Bempedoic

Indications

Nexletol refers to a prescription medicine containing bempedoic acid that is used to lower LDL-cholesterol levels in the blood.

Nexletol is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia.

Nexletol can be used together with other lipid-lowering medications for adults who need additional lowering of bad cholesterol.

Nexletol is a first-in-class oral, once-daily, non-statin LDL-C lowering medicine approved by the FDA in 2020.

Use and Dosage

Read the Patient Information Leaflet if available from your pharmacist before you start taking bempedoic acid and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

Take this medication regularly to get the most benefit from it. Remember to use it at the same time each day. Keep taking this medication even if you feel well. Most people with high cholesterol do not feel sick.

Continue to follow your doctor’s advice about diet and exercise. It may take up to 12 weeks before you get the full benefit of this drug.

Side Effects

Serious side effects, including:

• Increased levels of uric acid in your blood (hyperuricemia). This can happen within 4 weeks of you starting Nexletol and continue throughout your treatment. Your healthcare provider may 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 also can 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
  • Stop taking Nexletol until the tendon rupture has been ruled out by your healthcare provider. Avoid exercise and use the affected area.
  • 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.

The most common side effects of Nexletol include:

• Symptoms of the common cold, flu, or flu-like symptoms
• Back pain
• Stomach pain
• Increased liver enzymes
• Muscle spasms
• Pain in the shoulder, legs, or arms
• Anemia
• Bronchitis

Tell your healthcare provider if you have any side effects that bother you or that do not go away. These are not all the possible side effects of Nexletol.

Cautions

Before taking bempedoic acid, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, gout, and tendon problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially tendon problems.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using bempedoic acid. Bempedoic acid may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended. Consult your doctor before breastfeeding.

Form and Strengths

Nexletol is available in the following form and strengths:

• Nexletol Tablet:
  • 180 mg
• Bempedoic Acid Tablet:
  • 180 mg

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.

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.

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.

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.

Resources:

1. https://www.webmd.com/drugs/2/drug-178906/nexletol-oral/details
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211616s000lbl.pdf
3. https://www.drugs.com/nexletol.html#side-effects