Bempedoic acid is used together with diet and other medicines to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL).

Bempedoic acid is for use in adults with an inherited form of high cholesterol.

Bempedoic acid is also used to lower LDL cholesterol in adults with coronary artery disease (clogged arteries).

It is not known if bempedoic acid can lower the risk of complications related to high cholesterol (such as heart problems, heart attack, stroke, or death).

Bempedoic acid may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take bempedoic acid with or without food.

You may need frequent medical tests.

Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Usual Adult Dose for Heterozygous Familial Hypercholesterolemia:

180 mg orally once a day

Comments:
-This drug should be given with maximally tolerated statin therapy.
-Lipid levels should be checked within 8 to 12 weeks of treatment initiation.

Uses: As an adjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease in those requiring additional LDL-C lowering.

Usual Adult Dose for Cardiovascular Risk Reduction:

180 mg orally once a day

Comments:
-This drug should be given with maximally tolerated statin therapy.
-Lipid levels should be checked within 8 to 12 weeks of treatment initiation.

Uses: As an adjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease in those requiring additional LDL-C lowering.

Bempedoic acid may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the arm, shoulder, or Achilles' tendon of the heel. This can happen within days or months after you start taking bempedoic acid. Tendon problems may be more likely in certain people (older adults, people with kidney disease, or people who take steroid medicine or certain antibiotics.

Tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);

• liver disease;

• gout; or

• problems with your tendons.

Bempedoic acid may harm an unborn baby. Tell your doctor right away if you become pregnant.

You should not breastfeed while using bempedoic acid.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (small packet included with the tablets to absorb moisture) from your bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking bempedoic acid and seek medical attention right away if you have signs of tendon rupture:

• sudden pain, swelling, bruising, or tenderness;

• stiffness, movement problems; or

• or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

Bempedoic acid may cause serious side effects. Call your doctor at once if you have:

• severe foot or toe pain;

• joint pain or swelling;

• warmth or redness over your joints; or

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of bempedoic acid may include:

• pain in your back, shoulder, legs, or arms;

• muscle spasm;

• stomach pain;

• anemia;

• abnormal liver function tests;

• wheezing, cough, chest congestion; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all other cholesterol medicines you use, especially:

• pravastatin; or

• simvastatin.

This list is not complete. Other drugs may affect bempedoic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to bempedoic acid.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Nexlizet® (containing Bempedoic Acid, Ezetimibe)