Q: What is Nexlizet used for?

Nexlizet is used to treat LDL-C lowering in adults with primary hyperlipidemia (including HeFH ), and for cardiovascular risk reduction (myocardial infarction and coronary revascularization) in certain adults unable to take recommended statin therapy.

Q: How does Nexlizet work?

Dual Mechanism of Action Nexlizet contains two different medicines, bempedoic acid and ezetimibe, which work together to lower cholesterol levels in the blood through different pathways. How Bempedoic Acid Works Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor. It primarily works in the liver by blocking a specific enzyme needed to create cholesterol. When the liver produces less cholesterol, it compensates by increasing the number of receptors that pull LDL (bad) cholesterol out of the blood, thereby lowering overall levels. How Ezetimibe Works Ezetimibe is a cholesterol absorption inhibitor. Unlike bempedoic acid, it works in the small intestine. It blocks the absorption of cholesterol from the food you eat and from the bile produced by your body. This reduces the amount of cholesterol that is delivered to the liver and released into the bloodstream. Combined Effect By targeting cholesterol at two different stages—production in the liver and absorption in the intestines—Nexlizet provides a combined effect to help manage high cholesterol levels in people who need additional treatment alongside diet and other medications like statins.

Q: What are the active ingredients in Nexlizet?

The active ingredients in Nexlizet are bempedoic acid and ezetimibe .

Q: What are the side effects of Nexlizet?

Common side effects of Nexlizet may include: upper respiratory infection muscle pain back pain Always consult with a healthcare professional about potential side effects.

Q: What is the dosage of Nexlizet and how do I take it?

How to Take This Medication Nexlizet is taken by mouth, usually once every day. You may take the tablet with or without food. It is helpful to take the medication at the same time each day to maintain a consistent routine. When taking Nexlizet, you should swallow the tablet whole. Do not crush, chew, or break the tablet. If you are also taking certain other cholesterol-lowering medications known as bile acid sequestrants, you may need to space out when you take each medication to ensure they work properly. Missed Dose If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time to make up for a missed one.

Q: Is Nexlizet safe during pregnancy and breastfeeding?

Pregnancy Nexlizet is not recommended for use during pregnancy. This medication works by lowering cholesterol levels, but cholesterol and other products of cholesterol synthesis are necessary for the healthy development of a fetus. Reducing these levels could potentially cause harm to an unborn baby. Because of these risks, treatment with Nexlizet should usually be stopped as soon as pregnancy is detected. If you are planning to become pregnant or think you might be pregnant, talk to your healthcare provider about the risks and benefits of your treatment options. Breastfeeding It is not known if the active ingredients in Nexlizet pass into human breast milk. However, because of the potential for serious side effects in a nursing infant, breastfeeding is generally not recommended while taking this medication. Patients should discuss with their doctor whether to stop breastfeeding or stop taking the medication, taking into account the importance of the drug to the mother's health and the nutritional needs of the infant.

Q: What is the FDA approval status of Nexlizet?

FDA Approval History Nexlizet was first approved by the U.S. Food and Drug Administration (FDA) in February 2020. It is a fixed-dose combination of bempedoic acid and ezetimibe. In March 2024, the FDA expanded its approved uses to include the reduction of cardiovascular risk in certain populations. Approved Indications Nexlizet is indicated as an addition to diet, either alone or with other cholesterol-lowering therapies, for the treatment of primary hyperlipidemia in adults to reduce low-density lipoprotein cholesterol (LDL-C). It is also approved to reduce the risk of heart attack (myocardial infarction) and the need for heart procedures (coronary revascularization) in adults with established cardiovascular disease or those at high risk for a cardiovascular event. Safety and Regulatory Information The FDA has not required a boxed warning or a Risk Evaluation and Mitigation Strategy (REMS) for Nexlizet. However, the approved labeling includes specific warnings regarding the following risks: Hyperuricemia: Treatment may increase blood uric acid levels, which can lead to the development of gout. Tendon Rupture: There is an increased risk of tendon rupture or injury, which may occur more frequently in patients over 60, those taking corticosteroids or fluoroquinolones, or those with a history of tendon disorders.

Question 1

What is Nexlizet?

Accepted Answer

Nexlizet is a combination medicine that works in two different ways to reduce cholesterol. It contains bempedoic acid, which blocks an enzyme in the liver used to make cholesterol, and ezetimibe, which reduces the amount of cholesterol the body absorbs from food.

By combining these two active ingredients, the medication helps lower the amount of low-density lipoprotein (LDL) cholesterol, often referred to as bad cholesterol, circulating in the bloodstream. This dual-action approach targets both the production and absorption of cholesterol to help manage lipid levels.

Question 2

What is Nexlizet used for?

Accepted Answer

Nexlizet is used to treat LDL-C lowering in adults with primary hyperlipidemia (including HeFH), and for cardiovascular risk reduction (myocardial infarction and coronary revascularization) in certain adults unable to take recommended statin therapy.

Question 3

How does Nexlizet work?

Accepted Answer

Dual Mechanism of Action

Nexlizet contains two different medicines, bempedoic acid and ezetimibe, which work together to lower cholesterol levels in the blood through different pathways.

How Bempedoic Acid Works

Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor. It primarily works in the liver by blocking a specific enzyme needed to create cholesterol. When the liver produces less cholesterol, it compensates by increasing the number of receptors that pull LDL (bad) cholesterol out of the blood, thereby lowering overall levels.

How Ezetimibe Works

Ezetimibe is a cholesterol absorption inhibitor. Unlike bempedoic acid, it works in the small intestine. It blocks the absorption of cholesterol from the food you eat and from the bile produced by your body. This reduces the amount of cholesterol that is delivered to the liver and released into the bloodstream.

Combined Effect

By targeting cholesterol at two different stages—production in the liver and absorption in the intestines—Nexlizet provides a combined effect to help manage high cholesterol levels in people who need additional treatment alongside diet and other medications like statins.

Question 4

What are the active ingredients in Nexlizet?

Accepted Answer

The active ingredients in Nexlizet are bempedoic acid and ezetimibe.

Question 5

What are the side effects of Nexlizet?

Accepted Answer

Common side effects of Nexlizet may include:

upper respiratory infection
muscle pain
back pain

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Nexlizet?

Accepted Answer

Nexlizet belongs to the cholesterol absorption inhibitor and ATP citrate lyase inhibitor drug class.

Question 7

What is the dosage of Nexlizet and how do I take it?

Accepted Answer

How to Take This Medication

Nexlizet is taken by mouth, usually once every day. You may take the tablet with or without food. It is helpful to take the medication at the same time each day to maintain a consistent routine.

When taking Nexlizet, you should swallow the tablet whole. Do not crush, chew, or break the tablet. If you are also taking certain other cholesterol-lowering medications known as bile acid sequestrants, you may need to space out when you take each medication to ensure they work properly.

Missed Dose

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time to make up for a missed one.

Question 8

Is Nexlizet safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

Nexlizet is not recommended for use during pregnancy. This medication works by lowering cholesterol levels, but cholesterol and other products of cholesterol synthesis are necessary for the healthy development of a fetus. Reducing these levels could potentially cause harm to an unborn baby.

Because of these risks, treatment with Nexlizet should usually be stopped as soon as pregnancy is detected. If you are planning to become pregnant or think you might be pregnant, talk to your healthcare provider about the risks and benefits of your treatment options.

Breastfeeding

It is not known if the active ingredients in Nexlizet pass into human breast milk. However, because of the potential for serious side effects in a nursing infant, breastfeeding is generally not recommended while taking this medication.

Patients should discuss with their doctor whether to stop breastfeeding or stop taking the medication, taking into account the importance of the drug to the mother's health and the nutritional needs of the infant.

Question 9

What forms and strengths does Nexlizet come in?

Accepted Answer

Nexlizet is available as a film-coated tablet intended for oral administration. As a fixed-dose combination product, each tablet contains two different active ingredients in a single pill.

Question 10

What is the FDA approval status of Nexlizet?

Accepted Answer

FDA Approval History

Nexlizet was first approved by the U.S. Food and Drug Administration (FDA) in February 2020. It is a fixed-dose combination of bempedoic acid and ezetimibe. In March 2024, the FDA expanded its approved uses to include the reduction of cardiovascular risk in certain populations.

Approved Indications

Nexlizet is indicated as an addition to diet, either alone or with other cholesterol-lowering therapies, for the treatment of primary hyperlipidemia in adults to reduce low-density lipoprotein cholesterol (LDL-C). It is also approved to reduce the risk of heart attack (myocardial infarction) and the need for heart procedures (coronary revascularization) in adults with established cardiovascular disease or those at high risk for a cardiovascular event.

Safety and Regulatory Information

The FDA has not required a boxed warning or a Risk Evaluation and Mitigation Strategy (REMS) for Nexlizet. However, the approved labeling includes specific warnings regarding the following risks:

Hyperuricemia: Treatment may increase blood uric acid levels, which can lead to the development of gout.
Tendon Rupture: There is an increased risk of tendon rupture or injury, which may occur more frequently in patients over 60, those taking corticosteroids or fluoroquinolones, or those with a history of tendon disorders.

Question 11

What should I know about Nexlizet and cost?

Accepted Answer

Factors Affecting Cost

The price you pay for Nexlizet depends on several factors, including your insurance plan, your location, and the pharmacy you choose. Because Nexlizet is a brand-name drug and does not currently have a generic equivalent, it may be more expensive than older cholesterol medications.

Insurance Coverage

Many private insurance plans and Medicare Part D plans cover Nexlizet, but the amount you pay out-of-pocket will depend on your plan's formulary. Some plans may require prior authorization before they agree to cover the medication.

Financial Assistance

Manufacturer Savings: The manufacturer may offer a copay card or savings program for eligible patients with commercial insurance to help lower the monthly cost.
Patient Assistance Programs: Programs may be available for individuals who are uninsured or underinsured and meet specific income requirements.

It is recommended to check with your insurance provider or pharmacist to determine the exact cost and explore available savings options.

Nexlizet

📋Overview

How It Works

Uses

Active Ingredients

Common Side Effects

Warnings & Precautions

Dosage

Pregnancy & Breastfeeding

Frequently Asked Questions

📚References

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