PRALUENT pen if it has been dropped on a hard surface or damaged.

1. 2.

   Look at the window.

   1. • Check the liquid is clear, colourless to pale yellow and free from particles.
   2. • You may see air bubbles. This is normal.

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

• Do not use if the window appears solid yellow.

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

  Look at the label

  Expiration date

  Check window

• Let the pen warm up at room temperature for 45 minutes.
• This is important for administering the entire dose and helps minimize discomfort.
• Do not heat the pen; let it warm up on its own.
• Do not put the pen back in the refrigerator.

1. 4.

   Prepare the injection site.

   1. • Wash your hands with soap and water and dry with a towel.
   2. • Clean skin in the injection area with an alcohol wipe.
   3. •

      You can inject into your (see below picture):

      • thigh
      • belly (except for the 5 cm/2 inch area around your navel)
      • upper arm (to be given by a caregiver only)
   4. • You can stand or sit to give yourself an injection.

Important:

• Change (rotate) your injection site each time you give yourself an injection.
• If you need to use the same injection area, make sure it is not the same spot on the site you used last time.
• Do not use skin that is tender, hard, red, or hot.
• Do not use any area near a visible vein.

STEP B: HOW TO INJECT

Injection by caregiver only

Self-injection or by caregiver

1. 5.

   After completing all steps in “STEP A: GETTING READY FOR AN INJECTION”, pull off the blue cap.

   1. • Do not pull off the cap until you are ready to inject.
   2. • Do not put the blue cap back on.
   3. • Do not use the pen if the blue cap is missing or not securely attached.

1. 6.

   Hold the PRALUENT pen.

   1. • Do not touch the yellow safety cover. The needle is inside the yellow safety cover.
   2. • Make sure you can see the window.
   3. •

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

      Pull the blue cap straight off

      Needle inside

      Do not touch the yellow needle cover

Do not touch the yellow needle cover

1. 7.

   Press the yellow safety cover on your skin at roughly a 90° angle.

   1. • Pinch the skin to make sure the injection site is firm.
   2. • Press the pen straight down against your skin until the yellow safety cover is pushed all the way into the pen and hold (see picture).
   3. • The injection will not start until the yellow safety cover is fully depressed.
   4. • There will be a click when the injection starts. The window will start to turn yellow.

1. 8.

   Keep holding the pen firmly against your skin.

   1. • You may hear a second click.
   2. • Check that the entire window has turned yellow.
   3. • Then, slowly count to 5.

Check yellow window

Then slowly count to 5

1…2…3…4…5

Correct

Incorrect

1. 9.

   Check again that the window has turned yellow, before removing the pen.

   1. • If the window does not turn completely yellow, remove the pen and call 1-800-265-7927.
   2. • Do not give yourself a second injection without speaking to your healthcare provider.
2. 10.

   Pull pen away from your skin.

   • Do not rub the skin after the injection.
   • If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.

1. 11.

   Discard pen and cap.

   • Do not put the blue cap back on.
   • Discard into a puncture-resistant container according to your local regulations.
   • Always keep the container out of the reach and sight of children.