Patient leaflet - Praluent 300 mg solution for injection in a Pre-filled pen
1. What Praluent is and what it is used for
What Praluent is
- Praluent contains the active substance alirocumab.
- Praluent is a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body). Monoclonal antibodies are proteins that recognise and bind to other unique 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.
- “Bad” cholesterol is normally removed from your blood by binding to specific “receptors” (docking stations) in your liver.
PCSK9 lowers the number of these receptors in the liver – this causes your
Each pre-filled pen without activation button contains 1 ml of solution, delivering one single dose of 75 milligrams.
It is available in pack size of 1, 2 or 6 pre-filled pens without activation button.
Praluent 150 mg solution for injection in pre‑filled pen
Each pre-filled pen with grey button contains 1 ml of solution, delivering one single dose of 150 milligrams of alirocumab.
It is available in pack size of 1, 2 or 6 pre-filled pens.
Each pre-filled pen without activation button contains 1 ml of solution, delivering one single dose of 150 milligrams.
It is available in pack size of 1, 2 or 6 pre-filled pens without activation button.
Praluent 300mg solution for injection in pre‑filled pen
Each pre-filled pen without activation button contains 2 ml of solution, delivering one single dose of 300 milligrams.
It is available in pack size of 1 or 3 pre-filled pens without activation button.
Not all presentations and pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder sanofi-aventis groupe
54, rue La Boétie
F – 75008 Paris
France
Manufacturer
Genzyme Ireland Ltd
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in June 2021
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
Sanofi
Tel: 0800 035 2525
Email: uk-medicalinformation@sanofi.com “bad” cholesterol to be higher than it should.
- By blocking PCSK9, Praluent increases the number of receptors available to help remove the “bad” cholesterol – this lowers your “bad” cholesterol levels.
What Praluent is used for
- Adults with high cholesterol levels in their blood (hypercholesterolaemia [heterozygous familial and non-familial] or mixed dyslipidaemia).
- Adults with high cholesterol levels in their blood and with cardiovascular disease to reduce cardiovascular risk.
It is given:
- together with a statin (a commonly used medicine that treats high cholesterol) or other cholesterol lowering medicines, if the maximum dose of a statin does not lower levels of cholesterol sufficiently or, − alone or together with other cholesterol lowering medicines when statins are not tolerated or cannot be used.
Continue to follow your cholesterol-lowering diet while taking this medicine.
2. What you need to know before you use Praluent
Do not use Praluent
- if you are allergic to alirocumab or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Praluent.
If you develop a serious allergic reaction, stop using Praluent, talk to your doctor right away. Sometimes serious allergic reactions such as hypersensitivity, including angioedema (difficulties breathing, or swelling of the face, lips, throat or tongue), nummular eczema (reddish skin spots sometimes with blisters), and hypersensitivity vasculitis (which is a specific form of a hypersensitivity reaction with symptoms such as diarrhoea, with a rash, or purple-coloured skin spots on the skin) have occurred. For allergic reactions that may occur while taking Praluent, see section 4.
Tell your doctor if you have kidney or liver disease before using this medicine, because Praluent has been studied in few patients with severe kidney disease and not in patients with severe liver disease.
Children and adolescents
Praluent should not be given to children and adolescents under 18 years old because there is limited experience of using the medicine in these age groups.
Other medicines and Praluent
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
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Important information
Keep this leaflet. If you have questions, ask your doctor, pharmacist or nurse or call the Sanofi number on the package leaflet.
3 Keep the Praluent pen out of the
sight and reach of children.
3 Read all of the instructions
carefully before using the
Praluent pen.
3 Follow these instructions every
time you use a Praluent pen. Do
7 Do not touch the yellow safety cover.
7 Do not use the pen if it has been dropped
or damaged.
7 Do not use the pen if the blue cap is
missing or not securely attached.
7 Do not re-use a pen.
7 Do not shake the pen.
7 Do not freeze the pen.
7 Do not expose the pen to direct sunlight. Do not
STEP B: How to inject
2
1 4
3
5
Do not touch the
yellow safety cover.
Make sure you can
see the window.
- 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.
If needed, pinch the skin to make
sure the injection site is firm.
7
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.
After completing all steps in “Step A: Getting ready for an injection”, pull off the blue cap.
Hold the Praluent pen like this.
Press the yellow safety cover on your skin at roughly a
90° angle.
- Do not pull off the cap until you are ready to inject.
Do not put the blue cap back on.
6 8
- Do not put the blue cap back on.
- Throw away pen and cap into a puncture-resistant container immediately after use.
- Ask your doctor, pharmacist or nurse how to throw away the container.
- Always keep the container out of the sight and reach of children.
You will hear a click. Your
injection has now started.
The window will start to turn
yellow.
4
3
STEP A: Getting ready for an injection
2
1
- Check the liquid is clear, colourless to pale yellow and free from particles - if not, do not use (see picture A).
- You may see an air bubble. This is normal.
- Do not use if the window appears solid yellow (see picture B).
- Wash your hands with soap and water and dry with a towel.
- You can inject into your:
- thigh
- belly (except for the 5 cm area around your navel)
outer side of your upper arm
(See picture).
- You can stand or sit to give yourself an injection.
Clean skin in the injection area with an alcohol wipe.
Check that you have the correct
product and the correct dose.
Check the use by date:
do not use if this
date has passed.
Do not heat the pen, let it warm
up on its own.
Do not put the pen back in the
refrigerator.
The parts of the Praluent pen are shown in this picture.
The injection may take up
to 20 seconds.
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 thrown away after use.
Do not remove the pen
until the entire window has
turned yellow.
Your injection is complete,
when the window has
turned completely yellow,
you may hear a second
click.
If the window does not
turn completely yellow,
call Sanofi for help. Do
not give yourself a second
dose without speaking to
your doctor, pharmacist or
nurse.
Check if the window has turned yellow, before removing the pen.
Pull pen away from your skin.
Throw away pen and cap. Keep holding the pen against your skin after
releasing the button.
- Do not use skin that is tender, hard, red or hot.
- Do not use any area near a visible vein.
- Use a different spot each time you inject.
- Do not inject Praluent with other injectable medicines at the same spot.
Look at the label on the pen. Look at the window.
Let the pen warm up at room temperature for 30 to 40 minutes.
Prepare the injection site.
Push and immediately release the green button with your thumb.
Before you start you will need:
- the Praluent pen • alcohol wipes • cotton ball or gauze • a puncture-resistant container (see Step B, 8). Green Button
Body
Window
Yellow safety cover Needle inside
Blue cap
Blue cap
For single use only
Release the button immediately click!
click!
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Praluent is not recommended during pregnancy or breast-feeding.
Driving and using machines
This medicine is not expected to have any effect on your ability to drive or use machines.
3. How to use Praluent
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
How much to inject
Your doctor will tell you which dose is right for you and how often to 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 (up or down) during treatment. Always check the label of your pen to make sure you have the right medicine and the right strength.
When to inject
Inject Praluent once every 2 weeks (for the 75 mg or 150 mg dose), or once every 4 weeks/ monthly (for the 300 mg dose). To give the 300 mg dose, one 300 mg injection or two 150 mg injections should be given in a row at two different injection sites.
Before you inject
Praluent should be allowed to warm to room temperature prior to use.
Read the detailed instructions for use leaflet before you inject Praluent.
Where to inject
Praluent is injected under your skin into the thigh, abdomen or upper arm.
Read the detailed instructions for use leaflet on where to inject.
Learning how to use the pre-filled pen
Before you use the pen for the first time, your doctor, pharmacist or nurse will show you how to inject Praluent.
- Always read the “Instructions for Use” provided in the box.
- 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, talk to your doctor, pharmacist or nurse.
If you forget to use Praluent
If you miss a dose of Praluent, inject your missed dose as soon as you can. Then take your next dose at your regular scheduled time. This will keep you on the original schedule. If you are not sure when to inject Praluent, call your doctor, pharmacist or nurse.
If you stop using Praluent
Do not stop using Praluent without talking with your doctor. If you stop using Praluent, your cholesterol levels can increase.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you develop a serious allergic reaction, stop using Praluent, talk to your doctor right away. Sometimes serious allergic reactions such as hypersensitivity (difficulties breathing), nummular eczema (reddish skin spots sometimes with blisters), and hypersensitivity vasculitis (which is a specific form of a hypersensitivity reaction with symptoms such as diarrhoea, with a rash, or purple-coloured skin spots on the skin) have occurred (may affect up to 1 in 1,000 people).
Other side effects are:
Common (may affect up to 1 in 10 people)
- redness, itching, swelling, pain/tenderness where the medicine was injected (local injection site reactions)
- upper respiratory tract signs or symptoms such as sore throat, running nose, sneezing
- itching (pruritus).
Rare (may affect up to 1 in 1,000 people)
- red and itchy raised bumps or hives (urticaria)
Not Known
The following side effects have been reported since the marketing of Praluent, but how often they occur is not known:
- flu-like illness
- difficulties breathing, or swelling of the face, lips, throat or tongue (angioedema)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Praluent
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and
carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Keep the pen in the outer carton in order to protect from light.
If needed, individual pre-filled pens may be kept outside the refrigerator below 25°C for a maximum of 30 days. Protect from light. After removal from the refrigerator, Praluent must be used within 30 days or discarded.
Do not use this medicine if it looks discoloured or cloudy, or if it contains visible flakes or particles.
After use put the pen into a puncture-resistant container. Ask your doctor, pharmacist or nurse 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.
6. Contents of the pack and other information
What Praluent contains
- The active substance is alirocumab
Praluent 75 mg solution for injection in pre‑filled pen
Each pre-filled pen contains 75 milligrams of alirocumab.
Praluent 150 mg solution for injection in pre‑filled pen
Each pre-filled pen contains 150 milligrams of alirocumab.
Praluent 300 mg solution for injection in pre‑filled pen
Each pre-filled pen contains 300 milligrams of alirocumab.
- The other ingredients are histidine, sucrose, polysorbate 20 and water for injections.
What Praluent looks like and contents of the pack
Praluent is a clear, colourless to pale yellow solution for injection that comes in a pre-filled pen.
Praluent 75 mg solution for injection in pre‑filled pen
Each pre-filled pen with green button contains 1 ml of solution, delivering one single dose of 75 milligrams of alirocumab. It is available in pack size of 1, 2 or 6 pre-filled pens.