• Nexletol (generic name: bempedoic acid) works by lowering the production of cholesterol in your liver. It blocks an enzyme needed to make LDL (“bad cholesterol”) and therefore lowers your cholesterol levels.
• It is a prescription medication used along with diet and other cholesterol-lowering medicines in adults. It is not a statin drug, but is used alongside a statin.
• Administration of this medicine with a maximum tolerated dose of a statin (with or without other lipid-modifying agents) decreases LDL-C (low density lipoprotein cholesterol or “bad” cholesterol), non-high density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (apo B), and total cholesterol (TC) in patients with hyperlipidemia.
• Nexletol belongs to the class of medicines known as adenosine triphosphate-citrate lyase (ACL) inhibitors. It’s a prodrug and is converted to an active drug in the liver. Prodrugs are inactive when first taken. Once they are in your system, they are converted to an active medication.

• Nexletol is used to lower LDL-C (low-density lipoprotein C) levels in adults with heterozygous familial hypercholesterolemia or established heart disease whose LDL-C levels are still high despite maximally tolerated statin treatment and following a cholesterol-lowering diet.
• Taken as one tablet by mouth, once a day. It can be taken with or without food. No dose titration is needed.
• Can be used with or without other cholesterol-lowering medications like statins, fenofibrate, or bile-acid sequestrants that also help to lower lipids.
• No dosage adjustments are recommended for people with mild or moderate kidney impairment, but there is limited experience in people with severe kidney disease or on dialysis.
• No dosage adjustments are recommended for people with mild to moderate liver impairment, but people with severe liver disease have not been studied.
• No differences in safety or effectiveness were observed between patients 65 years and older, when compared to younger patients. However, greater sensitivity in older patients cannot be ruled out. No dosage adjustments are recommended based on advanced age.
• Dose changes of Nexletol are not needed when administered with atorvastatin (Lipitor) or rosuvastatin (Crestor), according to the manufacturer.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Symptoms of the common cold or flu, muscle spasms, back pain, pain in the shoulders, legs or arms, anemia, bronchitis, increased liver enzymes, or stomach pain are listed as some of the most common side effects.
• It is not known if Nexletol can decrease complications from high cholesterol, such as heart attacks, other heart problems, stroke, and death.
• It is not known if Nexletol is safe and effective in people with severe kidney problems. This includes people with end-stage kidney disease, those on dialysis, with severe liver problems, or in children under the age of 18 years.
• Using the statin medications simvastatin (Zocor) or pravastatin with Nexletol may require dose adjustments.
• Tendon rupture has occurred in people using Nexletol. Stop use of Nexletol at the first sign of tendon rupture and contact your doctor. You may not be able to use Nexletol if you have a history of tendon disorders or tendon rupture.
• Elevations in serum uric acid have occurred and may lead to gout.
• There is no available data on use in pregnant women. The risk of major birth defects, miscarriage, or other side effects in the mother or fetus are unknown.
• Breastfeeding is not recommended with Nexletol.
• There are currently no generic alternatives for Nexletol. It can be an expensive medicine if your insurance does cover it.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Your healthcare provider will schedule a laboratory appointment to analyze your blood lipid levels within 8 to 12 weeks after you start Nexletol treatment.
• If you have or have ever had gout, high uric acid levels or problems with your tendons, tell your healthcare provider before you start treatment. Let your doctor know if you have kidney or liver problems before you start taking Nexletol.
• Tell your healthcare provider right away if you become pregnant while taking this medicine. Let your doctor know if you are pregnant or planning a pregnancy before treatment starts.
• Breastfeeding is not recommended with Nexletol. If you are breastfeeding or plan to breastfeed, tell your doctor before treatment. It is not known if Nexletol passes into your breast milk.
• This medicine may be taken at any time of the day or night; however, you should try to take your medicine at the same time each day.
• Taking statins with Nexletol may increase your risk of muscle injury. Contact your doctor if you experience muscle pain.
• You will need to follow a cholesterol-lowering diet and exercise plan while taking this medicine. Ask your doctor if you need information on a diet plan or the best food choices. If you smoke, discuss options for a smoking cessation plan to help you quit. This may include medicine and group therapy.
• If you cannot afford this medicine, the manufacturer, Esperion Therapuetics, may be able to help you lower your costs. You can call them at 1-833-639-5386, Monday-Friday, 8:00 AM-8:00 PM ET.
• Do not stop taking any medications without first talking to your doctor.

• In two 52-week long, placebo-controlled studies with over 3,000 patients, Nexletol was evaluated in adults with heterozygous familial hypercholesterolemia (HeFH) or established heart disease (ASCVD) whose LDL-C levels were still high despite statin treatment at the highest tolerated dose, alone or with other lipid-lowering therapies.
• In Study 1, Nexletol was added to the maximally tolerated statin dose, either alone (with only the statin) or with other lipid-lowering therapies. At 12 weeks, Nexletol lowered LDL-C levels by a mean of 18% compared to placebo, a statistically significant effect.
• In Study 2, Nexletol was added to the maximally tolerated statin dose (including no statin at all) either alone or with other lipid-lowering therapies. At 12 weeks, Nexletol lowered LDL-C levels by a mean of 17% compared to placebo, a statistically significant effect.
• In both trials, the maximum LDL-C lowering effects occurred at Week 4. Your healthcare provider will check your lipid levels 8 to 12 weeks after you start treatment.

Medicines that interact with Nexletol might decrease its therapeutic effect, increase its side effects, or change how well other medicines work. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor or pharmacist about how drug interactions should be managed.

• Do not use Nexletol with doses of simvastatin greater than 20 mg or doses of pravastatin greater than 40 mg. This may cause an increase in the statin level and may cause or worsen myopathy (a type of muscle damage, which can be serious).
• Caution is advised if Nexletol is used concomitantly with drugs that are substrates of OATP1B1 or 1B3, particularly those with a narrow therapeutic range.
• Concomitant administration of Nexletol may potentiate the risk of tendon rupture or injury associated with fluoroquinolones (for example: ciprofloxacin or levofloxacin) and corticosteroids (such as prednisone, dexamethasone or methylprednisolone).
• Check with your pharmacist and doctor to review your medications for possible drug interactions with Nexletol. Tell your healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal or dietary supplements.

Note: This list is not all-inclusive and includes only common medications that may interact with Nexletol. Refer to the prescribing information for a complete list of interactions, and ask your doctor or pharmacist.