Inclisiran

Pronunciation: in-cliz-i-ran
Generic name: inclisiran
Brand name: Leqvio
Dosage form: subcutaneous injection (284 mg/1.5 mL)
Drug class: Miscellaneous antihyperlipidemic agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Jan 22, 2025.

What is inclisiran?

Inclisiran is used to lower LDL-C (low-density lipoprotein cholesterol) levels alongside diet and statin therapy in adults with high cholesterol caused by genetic reasons (primary hyperlipidemia). It is an injection given subcutaneously (under the skin) by a healthcare provider 2 times a year as maintenance dosing.

Inclisiran is often compared to Repatha, another injectable PCSK9 inhibitor for high cholesterol that needs to be given more frequently but is approved for use in children (see What is the difference between Leqvio (inclisiran) and Repatha?).

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

Uses and FDA approvals

Inclisiran is FDA-approved to reduce low-density lipoprotein (LDL-C) levels, as an adjunct to diet and statin therapy in adults with primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH).

• This includes people with primary hyperlipidemia who have not had a cardiovascular event but are at an increased risk of heart disease because they have other conditions, such as high blood pressure or diabetes.
• It also includes people with atherosclerotic cardiovascular disease (ASCVD) - the term used to describe a build-up and hardening of plaque in your arteries leading to heart disease.

For those unable to take statins (such as atorvastatin [Lipitor], rosuvastatin [Crestor], or pravastatin) - either because they're not safe for you or your body doesn't tolerate them well - your healthcare provider might suggest other cholesterol-lowering medications like ezetimibe (Zetia) or using inclisiran injection by itself (see Can Leqvio (inclisiran) be taken without a statin?).

• Inclisiran is not a statin but it is usually given with statins.

Mechanism

Inclisiran works through a unique mechanism that targets PCSK9 protein production. By interfering with mRNA translation, it allows more LDL-C receptors to remain active on liver cells, enhancing the removal of bad cholesterol from the bloodstream. When combined with statin therapy, clinical trials have reported inclisiran is very effective at managing high cholesterol.

Inclisiran belongs to the small interfering RNA (siRNA) molecule drug class and was the first-in-class siRNA to be developed.

Inclisiran side effects

The most common side effects of inclisiran 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 inclisiran in clinical trials.

Serious side effects and warnings

Inclisiran 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.

Inclisiran 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

Inclisiran cost

The cost of inclisiran depends on what type of insurance you have and your eligibility for the Leqvio Copay card. In general, inclisiran 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 inclisiran with just over 50% paying $0.
• 92% of patients with an insurance plan have medical benefits confirmed for inclisiran.
• Patients with traditional Medicare and supplemental insurance pay as little as $0.
• No matter what insurance you have, the Leqvio (inclisiran) Service Center can help you understand the costs associated with inclisiran.

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

Before taking this medicine

Do not receive inclisiran if you are allergic to inclisiran, Leqvio, or any inactive ingredients in the inclisiran 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 an inclisiran injection if you are pregnant or under 18 years of age.

Pregnancy

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

Breastfeeding

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

How is inclisiran administered?

Inclisiran is a subcutaneous injection administered by a healthcare provider with twice-yearly maintenance dosing.

It can be injected under the skin of the abdomen, upper arm, or thigh. 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.

Inclisiran injection is given as an initial dose, repeated in 3 months, and then administered every 6 months after that.

• Do not stop receiving this medication without talking to your healthcare provider, as your LDL cholesterol levels may increase.
• See How is Leqvio (inclisiran) injection administered? for more information.

This medicine is an adjunct (add-on) treatment to an improved diet and usually the maximum tolerated statin dose.

Inclisiran dosing

Recommended inclisiran dosage for adults:

Dose 1: Inclisiran 284 mg SC

Dose 2 (3 months later): Inclisiran 284 mg SC

Dose 3 (6 months later and every 6 months thereafter): Inclisiran 284 mg SC.

Inclisiran is available in a single-dose prefilled syringe containing inclisiran (generic name) 284 mg/1.5 mL (189 mg/mL).

What happens if I miss a dose?

If you miss a dose of inclisiran 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 inclisiran?

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

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

Storage

Inclisiran is stored by your healthcare provider at room temperature, 20°C to 25°C (68°F to 77°F).

• Excursions are permitted between 15°C and 30°C (59°F and 86°F).
• Do not freeze

For single-use only.

Inclisiran 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.

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

Contains no preservatives.

Who makes inclisiran?

Inclisiran (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. Notable medications produced by Novartis include:

• Entresto (for heart failure)
• Cosentyx (for psoriasis and arthritis conditions)
• Gilenya (for multiple sclerosis)
• Kisqali (for breast cancer)
• Zolgensma (for spinal muscular atrophy)
• Xiidra (for dry eye disease)
• Xolair (for asthma and allergic conditions)
• Kymriah (for certain types of blood cancer)

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

Popular FAQ

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Further information

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

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