Nexletol
Pronunciation: NEX-le-tol
Generic name: bempedoic acid
Dosage form: oral tablet
Drug class: Miscellaneous antihyperlipidemic agents
What is Nexletol?
Nexletol (bempedoic acid) is an oral pill for high cholesterol that may be used to reduce the risk of heart attacks and other heart problems in adults with heart disease or at high risk OR lower LDL ("bad") cholesterol levels in adults with high cholesterol.
Nexletol works by blocking an enzyme in your liver called ACL. This enzyme helps make cholesterol, so blocking it helps lower your cholesterol levels.
Nexletol was first FDA-approved on February 21, 2020. It is only available as the brand Nexletol, there is no bempedoic acid generic.
What is Nexletol used for?
Nexletol is an oral prescription medicine 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.
- along with diet and 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).
It is not known if Nexletol is safe and effective in children.
Nexletol side effects
The most common side effects of Nexletol are:
- symptoms of the common cold, flu, or flu-like symptoms
- back pain
- stomach pain
- high uric acid levels
- increased liver enzymes
- muscle spasms
- pain in the shoulder, legs, or arms
- anemia
- bronchitis.
There's no evidence that Nexletol affects your weight. Any weight changes are likely due to diet and exercise, not the medication. It is important to follow a healthy diet while taking Nexletol to manage your cholesterol or reduce your risk of a major heart event.
Serious side effects and warnings
Serious hypersensitivity reactions have occurred with Nexletol, including angioedema (swelling of the face and airways), wheezing, rash, and urticaria (hives). Do not take Nexletol if you are allergic to it or any of its inactive ingredients.
Nexletol may cause the following serious side effects.
Increased levels of uric acid in your blood (hyperuricemia). This can happen within 4 weeks of starting treatment and continue throughout. Your healthcare provider will monitor your blood uric acid levels while you are taking Nexletol. 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 Nexletol. 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 Nexletol. Tendon ruptures can happen within days or months of starting Nexletol.
- The risk of getting tendon problems while you take Nexletol 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 Nexletol 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
- If you suspect a tendon rupture, do not take Nexletol until this has been ruled out by your healthcare provider. Avoid exercise and using the affected area. 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 the continued use of Nexletol. You may need a different lipid-lowering medicine to treat your cholesterol levels.
May cause harm to an unborn baby. Breastfeeding is not recommended.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Nexletol. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Before taking Nexletol
It is not known if Nexletol 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.
Do not take Nexletol if you are allergic to bempedoic acid or any of the inactive ingredients in Nexletol (see Nexletol ingredients below for a list of ingredients). Stop taking Nexletol 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
- trouble breathing
- wheezing
- skin rashes, redness, or swelling
- severe itching
- dizziness or fainting
- fast heartbeat or pounding in your chest.
Before you start taking Nexletol, 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 severe liver problems
- are pregnant, think you might be pregnant, or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
Nexletol 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 Nexletol 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 Nexletol passes into your breast milk. You and your healthcare provider should decide if you will take Nexletol or breastfeed. You should not do both.
How should I take Nexletol?
Take Nexletol exactly as your healthcare provider tells you to take it. Check with your healthcare provider or pharmacist if you are not sure.
- Take 1 Nexletol 180 mg tablet by mouth each day. Each tablet contains 180mg of bempedoic acid.
- You may take it with or without food.
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 Nexletol, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What other drugs will affect Nexletol?
Nexletol may affect the way other medicines work, and other medicines may affect how Nexletol works. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Tell your healthcare provider if you take simvastatin or pravastatin (other cholesterol-lowering medicines). Taking statins with Nexletol may increase your risk of developing muscle pain or weakness (myopathy).
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Storage
Store Nexletol in its original package at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
Do not throw away the packet that helps to keep your medicine dry (desiccant).
Keep Nexletol and all medicines out of the reach of children.
Nexletol ingredients
Active ingredient: bempedoic acid 180 mg
Inactive ingredients: colloidal silicon dioxide, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.
Tablet coating: partially hydrolyzed polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide.
Nexletol tablets are available in one strength: Nexletol 180 mg. This contains 180 mg of bempedoic acid. There is no Nexletol generic.
Who makes Nexletol?
Esperion Therapeutics, Inc. makes Nexletol.
Popular FAQ
Is Nexletol better than a statin?
The manufacturer has not conducted head-to-head studies to determine if Nexletol can decrease problems related to high cholesterol better than a statin. Nexletol is normally prescribed with a statin. In general, Nexletol has been shown to lower LDL (“bad”) cholesterol by about 18%, while statins lower LDL from 17% to 63%, based on the drug selected and potency.
Does Nexletol cause high blood pressure?
Nexletol (bempedoic acid) does not cause high blood pressure (hypertension) as a side effect according to the manufacturer’s package insert. However, in a clinical study, more people taking Nexletol (4.3%) had a report of hypertension compared to those on placebo (1.8%).
What time of day should you take Nexletol?
You can take Nexletol (bempedoic acid) at any time of the day, along with your statin, but take it at the same time each day. Do not take more than 1 dose per day, or as directed by your healthcare provider. Nexletol can be taken with or without food.
How long does it take Nexletol to work?
Nexletol (bempedoic acid) will start lowering your cholesterol levels right away. Your doctor will check your progress in about 8 to 12 weeks with a blood test. Continue your statin therapy as directed. In studies, LDL-C (“bad”) cholesterol levels declined to their maximum level by the 4th week of treatment.
References
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.