Pronunciation:

bem-pe-DOE-ik AS-id, e-ZET-i-mibe

Brand Names:

• Nexlizet

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antihyperlipidemic

Pharmacologic—

Cholesterol Absorption Inhibitor

Uses of This Medicine:

Bempedoic acid and ezetimibe combination is used together with diet and other cholesterol-lowering medicines (eg, statins) to treat patients with heterozygous familial hypercholesterolemia (HeFH) and patients with heart disease who need additional lowering of their bad cholesterol (LDL) levels.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of bempedoic acid and ezetimibe combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bempedoic acid and ezetimibe combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bezafibrate
• Cholestyramine
• Ciprofibrate
• Clofibrate
• Colesevelam
• Colestipol
• Cyclosporine
• Fenofibrate
• Fenofibric Acid
• Gemfibrozil
• Pravastatin
• Simeprevir
• Simvastatin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Eltrombopag

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Gout or
• Muscle problems or
• Tendon problems, or history of—Use with caution. May make these conditions worse.

• Heart problems, including heart attack or
• Patients with end-stage kidney disease receiving dialysis or
• Stroke—Use has not been studied in patients with these conditions.

• Liver disease, moderate or severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with patient information insert. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Take this medicine with or without food. Swallow the tablet whole. Do not cut, crush, or chew it.

Take this medicine at least 2 hours before or at least 4 hours after using bile acid sequestrants (eg, cholestyramine, colesevelam, colestipol).

Carefully follow your doctor's orders about any special diet.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For heterozygous familial hypercholesterolemia (HeFH) and patients with heart disease who need additional lowering of their bad cholesterol (LDL) levels:
    • Adults—One tablet once a day together with a statin medicine. Each tablet contains 180 milligrams (mg) bempedoic acid and 10 mg ezetimibe.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Ezetimibe may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may increase the uric acid levels in the blood (hyperuricemia), which can lead to gout. This can occur within 4 weeks of using this medicine. Check with your doctor right away if you have joint pain, stiffness, or swelling, lower back, side, or stomach pain, or swelling of the feet or lower legs.

Tendon problems, including swelling, inflammation, or rupture can occur in the shoulder (rotator cuff), upper arm (biceps tendon), or Achilles tendon at the back of the ankle, within days or months after starting treatment with bempedoic acid and ezetimibe combination. If you hear or feel a snap or pop, have bruising right after an injury, or are unable to move or put weight in an affected tendon area, check with your doctor right away. Avoid using and exercising the affected area.

Using this medicine together with simvastatin or pravastatin may increase your risk of developing muscle pain or weakness. Talk to your doctor if you have any concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Ankle, knee, or great toe joint pain

arm, back, or leg pain

bloody urine

body aches or pain

chills

cough

cough producing mucus

difficulty breathing

difficulty in moving

difficulty urinating

dizziness

ear congestion

fainting

fast or irregular heartbeat

fever

frequent urination

headache

joint pain, stiffness, or swelling

loss of voice

lower back, side, or stomach pain

muscle pain, spasm, or stiffness

pain or tenderness around the eyes and cheekbones

pale skin

runny or stuffy nose

sneezing

sore throat

swelling of the feet or lower legs

tightness in the chest

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

Rare

Bone pain

Incidence not known

Black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

bloating

chills

constipation

dark urine

diarrhea

difficulty swallowing

gaseous stomach pain

hives, itching, skin rash

indigestion

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

light-colored stools

loss of appetite

muscular tenderness, wasting, or weakness

pains in the stomach, side, or abdomen, possibly radiating to the back

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

recurrent fever

red, irritated eyes

severe nausea or vomiting

sores, ulcers, or white spots in the mouth or on the lips

stomach fullness

upper right stomach pain

yellow eyes or skin

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

discouragement

feeling sad or empty

irritability

loss of interest or pleasure

trouble concentrating

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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