What is Nexlizet?

Nexlizet (bempedoic acid and ezetimibe) 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.

• Nexlizet should be used in addition to dietary changes.
• Nexlizet is not a statin, does not contain a statin, but it can be used together with a statin.

Nexlizet has a dual mechanism of action. The bempedoic acid component lowers LDL-C blood levels by blocking an enzyme involved in the production of cholesterol by the liver. This helps restore blood flow in adults with or at high risk of cardiovascular disease (CVD) who cannot take statins. The ezetimibe component reduces blood cholesterol by inhibiting the absorption of dietary cholesterol in the small intestine.

Nexlizet first gained FDA approval on February 26, 2020. There is no Nexlizet generic available. Nexlizet is not the same as Nexletol, a medicine that only contains bempedoic acid.

Nexlizet side effects

The most common side effects of Nexlizet are:

• symptoms of the common cold, flu, or flu-like symptoms
• back pain
• bronchitis or a lung infection
• low red blood cell levels
• high uric acid levels
• diarrhea
• muscle spasms or pain
• stomach pain
• pain in the shoulder, legs, or arms
• increased liver enzymes
• fatigue/tiredness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Serious side effects and warnings

Nexlizet may cause the following serious side effects.

Increased levels of uric acid in your blood (hyperuricemia). This can happen within 4 weeks of starting Nexlizet and can continue throughout your treatment. Your healthcare provider may monitor your blood uric acid levels while 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 can also 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 your healthcare provider has ruled out the tendon rupture. 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.

Allergic reactions. 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.

May cause harm to an unborn baby. Use effective contraception while taking Nexlizet if you are a female with childbearing potential. Breastfeeding is not recommended.

These are not all the possible side effects of Nexlizet. 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 the FDA .

What is the cost of Nexlizet?

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our  Nexlizet price guide page for more information about Nexlizet cost.

You may also be eligible for a Nexlizet copay card or Nexlizet coupon through the NEXSTEP Patient Support Program. This program provides information about why you have been prescribed Nexlizet to treat your cholesterol and can offer you a Nexlizet Copay card if you have commercial insurance. Ask your doctor or pharmacist if you qualify. There is no Nexlizet generic available.

Is Nexlizet covered by Medicare?

This depends on the prescription drug plan you have because 58% of Medicare plans cover Nexlizet.

Before taking

Do not take Nexlizet if you are allergic to ezetimibe, bempedoic acid, Nexlizet, or any of the inactive ingredients in the tablet (see Nexlizet ingredients list below). 

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.

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, think you may be pregnant, or plan to get pregnant
• are breastfeeding or plan to breastfeed. 

Pregnancy

Nexlizet 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 Nexlizet 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 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.

How should I take 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 180-10 mg 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 Nexlizet with or without food.
• Nexlizet does not need to be taken at night. You can take it at any time, but you should try and take it at approximately the same time each day.

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.

Nexlizet dosage

• The recommended adult dose is Nexlizet 180-10 mg once a day.

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 Nexlizet, call your poison control center or go to the nearest hospital emergency room right away.

What other medicines will affect Nexlizet?

Nexlizet may affect how other medicines work, and other medicines may affect how Nexlizet works. Tell your healthcare provider about all your medicines, 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 simvastatin or pravastatin with Nexlizet 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 to show your healthcare provider and pharmacist when you get a new medicine.

Storage

Store Nexlizet 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, as the Nexlizet 180-10 mg tablet, which contains 180 mg bempedoic acid and 10 mg ezetimibe.

What is ezetimibe and rosuvastatin?

Ezetimibe and rosuvastatin is a combination medicine that is used to lower blood levels of “bad” cholesterol (low-density lipoprotein, or LDL).

Ezetimibe and rosuvastatin is used together with a low-fat diet and other treatments to lower cholesterol in adults.

Ezetimibe and rosuvastatin may also be used for purposes not listed in this medication guide.

Ezetimibe and rosuvastatin side effects

Get emergency medical help if you have signs of an allergic reaction: hives, rash, itching; wheezing, dizziness, difficult breathing; swelling of your face, lips, tongue, or throat.

ezetimibe and rosuvastatin may cause serious side effects. Stop using ezetimibe and rosuvastatin and call your doctor at once if you have:

• unexplained muscle pain, tenderness, or weakness (especially if you also have fever);
• upper stomach pain, loss of appetite;
• severe weakness or tiredness;
• dark colored urine; or
• jaundice (yellowing of the skin or eyes).

Common side effects of ezetimibe and rosuvastatin may include:

• headache, dizziness;
• stomach pain, nausea, diarrhea, constipation;
• muscle or joint pain;
• pain in your hands, legs, or back;
• feeling weak or tired; or
• cold symptoms such as stuffy nose, sneezing, sinus pain, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA.

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use ezetimibe and rosuvastatin if you are allergic to rosuvastatin (Crestor) or ezetimibe (Vytorin, Zetia), or if you have:

• active liver disease; or
• cirrhosis.

May harm an unborn baby. Do not use if you are pregnant. Stop taking the medicine and tell your doctor right away if you become pregnant. Ask your doctor about the best method of birth control to prevent pregnancy while taking ezetimibe and rosuvastatin.

Do not breastfeed.

Ezetimibe and rosuvastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in adults 65 or older, in people of Asian descent, and in people who use certain other medicines or have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Tell your doctor if you have ever had:

• unexplained weakness or muscle pain;
• a thyroid disorder;
• diabetes;
• liver or kidney disease;
• a habit of drinking more than 2 alcoholic drinks per day; or
• liver problems caused by alcohol.

Not approved for use by anyone younger than 18 years old.

How should I take ezetimibe and rosuvastatin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take this medicine at the same time each day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Your treatment may also include diet, exercise, weight control, and blood tests.

Tell any doctor who treats you that you take this medicine, especially if you have a major illness, surgery, or medical emergency.

Keep using this medicine even if you feel well. You will need blood tests to determine if this medicine is lowering your cholesterol.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. Remove a tablet only when you’re ready to take it.

Throw away any tablets not used within 30 days.

Ezetimibe and rosuvastatin dosing information

Usual Adult Dose for Hyperlipidemia:

1 tablet orally once a day

Tablet strengths available:
-Rosuvastatin 5 mg/ezetimibe 10 mg
-Rosuvastatin 10 mg/ezetimibe 10 mg
-Rosuvastatin 20 mg/ezetimibe 10 mg
-Rosuvastatin 40 mg/ezetimibe 10 mg

Comments:
-Patient’s dose should be individualized based on indication, low-density lipoprotein cholesterol (LDL-C), and individual risk for cardiovascular events.
-LDL-C may be assessed early as 2 weeks after initiating therapy.
-Dose should be adjusted based on LDL-C levels.

Uses:
-As an adjunct to diet to reduce LDL-C in patients with primary non-familial hyperlipidemia.
-Alone or as an adjunct to other LDL-C lowering therapies to reduce LDL-C in patients with homozygous familial hypercholesterolemia (HoFH).

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

1 tablet orally once a day

Tablet strengths available:
-Rosuvastatin 5 mg/ezetimibe 10 mg
-Rosuvastatin 10 mg/ezetimibe 10 mg
-Rosuvastatin 20 mg/ezetimibe 10 mg
-Rosuvastatin 40 mg/ezetimibe 10 mg

Comments:
-Patient’s dose should be individualized based on indication, low-density lipoprotein cholesterol (LDL-C), and individual risk for cardiovascular events.
-LDL-C may be assessed early as 2 weeks after initiating therapy.
-Dose should be adjusted based on LDL-C levels.

Uses:
-As an adjunct to diet to reduce LDL-C in patients with primary non-familial hyperlipidemia.
-Alone or as an adjunct to other LDL-C lowering therapies to reduce LDL-C in patients with homozygous familial hypercholesterolemia (HoFH).

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses within 12 hours.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking ezetimibe and rosuvastatin?

Avoid taking an antacid within 2 hours after you take ezetimibe and rosuvastatin.

Grapefruit may interact with ezetimibe and rosuvastatin and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid drinking alcohol.

Avoid eating foods high in fat or cholesterol, or ezetimibe and rosuvastatin will not be as effective.

What other drugs will affect ezetimibe and rosuvastatin?

If you also take cholestyramine, colesevelam, or colestipol: Take your ezetimibe and rosuvastatin dose 2 hours before or 4 hours after you take the other medicine.

Tell your doctor about all your other medicines. Some drugs can increase the risk of serious muscle problems when used with ezetimibe and rosuvastatin, especially:

• colchicine, cyclosporine;
• antifungal medication–fluconazole, itraconazole, ketoconazole;
• a blood thinner–warfarin, Coumadin, Jantoven;
• cancer medicine–darolutamide, regoragenib;
• other cholesterol medications–fenofibrate, fenofibric acid, gemfibrozil, niacin, nicotinic acid;
• hepatitis C medication that contains–dasabuvir, elbasvir, glecaprevir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, pibrentasvir, sofosbuvir, velpatasvir, or voxilaprevir; or
• HIV/AIDS medication–atazanavir, fosamprenavir, lopinavir, ritonavir, simeprevir, tipranavir.