Is Nexlizet approved by the FDA?

Yes, Nexlizet is FDA approved. The U.S. Food and Drug Administration (FDA) approved Nexlizet, a combination of bempedoic acid and ezetimibe, on February 26, 2020. This medication is designed to lower LDL cholesterol levels in adults with primary hyperlipidemia, including those with heterozygous familial hypercholesterolemia (HeFH).

What is Nexlizet?

Nexlizet is an oral combination tablet that includes two key components:

1. Bempedoic Acid: An ACL inhibitor that reduces cholesterol production in the liver.
2. Ezetimibe: A cholesterol absorption inhibitor that blocks the absorption of dietary cholesterol in the small intestine.

How Does Nexlizet Work?

Nexlizet lowers LDL cholesterol by targeting two different pathways:

• Bempedoic Acid: Blocks the enzyme adenosine triphosphate-citrate lyase (ACL), which is involved in cholesterol production in the liver.
• Ezetimibe: Inhibits the sterol transporter Niemann-Pick C1-Like 1 (NPC1), reducing the absorption of cholesterol from the diet.

Indications for Nexlizet

Nexlizet is used to:

• Reduce LDL cholesterol levels in adults with primary hyperlipidemia, including HeFH.
• Lower the risk of heart attack and the need for cardiac procedures in adults with established cardiovascular disease or those at high risk for a cardiovascular event who cannot take statins.

Dosage and Administration

The recommended dosage of Nexlizet is one tablet (containing 180 mg bempedoic acid and 10 mg ezetimibe) taken orally once daily. The tablet should be swallowed whole and can be taken with or without food.

Side Effects

Nexlizet can cause several side effects, including:

• Common cold symptoms
• Back pain
• Bronchitis
• Anemia
• High uric acid levels, potentially leading to gout
• Diarrhea
• Muscle spasms
• Stomach pain
• Pain in the shoulder, legs, or arms
• Increased liver enzymes
• Fatigue

Serious Side Effects

Some serious side effects include:

• Hyperuricemia: Increased uric acid levels can lead to gout.
• Tendon Rupture or Injury: Tendon problems are more likely in individuals over 60, those taking corticosteroids or fluoroquinolones, and those with renal failure or previous tendon issues.

Warnings and Precautions

Before taking Nexlizet, inform your healthcare provider if you have a history of:

• Gout
• Tendon problems
• Severe kidney or liver issues
• Pregnancy or breastfeeding

Nexlizet may cause fetal harm and is not recommended during breastfeeding.

Conclusion

Nexlizet, approved by the FDA on February 26, 2020, is an effective medication for lowering LDL cholesterol in adults with primary hyperlipidemia and for reducing cardiovascular risks in certain high-risk groups. Always consult with a healthcare provider for personalized advice and information on managing cholesterol levels.

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