Bempedoic Acid

Bempedoic Acid is a prescription medication used along with diet and other lipid-lowering medicines in the treatment of Hypercholesterolemia.

• Bempedoic Acid is available under the following different brand names: Nexletol

Adult dosage

Tablet

• 180mg

Hypercholesterolemia

Adult dosage

• 180 mg orally once a day in combination with maximally tolerated statin therapy

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Bempedoic Acid include:

• upper respiratory tract infection,
• muscle spasms,
• high levels of uric acid in the blood,
• back pain,
• abdominal pain or discomfort,
• bronchitis,
• pain in the extremities,
• anemia, and
• elevated liver enzymes

Serious side effects of Bempedoic Acid include:

• sudden pain, swelling, bruising, or tenderness;
• stiffness, movement problems; or
• or a snapping or popping sound in any of the joints (rest the joint till further medical care is received).
• severe foot or toe pain;
• joint pain or swelling;
• warmth or redness over the joints; or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Rare side effects of Bempedoic Acid include:

• None 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Bempedoic Acid has severe interactions with no other drugs.
• Bempedoic Acid has serious interactions with no other drugs.
• Bempedoic Acid has moderate interactions with the following drugs:
  • pravastatin
  • simvastatin
• Bempedoic Acid has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Bempedoic Acid?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Bempedoic Acid?”

Cautions

• Hyperuricemia
  • Inhibits renal tubular OAT2 and may increase blood uric acid levels
  • Elevated uric acid levels usually occurred within the first 4 weeks of treatment initiation and persisted throughout treatment; elevated blood uric acid may lead to gout
• Tendon rupture
  • Associated with increased risk of tendon rupture or injury
  • Tendon rupture occurred within weeks to months of initiating
  • May occur more frequently in patients aged above 60 years
  • Discontinue immediately if tendon rupture occurs
  • Consider discontinuing joint pain, swelling, or inflammation
• Drug interaction overview
  • Simvastatin or pravastatin
    • Coadministration increases simvastatin or pravastatin serum concentrations and may increase simvastatin/pravastatin-related myopathy
    • Avoid use with simvastatin doses above 20 mg
    • Avoid use with pravastatin doses above 40 mg
    • Atorvastatin and rosuvastatin: Elevations of 1.7-fold in AUC of atorvastatin, rosuvastatin, and/or their major metabolites were observed with Bempedoic Acid coadministration, suggesting a weak interaction; these elevations were generally within the individual statin exposures and do not affect dosing recommendations

Pregnancy and Lactation

• Discontinue Bempedoic Acid when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus
• No available data regarding use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Note: Statins are contraindicated in pregnant women
• Clinical considerations
  • Treatment of hyperlipidemia is not generally necessary during pregnancy
  • Cholesterol and cholesterol derivatives are needed for normal fetal development
• Lactation
  • Data are not available regarding drug presence in human or animal milk, effects on breastfed infants, or effects on milk production
  • Since Bempedoic Acid decreases cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, these actions may cause harm to the breastfed infant
  • Based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment