What are the side effects of Nexletol (bempedoic acid)?

Side Effects of Nexletol (Bempedoic Acid)

Nexletol (bempedoic acid) commonly causes hyperuricemia, muscle spasms, tendon problems, and liver enzyme elevations as its main side effects. 1, 2

Common Side Effects

Bempedoic acid is associated with several common side effects:

• Upper respiratory tract infections (cold, flu-like symptoms)
• Muscle spasms (though less common than with statins)
• Back pain
• Abdominal pain or discomfort
• Pain in extremities (shoulder, legs, arms)
• Anemia
• Elevated liver enzymes
• Bronchitis 1, 2

Serious Side Effects

1. Hyperuricemia

• Occurs within 4 weeks of starting treatment
• May continue throughout treatment
• Can lead to gout
• Symptoms include:
  • Severe foot pain (especially in toe joints)
  • Warm, swollen, tender, red joints 1, 2

2. Tendon Rupture or Injury

• Can happen within weeks or months of starting treatment
• Higher risk in patients who:
  • Are over 60 years old
  • Take fluoroquinolone antibiotics
  • Have history of tendon problems
  • Take corticosteroids
  • Have renal failure
• Most commonly affects:
  • Rotator cuff (shoulder)
  • Biceps tendon (upper arm)
  • Achilles tendon
• Warning signs:
  • Snap or pop in tendon area
  • Bruising after injury
  • Inability to move affected area 2

3. Hypersensitivity Reactions

• Serious allergic reactions can occur, including:
  • Swelling of face, lips, mouth or tongue
  • Wheezing
  • Severe itching
  • Fast heartbeat
  • Trouble breathing
  • Skin rashes
  • Dizziness or fainting 2

Drug Interactions

• Simvastatin or pravastatin: Avoid doses higher than 20 mg daily (simvastatin) or 40 mg daily (pravastatin) when taken with Nexletol due to increased risk of myopathy 1, 2

Special Populations

Pregnancy

• Should be discontinued when pregnancy is recognized unless benefits outweigh potential risks
• No adequate data on use in pregnant women 1

Breastfeeding

• No information on presence in human milk or effects on breastfed infants
• Decision should be made whether to discontinue breastfeeding or discontinue the drug 2

Monitoring Recommendations

• Monitor uric acid levels before initiation and if signs of hyperuricemia occur
• Monitor liver enzymes periodically
• Check for signs of tendon problems, especially in high-risk patients
• LDL-C levels should be checked 8-12 weeks after starting treatment 1, 2

Advantages Over Other Lipid-Lowering Agents

Bempedoic acid has a unique mechanism as an ACL inhibitor that is activated in the liver but not in skeletal muscle, which may explain its lower incidence of muscle-related side effects compared to statins 3, 4. This makes it particularly useful for statin-intolerant patients 5.

When to Seek Medical Attention

Patients should contact their healthcare provider immediately if they experience:

• Signs of tendon rupture
• Symptoms of gout
• Allergic reactions
• Significant muscle pain
• Unusual bleeding or bruising 2

Remember that Nexletol has demonstrated cardiovascular benefits in statin-intolerant patients, with a 13% reduction in major adverse cardiovascular events in the CLEAR Outcomes trial 5. When considering the side effect profile, it's important to weigh these benefits against the potential risks.