Nexlizet (Bempedoic Acid and Ezetimibe) – Oral

What Is Nexlizet?

Nexlizet (bempedoic acid and ezetimibe) is a prescription oral tablet that contains both bempedoic acid and ezetimibe. This medication is approved by the Food and Drug Administration (FDA) to be combined with diet and statin therapy for the treatment of familial hypercholesterolemia (genetic high cholesterol) or certain heart diseases that require additional lowering of bad cholesterol.

Bempedoic acid acts as an adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers “bad” cholesterol, or low-density lipoprotein (LDL) cholesterol, by decreasing the amount of cholesterol your liver makes.

Throughout the body, there are specific proteins that speed up reactions that happen inside our bodies known as enzymes.

These enzymes can help speed up important reactions that would normally take hours, allowing them to occur in minutes instead.

ACL is one of many enzymes required to make cholesterol. By inhibiting ACL, the amount of cholesterol produced in the liver decreases. With this decrease in cholesterol, the liver cells increase the uptake of bad cholesterol from the blood, thus lowering LDL.

Ezetimibe acts on Niemann-Pick C1-Like 1 (NPC1L1), which is a unique transporter responsible for taking up cholesterol. By inhibiting NPC1L1, the amount of cholesterol absorbed from the small intestine is decreased, leading to a decrease in the delivery of cholesterol to the liver.

Nexlizet is available for oral consumption in film-coated tablet form.

What Is Nexlizet Used For?

The FDA approved Nexlizet along with diet and statins for the treatment of adults with the following conditions:

• Genetic high cholesterol (heterozygous familial hypercholesterolemia)
• Established heart disease for people who require additional lowering of LDL
  

How to Take Nexlizet

Nexlizet usually is taken once a day with or without food. It is important to swallow the tablet whole. Do not chew the medication.

Nexlizet should be taken either at least two hours before or four hours after bile acid sequestrants, including Colestid (colestipol), Welchol (colesevelam), and Prevalite (cholestyramine).

Storage

Nexlizet should be stored in a cool, dry place. In general, medications should be kept away from places that are very hot like above your stove, or in places that are very humid like your bathroom.

These environments can impact how well the medications work. Keep this medication away from children and pets to avoid accidental consumption.

No specific travel requirements are provided by the Transportation Security Administration for Nexlizet.

When you want to refill this medication, request a refill from your pharmacy before you run out of Nexlizet.

What Are the Side Effects of Nexlizet?

This is not a complete list of side effects, and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Common side effects of Nexlizet include:

• Signs of a common cold
• Flu-like symptoms
• Back pain
• Stomach pain
• Muscle spasms
• Diarrhea
• Constipation 
• Drowsiness  
• Urinary tract infection (UTI)
• Elevated uric acid in the blood
• Bronchitis

Severe Side Effects

Potential serious side effects associated with Nexlizet use include:

• Anaphylaxis 
• Hyperuricemia (high acid levels)
• Abdominal pain
• Increased risk of gout
• Increased risk of tendon rupture
• Imbalance in atrial fibrillation
• Benign prostatic hyperplasia (BPH)
  

You should call 911 if your symptoms feel life-threatening, or if you think you are experiencing a medical emergency.

Dosage: How Much Nexlizet Should I Take?

Modifications

For adults with normal-functioning kidneys, no dose modifications are necessary. However, this medication is not recommended for adults with moderate to severe liver problems.

It is not known if Nexlizet is safe and effective in children under 18 years of age. In pregnant people, it is recommended to discontinue Nexlizet unless the benefits of therapy outweigh the potential risks to the fetus.

Breastfeeding is not recommended with Nexlizet. The use of Nexlizet in adults 65 and older have been determined to be safe and effective, although greater sensitivity of the drug may occur in older individuals.

Missed Dose

If you miss a dose of Nexlizet, you should take it as soon as you remember. If the time when you remember happens to be close to the next scheduled dose, you should take just the scheduled dose and not take the one that was missed. You should not take more than one dose at a time.

Overdose: What Happens If I Take Too Much Nexlizet?

Precautions

What Are Reasons I Shouldn't Take Nexlizet?

This medication should be used cautiously if you have a history of gout. The use of Nexlizet has been shown to increase uric acid levels, which can cause a gout flare-up. If you are on Nexlizet, monitor your uric acid if you are experiencing any signs and symptoms of high uric acid levels.

People who are 60 or older, people taking corticosteroids, people taking antibiotics such as fluoroquinolones Cipro (ciprofloxacin), or Levaquin (levofloxacin), and those with renal (kidney) failure have an increased risk of experiencing tendon ruptures.

This medication should be avoided if you have a history of tendon disorders or tendon ruptures. It’s also important to remember that Nexlizet is discouraged in people with a known hypersensitivity to ezetimibe tablets.

What Other Medications Interact With Nexlizet?

Nexlizet should be separated when taking bile acid sequestrants, another class of drugs that also lowers bad cholesterol, and includes Colestid (colestipol), Welchol (colesevelam), and Questran (cholestyramine).

Most of the medications that interact with Nexlizet are common drugs taken for high cholesterol.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take or plan to take the following cholesterol-lowering medications:

• Zocor (simvastatin)
• Pravastatin
• Cyclosporine
• Fibrates, such as TriCor (fenofibrate)
• Bile acid sequestrants 

Taking Nexlizet with simvastatin or pravastatin may increase the likelihood of muscle pain or muscle weakness. The use of Nexlizet with fibrates such as fenofibrate can also increase the likelihood of muscle pain or muscle weakness.

When using Nexlizet with bile acid sequestrants, take your Nexlizet either two hours before or four hours after you take your bile acid sequestrants as it may decrease how good your Nexlizet works.

This is not a complete list of all the drugs that may interact with Nexlizet. Always keep an up-to-date list of all the medicines you take and share this information with your healthcare provider and pharmacist any time there are changes.

What Medications Are Similar?

Nexlizet is a medication that has been approved by the FDA for genetic high cholesterol or certain heart diseases that require additional lowering of bad cholesterol.

Examples of similar drugs that lower cholesterol includes:

• Lipitor (atorvastatin)
• Crestor (rosuvastatin)
• Zocor (simvastatin)
• Pravastatin
• Questran (cholestyramine)
• Zetia (ezetimibe)

This is a list of drugs that are commonly prescribed for high cholesterol. It is not a list of drugs recommended to take with Nexlizet.

You should ask your pharmacist or your healthcare provider if you have any questions or concerns.

How Can I Stay Healthy While Taking Nexlizet?

In order to stay healthy while taking Nexlizet, it is important to take Nexlizet as directed by your healthcare provider. Nexlizet should be taken daily to control your cholesterol levels.

Along with regular use of Nexlizet, aim to live a healthy lifestyle by maintaining a healthy diet, exercising regularly, and taking your statins and other cholesterol medications as directed.