Nexletol (bempedoic acid)

Description

What is Nexletol (bempedoic acid) for?

Nexletol (bempedoic acid) is an adenosine triphosphate-citrate lyase (ACL) inhibitor indicated for the treatment of hypercholesterolemia (high blood cholesterol levels) with:

• heterozygous familial hypercholesterolemia
• established atherosclerotic cardiovascular disease

Nexletol (bempedoic acid) is taken as an addition (adjunct) to diet and highest tolerated statin therapy.

It is available in capsule form containing 180 mg bempedoic acid.

How does Nexletol (bempedoic acid) work?

Bempedoic acid is a medicine that lowers low-density lipoprotein (LDL) cholesterol (known as ‘bad’ cholesterol). It does so by blocking adenosine triphosphate citrate lyase, which is an enzyme in the liver that is responsible for making cholesterol. As a result, bempedoic acid lowers blood levels of cholesterol, including LDL-cholesterol and other fatty substances made by the liver.

Statins lower cholesterol by blocking the activity of another cholesterol-forming enzyme, named HMG-CoA reductase. Even with maximally tolerated statin dosage, which may mean no statins at all, LDL-C cannot be lowered to a safe concentration in some patients.

Where has Nexletol (bempedoic acid) been approved?

Nexletol (bempedoic acid) was approved by:

• The Food and Drug Administration (FDA), USA, on February 21, 2020, for the treatment of hypercholesterolemia in combination with diet and the highest tolerated statin therapy.
• The European Medicines Agency (EMA), Europe, on April 1, 2020, under the brand name Nilemdo for the treatment of primary hypercholesterolaemia or mixed dyslipidemia (conditions that cause high levels of fats, including cholesterol, in the blood). It is used in combination with diet and the highest tolerated statin therapy, with or without other fat-lowering medicines.

Nexletol is the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002 for indicated patients.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to us.

How is Nexletol (bempedoic acid) taken?

The standard dosage is:

• One 180 mg capsule per day, taken with or without food.

Complete information about Nexletol (bempedoic acid) dosage and administration can be found in the official prescribing information listed in our references section.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Nexletol (bempedoic acid)?

Common adverse reactions

The most common side effects (≥20% of patients) listed in the prescribing information include:

• Pain in your back, shoulder, legs, or arms
• Muscle spasm
• Stomach pain
• Anemia
• Abnormal liver function tests
• Wheezing, cough, chest congestion
• Cold symptoms such as stuffy nose, sneezing, sore throat.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:

Increased levels of uric acid in your blood (hyperuricemia)

• • Tendon rupture or injury

Use in a specific population

Nexletol (bempedoic acid) can cause fetal harm when administered to a pregnant woman, it is advised to avoid pregnancies and breastfeeding.