What is Leqvio (inclisiran) for?

Leqvio (inclisiran) is a small interfering ribonucleic acid (siRNA) medication indicated for the treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia (conditions that cause high levels of fats, including cholesterol, in the blood). Leqvio (inclisiran) reduces cholesterol in the blood.^[1]

It is given in addition to a cholesterol-lowering diet. Leqvio (inclisiran) is used:

• together with a statin (a cholesterol-lowering medicine), sometimes combined with another cholesterol-lowering treatment if the maximum dose of the statin does not work well enough, or
• alone or together with other cholesterol-lowering medicines when statins do not work well or cannot be used.

It is available as a pre-filled syringe for under-the-skin (subcutaneous) injection, containing 284 mg inclisiran in 1.5 ml solution.^[1]

How does Leqvio (inclisiran) work?

Cardiovascular disease, a disease causing problems in the heart and blood circulation, is the number one cause of death worldwide.2 One of the risk factors for the development of CVD is having high levels of LDL-cholesterol (‘bad’ cholesterol), which is also called hypercholesterolemia.^[1,2]

Inclisiran, the active ingredient of Leqvio, is an siRNA. It works via an RNA interference (RNAi) mechanism that can interfere with RNA (genetic material found in our cells) to block the production of the protein PCSK9.3 PCSK9 is a protein that can increase the levels of LDL-cholesterol.^[1,2]

By blocking the production of PCSK9, inclisiran can help lower LDL-cholesterol levels and protect against cardiovascular disease.^[1,2]

Where has Leqvio (inclisiran) been approved?

Leqvio (inclisiran) was approved to treat adults with hypercholesterolemia or mixed dyslipidemia by:

• The European Medicines Agency (EMA) on December 11, 2020.^[3]
• The Food and Drug Administration (FDA) on December 22, 2021.^[4]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Leqvio (inclisiran) taken?

The standard dosage is:^[1]

• 284 mg inclisiran given as a single injection under the skin (subcutaneous) initially
• The next dose is given 3 months later
• And subsequently every 6 months

The medicine is to be administered by a healthcare professional. It is injected in the belly usually but also the upper arm or thigh. Injections should not be given into areas of active skin disease or injury such as sunburns, skin rashes, inflammation or skin infections.^[1]

Complete information about Leqvio (inclisiran) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Leqvio (inclisiran)?

Common adverse reactions

The adverse reaction listed in the prescribing information was:^[1]

• Injection site reactions, such as pain, redness or rash (8.2% of patients)

Use in a specific population

There is no or limited amount of data from the use of inclisiran in pregnant women or during breastfeeding.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [EMA]: Leqvio (inclisiran) [PDF] Novartis, Dec 2020

2. Inclisiran: A New Promising Agent in the Management of Hypercholesterolemia
Kosmas CE, Diseases, Sep 2018

3. Novartis receives EU approval for Leqvio (inclisiran), a first-in-class siRNA to lower cholesterol with two doses a year
Novartis, Dec 11, 2020

4. FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year
Novartis, Dec, 2021