Bempedoic acid and ezetimibe is a combination medicine that is used to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL).

Bempedoic acid and ezetimibe is used together with a low-fat diet and other medicines to lower LDL cholesterol in adults with an inherited form of high cholesterol. bempedoic acid and ezetimibe is also used in adults with heart disease who need additional lowering of LDL cholesterol.

It is not known whether this medicine reduces your risk of heart attack, stroke, or death.

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

Some cholesterol medications should not be taken at the same time. If you take ezetimibe with another cholesterol medicine, follow your doctor's dosing instructions very carefully.

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

You may take this medicine with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

You will 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:

Bempedoic acid 180 mg/ ezetimibe 10 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 who require additional LDL-C lowering.

Usual Adult Dose for Cardiovascular Risk Reduction:

Bempedoic acid 180 mg/ ezetimibe 10 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 who require additional LDL-C lowering.

You should not use bempedoic acid and ezetimibe if you are allergic to bempedoic acid or ezetimibe.

You may not be able to use bempedoic acid and ezetimibe if you have severe liver or kidney disease, or if you are on dialysis.

This medicine 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 during treatment or several weeks after you start taking bempedoic acid and ezetimibe. Tendon problems may be more likely if you are older than 60, if you have kidney failure, if you already have tendon problems, or if you use steroid medicine or certain antibiotics (such as Cipro or Levaquin).

Tell your doctor if you have ever had:

• problems with your tendons;

• gout;

• liver disease; or

• kidney disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor right away if you become pregnant.

You should not breastfeed while using this medicine.

Bempedoic acid and ezetimibe is not approved for use by anyone younger than 18 years old.

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.

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, rash, severe itching, skin redness or swelling; wheezing, difficult breathing, feeling light-headed; fast or pounding heartbeats; swelling of your face, lips, tongue, or throat.

Some side effects of bempedoic acid and ezetimibe can occur weeks or months after you have started taking this medicine.

Stop taking this medicine and get medical help right away if you have signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

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

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

• symptoms of gout--joint pain or swelling, warmth or redness around your joints, severe foot or toe pain.

Common side effects of bempedoic acid and ezetimibe may include:

• stomach pain, diarrhea;

• anemia;

• cough, chest tightness, shortness of breath;

• muscle spasm, back pain, joint pain;

• pain in your shoulder, arms, or legs;

• abnormal liver function tests;

• tiredness; or

• cold or flu symptoms such as fever, chills, body aches, 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.

Ask your doctor before using pravastatin or simvastatin. Statin medications can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Your doctor may need to adjust the doses of pravastatin or simvastatin if you take either medicine with bempedoic acid and ezetimibe.

If you take any of the following medicines, take your bempedoic acid and ezetimibe dose 2 hours before or 4 hours after you take the other medicine:

• cholestyramine;

• colestipol; or

• colesevelam.

Tell your doctor about all your other medicines, especially:

• cyclosporine;

• fenofibrate, fenofibric acid;

• gemfibrozil; or

• any other cholesterol-lowering medicines.

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