Nexlizet is a new cholesterol-reducing drug that combines two non-statin drugs.
Although Nexlizet is not a statin, it’s meant to be used along with a statin medication, such as Lipitor (atorvastatin).
Nexlizet is intended for people with serious health problems, such as hereditary high cholesterol or atherosclerotic heart disease, and those who are taking the highest dose of a statin that they can bear.
Take one Nexlizet tablet once per day.
Nexlizet is a once-daily prescription medication that reduces low-density lipoprotein cholesterol (LDL-C). Healthcare providers use it to treat high cholesterol in adults with hereditary high cholesterol or in those who have heart arteries partly blocked by plaque, a condition called atherosclerosis. The U.S. Food and Drug Administration (FDA) has approved it only for people currently taking a statin or for those who cannot take a statin. Nexlizet combines two non-statin cholesterol-lowering drugs, bempedoic acid, and ezetimibe, into a single once-daily tablet. Bempedoic acid reduces the body’s production of cholesterol, while ezetimibe blocks the body’s absorption of cholesterol from foods.
Nexlizet is available in only one dosage form and strength.
Tablet: 180 mg bempedoic acid/10 mg ezetimibe
Nexlizet combines two non-statin drugs to lower cholesterol in people who take the highest statin doses they can, called maximally tolerated statin therapy. In other words, they can’t take any higher statin doses. Doctors use it as an add-on (adjunct) treatment rather than a primary treatment, so people will continue to take their statin doses.
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Nexlizet dosage chart |
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|---|---|---|---|
| Indication | Starting dosage | Standard dosage | Maximum dosage |
| High cholesterol | 180/10 mg tablet once daily | 180/10 mg tablet once daily | Not specified |
For people with high cholesterol (hyperlipidemia) already taking a statin, Nexlizet is a combination drug that further lowers cholesterol in people diagnosed with atherosclerotic cardiovascular disease (ASCVD), or those who have a hereditary high cholesterol condition called heterozygous familial hypercholesterolemia (HeFH). In clinical trials, Nexlizet lowered LDL-C cholesterol levels by 38% when used with a statin and significantly reduced the risk of heart attack and heart surgery.
The active ingredients in Nexlizet are bempedoic acid and ezetimibe. Bempedoic acid is an adenosine triphosphate-citrate lyase inhibitor (ACL inhibitor). As such, it blocks a liver enzyme that synthesizes cholesterol. Ezetimibe is a selective cholesterol-absorption inhibitor. It blocks the ability of the digestive system to absorb cholesterol from foods. In other words, Nexlizet blocks cholesterol in two ways—it blocks the body from making cholesterol and getting cholesterol from food.
Standard Nexlizet dosage for high cholesterol: 180/10 mg tablet taken once per day along with a statin
Nexlizet is FDA-approved only for adults who are 18 years of age and older. Its safety and effectiveness in children have yet to be established.
No dose adjustments are needed for people with mild to moderate kidney disease or liver problems. Dosage restrictions or adjustments have not yet been specified for people with severe hepatic impairment, severe renal impairment, end-stage renal failure, or those on dialysis. However, bempedoic acid may not be safe for people with these conditions.
Each tablet is taken by mouth once per day at any time, with or without food. It can be taken at the same time as a statin as well. Here are some helpful tips on how to take Nexlizet:
Your doctor will specify how much medicine to take. Take it only as directed.
Read the patient information sheet that comes with this medicine before taking the first dose.
Take one Nexlizet tablet each day.
Swallow the tablet whole. Do not chew, crush, or cut the tablet.
If Nexlizet doses cause stomach upset or similar problems, try taking the dose with food.
Store Nexlizet tablets in their original bottle at room temperature, protected from extreme heat and humidity.
Do not throw away the small package inside of the bottle. It contains a substance that helps keep the medicine dry.
In clinical trials, Nexlizet’s maximum effects at lowering cholesterol were achieved after four weeks of daily doses. However, healthcare providers often use it to prevent serious heart problems. In those cases, the results are experienced in the long-term—months or years
.
Both bempedoic acid and ezetimibe last about the same time in your system. Bempedoic acid has a half-life of 21 hours, and ezetimibe’s half-life is about 22 hours. When Nexlizet is stopped, it will take about four to five days for both drugs to fall to undetectable levels.
If a dose is missed, take it as soon as possible. However, if it’s almost time to take the next scheduled dose, skip the missed dose. Never take two doses to make up for a missed dose.
You will probably take Nexlizet for months, years, or even a lifetime to control cholesterol. Long-term use is appropriate as long as Nexlizet works and doesn’t cause serious side effects. Bempedoic acid was studied in year-long clinical trials, and no side effects were identified due to long-term use. Adverse effects of ezetimibe and Nexlizet were studied in 12-week trials, and no long-term side effects are associated with ezetimibe.
Nexlizet does not cause withdrawal when stopped, so a healthcare provider won’t need to taper the dose at the end. However, unless a tendon ruptures or there’s an allergic reaction, don’t stop taking Nexlizet until you get medical advice from a healthcare provider first. The prescriber may need to substitute another drug to control cholesterol levels.
While there is no specified maximum dosage, there is only one FDA-approved dose: 180/10 mg once daily.
Take the prescribed dose. Do not increase the dose or take it more than once per day. If you take too much, call a poison control center or seek medical help. Ezetimibe overdoses aren’t known to cause symptoms or other problems. The symptoms of a bempedoic acid overdose are unknown.
To avoid Nexlizet drug interactions, make sure to tell the prescriber about all prescription drugs, over-the-counter medications, and supplements being taken. Most importantly, ensure that the prescriber knows if you’re taking the immunosuppressant cyclosporine or the blood thinner warfarin.
There are three drug interactions patients should be aware of. They all involve other lipid-lowering drugs that may be prescribed along with Nexlizet:
Statins: Nexlizet is supposed to be prescribed with a statin. However, the statins Zocor (simvastatin) and Pravachol (pravastatin) are more likely to cause side effects when taken with Nexlizet, so prescribers will probably avoid their co-administration.
Bile acid sequestrants: Cholestyramine, colestipol, and colesevelam may also be part of your treatment. These drugs work in the intestines, just like ezetimibe, so they reduce the effectiveness of the ezetimibe dose in Nexlizet. The doctor will instruct you to take the Nexlizet dose at least two hours before or four hours after taking a dose of one of these drugs.
Fibrates: Combining ezetimibe with a fibrate cholesterol drug, such as fenofibrate,may increase the risk of developing gallstones.
Although alcohol does not interact with Nexlizet, the prescribing healthcare provider will advise that alcohol intake be light or moderate. Bempedoic acid and ezetimibe can adversely affect the liver. So can statins. Combining these drugs with too much alcohol—which also can disrupt liver function—increases the risk of liver problems or liver damage.
Healthcare professionals only prescribe Nexlizet to pregnant women when the benefits outweigh the risks to the fetus. If a woman becomes pregnant while taking Nexlizet, she should immediately inform the healthcare provider.
Breastfeeding is not recommended in women taking Nexlizet. Although no lactation or breastfeeding studies have been conducted for either ezetimibe or bempedoic acid, healthcare professionals believe that both drugs might harm a nursing infant. Women will be offered the choice of breastfeeding their infant or taking Nexlizet.
The most common side effects of Nexlizet are increased uric acid, upper respiratory tract infections, flu-like symptoms, muscle spasms, back pain, joint pain, constipation, bronchitis, sinusitis, diarrhea, fatigue, and increased liver enzymes. In people with atherosclerotic cardiovascular disease, the most common side effects are kidney problems, muscle spasms, anemia, gallstones, and liver enzyme elevations.
People taking Nexlizet are at an increased risk of having gout and tendon rupture. The prescribing physician should explain these conditions, their symptoms, and what to do if they appear.
Bempedoic acid may cause increased uric acid levels in the body, a condition called hyperuricemia. High uric acid levels could bring on gout, a painful joint condition. Call the doctor if you notice signs of gout, such as severe foot pain, joint pain, warm joints, swelling, and joint redness.
Tendon rupture is a more serious problem and can be expected to happen in 1 out of 200 patients taking bempedoic acid. People who are older than 65 years of age, have a history of tendon problems or are taking drugs like corticosteroids or fluoroquinolone antibiotics are most at risk. Immediately stop taking Nexlizet and see a doctor if a tendon ruptures. The tendons most likely to rupture are the Achilles tendon, shoulder tendon, or biceps tendon. When a tendon ruptures, the tendon might snap or pop and be very painful. That’s usually the first sign. Other symptoms include bruising, pain, and difficulty moving the joint.
Ezetimibe, StatPearls (2023)
Ezetimibe tablet, NIH National Library of Medicine (2023)
Nexlizet (bempedoic acid/ezetimibe) tablets, Esperion Therapeutics, Inc.
Nexlizet- bempedoic acid and ezetimibe tablet, film coated, NIH National Library of Medicine (2024)
Highlights of prescribing information, Esperion Therapeutics, Inc. (2024)
Statin side effects: Weigh the benefits and risks, Mayo Clinic (2023)
Josephine Bawab, Pharm.D., graduated from Virginia Commonwealth University School of Pharmacy. She began working in community pharmacy in 2012 and has worked for multiple chain pharmacies since then. She is passionate about helping patients and precepting students. She currently works and resides in Virginia, where she is just a few minutes away from the beach.
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