Praluent 150 mg solucion inyectable en pluma precargada

Product Information for the User

Praluent 75mg Pre-filled Syringe

Praluent 150mg Pre-filled Syringe

Praluent 300mg Pre-filled Syringe

alirocumab

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information.See section4.

What is Praluent

• The active ingredient of Praluent is alirocumab.

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

How Praluent works

Praluent helps to reduce your levels of "bad" cholesterol (also known as "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" (binding sites) in the liver.
• PCSK9 reduces the number of these receptors in the liver, causing "bad" cholesterol levels to be higher than they should be.
• By blocking PCSK9, Praluent increases the number of available receptors to help remove "bad" cholesterol, thus reducing "bad" cholesterol levels.

How Praluent is used

• In adults with high levels of cholesterol in their blood (familial heterozygous and non-familial hypercholesterolemia or mixed dyslipidemia) and children and adolescents 8 years of age and older with familial heterozygous hypercholesterolemia (FHHe).
• To reduce the risk of cardiovascular disease in adults with high levels of cholesterol in their blood and cardiovascular disease.

Praluent is administered:

• Together with a statin (a medication commonly used to treat high cholesterol) or with other medications to reduce cholesterol, if the maximum dose of a statin does not sufficiently lower cholesterol levels or,
• Alone or with another medication to reduce cholesterol when statins cannot be tolerated or used.

• Continue with your diet to reduce cholesterol while taking this medication.

Do not use Praluent

• if you are allergic to alirocumab or any of the other ingredients of this medication (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Praluent.

If you experience a severe allergic reaction, stop treatment with Praluent and seek medical attention immediately. Severe allergic reactions have included hypersensitivity, including angioedema (difficulty breathing, or swelling of the face, lips, throat, or tongue), nummular eczema (red 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 patches on the skin). For information on allergic reactions that may occur while taking Praluent, see section4.

Inform your doctor before using this medication if you have any kidney or liver disease, as Praluent has been studied in few patients with severe kidney disease and no patients with severe liver disease.

Children and adolescents

Praluent should not be administered to children under 8years of age, as there is no experience with the use of this medication in this age group.

Use of Praluent with other medications

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Praluent is not recommended during pregnancy or breastfeeding.

Driving and operatingmachinery

No effect on your ability to drive or operate machinery is expected from this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor, pharmacist or nurse. In case of doubt, consult your doctor, pharmacist or nurse again.

How much to inject

Your doctor will tell you what dose is appropriate 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 check your cholesterol levels and may adjust the dose (increasing or decreasing it) during treatment.

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

When to inject

Adults

Inject Praluent once every 2 weeks (for doses of 75 mg or 150 mg) or once every 4 weeks/monthly (for the dose of 300 mg). To administer the dose of 300 mg, you must administer a 300 mg injection or two consecutive 150 mg injections in two different injection sites.

Children and adolescents 8 years and older with HFE:

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

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

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

Before injecting

Praluent should be allowed to reach room temperature before use.

Read the detailed usage instructions in the package insert before injecting Praluent.

Where to inject

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

Read the detailed usage instructions in the package insert on where to inject.

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“Usage Instructions”included in the package.
• Always use the pen as described in the“Usage Instructions”.

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

If you interrupt treatment with Praluent

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

If you have any other questions about the use of this medication, ask your doctor, pharmacist or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

If you experience a severe allergic reaction, discontinue treatment with Praluent and consult your doctor immediately. Severe allergic reactions such as hypersensitivity (difficulty breathing), nummular eczema (red 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 patches on the skin) (may affect up to 1 in 1,000 people) have occurred.

Other adverse effects are:

Frequent(may affect up to 1 in 10people)

• redness, itching, swelling, pain/sensitivity at the site where the medication was injected (local reactions at the injection site)
• upper respiratory tract symptoms such as sore throat, nasal discharge, and sneezing
• itching (pruritus).

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

• red, itchy, raised bumps or hives (urticaria).

Unknown frequency

Since the marketing of Praluent, the following adverse effects have been reported, with an unknown frequency:

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

Reporting Adverse Effects

If you experienceany type of adverse effect,consult your doctor, pharmacist, or nurse, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly throughthe national notification system included in theAppendixV. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the box after CAD. The expiration date is the last day of the month indicated.

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

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

Individual preloaded pens may be stored outside the refrigerator below 25°C for a maximum of 30 days, protected from light. After removing it from the refrigerator, Praluent must be used within 30 days or discarded.

Do not use this medication if it presents color changes, is cloudy or contains visible particles.

After use, insert the pen into a sharp object container. Ask your doctor, pharmacist or nurse how to dispose of the container. Do not recycle the container.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Praluent

• The active ingredient is alirocumab.

Praluent 75 mg pre-filled syringe

Each pre-filled syringe contains 75 milligrams of alirocumab.

Praluent 150 mg pre-filled syringe

Each pre-filled syringe contains 150 milligrams of alirocumab.

Praluent 300 mg pre-filled syringe

Each pre-filled syringe contains 300 milligrams of alirocumab.

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

Appearance of the product and contents of the pack

Praluent is a transparent, colorless to pale yellow solution, presented in a pre-filled syringe.

Praluent 75 mg pre-filled syringe

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

It is available in packs of 1, 2, or 6 pre-filled syringes.

Each pre-filled syringe without a push-button contains 1 ml of solution that delivers a single dose of 75 milligrams of alirocumab.

It is available in packs of 1, 2, or 6 pre-filled syringes without a push-button.

Praluent 150 mg pre-filled syringe

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

It is available in packs of 1, 2, or 6 pre-filled syringes.

Each pre-filled syringe without a push-button contains 1 ml of solution that delivers a single dose of 150 milligrams of alirocumab.

It is available in packs of 1, 2, or 6 pre-filled syringes without a push-button.

Praluent 300 mg pre-filled syringe

Each pre-filled syringe without a push-button contains 2 ml of solution that delivers a single dose of 300 milligrams of alirocumab.

It is available in packs of 1 or 3 pre-filled syringes without a push-button.

Possible only some presentations and pack sizes are marketed.

Marketing Authorization Holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Responsible for manufacturing

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

Brüningstraße 50

65926 Frankfurt am Main

Germany

Genzyme Ireland Ltd

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

Further information on this medicinal product can be obtained by contacting the local representative of the Marketing Authorization Holder:

Last update of this leaflet:

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

Praluent pre-filled syringe

Instructions for use

The following image shows the parts of the Praluent pre-filled syringe.

Important information

• This device is a single-use, pre-filled syringe for a single use. It contains 150 mg of Praluent (alirocumab) in 1 ml. The Praluent pre-filled syringe contains the prescribed medication.
• The medication is injected under the skin and can be administered by yourself or another person (caregiver).
• It is essential that you do not attempt to administer it to yourself or another person unless they have been trained by a healthcare professional.
• This syringe should only be used for a single injection and then discarded.

What to do

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

What not to do

• Do nottouch the orange needle guard.
• Do notuse the syringe if it has fallen on a hard surface or is damaged.
• Do notuse the syringe if the blue cap is missing or not securely attached.
• Do notre-use the syringe.
• Do notshake the syringe.
• Do notfreeze the syringe.
• Do notexpose the syringe to extreme heat.
• Do notexpose the syringe to direct sunlight.

Keep this leaflet. If you have any questions, consult your doctor, pharmacist, or nurse orcontact the local representative of the Marketing Authorization Holderlisted in the leaflet.

Step A: Preparing the injection

1. Check the label of the syringe.

1. Check that it contains the correct medication and dose.

1. Check the expiration date of the syringe; do not use if expired.

Do notuse the Praluent pre-filled syringe if it has fallen on a hard surface or is damaged.

1. Check the window

1. Check that the liquid is transparent, colorless to pale yellow, and free of particles.

You may see air bubbles. This is normal.

Do notuse this medication if the solution is discolored or turbid, or if it contains visible scales or particles.

Do notuse if the window appears solid yellow.

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

3. Atemperar the syringe and other items

1. Leave the syringe to reach room temperature for 45 minutes.

Do notheat the syringe. Let the syringe reach room temperature on its own.

Do notexpose the syringe to direct sunlight.

Do notput the syringe back in the refrigerator.

1. While waiting for the syringe to reach room temperature, obtain the following items:

• Alcohol wipes
• Cotton ball or gauze
• Sharps container (see Step B9. Desechar)

1. Prepare the injection site

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

1. You can inject it in (see IMAGE):
   • The upper part of your thighs
   • The abdomen (except in the area 5 cm around the navel)
   • The upper outer part of your arm (only for administration by a caregiver)

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

• • You can be standing or sitting.
  • Use a different area each time you inject.
• Do notchoose a skin area that is painful, hardened, red, or inflamed.
• Do notchoose an area close to a visible vein.
• Do notinject Praluent with other injectable medications in the same area.

Step B: How to inject

1. Remove the blue cap

1. Throw away the blue cap.

Do notrotate the blue cap

Do notremove the blue cap until you are ready to inject.

Do nottouch the orange needle guard. The needle is inside the orange needle guard.

Do notput the blue cap back on.

Do notuse the syringe if the blue cap is missing or not securely attached.

1. Pinch the skin and place the syringe

1. Pinch the skin to ensure the injection site is firm. This is necessary for children under 12 years old.
2. When placing the orange needle guard on your skin, hold the syringe so you can see the window.
3. Place the orange needle guard on your skin at an angle of approximately 90 degrees.

Do notpress the syringe against your skin until you are ready to inject.

Do nottouch the orange needle guard. The needle is inside the orange needle guard.

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

1. Press the syringe down against the skin until the orange needle guard is inside the syringe and hold it in place.

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

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

1. Maintain pressure on the syringe 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 syringe and contact the local representative of the Marketing Authorization Holder listed in the leaflet.

Do notadminister a second dose without first consulting your doctor, pharmacist, or nurse.

8.Retirar

1. Remove the syringe from your skin

Do notrub the surface of the skin after the injection.

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

9.Desechar

a.Discard the syringe and the cap in a sharps container immediately after use.

Do notput the blue cap back on.

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