Pronunciation: leck-vee-oh
Generic name: inclisiran
Dosage form: subcutaneous injection (284 mg/1.5 mL)
Drug class: Miscellaneous antihyperlipidemic agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 12, 2025.

What is Leqvio?

Leqvio is used in adults with primary hyperlipidemia to reduce low-density lipoprotein (LDL-C) levels alongside dietary changes. It is administered by subcutaneous (under the skin) injection, twice a year. 

Leqvio (inclisiran) first gained FDA approval on December 22, 2021. There is no generic.

FDA approvals and indications

Leqvio is FDA-approved to reduce low-density lipoprotein (LDL-C) levels, alongside dietary changes in adults with primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH).

Leqvio is not a statin, but is usually given with other cholesterol medications, including statins. For those unable to take statins, Leqvio can be used alone (see Can Leqvio be taken without a statin?).

How does Leqvio work?

Leqvio's mechanism of action involves targeting, binding to, and blocking PCSK9 protein production, reducing levels of LDL-C.

• This protein breaks down receptors on liver cells that remove LDL-C from your blood.
• The more receptors there are, the more LDL-C is removed.
• Leqvio blocks the instructions (mRNA) that tell your body to make PCSK9 (this is a unique way of working compared to other PCSK9 blockers).
• It uses a special technology that targets just this one protein and belongs to the drug class called small interfering RNAs (siRNAs).
• This enhances the removal of LDL-C. 

Leqvio side effects

The most common side effects of Leqvio are:

• injection site reactions, such as redness, pain, or bruising where the injection was given
• joint pain
• bronchitis, colds in your chest, or breathing problems.

Weight gain has not been reported as a side effect of Leqvio in clinical trials.

Serious side effects and warnings

Leqvio may cause serious side effects, such as allergic reactions. Get emergency medical help if you have signs of an allergic reaction: hives, severe itching, difficulty breathing, swelling of your face, lips, tongue, or throat.

Leqvio may increase your risk of urinary tract infections. Symptoms may include pain or burning while you are urinating, having to pass urine more frequently or more urgently than is usual for you, pelvic or rectal pain, or urine that is discolored or has a strong odor. Call your healthcare provider at once if you have any of these symptoms.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Leqvio cost

The cost of Leqvio depends on what type of insurance you have and your eligibility for the Leqvio Copay card. In general, Leqvio is broadly covered and affordable for most patients because it is given by your doctor and is covered primarily under the medical benefit, not the pharmacy benefit.

• 75% of people with commercial insurance pay less than $10 for Leqvio with just over 50% paying $0.
• 92% of patients with an insurance plan have medical benefits confirmed for Leqvio.
• Patients with traditional Medicare and supplemental insurance pay as little as $0.
• No matter what insurance you have, the Leqvio Service Center can help you understand the costs associated with Leqvio.

See Leqvio Prices, Coupons, Copay Cards, & Patient Assistance for more information.

Before taking this medicine

Do not receive Leqvio if you are allergic to Leqvio, inclisiran, or any inactive ingredients in the Leqvio injection. See below for a complete list of ingredients.

Tell your healthcare provider about all the medical conditions you have, especially tell them if you have:

• severe kidney disease or are receiving dialysis
• severe liver disease
• arthritis
• asthma, COPD, or breathing problems
• a history of urinary tract infections
• skin conditions such as psoriasis or eczema
• are pregnant or intending to become pregnant
• are breastfeeding or intending to breastfeed.

You should not receive a Leqvio injection if you are pregnant or under 18 years of age.

Pregnancy

Leqvio should not be used during pregnancy because it may harm an unborn baby. Tell your healthcare provider immediately if you become pregnant while receiving Leqvio.

Breastfeeding

It is not known if Leqvio passes into human breast milk. Talk to your healthcare provider about the best way to feed your baby if you are having treatment with Leqvio. 

How is Leqvio administered?

Leqvio is a subcutaneous injection administered by a healthcare provider. 

• After your first 2 doses of leqvio, you only need it every 6 months.
• It can be injected under the skin of the abdomen, upper arm, or thigh.
• It should not be injected into skin that is bruised, scarred, or is broken. Tell your healthcare provider about any skin conditions or areas of injury you may have such as psoriasis, eczema, sunburn, skin rashes, inflammation, or skin infections.
• See How is Leqvio injection administered? for more information.

This medicine is an add-on treatment to an improved diet and usually other cholesterol medications, such as statins.

Do not stop receiving this medication without talking to your healthcare provider, as your LDL cholesterol levels may increase.

Leqvio dosing

Recommended Leqvio dosage for adults:

• Initial. Dose 1: Leqvio 284 mg SC
• 3 months later. Dose 2: Leqvio 284 mg SC
• 6 months later and every 6 months thereafter. Dose 3: Leqvio 284 mg SC.

Leqvio is available in a single-dose prefilled syringe containing 284 mg/1.5 mL. 

What happens if I miss a dose?

If you miss a dose of Leqvio and it has been less than 3 months, then see your healthcare provider for a dose and continue with your original dosing schedule.

If you miss a dose of this medicine and it has been more than 3 months, then see your healthcare provider and restart with a new dosing schedule - starting with an initial dose, then another dose at 3 months, and then every 6 months after that.

What happens if I overdose?

There is no specific treatment for an overdose of this medicine If you receive too much, your healthcare provider will check you for side effects and treat any side effects as required.

What other drugs affect Leqvio?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Leqvio is not expected to cause drug-drug interactions or to be affected by inhibitors or inducers of cytochrome P450 enzymes or transporters.

Leqvio ingredients

Active ingredient: inclisiran sodium 284 mg (present as 300 mg inclisiran sodium salt).

Inactive ingredients: Water for Injection and may also contain sodium hydroxide or phosphoric acid for pH adjustment to a target pH of 7.0.

Leqvio is available as a 284 mg/1.5 mL (189 mg/mL) single-dose prefilled syringe.

Contains no preservatives. 

Who makes Leqvio?

Leqvio is manufactured by Novartis Pharmaceuticals Corporation, which is based in East Hanover, New Jersey, with global headquarters in Basel, Switzerland. The medication was developed under license from Alnylam Pharmaceuticals, Inc. 

Novartis was formed in 1996 through the merger of Ciba-Geigy and Sandoz.

Popular FAQ

View more FAQ

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer