Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Praluent?
Praluent contains the active ingredient alirocumab. Praluent is used to treat high
levels of cholesterol in the blood.
2. What should I know before I use Praluent?
Do not use if you have ever had an allergic reaction to Praluent or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Praluent and affect how it works.
4. How do I use Praluent?
Follow all directions given to you by your doctor and pharmacist carefully. They may
differ from the information contained in this leaflet.
5. What should I know while using Praluent?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Praluent.
Follow your doctor’s instructions carefully.
Tell your doctor if you are breastfeeding or become pregnant while you are using Praluent.
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Things you should not do
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Do not stop using this medicine or change the dosage without checking with your doctor.
Do not use Praluent if it is not clear to pale yellow or if it contains particles.
Do not give Praluent to children.
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Looking after your medicine
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Refrigerate do not freeze, do not expose to heat and do not shake Praluent.
Keep in the outer carton in order to protect from light.
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6. Are there any side effects?
Less serious side effects: allergic reaction symptoms include diarrhoea, rash or purple-coloured
spots on the skin, hives and reddish skin spots sometimes with blisters, redness,
swelling, pain or bruising where the injection is given, itching, painless swelling
under the skin, muscle pain, flu-like symptoms that include sore throat, runny nose
or sneezing.
Serious side effects: shortness of breath, wheezing or difficulty breathing, swelling
of the face, lips, tongue or other parts of the body.
Active ingredient: alirocumab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Praluent. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Praluent.
Where to find information in this leaflet:
1. Why am I using Praluent?
Praluent contains the active ingredient alirocumab, a protein produced in Chinese hamster ovary cells.
Praluent is an injectable medicine and belongs to a group of medicines called monoclonal
antibodies. Monoclonal antibodies are proteins that specifically identify and attach
to other proteins in the body. Praluent recognises and attaches to a protein called
PCSK9.
PCSK9 lowers the level of a receptor called LDL-R, which is needed to remove LDL cholesterol.
Praluent blocks the PCSK9 protein, thereby increasing the LDL-R receptors that are
available to remove LDL cholesterol. This results in lower levels of LDL cholesterol.
Praluent is used with other cholesterol lowering medicines to treat high levels of
cholesterol in the blood.
Cholesterol is one of several fatty substances found in the bloodstream. Your total
cholesterol is made up of mainly of Low Density Lipoprotein (LDL) and High Density
Lipoprotein (HDL) cholesterol. Praluent reduces LDL cholesterol.
LDL cholesterol can build up in the walls of your arteries forming plaque. Eventually
this plaque build-up can lead to a narrowing of the arteries.
This narrowing can slow or block blood flow to vital organs such as the heart and
brain. This blocking of blood flow can result in a heart attack or stroke and can
cause other health problems.
Praluent reduces the risk of heart attack, stroke, and chest pain that may be caused
by too little blood and oxygen getting to the heart (angina), in adults with cardiovascular
disease and high cholesterol levels in their blood.
Praluent is used in adults who cannot reduce their cholesterol levels by cholesterol
lowering diet and exercise.
Praluent should be used with other lipid lowering medicines such as statins to treat
high cholesterol and lipid disorders. When a statin cannot be used or does not work
well, Praluent can be used alone or together with other cholesterol lowering medicines.
Praluent should be used along with cholesterol lowering diet and exercise as recommended
by your doctor.
Your doctor, however, may have prescribed Praluent for another purpose. Ask your doctor
if you have any questions about why it has been prescribed for you.
This medicine is only available with a doctor's prescription
2. What should I know before I use Praluent?
Warnings
Do not use Praluent if:
you are allergic to alirocumab, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine.
you are allergic to medicines or other products that are produced by DNA technology
using Chinese Hamster Ovary cells.
Symptoms that may indicate an allergic reaction include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Tell your doctor if you are experiencing these symptoms.
Praluent should not be used after the expiry date (exp) printed on the pack.
If you use this medicine after the expiry date it may have no effect at all, or worse,
an unexpected effect.
Praluent should not be used if the packaging is torn or shows signs of tampering.
If you are not sure whether you should start using this medicine, talk to your doctor.
Check with your doctor if you:
allergies to any other medicines or substances such as foods, preservatives or dyes
take any medicines for any other condition
have any kidney or liver problems.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
The effects of Praluent in pregnant women are not known. Therefore the use of this
medicine in pregnant women is not recommended.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known
whether Praluent passes into breast milk.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Praluent and affect how well it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Praluent.
4. How do I use Praluent?
How much to use
The recommended starting dose of Praluent is either 75mg once every two weeks or 300
mg once every four weeks. Your doctor may adjust your dose depending on your cholesterol
levels.
To administer the 300 mg dose, inject one 300 mg injection at one injection site,
or inject two 150 mg injections, one after the other, at two different injection sites.
Follow the instructions provided by your doctor and use Praluent until your doctor
tells you to stop.
When to use Praluent
Praluent is either used 75mg once every 2 weeks or 300 mg once every 4 weeks (monthly).
How to use Praluent
Follow all directions given to you by your doctor and pharmacist carefully. They may
differ from the information contained in this leaflet.
If you do not understand the instructions on the label or in this leaflet, ask your
doctor or pharmacist for help.
Always check the Praluent label before each injection to make sure you are using the
right injection.
Praluent is a clear to pale yellow liquid. Do not shake the Praluent liquid. Do not
use Praluent if it is not clear to pale yellow or if it contains particles.
To avoid discomfort, Praluent should be allowed to warm to room temperature (up to
25°C) for 30 - 40 minutes before injection. Do not use a heat source to warm up Praluent.
Do not put Praluent near direct sunlight.
The injection can be self-administered or given by another person, after proper training
in injection technique.
See the detailed "Instructions for Use" provided with the medicine for instructions
about the right way to store, prepare, and use Praluent at home.
Praluent is injected under the skin (subcutaneous injection) of your stomach area
(abdomen), thigh or upper arm. Change the place that you inject each time so that
you do not become sore in one area.
After injecting Praluent, immediately throw away the used pre-filled pen or pre-filled
syringe in a sharps container as instructed by your doctor or pharmacist.
Do not inject in an area where the skin is tender, reddened, bruised or hard. This
may mean there is an infection.
Do not inject into the skin if it is sunburnt or injured.
Do not inject Praluent with other injectable medicines, at the same injection site.
How long to use Praluent
Praluent helps lower your cholesterol levels. It does not cure your condition. Therefore
keep using Praluent as directed by your doctor. If you stop taking Praluent, your
cholesterol levels may rise again.
If you forget to use Praluent
If you missed a dose of Praluent by less than 7 days, inject your missed dose as soon
as you can, then have your next dose at your regular scheduled time. This will keep
you on the original schedule.
If you missed a dose of Praluent by more than 7 days and you inject every 2 weeks,
wait until your next scheduled dose to re-start Praluent. If you inject every 4 weeks,
start a new schedule from the time you inject your missed dose.
If you are not sure when to inject Praluent, call your doctor, pharmacist or nurse.
It is important to use Praluent as prescribed by your doctor.
Do not take a double dose to make up for the dose you missed.
If you use too much Praluent
If you think that you have used too much Praluent, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26) or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention. Keep telephone numbers of these places handy.
5. What should I know while using Praluent?
Things you should do
Always follow your doctor's instructions carefully.
Keep Praluent in a refrigerator (2°C - 8°C). Do not freeze. Do not expose to extreme
heat.
Allow Praluent to warm to room temperature (up to 25°C) for 30 - 40 minutes before
injection. Do not use a heat source to warm up Praluent. Do not put Praluent near
direct sunlight.
It is important to keep using Praluent even if you feel well. Praluent helps to control
your condition but does not cure it.
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking Praluent.
Remind any doctor, dentist or pharmacist you visit that you are using Praluent.
Call your doctor straight away if you:
become pregnant while you are using Praluent.
Things you should not do
Do not stop using this medicine suddenly or change the dosage without checking with
your doctor.
Do not give Praluent to anyone else, even if they have the same condition as you.
Do not use Praluent to treat any other complaints unless your doctor tells you to.
Do not shake Praluent.
Do not use a heat source to warm up Praluent.
Do not put Praluent near direct sunlight.
Do not use Praluent if it is not clear to pale yellow or if it contains particles.
Do not give Praluent to children. The safety and benefit of Praluent in children under
the age of 18 years has not been established.
Looking after your medicine
Keep Praluent in the pack to protect from light, until it is time to use it.
Keep Praluent in a refrigerator (2°C - 8°C). Do not freeze. Do not expose to extreme
heat.
Keep Praluent in the refrigerator in an area where children cannot reach it.
If needed, the medicine may be kept outside the refrigerator below 25°C for a maximum
of 30 days.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in the refrigerator, away from heat or sunlight; for example, do not store
it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
When to discard your medicine
After removal from the refrigerator, Praluent must be used within 30 days or discarded.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems .
By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Praluent contains
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Active ingredient
(main ingredient)
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Alirocumab
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Other ingredients
(inactive ingredients)
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histidine
sucrose
polysorbate 20
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What Praluent looks like
Praluent is a clear to pale yellow sterile solution for injection available in a pre-filled
pen or pre-filled syringe. (Aust R 238285, AUST R 238299, AUST R 238304, AUST R 238305,
AUST R 377452)
Pre-filled pen:
Each pre-filled pen contains 1 mL or 2 mL of solution and is available in the following
strengths:
75 mg/1 mL available in pack sizes of 1, 2 or 6
150 mg/1 mL available in pack sizes of 1, 2 or 6
300 mg/2 mL available in pack sizes of 1 or 3
Pre-filled syringe:
Each pre-filled syringe contains 1 mL of solution and is available in two different
strengths:
75 mg/mL available in pack sizes of 1, 2 or 6
150 mg/mL available in pack sizes of 1, 2 or 6
Who distributes Praluent
Praluent is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Toll Free No: 1800 818 806
This leaflet was prepared in October 2022.
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