Question 1

What is Nexletol?

Accepted Answer

Nexletol is a medication designed to help manage cholesterol levels in the body. It contains the active ingredient bempedoic acid, which is classified as an adenosine triphosphate-citrate lyase (ACL) inhibitor.

The drug works by targeting a specific enzyme in the liver involved in the production of cholesterol. By blocking this process, the medication assists in reducing the overall amount of low-density lipoprotein circulating in the blood.

Question 2

What is Nexletol used for?

Accepted Answer

Nexletol is used to treat:

LDL-C lowering in adults with primary hyperlipidemia (including HeFH)

LDL-C lowering in adults with established ASCVD

Cardiovascular risk reduction (myocardial infarction and coronary revascularization) in certain adults unable to take recommended statin therapy

Question 3

How does Nexletol work?

Accepted Answer

Mechanism of Action

Nexletol belongs to a class of medications called adenosine triphosphate-citrate lyase (ACL) inhibitors. It is used to lower levels of low-density lipoprotein (LDL) cholesterol, commonly known as bad cholesterol.

The medication works through the following steps:

Enzyme Inhibition: Nexletol targets and blocks an enzyme in the liver called ACL. This enzyme is necessary for the body to manufacture cholesterol.

Reduced Production: By interfering with this enzyme, the drug slows down the liver's ability to create new cholesterol.

Increased Removal: When the liver senses it has less cholesterol, it increases the number of receptors on its surface. These receptors capture LDL cholesterol from the blood and bring it into the liver to be broken down.

Nexletol is a prodrug, meaning it only becomes active after it is processed by the liver. Because the specific enzyme required to activate the drug is not typically found in muscle tissue, Nexletol is designed to lower cholesterol without the muscle-related side effects often associated with other treatments.

Question 4

What are the active ingredients in Nexletol?

Accepted Answer

The active ingredient in Nexletol is bempedoic acid .

Question 5

What are the side effects of Nexletol?

Accepted Answer

Common side effects of Nexletol may include:

upper respiratory infection

muscle spasms

back pain

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Nexletol?

Accepted Answer

Nexletol belongs to the ATP citrate lyase inhibitor drug class.

Question 7

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

Accepted Answer

How to Take Nexletol

Nexletol is taken by mouth as a tablet. It is typically prescribed to be taken once every day. You can take this medication at any time of day, and it may be taken with or without food.

It is important to take this medication exactly as directed by a healthcare provider. To help you remember, try to take it at the same time each day. This medication is usually used in combination with a heart-healthy diet and other cholesterol-lowering treatments.

Missed Dose

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

Question 8

Is Nexletol safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

There is limited data regarding the safety of Nexletol in pregnant women. Because cholesterol and other fats are necessary for the development of an unborn baby, lowering cholesterol levels during pregnancy may cause harm. Animal studies have shown that bempedoic acid can lead to decreased fetal body weight and other developmental issues. Most healthcare providers recommend stopping this medication before or as soon as pregnancy is confirmed.

Breastfeeding

It is currently unknown if Nexletol passes into human breast milk or if it affects a nursing infant. Due to the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended while taking this medication. Patients should consult with their healthcare provider to discuss the risks and benefits of continuing treatment versus breastfeeding.

Question 9

What forms and strengths does Nexletol come in?

Accepted Answer

Nexletol is supplied as a film-coated tablet for oral use. It is designed to be taken by mouth, usually once daily, and can be taken with or without food.

Question 10

What is the FDA approval status of Nexletol?

Accepted Answer

FDA Approval Status

Nexletol was first approved by the U.S. Food and Drug Administration (FDA) in February 2020. It is classified as an adenosine triphosphate-citrate lyase (ACL) inhibitor. In March 2024, the FDA expanded the drug's approved indications to include cardiovascular risk reduction.

Approved Indications

Nexletol is indicated for use in adults in the following cases:

To reduce the risk of heart attack (myocardial infarction) and certain heart procedures (coronary revascularization) in patients who are unable to take recommended statin therapy, or those with established cardiovascular disease.

To lower low-density lipoprotein (LDL) cholesterol in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

The medication is intended for use alongside a heart-healthy diet and may be used alone or with other cholesterol-lowering drugs.

Safety Communications

The FDA-approved labeling for Nexletol does not include a boxed warning. However, it does contain warnings regarding the risk of hyperuricemia (elevated uric acid levels), which may lead to gout, and the risk of tendon rupture. There are no specific Risk Evaluation and Mitigation Strategies (REMS) required for its distribution.

Question 11

What should I know about Nexletol and cost?

Accepted Answer

Factors Influencing Cost

The price you pay for Nexletol can vary based on several factors:

Insurance Coverage: Most commercial insurance plans and Medicare Part D plans cover Nexletol, but your specific out-of-pocket cost will depend on your plan's deductible, copayment, or coinsurance requirements.

Pharmacy Choice: Prices may differ between retail pharmacies, and some mail-order services may offer different pricing structures.

Generic Availability: Nexletol is currently only available as a brand-name medication. There is no lower-cost generic version available at this time.

Financial Assistance Programs

There are options available that may help reduce the cost of Nexletol for eligible patients:

Manufacturer Savings Card: The drug manufacturer may offer a savings card for people with commercial insurance, which can significantly lower monthly copays.

Patient Assistance Programs: For individuals who are uninsured or underinsured, patient assistance programs may provide the medication at a reduced cost or for free, depending on income eligibility and other requirements.

It is recommended to check with your insurance provider and your pharmacist to determine the exact cost for your prescription.

Nexletol

Medication Quick Facts

📋Overview

What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Price Information

FAQ

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