Nexletol

Generic name: Bempedoic Acid
Dosage form: oral tablet
Drug class: Miscellaneous antihyperlipidemic agents

Usage of Nexletol

Nexletol (Bempedoic acid) may be used to lower high blood cholesterol levels alongside a cholesterol-lowering diet and statin treatment in people with:

heterozygous familial hypercholesterolemia (HeFH)

atherosclerotic cardiovascular disease who need additional lowering of low-density lipoprotein cholesterol (LDL-C).

Nexletol (bempedoic acid) works by inhibiting an enzyme called adenosine triphosphate-citrate lyase (ACL) that is involved in cholesterol synthesis in the liver. This decreases cholesterol synthesis in the liver and lowers LDL-C levels in the blood.

HeFH is an inherited genetic condition characterized by dangerously high cholesterol levels, which can cause serious cardiovascular disease and events (such as a heart attack or stroke) at an early age if left untreated. Atherosclerotic cardiovascular disease is the thickening or hardening of the arteries caused by a buildup of fats, cholesterol, and other substances (called a plaque) on the inner artery wall. This can cause a narrowing of the arteries, blocking blood flow and increasing the risk of a heart attack or stroke.

Nexletol was FDA-approved on February 21, 2020.

Nexletol side effects

Nexletol may cause serious side effects, including the following.

Increased levels of uric acid in your blood (hyperuricemia). This can happen within 4 weeks of starting treatment and continue throughout. Your healthcare provider will monitor your blood uric acid levels while you are taking Nexletol. High levels of blood uric acid may lead to gout. Call your healthcare provider if you have the following symptoms of hyperuricemia and gout:

severe foot pain especially in the toe joint

warm joints

swelling

tender joints

joint redness.

Gout may happen more in people who have had gout before but also can happen in people who have never had it before.

Tendon rupture or injury. Tendon problems can happen in people who take Nexletol. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include pain, swelling, tears, and inflammation of tendons including the arm, shoulder, and back of the ankle (Achilles).

Tendon rupture can happen while you are taking Nexletol. Tendon ruptures can happen within days or months of starting Nexletol.

The risk of getting tendon problems while you take Nexletol is higher if you:

are over 60 years of age

are taking antibiotics (fluoroquinolones)

have had tendon problems

are taking steroids (corticosteroids)

have renal failure.

Stop taking Nexletol immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture:

hear or feel a snap or pop in a tendon area

bruising right after an injury in a tendon area

unable to move the affected area or put weight on the affected area

If you suspect a tendon rupture, do not take Nexletol until this has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common areas of pain and swelling are the rotator cuff (the shoulder), the biceps tendon (upper arm), and the Achilles tendon at the back of the ankle. This can happen with other tendons.

Talk to your healthcare provider about the risk of tendon rupture with continued use of Nexletol. You may need a different lipid-lowering medicine to treat your cholesterol levels.

The most common side effects of Nexletol affecting 2% or more people include:

symptoms of the common cold, flu, or flu-like symptoms

back pain

stomach pain

high uric acid levels

increased liver enzymes

muscle spasms

pain in the shoulder, legs, or arms

anemia

bronchitis.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Nexletol. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Nexletol

Before you start taking Nexletol, tell your healthcare provider about all your medical conditions, including if you:

have or had gout.

have or had tendon problems

have severe kidney problems.

have severe liver problems

are pregnant. Tell your healthcare provider right away if you become pregnant while taking Nexletol. You and your healthcare provider will decide if you should take Nexletol while you are pregnant

are breastfeeding or plan to breastfeed. It is not known if Nexletol passes into your breast milk. You and your healthcare provider should decide if you will take Nexletol or breastfeed. You should not do both.

Relate drugs

How to use Nexletol

Take Nexletol exactly as your healthcare provider tells you to take it. Check with your healthcare provider or pharmacist if you are not sure.

Take 1 Nexletol tablet by mouth each day. Each tablet contains 180mg bempedoic acid.

You may take it with or without food.

Warnings

It is not known if Nexletol is safe and effective in:

people with severe liver problems

severe kidney problems including people with end-stage kidney disease who are on dialysis

children under 18 years of age.

Elevations in serum uric acid have occurred. Your healthcare provider will monitor your uric acid levels and you for symptoms of gout and treat if appropriate.

Nexletol is associated with an increased risk of tendon rupture within weeks to months of starting treatment. The risk is higher in those who are over 60 years of age, taking corticosteroids or fluoroquinolones, in patients with renal failure, and those with previous tendon disorders. Tell your doctor right away if you experience joint pain, swelling, or inflammation of a joint.

May cause fetal harm. Breastfeeding is not recommended.

What other drugs will affect Nexletol

Nexletol may affect the way other medicines work, and other medicines may affect how Nexletol works. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider if you take simvastatin or pravastatin (other cholesterol-lowering medicines). Taking simvastatin or pravastatin with Nexletol may increase your risk of developing muscle pain or weakness (myopathy). Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

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