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.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I using Leqvio?
Leqvio contains the active ingredient inclisiran. Leqvio is used to lower LDL-cholesterol
('bad' cholesterol) in addition to a cholesterol-lowering diet and exercise if you
are an adult with a high cholesterol level in your blood.
2. What should I know before I use Leqvio?
Do not use if you have ever had an allergic reaction to Leqvio 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?
Leqvio is not expected to interact with other medicines even though it has not been
tested.
4. How is Leqvio given?
Leqvio is given as an injection under the skin in your abdomen, alternatively the
upper arm or thigh. It will be given to you by a doctor or healthcare provider.
The recommended dose is one injection initially, again at 3 months, followed by every
6 months.
5. What should I know while using Leqvio?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Leqvio.
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Things you should not do
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Do not use this medicine if you are allergic to inclisiran, or any of the ingredients
listed at the end of this leaflet.
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Driving or using machines
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Leqvio is not expected to affect your ability to drive or use machines.
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Drinking alcohol
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There are no known interactions between Leqvio and alcohol
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6. Are there any side effects?
As with all medicines, patients treated with Leqvio may experience side effects, although
not everybody gets them. If you notice any of the following side effects or if these
side effects become severe, please tell your doctor or healthcare provider.
Common side effects that may affect up to 1 in every 10 people, include injection
site reactions, such as pain, redness or rash.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s): inclisiran
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Leqvio. 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 Leqvio.
Where to find information in this leaflet:
1. Why am I using Leqvio?
Leqvio contains the active ingredient inclisiran. Leqvio is a cholesterol-lowering double stranded small interfering ribonucleic acid
(siRNA).
Leqvio is used to lower levels of LDL-cholesterol ('bad' cholesterol), which can cause
heart disease and blood circulation problems. LDL-cholesterol can build up in the walls of your arteries leading to narrowing of
the arteries. This narrowing can slow or block blood flow to vital organs such as
the heart and brain leading to a heart attack or stroke and other health problems.
You need to use Leqvio while also following a cholesterol-lowering diet and exercising.
Leqvio is used in adults with high LDL-cholesterol levels, in adults who have heart
disease (such as a previous heart attack or stroke), or in adults with a higher chance
of having a heart attack.
Leqvio may be used with other cholesterol-lowering medicines, for example a statin
(a commonly used medicine that treats high cholesterol). Leqvio may also be used alone
if your doctor say you cannot take a statin.
Inclisiran lowers levels of 'bad' cholesterol by silencing or turning off the gene
for a protein called PCSK9.
2. What should I know before I use Leqvio?
Warnings
Do not use Leqvio if:
you are allergic to inclisiran, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
take any medicines for any other conditions
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
The effects of Leqvio in pregnant women are not known. Check with your doctor if you
are pregnant, intend to become pregnant, or think you may be pregnant when taking
Leqvio.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known
if Leqvio is found in breast milk. Your doctor can discuss the risks and benefits
with you.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including vitamins
or supplements that you buy without a prescription from your pharmacy, supermarket
or health food shop.
Leqvio is not expected to interact with other medicines even though it has not been
tested.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Leqvio.
4. How is Leqvio given?
How much is given
The recommended dose of Leqvio is one injection initially. Then you will be given
your next dose at 3 months, and then every 6 months.
Follow the instructions provided and use Leqvio until your doctor tells you to stop.
How Leqvio is given
Leqvio is given as an injection under the skin (subcutaneous injection) in your abdomen.
Alternatively, the upper arm or thigh.
It will be given to you by a doctor or healthcare provider.
Before starting Leqvio you should be on a cholesterol-lowering diet and exercise as
part of a lifestyle change, and it is likely that you will be taking a statin (a commonly
used medicine that treats high cholesterol). You should stay on this cholesterol-lowering
diet and exercise, and any medications as advised by your doctor while receiving Leqvio,
as they act together to provide maximum cholesterol control for you.
If you have missed a dose of Leqvio
If you miss your appointment to have Leqvio administered, contact your doctor or healthcare
provider as soon as you remember so that you can arrange your next treatment.
If you have any further questions on the use of this medicine, ask your doctor or
healthcare provider.
If you have been given too much Leqvio
It is unlikely you would be given too much Leqvio given that it is administered by
a healthcare professional but if you think that you have been given too much, you
may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Leqvio?
Things you should do
Remind any doctor, dentist or pharmacist that you are using Leqvio.
Tell your doctor or healthcare provider if you experience an allergic reaction, feel
unwell, or have any side effects that worry you during or after injection.
Driving or using machines
Leqvio is not expected to affect your ability to drive or use machines.
How Leqvio is stored
Store below 30°C. Do not freeze.
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
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 Leqvio contains
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Active ingredient
(main ingredient)
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inclisiran
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Other ingredients
(inactive ingredients)
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sodium hydroxide, phosphoric acid and water for injection
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Do not take this medicine if you are allergic to any of these ingredients.
What Leqvio looks like
Leqvio is a pre-filled syringe containing a clear, colorless to pale yellow solution
for injection essentially free of particulate (Aust R 342250).
Who distributes Leqvio
Novartis Pharmaceuticals Australia Pty Limited
54 Waterloo Road
Macquarie Park
NSW 2213
Australia
This leaflet was prepared in September 2021.
Internal document code:
leq030522c based on PI leq030522i