Is NEXLIZET right for you?
Your doctor may prescribe NEXLIZET to:
Lower your bad cholesterol, along with diet and exercise
- NEXLIZET is used alone or in combination with other cholesterol-lowering medications
Reduce the risk of a serious heart event*
- If you are unable to take recommended statin treatment, or are not taking a statin
*Serious heart event=cardiovascular death, heart attack, stroke, heart stent or bypass surgery.
Factors that can impact your risk of a serious heart event include diabetes. Your doctor may do tests to determine your risk of a serious 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.
What are the side effects of NEXLIZET?
The most common side effects of the medications in NEXLIZET observed in clinical trials 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, fatigue, kidney problems, and gallstones.
The safety of bempedoic acid, a component of NEXLIZET, has been studied in 4 clinical trials in more than 9,000 people
Do not take NEXLIZET if you are allergic to ezetimibe or bempedoic acid, or any ingredients in NEXLIZET.
NEXLIZET can cause serious side effects, including:
- increased levels of uric acid in the blood, which can lead to gout. 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. The risk of getting tendon problems while you take NEXLIZET is increased (1.2% vs 0.9% in placebo in Trial 1 and 0.5% vs 0% in placebo in Trial 2). 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. See additional Important Safety Information below and ask your healthcare provider or pharmacist for more information.
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.
What are the side effects of NEXLETOL?
The most common side effects of NEXLETOL 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, kidney problems, and gallstones.
The safety of bempedoic acid, a component of NEXLETOL, has been studied in 4 clinical trials in more than 9,000 people
Do not take NEXLETOL if you are allergic to bempedoic acid or any of its ingredients.
NEXLETOL can cause serious side effects, including:
- increased levels of uric acid in the blood, which can lead to gout. 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. The risk of getting tendon problems while you take NEXLETOL is increased (1.2% vs 0.9% in placebo in Trial 1; 0.5% vs 0% in placebo in Trial 2). 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. See additional Important Safety Information below and ask your healthcare provider or pharmacist for more information.
What are NEXLIZET and NEXLETOL?
- Along with diet and exercise:
- 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 hypercholesterolemia, including a type of high blood cholesterol called heterozygous familial hypercholesterolemia.
- NEXLIZET is used to reduce LDL in adults with high blood cholesterol levels called hypercholesterolemia, including a type of high cholesterol called heterozygous familial hypercholesterolemia.
- Bempedoic acid, a component of NEXLIZET and NEXLETOL is used to lower the risk of major adverse cardiovascular events, such as death from cardiovascular disease, heart attack, stroke, stent placement or bypass surgery in adults at increased risk for these events who are unable to take recommended statin treatment or are not taking a statin.
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 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
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. NEXLIZET or NEXLETOL may pass into your breastmilk. You and your healthcare provider should decide if you will take NEXLIZET or NEXLETOL or breastfeed.
- have moderate 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 if you take or plan to take simvastatin, pravastatin, cyclosporine, fibrates, or cholestyramine.
NEXLIZET and NEXLETOL can cause serious side effects, including:
- increased levels of uric acid in the blood, which can lead to gout. 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. The risk of getting tendon problems while you take NEXLIZET or NEXLETOL is increased (1.2% vs 0.9% in placebo in Trial 1; 0.5% vs 0% in placebo in Trial 2). 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 observed in trials of:
- 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, increased liver enzymes, kidney problems, and gallstones.
- 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.
These are not all the possible side effects of NEXLIZET and NEXLETOL. 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 diet and exercise:
- 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 hypercholesterolemia, including a type of high blood cholesterol called heterozygous familial hypercholesterolemia.
- NEXLIZET is used to reduce LDL in adults with high blood cholesterol levels called hypercholesterolemia, including a type of high cholesterol called heterozygous familial hypercholesterolemia.
- Bempedoic acid, a component of NEXLIZET and NEXLETOL is used to lower the risk of major adverse cardiovascular events, such as death from cardiovascular disease, heart attack, stroke, stent placement or bypass surgery in adults at increased risk for these events who are unable to take recommended statin treatment or are not taking a statin.
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 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
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. NEXLIZET or NEXLETOL may pass into your breastmilk. You and your healthcare provider should decide if you will take NEXLIZET or NEXLETOL or breastfeed.
- have moderate 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 if you take or plan to take simvastatin, pravastatin, cyclosporine, fibrates, or cholestyramine.
NEXLIZET and NEXLETOL can cause serious side effects, including:
- increased levels of uric acid in the blood, which can lead to gout. 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. The risk of getting tendon problems while you take NEXLIZET or NEXLETOL is increased (1.2% vs 0.9% in placebo in Trial 1; 0.5% vs 0% in placebo in Trial 2). 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 observed in trials of:
- 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, increased liver enzymes, kidney problems, and gallstones.
- 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.
These are not all the possible side effects of NEXLIZET and NEXLETOL. 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.