Patient leaflet - Praluent 75 mg solution for injection in 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 “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) and children and adolescents 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH).
- 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 under 8 years old because there is no experience using the medicine in this age group.
Other medicines and Praluent
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
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
Adults
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.
Children and adolescents 8 years of age and older with HeFH: Inject Praluent once every 2 weeks (for the 75 mg or 150 mg dose), or once every 4 weeks/monthly (for the 150 mg or 300 mg dose).
In adolescents 12 years of age and older, Praluent should be given by or under the supervision of an adult.
In children less than 12 years of age, Praluent must be given by a caregiver.
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.
Each pre-filled pen contains 75 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.
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.
Product Licence Holder and Manufacturer
Procured from within the EU by the Product Licence holder Orifarm UK Ltd., Ground Floor Suite A2, Breakspear Park, Breakspear Way, Hemel Hempstead, HP2 4TZ, UK
For any information about this medicine, please contact the Product Licence Holder on
www.orifarm.com/uk
Or phone: (+44) 1923 204333
Repacked by Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice, Czech Republic
Manufactured by Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Praluent 75 mg solution for injection in a pre-filled pen PL 45985/0839
POM
Leaflet revision date: 04/07/2024
Blind or partially sighted? Is this leaflet hard to see or read?
Call +45 63 95 27 00 to obtain the leaflet in a format suitable for you.
Package leaflet: Information for the user
Praluent ® 75 mg solution for injection in a pre-filled pen
alirocumab
Check if the window has turned yellow, before
removing the pen.
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.
Look at the window
- Check the liquid is clear, colourless to pale yellow and free from particles – if not, do not use (see picture A).
You may see air bubble(s). This is normal. ● Do not use if the window appears solid yellow (see picture B).
Prepare the injection site.
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.
- 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.
Important information
- 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.
- In adolescents 12 years of age and older, it is recommended that Praluent be administered by or under the supervision of an adult.
- In children less than 12 years of age, Praluent must be given by a caregiver.
Keep this leaflet. If you have questions, ask your doctor, pharmacist or nurse or call the Sanofi number on the package leaflet.
Do Do not
Keep the Praluent pen out of the sight and reach of children.
Read all of the instructions
carefully before using the
Praluent pen.
Follow these instructions every time you use a Praluent pen.
Do not touch the yellow safety cover.
Do not use the pen if it has been dropped or damaged.
Do not use the pen if the blue cap is missing or not securely attached.
Do not re-use a pen.
Do not shake the pen.
Do not freeze the pen.
Do not expose the pen to direct sunlight.
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).
STEP B: How to inject
Green button
Body
Window
Yellow safety cover Needle inside
Blue Cap For single
use only
The parts of the Praluent pen are shown in this picture.
Press the yellow safety cover on your skin at roughly a
90° angle.
- Pinching of the skin before and during the injection is required in children less than 12 years of age.
- In adolescents 12 years of age and older and adults, pinching of skin may be required to make the injection site firm.
- 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.
Keep holding the pen against your skin after releasing the button.
The injection may take up
to 20 seconds.
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.
Throw away pen and cap.
- 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. Let the pen warm up at room temperature for 30 to 40 minutes.
- Do not heat the pen, let it warm up on its own.
Do not put the pen back in the refrigerator.
30-40minutes
Look at the label on the pen.
Check that you have the correct product and the correct dose. ● Check the use by date:
do not use if this
date has passed.
Push and immediately release the green button with your thumb.
You will hear a click. Your
injection has now started.
The window will start to turn
yellow.
Release the button immediately
click!
After completing all steps in "Step A: Getting ready for an injection", pull off the blue cap.
- Do not pull off the cap until you are ready to inject.
Do not put the blue cap back on.
Blue cap
Hold the Praluent pen like this.
Do not touch the
yellow safety cover.
Make sure you can
see the window.