Bempedoic Acid (bem-pe-DOE-ik AS-id), Ezetimibe (e-ZET-i-mibe)

Used together with diet and other medicines to reduce bad cholesterol (LDL) in patients with primary hyperlipidemia (high blood cholesterol), including heterozygous familial hypercholesterolemia (HeFH). Also used to reduce the risk of heart attack and heart procedures (including stent placement or bypass surgery).

Brand Name(s):

Nexlizet

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablet whole. Do not cut, crush, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how bempedoic acid/ezetimibe works. Tell your doctor if are using any of the following:
  • Cyclosporine, pravastatin, simvastatin
  • Fibrate medicine
  • Fluoroquinolone medicine (including ciprofloxacin, levofloxacin)
  • Steroid medicine
• Take this medicine at least 2 hours before or 4 hours after using bile acid sequestrants (including cholestyramine, colesevelam, colestipol).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart problems (including heart attack), stroke, gout, muscle problems, or a history of tendon problems.
• This medicine may cause the following problems:
  • Increased uric acid levels in the blood, which can lead to gout
  • Tendon problems, including swelling, inflammation, or rupture
  • Increased risk for muscle pain or weakness, especially when taken together with simvastatin or pravastatin
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, bloody urine
• Hearing or feeling a snap or pop, bruising right after an injury, or unable to move or put weight in an affected tendon area, including the shoulder, upper arm, or back of the ankle
• Joint pain, stiffness, or swelling, lower back, side, or stomach pain, swelling of the feet or lower legs
• Muscle pain or weakness
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Arm or leg pain
• Diarrhea

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088