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Is NEXLETOL right for you?

Your doctor may prescribe NEXLETOL to:

Lower your bad cholesterol, along with a healthy diet

  • NEXLETOL can be used in combination with other cholesterol-lowering medications or alone when use with other cholesterol-lowering medications is not possible

Reduce the risk of a major heart event*

  • If you are unable to take recommended statin treatment, or are not taking a statin

 

*Including heart attack and heart procedures like stent placement or bypass surgery.

 

 

Factors that can impact your risk of a major heart event include diabetes. Your doctor may do tests to determine your risk of a major heart event.

How does NEXLIZET work?

NEXLIZET works differently than statins.

NEXLIZET contains bempedoic acid and ezetimibe. NEXLIZET interrupts your body’s cholesterol-making process, reducing how much cholesterol your body can make and how much it can absorb.

How safe is NEXLIZET?

The safety of bempedoic acid, a component of NEXLIZET, has been studied in 4 clinical trials in more than 9,000 people

The most common side effects of NEXLIZET in people with high cholesterol include:

  • Symptoms of the common cold or flu-like symptoms, muscle spasms, back pain, stomach pain, bronchitis, pain in shoulder, legs, or arms, anemia, increased liver enzymes, diarrhea, joint pain, swelling of sinuses, and fatigue

The most common side effects of NEXLIZET in people with heart problems include:

  • Kidney problems, anemia, increased liver enzymes, muscle spasms, and gallstones

NEXLIZET can cause serious side effects, including:

  • Increased levels of uric acid in the blood, which can lead to gout, a painful joint condition. Call your doctor if you have any of the following symptoms: severe foot pain especially in the toe joint, warm joints, swelling, tender joints, or joint redness
  • Tendon rupture or injury. Tendon problems can happen in people who take bempedoic acid, one of the medicines in NEXLIZET. The risk of getting tendon problems while you take NEXLIZET is higher if you are over 60 years of age, are taking steroids, are taking antibiotics called fluoroquinolones, have renal failure, or have had tendon problems in the past. Stop taking NEXLIZET immediately and get medical help if you experience signs of tendon rupture, such as snap or pop in tendon area, bruising after an injury in a tendon area, or unable to move or put weight on the affected area

These are not all the possible side effects of NEXLIZET. For more information, ask your healthcare provider or pharmacist.

Talking to your doctor?

NEXLIZET is pronounced “NEX-lee-zet”

See What NEXLIZET Can Do

How does NEXLETOL work?

NEXLETOL works differently than statins.

NEXLETOL contains bempedoic acid, which is a nonstatin that interrupts your body’s cholesterol-making process by reducing the amount of cholesterol made by your liver.

How safe is NEXLETOL?

The safety of bempedoic acid, a component of NEXLETOL, has been studied in 4 clinical trials in more than 9,000 people

The most common side effects of NEXLETOL in people with high cholesterol include:

  • Symptoms of the common cold or flu-like symptoms, muscle spasms, back pain, stomach pain, bronchitis, pain in shoulder, legs, or arms, anemia, and increased liver enzymes

The most common side effects of NEXLETOL in people with heart problems include:

  • Kidney problems, anemia, increased liver enzymes, muscle spasms, and gallstones

NEXLETOL can cause serious side effects, including:

  • Increased levels of uric acid in the blood, which can lead to gout, a painful joint condition. Call your doctor if you have any of the following symptoms: severe foot pain especially in the toe joint, warm joints, swelling, tender joints, or joint redness
  • Tendon rupture or injury. Tendon problems can happen in people who take bempedoic acid, one of the medicines in NEXLETOL. The risk of getting tendon problems while you take NEXLETOL is higher if you are over 60 years of age, are taking steroids, are taking antibiotics called fluoroquinolones, have renal failure, or have had tendon problems in the past. Stop taking NEXLETOL immediately and get medical help if you experience signs of tendon rupture, such as snap or pop in tendon area, bruising after an injury in a tendon area, or unable to move or put weight on the affected area

These are not all the possible side effects of NEXLETOL. For more information, ask your healthcare provider or pharmacist.

Talking to your doctor?

NEXLETOL is pronounced “NEX-le-tol”

See What NEXLETOL Can Do

What are NEXLIZET and NEXLETOL?

  • Along with a diet:
    • NEXLETOL is used, with other cholesterol-lowering medicines, or alone when use with other cholesterol-lowering medicines is not possible, to reduce low-density lipoprotein (LDL, or bad cholesterol) in adults with high blood cholesterol levels called primary hyperlipidemia, including a type of high blood cholesterol called heterozygous familial hypercholesterolemia (HeFH).
    • NEXLIZET is used, with or without other cholesterol-lowering medicines, to reduce low-density lipoprotein (LDL, or bad cholesterol) in adults with high blood cholesterol levels called primary hyperlipidemia, including a type of high cholesterol called heterozygous familial hypercholesterolemia (HeFH).
  • The bempedoic acid portion of NEXLIZET and NEXLETOL is used to lower the risk of heart attack and heart procedures like stent placement or bypass surgery, in adults who are unable to take recommended statin treatment (a cholesterol-lowering medicine), or are not taking a statin, who:
    • have known heart disease, or
    • are at high risk for heart disease but without known heart disease.

IMPORTANT SAFETY INFORMATION

Do not take NEXLIZET if you are allergic to ezetimibe or bempedoic acid, or any ingredients in NEXLIZET or NEXLETOL. If you have any of the following signs and symptoms of a serious allergic reaction, call your healthcare provider or go to the nearest hospital emergency room:

  • swelling of your face, lips, mouth, or tongue
  • wheezing
  • severe itching
  • fast heartbeat or pounding in your chest
  • trouble breathing
  • skin rashes, redness, or swelling
  • dizziness or fainting

What should I tell my healthcare provider before taking NEXLIZET or NEXLETOL?

Tell your healthcare provider if you:

  • have, or had, gout
  • have, or had, tendon problems
  • are pregnant or breastfeeding or may become pregnant or plan to breastfeed. It is not known if NEXLIZET or NEXLETOL passes into your breastmilk
  • have severe kidney or severe liver problems

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

Especially tell your healthcare provider if you take or plan to take simvastatin or pravastatin, as taking either with bempedoic acid may increase your risk of developing muscle pain or weakness. If you take NEXLIZET, tell your doctor if you take cyclosporine, fibrates, or cholestyramine.

What is the most important safety information I should know about NEXLIZET and NEXLETOL?

NEXLIZET and NEXLETOL can cause serious side effects, including:

  • increased levels of uric acid in the blood, which can lead to gout, a painful joint condition. Call your doctor if you have any of the following symptoms: severe foot pain especially in the toe joint, warm joints, swelling, tender joints or joint redness.
  • tendon rupture or injury. Tendon problems can happen in people who take bempedoic acid, one of the medicines in NEXLIZET or NEXLETOL. The risk of getting tendon problems while you take NEXLIZET or NEXLETOL is higher if you: are over 60 years of age, are taking steroids, are taking antibiotics called fluoroquinolones, have renal failure, or have had tendon problems in the past. Stop taking NEXLIZET or NEXLETOL immediately and get medical help if you experience signs of tendon rupture such as snap or pop in tendon area, bruising after an injury in a tendon area, or unable to move or put weight on the affected area.

The most common side effects in patients with primary hyperlipidemia:

  • NEXLETOL includes symptoms of the common cold or flu-like symptoms, muscle spasms, back pain, stomach pain, bronchitis, pain in shoulder, legs, or arms, anemia and increased liver enzymes.
  • NEXLIZET includes symptoms of the common cold or flu-like symptoms, muscle spasms, back pain, stomach pain, bronchitis, pain in shoulder, legs, or arms, anemia, increased liver enzymes, diarrhea, joint pain, swelling of sinuses and fatigue.

The most common side effects of bempedoic acid, a component of NEXLIZET and NEXLETOL, in patients with heart problems include kidney problems, anemia, increased liver enzymes, muscle spasms, and gallstones.

These are not all the possible side effects of NEXLIZET and NEXLETOL. For more information, 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.

Please see full Prescribing Information for NEXLIZET and NEXLETOL, including Patient Product Information for NEXLIZET and NEXLETOL.

What are NEXLIZET and NEXLETOL?

  • Along with a diet:
    • NEXLETOL is used, with other cholesterol-lowering medicines, or alone when use with other cholesterol-lowering medicines is not possible, to reduce low-density lipoprotein (LDL, or bad cholesterol) in adults with high blood cholesterol levels called primary hyperlipidemia, including a type of high blood cholesterol called heterozygous familial hypercholesterolemia (HeFH).
    • NEXLIZET is used, with or without other cholesterol-lowering medicines, to reduce low-density lipoprotein (LDL, or bad cholesterol) in adults with high blood cholesterol levels called primary hyperlipidemia, including a type of high cholesterol called heterozygous familial hypercholesterolemia (HeFH).
  • The bempedoic acid portion of NEXLIZET and NEXLETOL is used to lower the risk of heart attack and heart procedures like stent placement or bypass surgery, in adults who are unable to take recommended statin treatment (a cholesterol-lowering medicine), or are not taking a statin, who:
    • have known heart disease, or
    • are at high risk for heart disease but without known heart disease.

IMPORTANT SAFETY INFORMATION

Do not take NEXLIZET if you are allergic to ezetimibe or bempedoic acid, or any ingredients in NEXLIZET or NEXLETOL. If you have any of the following signs and symptoms of a serious allergic reaction, call your healthcare provider or go to the nearest hospital emergency room:

  • swelling of your face, lips, mouth, or tongue
  • wheezing
  • severe itching
  • fast heartbeat or pounding in your chest
  • trouble breathing
  • skin rashes, redness, or swelling
  • dizziness or fainting

What should I tell my healthcare provider before taking NEXLIZET or NEXLETOL?

Tell your healthcare provider if you:

  • have, or had, gout
  • have, or had, tendon problems
  • are pregnant or breastfeeding or may become pregnant or plan to breastfeed. It is not known if NEXLIZET or NEXLETOL passes into your breastmilk
  • have severe kidney or severe liver problems

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

Especially tell your healthcare provider if you take or plan to take simvastatin or pravastatin, as taking either with bempedoic acid may increase your risk of developing muscle pain or weakness. If you take NEXLIZET, tell your doctor if you take cyclosporine, fibrates, or cholestyramine.

What is the most important safety information I should know about NEXLIZET and NEXLETOL?

NEXLIZET and NEXLETOL can cause serious side effects, including:

  • increased levels of uric acid in the blood, which can lead to gout, a painful joint condition. Call your doctor if you have any of the following symptoms: severe foot pain especially in the toe joint, warm joints, swelling, tender joints or joint redness.
  • tendon rupture or injury. Tendon problems can happen in people who take bempedoic acid, one of the medicines in NEXLIZET or NEXLETOL. The risk of getting tendon problems while you take NEXLIZET or NEXLETOL is higher if you: are over 60 years of age, are taking steroids, are taking antibiotics called fluoroquinolones, have renal failure, or have had tendon problems in the past. Stop taking NEXLIZET or NEXLETOL immediately and get medical help if you experience signs of tendon rupture such as snap or pop in tendon area, bruising after an injury in a tendon area, or unable to move or put weight on the affected area.

The most common side effects in patients with primary hyperlipidemia:

  • NEXLETOL includes symptoms of the common cold or flu-like symptoms, muscle spasms, back pain, stomach pain, bronchitis, pain in shoulder, legs, or arms, anemia and increased liver enzymes.
  • NEXLIZET includes symptoms of the common cold or flu-like symptoms, muscle spasms, back pain, stomach pain, bronchitis, pain in shoulder, legs, or arms, anemia, increased liver enzymes, diarrhea, joint pain, swelling of sinuses and fatigue.

The most common side effects of bempedoic acid, a component of NEXLIZET and NEXLETOL, in patients with heart problems include kidney problems, anemia, increased liver enzymes, muscle spasms, and gallstones.

These are not all the possible side effects of NEXLIZET and NEXLETOL. For more information, 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.

Please see full Prescribing Information for NEXLIZET and NEXLETOL, including Patient Product Information for NEXLIZET and NEXLETOL.