Bempedoic acid and ezetimibe

Pronunciation: bem-pee-doe-ick az-cid and ez-e-tee-mibe
Generic name: bempedoic acid and ezetimibe
Brand name: Nexlizet
Dosage form: oral tablets
Drug class: Antihyperlipidemic combinations

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 18, 2024.

What is bempedoic acid and ezetimibe?

Bempedoic acid and ezetimibe is an oral combination tablet that combines an ACL inhibitor (bempedoic acid) with a cholesterol absorption inhibitor (ezetimibe) that may be used to reduce LDL-C levels in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), alone or in combination with other LDL-C lowering therapies. Should be used in addition to dietary changes.

The bempedoic acid component also helps to reduce the risk of a heart attack or the need to undergo cardiac procedures to restore blood flow (coronary revascularization) in adults with established cardiovascular disease (CVD), or, without CVD but at high risk for a CVD event, who are unable to take (or do not take) recommended statin therapy.

Bempedoic acid and ezetimibe works by blocking an enzyme called adenosine triphosphate-citrate lyase (ACL) that is involved in the production of cholesterol by the liver (bempedoic acid component). This lowers LDL-C levels in the blood. The ezetimibe component reduces blood cholesterol by inhibiting the absorption of dietary cholesterol by the sterol transporter, Niemann-Pick C1-Like 1 (NPC1), which is located in the small intestine.

Bempedoic acid and ezetimibe was first FDA-approved on February 26, 2020, under the brand name Nexlizet. There is no Nexlizet generic.

Bempedoic acid and ezetimibe side effects

Bempedoic acid and ezetimibe may cause serious side effects, including the following.

Increased levels of uric acid in your blood (hyperuricemia). This can happen within 4 weeks of you starting bempedoic acid and ezetimibe and continue throughout your treatment. Your healthcare provider may monitor your blood uric acid levels while you are taking bempedoic acid and ezetimibe. 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 bempedoic acid, one of the medicines in Nexlizet. 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 bempedoic acid and ezetimibe. Tendon ruptures can happen within weeks or months of starting bempedoic acid and ezetimibe.
The risk of getting tendon problems while you take bempedoic acid and ezetimibe 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 bempedoic acid and ezetimibe 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
Stop taking bempedoic acid and ezetimibe until tendon rupture has been ruled out by your healthcare provider. 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 bempedoic acid and ezetimibe. You may need a different lipid-lowering medicine to treat your cholesterol levels.

The most common side effects of bempedoic acid and ezetimibe affecting 2% or more people include:

symptoms of the common cold, flu, or flu-like symptoms
back pain
bronchitis
anemia
high uric acid levels
diarrhea
muscle spasms
stomach pain
pain in the shoulder, legs, or arms
increased liver enzymes
fatigue.

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. Ask your healthcare provider or pharmacist for more information.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

The ezetimibe ingredient may cause hypersensitivity reactions, including anaphylaxis, angioedema, rash, or urticaria. Do not use in people with a known hypersensitivity to ezetimibe. Stop taking bempedoic acid and ezetimibe and call your healthcare provider, or go to the nearest hospital emergency room right away if you have any signs or symptoms of an allergic reaction including:

swelling of your face, lips, mouth, or tongue
wheezing
severe itching
a fast heartbeat or pounding in your chest
trouble breathing
dizziness or fainting.

It is not known if bempedoic acid and ezetimibe 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 symptoms of gout and treat if appropriate.

Bempedoic acid and ezetimibe 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.

Bempedoic acid and ezetimibe cost

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Bempedoic acid and ezetimibe is only available under the brand name, Nexlizet. Refer to our price guide page for more information about Nexlizet cost.

You may also be eligible for a Nexlizet coupon or Nexlizet copay card. Ask your doctor or pharmacist if you qualify. There is no Nexlizet generic.

Before taking

Before you start taking bempedoic acid and ezetimibe, 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 moderate or severe liver problems
are pregnant, think you may be pregnant, or plan to get pregnant
are breastfeeding or plan to breastfeed.

Pregnancy

Bempedoic acid and ezetimibe may cause harm to your unborn baby. You and your healthcare provider will decide if you should take it while you are pregnant. If you become pregnant during bempedoic acid and ezetimibe treatment, tell your healthcare provider right away and call Esperion at 1-833-377-7633 to share information about the health of you and your baby.

Breastfeeding

It is not known if bempedoic acid and ezetimibe passes into your breast milk. You and your healthcare provider should decide if you will take bempedoic acid and ezetimibe or breastfeed. You should not do both.

How should I take bempedoic acid and ezetimibe?

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

Take 1 Nexlizet 180-10 tablet (bempedoic acid and ezetimibe) by mouth every day. Each Nexlizet tablet contains 180 mg bempedoic acid and 10 mg ezetimibe.
Swallow the tablet whole. Do not cut, chew, or crush the tablet.
You may take the tablet with or without food.

If you take a medicine that lowers cholesterol by binding bile acids, such as colesevelam or cholestyramine, take bempedoic acid and ezetimibe at least 2 hours before or 4 hours after you take bile acid-binding medicines. Ask your healthcare provider if you are not sure if you take these medicines.

What happens if I miss a dose?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and just go back to your regular dosing schedule. Do not take two doses at once.

What happens if I overdose?

If you take too much bempedoic acid and ezetimibe, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What other medicines will affect bempedoic acid and ezetimibe?

Bempedoic acid and ezetimibe may affect the way other medicines work, and other medicines may affect how bempedoic acid and ezetimibe 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 or plan to take:

simvastatin or pravastatin (other cholesterol-lowering medicines). Taking statins with bempedoic acid and ezetimibe may increase your risk of developing muscle pain or weakness (myopathy)
cyclosporine (often used in organ transplant patients)
fibrates (used to lower cholesterol)
cholestyramine (used to lower cholesterol).

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Storage

Store bempedoic acid and ezetimibe in the original package at room temperature between 68ºF to 77ºF (20ºC to 25ºC).

Protect from heat and moisture. Do not throw away the packet that helps to keep your medicine dry (desiccant).

Nexlizet comes in a bottle with a child-resistant cap. Keep all medicines out of the reach of children and pets.

Nexlizet ingredients

Active Ingredients: bempedoic acid and ezetimibe.

Inactive Ingredients: colloidal silicon dioxide, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K30, sodium lauryl sulfate, sodium starch glycolate.

Tablet coating: FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, glyceryl monocaprylocaprate, partially hydrolyzed polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide.

Only available in one strength that contains 180 mg bempedoic acid and 10 mg ezetimibe.