Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
2. What you need to know before you use Praluent
3.How to use Praluent
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
tivity reaction with symp! 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.
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 ina 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.
Ifyou have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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 (reddis|
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
'6. Contents of the pack and other information
What Praluent is and what it is used
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 iL familial and 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.
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.
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 prefilled 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 prefilled 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.
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 mlof 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 300 mg 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
410 Thames Valley Park Drive Reading
Berkshire
RG6 1PT
UK Tel: 0800 035 2525 Email: [email protected]
Manufacturer
Sanofi-Aventis Deutschland GmbH Industriepark Hoechst BriiningstraBe 50
65926 Frankfurt am Main Germany
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 October 2024
Praluent® pre- Instructions for use
STEP B: How to inject
G.) Remove the cap
a.
The parts of the Praluent pen are shown in this picture.
Medication Label
t id
Body
Window
_»p (ieee °
Orange needle cover Needle inside
Blue cap
For single use only
Pull off the blue cap and throw it away.
«i
Pull the blue cap straight off
=
Needle inside
Do not touch the orange needle cover Do not twist the blue cap off. Do not pull off the blue cap until you are ready to inject.
Do not touch the orange needle cover. The needle is inside the orange needle cover.
Do not put the blue cap back on.
Do not use the pen if the blue cap is missing or not securely attached.
Important information
+ This device is a single use disposable pre-filled pen. It contains 150mg of Praluent (alirocumab) in ImL.
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).
Itis 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 thrown away after use.
hl
v Keep the Praluent pen out X Do not touch the orange of the sight and reach of needle cover. children. X Do not use the pen if it has ~ Read all of the instructions been dropped or damaged. carefully before using the X Do not use the pen if the blue Praluent pen. cap is missing or not securely v Follow these instructions attached. Pal ve yeuteea X Do not re-use a pen. Teas X Do not shake the pen. Vv Store in a refrigerator (2°C to 8°) X Do not freeze the pen. ¥ Keep the pen in the outer vt pe mou teat the pen to carton in order to protect extreme heat. from light. X Do not expose the pen to direct sunlight.
Keep this leaflet. If you have questions, ask your doctor, pharmacist or nurse or call the Sanofi number on the package leaflet.
Pinch the skin and place pen
a.
Pinch the skin to make sure the injection site is firm. This is required for children less than 12 years of age.
. When placing the orange needle cover on your skin, hold the pen so that you can see the window.
Place the orange needle cover on your skin at roughly a 90-degree angle.
a
Do not touch the orange needle cover
Do not press the pen down against your skin until you are ready to inject.
Do not touch the orange needle cover. The needle is inside the orange needle cover.
STEP A: Getting ready for an injection
@) Look at the label of the pen
a. Check that you have the correct product and the correct dose.
Look at the label
> frovend wai rol
b. Check the use by date: do not use if this date has passed.
Expiration date
Do not use the Praluent pen if it has been dropped on a hard surface or damaged.
Zo ™~ CT
(©) Deliver injection (press > hold > check)
a, Press the pen straight down against your skin until the orange needle cover is pushed all the way into the pen and hold,
The injection will not start until the orange needle cover is fully
depressed.
There will be a click when the injection starts. The window will start to turn yellow.
Correct
Incorrect
@.) Look at the window
G.) Warm pen and gather supplies
a. Check if the liquid is clear, colorless to pale yellow and free from a. Let the pen warm up at room temperature for 45 minutes. particles.
You may see air bubble(s). Thi
Check window
oe,
{ Do not put the pen into direct sunlight.
<
Do not heat the pen. Let it warm up on its own.
Do not put the pen back in the refrigerator.
Do not use this medicine if the solution is discoloured or cloudy, or if it contains visible flakes or particles. following items:
+ Alcohol wipes
© Cotton ball or gauze
+ Apuncture-resistant container (see Step B9 Dispose).
b. While you wait for the pen to reach room temperature, gather the
Do not use if the window appears solid yellow. Solid yellow in the window means that the device has been used.
ALCOHOL. WIPE
Remove
b. Keep holding the pen firmly against your skin. You may hear a a, Pull pen away from your skin. second click.
c. Check that the entire window has turned to yellow.
Do not rub the skin after the injection.
If the window has not turned completely yellow, remove the pen a and call the Sanofi number on the package leaflet. b. If you see any blood, press a cotton ball or gauze on the site until the
, ne - bleeding stops. Do not give yourself a second injection without speaking to your
doctor, pharmacist or nurse.
y,
Prepare the injection site
se
Wash your hands with soap and water and dry with a towel.
You can inject into (see PICTURE) + The top of your thighs
+ Your belly (except for the 5 cm area around your navel) + Outer side of your upper arm (to be given by your caregiver only) Clean skin in the injection area with an alcohol wipe.
Injection by caregiver only
|
Self-injection or by caregiver
You can stand or sit to give yourself an injection. Use a different spot each time you inject.
Do not use skin that is tender, hard, red or hot.
Do not use any area near a visible vein.
Do not inject Praluent with other injectable medicines at the same spot.
Dispose
a. Throw away the pen and cap into a puncture-resistant container immediately after use.
Do not put the blue cap back on.
_
b. Ask your doctor, pharmacist, or nurse how to throw away the container.
Always keep the container out of sight and reach of children
Praluent 150 mg solution for injection in pre-filled pen comes as solution containing 150 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Praluent 150 mg solution for injection in pre-filled pen is alirocumab.
Medicines with the same active substance include: Praluent 300 mg solution for injection in pre-filled pen, Praluent 75 mg solution for injection in pre-filled pen. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Praluent 150 mg solution for injection in pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Primary hypercholesterolaemia and mixed dyslipidaemia
Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet:
- in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Established atherosclerotic cardiovascular disease
Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
- in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
Posology
Adults
Prior to initiating alirocumab secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.
The recommended alirocumab doses are 75 mg once every 2 weeks, 150 mg once every 2 weeks, 300 mg once every 4 weeks (monthly), administered subcutaneously. All doses may be used for initiation of treatment.
The dose of alirocumab can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response to treatment. Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, and dose adjusted accordingly (up-titration or down-titration). Intense LDL-C reduction is expected with alirocumab 150 mg once every 2 weeks and 300 mg once every 4 weeks (monthly), where 150 mg once every 2 weeks is the maximum dose (see section 5.1).
HeFH in paediatric patients 8 years of age and older
| Body weight of patients | Recommended dose | Recommended dose if additional LDL-C reduction is needed* |
| Less than 50 kg | 150 mg once every 4 weeks | 75 mg once every 2 weeks |
| 50 kg or more | 300 mg once every 4 weeks | 150 mg once every 2 weeks |
* Lipid levels can be assessed 8 weeks after treatment initiation or titration and dose adjusted accordingly.
Missed dose
If a dose is missed, the dose should be administered as soon as possible and thereafter, dosing should be resumed on the original schedule.
Special populations
Elderly
No dose adjustment is needed for elderly patients.
Hepatic impairment
No dose adjustment is needed for patients with mild or moderate hepatic impairment. No data are available in patients with severe hepatic impairment (see section 5.2).
Renal impairment
No dose adjustment is needed for patients with mild or moderate renal impairment. Limited data are available in patients with severe renal impairment (see section 5.2).
Body weight
No dose adjustment is needed in patients based on weight.
Paediatric population
The safety and efficacy of Praluent in children less than 8 years of age have not been established. No data are available.
Method of administration
Subcutaneous use.
Alirocumab is injected as a subcutaneous injection into the thigh, abdomen or upper arm.
Each pre-filled pen is for single use only.
To administer the 300 mg dose, either one 300 mg injection or two 150 mg injections should be given consecutively at two different injection sites.
It is recommended to rotate the injection site with each injection.
Alirocumab should not be injected into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections.
Alirocumab must not be co-administered with other injectable medicinal products at the same injection site.
Precautions to be taken before handling or administering the medicinal product
The solution should be allowed to warm to room temperature prior to use (see section 6.6).
Paediatric patients 8 years of age and older
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.
Adults
Adult patients may either self‑inject alirocumab, or a caregiver may administer alirocumab, after guidance has been provided by a healthcare professional on proper subcutaneous injection technique.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Effects of alirocumab on other medicinal products
Since alirocumab is a biological medicinal product, no pharmacokinetic effects of alirocumab on other medicinal products and no effect on cytochrome P450 enzymes are anticipated.
Effects of other medicinal products on alirocumab
Statins and other lipid‑modifying therapy are known to increase production of PCSK9, the protein targeted by alirocumab. This leads to the increased target-mediated clearance and reduced systemic exposure of alirocumab. Compared to alirocumab monotherapy, the exposure to alirocumab is about 40%, 15%, and 35% lower when used concomitantly with statins, ezetimibe, and fenofibrate, respectively. However, reduction of LDL-C is maintained during the dosing interval when alirocumab is administered every two weeks.
Pregnancy
There are no data from the use of Praluent in pregnant women. Alirocumab is a recombinant IgG1 antibody, therefore it is expected to cross the placental barrier (see section 5.3).
Animal studies do not indicate direct or indirect harmful effects with respect to maintenance of pregnancy or embryo-foetal development; maternal toxicity was noted in rats, but not in monkeys at doses in excess of the human dose, and a weaker secondary immune response to antigen challenge was observed in the offspring of monkeys (see section 5.3).
The use of Praluent is not recommended during pregnancy unless the clinical condition of the woman requires treatment with alirocumab.
Breast‑feeding
It is not known whether alirocumab is excreted in human milk. Human immunoglobulin G (IgG) is excreted in human milk, in particular in colostrum; the use of Praluent is not recommended in breast-feeding women during this period. For the remaining duration of breast-feeding, exposure is expected to be low.
Since the effects of alirocumab on the breast-fed infant are unknown, a decision should be made whether to discontinue nursing or to discontinue Praluent during this period.
Fertility
In animal studies, there were no adverse effects on surrogate markers of fertility (see section 5.3). There are no data on adverse effects on fertility in humans.
Praluent has no or negligible influence on the ability to drive and use machines.
There is no specific treatment for alirocumab overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
Ask anything about Praluent 150 mg solution for injection in pre-filled pen. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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