Leqvio is a brand-name prescription medication. It’s FDA-approved to help decrease low-density lipoprotein (LDL) cholesterol in certain adults. LDL is often called “bad” cholesterol.

Leqvio is prescribed to treat:

  • heterozygous familial hypercholesterolemia, a genetic condition that causes a high level of LDL cholesterol
  • atherosclerotic cardiovascular disease, a type of heart disease that’s related to a high level of LDL cholesterol

Leqvio is typically prescribed in combination with a low cholesterol diet and statin drug. Leqvio has certain limitations of use. For more information, see the “Leqvio uses” section below.

Drug details

Leqvio belongs to a drug class called small interfering RNAs (siRNAs). Leqvio comes as a solution in a single-dose prefilled syringe. A healthcare professional will give you the medication as a subcutaneous injection.

Leqvio comes in one strength: 284 milligrams (mg) in 1.5 milliliters (mL) of solution.

FDA approval

The Food and Drug Administration (FDA) approved Leqvio in 2021. This medication is the first siRNA drug approved to decrease LDL cholesterol levels. At this time, Leqvio is the only siRNA available to lower LDL cholesterol.

Effectiveness

For information about the effectiveness of Leqvio, see the “Leqvio uses” section below.

Leqvio is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics typically cost less than brand-name drugs.

Leqvio contains the active drug inclisiran.

As with all medications, the cost of Leqvio can vary. To find current prices for Leqvio in your area, check out WellRx.com.

The cost you find on WellRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Before approving coverage for Leqvio, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Leqvio, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Leqvio, or if you need help understanding your insurance coverage, help is available.

Novartis Pharmaceuticals Corporation, the manufacturer of Leqvio, offers the Leqvio Co-Pay Program. For more information and to find out if you’re eligible for support, call 833-LEQVIO2 (833-537-8462) or visit the drug website.

To learn more about saving money on prescriptions, check out this article.

Generic version

Leqvio is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Here are answers to some frequently asked questions about Leqvio.

How do Leqvio and Repatha compare?

Leqvio and Repatha (evolocumab) are medications that may be used to lower low-density lipoprotein (LDL) levels. (LDL is often called “bad” cholesterol.) Both drugs are approved to treat a genetic condition called heterozygous familial hypercholesterolemia (HeFH). Leqvio is approved for this use in adults. Repatha, on the other hand, is approved for this use in adults as well as children ages 10 years and older.

Leqvio is also used to treat a condition called atherosclerosis. Repatha is also used to treat a genetic condition called homozygous familial hypercholesterolemia. In addition, Repatha is approved to decrease the risk of stroke and heart attack due to heart disease.

Both Leqvio and Repatha are given as subcutaneous injections. A healthcare professional will administer Leqvio. You may be able to inject Repatha yourself at home after being taught how to do so.

Leqvio and Repatha belong to different drug classes. Because the drugs don’t work in the same way, their side effects may differ as well.

If you have additional questions about Leqvio and Repatha, talk with your doctor. They can help determine the right treatment plan for you.

Is Leqvio a statin?

No, Leqvio is not a statin medication. Leqvio belongs to a drug class called small interfering RNAs (siRNAs).

Both statins and siRNAs help lower cholesterol. However, the two drugs classes work in different ways. In fact, Leqvio is typically prescribed with a statin drug. For more information, see the “Leqvio use with other treatments” section below.

You can find details about how Leqvio works in the “How Leqvio works” section below.

If you’d like to learn more about statins and siRNAs, talk with your doctor or pharmacist.

Why do I need to keep taking my current cholesterol medication with Leqvio?

You should continue to take your current cholesterol medication with Leqvio to help lower your cholesterol further. It’s also recommended that you follow a low cholesterol diet while receiving Leqvio. To learn more, see the “Leqvio use with other treatments” section below. You can also talk with your doctor or pharmacist.

Leqvio can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while receiving Leqvio. These lists do not include all possible side effects.

For more information about the possible side effects of Leqvio, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Leqvio, you can do so through MedWatch.

Mild side effects

Mild side effects* of Leqvio can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Leqvio. To learn about other mild side effects, talk with your doctor or pharmacist, or view Leqvio’s prescribing information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Leqvio aren’t common. However, they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

* For more information about this side effect, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Leqvio.

Injection site reaction

Leqvio can cause injection site reactions. These reactions may occur in the area where your dose of Leqvio is injected.

People who received Leqvio in clinical trials commonly reported injection site reactions. Examples of injection site reactions include redness or deepening of skin color, pain, and skin rash.

In the trials, injection site reactions were the most common reason that people stopped Leqvio treatment.

What you can do

If you have an injection site reaction during treatment with Leqvio, talk with your doctor. They may recommend ways to ease your symptoms. For example, if you have injection site pain, your doctor may suggest an over-the-counter (OTC) pain medication such as acetaminophen (Tylenol).

If your injection site reaction is severe or bothersome, your doctor may recommend a treatment other than Leqvio.

Joint pain

Joint pain was one of the most common side effects in people who received Leqvio in clinical trials. Symptoms of joint pain may include:

What you can do

If you have joint pain with Leqvio, talk with your doctor. They may recommend an OTC pain medication such as acetaminophen (Tylenol) or ibuprofen (Advil, Motrin).

Urinary tract infection

Urinary tract infections (UTIs) may occur during treatment with Leqvio. In clinical trials, UTIs were one of the most common side effects in people who received the drug. Symptoms of UTIs may include:

  • feeling as though you have to urinate more often than usual
  • pain when you urinate
  • blood in your urine
  • cloudy urine

What you can do

If you have symptoms of a UTI with Leqvio, talk with a doctor right away. In most cases, they’ll prescribe an antibiotic such as nitrofurantoin (Macrobid). It’s important that you receive treatment for a UTI, so the infection doesn’t spread to your kidneys.

Be sure to tell your doctor if you frequently have UTIs. They may be able to recommend ways to help prevent the infections. In some cases, your doctor may switch you to a different cholesterol medication.

Allergic reaction

As with most drugs, some people can have an allergic reaction after receiving Leqvio.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Leqvio, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Leqvio comes as a solution inside a single-dose prefilled syringe. The drug is available in one strength: 284 milligrams (mg) in 1.5 milliliters (mL) of solution. There’s one dose in each syringe.

A healthcare professional will administer Leqvio as a subcutaneous injection. To learn more about how the drug is given, see the “How Leqvio is given” section below.

Dosage for heterozygous familial hypercholesterolemia

Leqvio is approved to treat a genetic condition called heterozygous familial hypercholesterolemia.

For this purpose, you’ll first receive an injection of 284 mg. You’ll receive a second 284-mg dose 3 months later. After that, you’ll receive a 284-mg dose of Leqvio every 6 months.

Dosage for heart disease related to high LDL cholesterol

Leqvio is also approved to treat atherosclerotic cardiovascular disease. This is a type of heart disease that’s related to a high level of low-density lipoprotein (LDL) cholesterol.

For this purpose, you’ll first receive an injection of 284 mg. You’ll receive a second 284-mg dose 3 months later. After that, you’ll receive a 284-mg dose of Leqvio every 6 months.

What if I miss an appointment for a dose?

If you miss an appointment for a dose of Leqvio, call to reschedule as soon as you remember. If it’s been less than 3 months since the missed dose, you can receive a dose and continue with your regular treatment schedule.

If it’s been more than 3 months since the missed dose, you’ll need to start the dosing for Leqvio again. This means you would start from the beginning of your dosing schedule. (See “Dosage for heterozygous familial hypercholesterolemia” and “Dosage for heart disease related to high LDL cholesterol” above for details.)

If you miss an appointment and you aren’t sure when you should receive your next dose, talk with your doctor.

To help make sure that you don’t miss an appointment for a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Will I need to receive this drug long term?

Leqvio is meant to be a long-term treatment. If you and your doctor determine that Leqvio is safe and effective for you, you’ll likely receive it long term.

The Food and Drug Administration (FDA) approves prescription drugs such as Leqvio to treat certain conditions. The uses a drug is approved for are called its indications.

Leqvio for heterozygous familial hypercholesterolemia

Leqvio is approved to treat a condition called heterozygous familial hypercholesterolemia (HeFH). The drug is for use in adults who need to decrease their level of low-density lipoprotein (LDL) cholesterol. LDL is often called “bad” cholesterol.

Leqvio is meant to be prescribed in combination with a statin drug and a low cholesterol diet. For more information, see the “Leqvio use with other treatments” section below.

There is a limitation of use of Leqvio. At this time, it’s not known whether the drug decreases the risk of illness or death from cardiovascular disease. (The term cardiovascular refers to the heart and blood vessels.)

Explanation of heterozygous familial hypercholesterolemia

HeFH is a genetic condition that causes very high cholesterol. Having a high LDL level can increase your risk of serious problems, such as a heart attack or stroke. Leqvio works to lower the level of LDL cholesterol.

High cholesterol typically doesn’t cause any symptoms. You may first learn that you have HeFH when your doctor checks your cholesterol levels with a blood test.

When familial hypercholesterolemia is heterozygous, it means that you inherited a gene mutation from one parent. This mutation causes HeFH.

For more information about high cholesterol and treatment options, see our cholesterol hub.

Effectiveness for heterozygous familial hypercholesterolemia

Leqvio is an effective treatment option for HeFH. Treatment guidelines from the Journal of the Endocrine Society mention the drug as a possible therapy. For more information about how Leqvio performed in clinical trials, see the drug’s prescribing information.

Leqvio for heart disease related to high LDL cholesterol

Leqvio is approved to treat a type of heart disease related to a high level of LDL cholesterol. (LDL is short for low-density lipoprotein, which is often called “bad” cholesterol.) The clinical name of the heart disease is atherosclerotic cardiovascular disease (ASCVD).

Leqvio is prescribed for ASCVD in adults who need to decrease their LDL levels. Leqvio is meant to be used in combination with a statin drug and a low cholesterol diet. For more information, see the “Leqvio use with other treatments” section below.

There is a limitation of use of Leqvio. At this time, it’s not known whether the drug decreases the risk of illness or death from cardiovascular disease. (The term cardiovascular refers to the heart and blood vessels.)

Explanation of heart disease related to high LDL cholesterol

ASCVD occurs when arteries become thick and stiff due to buildup. The buildup is from plaques (substances) such as cholesterol. This can increase the risk of serious complications, such as heart attack or stroke. Leqvio works to lower LDL cholesterol levels.

ASCVD often has no symptoms unless part of the plaque in your arteries breaks off. At that point, symptoms depend on where this occurs in the body.

For example, if this happens in a carotid artery, which provides blood to the brain, you may experience symptoms of a stroke. These symptoms can include weakness, facial numbness, and difficulty breathing. If the plaque breaks off in a coronary artery, which provides blood to the heart, you may have symptoms of a heart attack. These symptoms can include chest pain or feeling faint.

You may first learn that you have ASCVD when your doctor checks your cholesterol levels and blood sugar with a blood test.

Effectiveness for heart disease related to high LDL cholesterol

Leqvio is an effective treatment option for ASCVD. For more information about how Leqvio performed in clinical trials, see the drug’s prescribing information.

Leqvio and children

At this time, Leqvio is not approved for use in children. It’s not known whether Leqvio is safe or effective for this age group.

Your child’s doctor can advise you on available treatment options.

Leqvio is given in combination with other treatments to further reduce your low-density lipoprotein (LDL) cholesterol. LDL is often called “bad” cholesterol.

Your doctor will likely recommend that you follow a low cholesterol diet. This may include eating plenty of nutritious foods such as whole grains, fruit, and vegetables. Your doctor can advise you on what to eat and what to avoid.

Leqvio is typically prescribed with a statin drug. Examples of statins include:

If you have an allergy to statin medications, your doctor may recommend a different cholesterol-lowering treatment such as ezetimibe (Zetia).

Talk with your doctor about what would be the best treatment plan for you.

Leqvio is approved to treat a genetic condition called heterozygous familial hypercholesterolemia. The drug is also approved to treat atherosclerotic cardiovascular disease. This is a type of heart disease related to a high level of LDL cholesterol. LDL is short for low-density lipoprotein, which is often called “bad” cholesterol.

Leqvio’s mechanism of action (how it works) is to decrease the level of LDL cholesterol.

Your liver makes a protein called PCSK9. This protein works to increase the level of LDL cholesterol in your body. Leqvio decreases the level of PCSK9 that your liver makes. By doing this, Leqvio helps lower your LDL cholesterol level.

How long does it take to work?

Leqvio should begin working as soon as you receive your first dose. However, it may take time for your LDL level to drop. In clinical trials, people had decreased levels of LDL cholesterol 14 days after their first Leqvio dose.

It’s important to note that you may not notice any changes in the way you feel while receiving Leqvio. This is because there are typically no symptoms related to high cholesterol. Your doctor will monitor your cholesterol levels with blood tests to see how well the treatment is working.

Before you receive your first dose of Leqvio, your doctor will discuss details of the drug’s administration with you. Administration is the way in which the drug is given.

Leqvio comes as a solution in a single-dose prefilled syringe. A healthcare professional will give you the medication as a subcutaneous injection. This is an injection just below your skin. You’ll go to your doctor’s office to receive your doses.

Leqvio can be injected into your abdomen, upper part of your arm, or thigh. The healthcare professional will avoid areas that have a rash, sunburn, infection, or swelling.

If you have any questions about receiving Leqvio doses, talk with your doctor.

When you’ll receive a dose

After your first dose of Leqvio, you’ll receive your second dose 3 months later. Then you’ll receive a dose once every 6 months. For more information, see the “Leqvio dosage” section above.

To help make sure that you don’t miss an appointment for your doses, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Leqvio, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.

Alternatives for heterozygous familial hypercholesterolemia

Examples of other drugs that may be prescribed for heterozygous familial hypercholesterolemia include:

Alternatives for heart disease related to high LDL cholesterol

Examples of other drugs that may be prescribed for heart disease related to high levels of low-density lipoprotein (LDL) cholesterol include:

  • evolocumab (Repatha)
  • alirocumab (Praluent)
  • atorvastatin (Lipitor)
  • rosuvastatin (Crestor)
  • ezetimibe (Zetia)
  • cholestyramine (Prevalite)
  • fenofibrate (Tricor)

There are no known interactions between Leqvio and alcohol.

However, Leqvio is typically prescribed with a statin drug to treat high cholesterol. Both alcohol and statin drugs may harm the liver. So in some cases, your doctor may recommend that you avoid alcohol during treatment with a statin drug.

Talk with your doctor to see how much alcohol, if any, is safe for you to drink with Leqvio.

Leqvio is not known to interact with other medications. It’s also not known to interact with any supplements or foods.

However, interactions could still occur. To be safe, you should talk with your doctor and pharmacist before starting Leqvio treatment. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions and help determine whether Leqvio is right for you.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

It’s not known if Leqvio treatment is safe during pregnancy. There haven’t been any clinical trials of the drug in people who are pregnant to determine whether Leqvio is safe. However, based on the way the medication works to decrease cholesterol, it’s possible that Leqvio may harm a developing fetus. Due to this risk, your doctor will likely recommend that you stop Leqvio treatment if you become pregnant.

It’s important to note that Leqvio is typically prescribed in combination with a statin drug. According to the Food and Drug Administration (FDA), in most cases, the use of statins during pregnancy is not recommended.

If you’re pregnant or planning to become pregnant, talk with your doctor before starting treatment with Leqvio. They can recommend a different medication, if needed.

It’s not known if Leqvio treatment is safe during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re receiving Leqvio.

For more information about receiving Leqvio during pregnancy, see the “Leqvio and pregnancy” section above.

It’s unknown whether it’s safe to receive Leqvio while breastfeeding. This is because it’s not known whether the drug passes into breast milk or what effects it might have on a child who is breastfed.

In animal studies, Leqvio did pass into breast milk. However, animal studies do not always indicate what may happen in humans.

It’s important to note that Leqvio is typically prescribed in combination with a statin drug. According to the Food and Drug Administration (FDA), the use of statins while breastfeeding is not recommended.

If you’re breastfeeding or planning to breastfeed, talk with your doctor before receiving Leqvio. They can advise you on treatment options and healthy ways to feed your child.

This drug comes with several precautions. Before receiving Leqvio, talk with your doctor about your health history. Leqvio may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Allergic reaction. If you’ve had an allergic reaction to Leqvio or any of its ingredients, your doctor will likely not prescribe Leqvio. Ask your doctor what other medications may be better options for you.
  • Pregnancy. It’s not known if Leqvio treatment is safe during pregnancy. For more information, see the “Leqvio and pregnancy” section above.
  • Breastfeeding. It’s not known if it’s safe to breastfeed during treatment with Leqvio. For more information, see the “Leqvio and breastfeeding” section above.

Note: For more information about the potential negative effects of Leqvio, see the “Leqvio side effects” section above.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.