Nexlizet

Generic name: Bempedoic Acid And Ezetimibe
Dosage form: oral tablets
Drug class: Antihyperlipidemic combinations

Usage of Nexlizet

Nexlizet is a combination medicine that contains two cholesterol-lowering medicines, Bempedoic acid and ezetimibe, which may be used to lower high blood cholesterol levels alongside a cholesterol-lowering diet and statin treatment in people with:

heterozygous familial hypercholesterolemia (HeFH)

atherosclerotic cardiovascular disease who need additional lowering of low-density lipoprotein cholesterol (LDL-C).

The bempedoic ingredient of Nexlizet works by inhibiting an enzyme called adenosine triphosphate-citrate lyase (ACL) that is involved in cholesterol synthesis in the liver. This decreases cholesterol synthesis in the liver and lowers LDL-C levels in the blood. Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the sterol transporter, Niemann-Pick C1-Like 1 (NPC1), which is located in the small intestine.

HeFH is an inherited genetic condition characterized by dangerously high cholesterol levels, which can cause serious cardiovascular disease and events (such as a heart attack or stroke) at an early age if left untreated. Atherosclerotic cardiovascular disease is the thickening or hardening of the arteries caused by a buildup of fats, cholesterol, and other substances (called a plaque) on the inner artery wall. This can cause a narrowing of the arteries, blocking blood flow and increasing the risk of a heart attack or stroke.

Nexlizet was FDA-approved on February 26, 2020.

Nexlizet side effects

Nexlizet 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 Nexlizet and continue throughout your treatment. Your healthcare provider may monitor your blood uric acid levels while you are taking Nexlizet. 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 Nexlizet. Tendon ruptures can happen within weeks or months of starting Nexlizet.

The risk of getting tendon problems while you take Nexlizet 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 Nexlizet 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 Nexlizet 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 Nexlizet. You may need a different lipid-lowering medicine to treat your cholesterol levels.

The most common side effects of Nexlizet 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.

Before taking Nexlizet

Before you start taking Nexlizet, 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 or think you may be pregnant. Tell your healthcare provider right away if you become pregnant while taking Nexlizet. You and your healthcare provider will decide if you should take Nexlizet while you are pregnant

are breastfeeding or plan to breastfeed. It is not known if Nexlizet passes into your breast milk. You and your healthcare provider should decide if you will take Nexlizet or breastfeed. You should not do both.

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How to use Nexlizet

Take Nexlizet 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 tablet by mouth each day. Each 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 Nexlizet 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.

Warnings

The ezetimibe ingredient in Nexlizet may cause hypersensitivity reactions, including anaphylaxis, angioedema, rash, or urticaria. Do not use in people with a known hypersensitivity to ezetimibe. Stop taking Nexlizet 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 Nexlizet 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.

Nexlizet 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.

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