Bempedoic acid

What is Bempedoic acid?

• Bempedoic acid (Nexletol) is an adenosine triphosphate-citrate lyase (ACL) inhibitor.

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What are the uses of this medicine?

This medicine is used along with diet and other lipid-lowering medicines in the treatment of adults with:

• heterozygous familial hypercholesterolemia (HeFH). HeFH is an inherited condition that causes high levels of "bad" cholesterol called low density lipoprotein (LDL).
• known heart disease who need additional lowering of "bad" cholesterol (LDL-C) levels.

How does this medicine work?

• Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibition of cholesterol synthesis in the liver.
• Bempedoic acid and its active metabolite, ESP15228, require coenzyme A (CoA) activation by very long-chain acyl-CoA synthetase 1 (ACSVL1) to ETC-1002-CoA and ESP15228-CoA, respectively.
• ACSVL1 is expressed primarily in the liver.
• Inhibition of ACL by ETC-1002-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of low-density lipoprotein receptors.

Who Should Not Use this medicine ?

Limitation of use:

• It is not known if Nexletol can decrease problems from high cholesterol, such as heart attacks, stroke, death, or other heart problems.
• It is not known if Nexletol is safe and effective in people with severe kidney problems including people with end-stage kidney disease who are on dialysis.
• It is not known if Nexletol is safe and effective in people with severe liver problems.
• It is not known if Nexletol is safe and effective in children under 18 years of age.

What drug interactions can this medicine cause?

• Avoid concomitant use of Nexletol with simvastatin greater than 20 mg.
• Avoid concomitant use of Nexletol with pravastatin greater than 40 mg.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

Recommended Dosage

• The recommended dosage of Nexletol, in combination with maximally tolerated statin therapy, is 180 mg administered orally once daily. Nexletol can be taken with or without food.
• After initiation of Nexletol, analyze lipid levels within 8 to 12 weeks.

Administration

• 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.
• You may take Nexletol with or without food.
• If you take too much Nexletol, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 180 mg

This medicine is available in fallowing brand namesː

• Nexletol

What side effects can this medication cause?

The most common side effects of this medicine include:

• symptoms of the common cold, flu, or flu-like symptoms
• back pain
• stomach pain
• increased liver enzymes
• muscle spasms
• pain in shoulder, legs, or arms
• anemia
• bronchitis

Nexletol may cause serious side effects, including:

• increased levels of uric acid in your blood (hyperuricemia)
• tendon rupture or injury

What special precautions should I follow?

• This medicine may cause hyperuricemia. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
• This medicine may cause tendon rupture. Discontinue Nexletol at the first sign of tendon rupture. Avoid Nexletol in patients who have a history of tendon disorders or tendon rupture.

What to do in case of emergency/overdose?

• In the event of an overdosage, contact Poison Control (1-800-222-1222) for latest recommendations.

Can this medicine be used in pregnancy?

• There are no available data on Nexletol use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Nexletol have not been established in pediatric patients.

What should I know about storage and disposal of this medication?

• Store Nexletol in the original package at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not throw away the packet that helps to keep your medicine dry (desiccant).

• Dailymed label info on Bempedoic acid
• FDA Bempedoic acid

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