LIVALO® (pitavastatin) tablets is a prescription medicine that, along with diet, has been approved for the treatment of high cholesterol. LIVALO has not been studied to evaluate its effect on reducing heart-related disease or death.

Other important information I should know about LIVALO.

  • LIVALO has not been studied to evaluate its effect on reducing heart-related disease or death.
  • LIVALO is available by prescription only.

Understanding Cholesterol

What is cholesterol?

  • Cholesterol is made by your body in the liver. It’s a waxy, fat-like substance found in the walls of cells in all parts of your body, from the nervous system to the liver.
  • Your body makes all the cholesterol it needs in order to work the right way. It uses cholesterol to make hormones, vitamin D, and substances that help you digest foods.
  • Cholesterol is also found in foods with a large percentage of saturated fats, such as egg yolks, whole-milk dairy products, and high-fat meats.
  • Cholesterol travels in the bloodstream in small packages called lipoproteins. Two main kinds of lipoproteins carry cholesterol in the blood. It’s important to have healthy levels of both.

What are the two major types of cholesterol?

  • High-density lipoprotein cholesterol, or HDL-C, is called “good” cholesterol because it takes cholesterol from tissues to the liver, which removes it from the body.
  • Low-density lipoprotein cholesterol, or LDL-C, is called “bad” cholesterol because it carries cholesterol to tissues, including the arteries. Most of the cholesterol in the blood is the LDL-C form.

What is high cholesterol?

When the level of LDL “bad” cholesterol in your blood is high, the condition can be serious. By itself, high cholesterol does not cause any symptoms, so many people are unaware of it.

LIVALO® has not been studied to evaluate its effect on reducing heart-related disease or death.

The chart below lists various levels of cholesterol. Be sure to ask your doctor about how often your cholesterol should be checked.

What do the following cholesterol numbers mean?

Please keep in mind that your doctor is the best source of information on cholesterol and what specific levels may mean to your health.

LDL “BAD” Cholesterol
<100 mg/dL Optimal
100-129 mg/dL Near Optimal/Above Optimal
130-159 mg/dL Borderline High
160-189 mg/dL High
≥190 mg/dL Very High
HDL “GOOD” Cholesterol
<40 mg/dL Low
Triglycerides
<150 mg/dL Normal
150-199 mg/dL Borderline High
200-499 mg/dL High
≥500 mg/dL Very High
Total Cholesterol
<200 mg/dL Desirable
200-239 mg/dL Borderline High
≥240 mg/dL High
Adapted from National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III).

What should I do about my high cholesterol?

Healthy eating habits and regular exercise are both important factors when working to lower your LDL “bad” cholesterol. Even small changes in your diet, such as eating foods with more soluble fiber and reducing your saturated fats, may help to lower LDL “bad” cholesterol. If diet and exercise don’t lower your total cholesterol, your doctor may prescribe a statin like LIVALO. Always talk to your doctor before starting or changing any diet and exercise program.

Managing My Cholesterol

Important Safety Information for LIVALO® (pitavastatin) tablets

Who should NOT take LIVALO?

LIVALO is not right for everyone. Do not take LIVALO if:
  • You have a known allergy to LIVALO or any of its ingredients.
  • You have active liver problems, including some abnormal liver test results.
  • You are nursing, pregnant or may become pregnant, as it may harm the baby.
  • You are currently taking cyclosporine or gemfibrozil.

What is the most important information I should know and talk to my doctor about?

  • Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, itching, or hives.
  • Muscle problems may be an early sign of rare, serious conditions. Tell your doctor right away if you have any unexplained muscle pain, weakness, or tenderness, particularly if accompanied by malaise or fever, or if these muscle signs or symptoms persist after discontinuing LIVALO.
  • Serious liver problems have been reported rarely in patients taking statins, including LIVALO. Your doctor should do liver tests before you start, and if you have symptoms of liver problems while you are taking LIVALO. Tell your healthcare provider right away if you feel more tired than usual, have a loss of appetite, upper belly pain, dark-colored urine, or yellowing of the skin or eyes.
  • Tell your doctor about all your medical conditions and medications you take including nonprescription medicines, vitamins, or herbal supplements.
  • Increases in blood sugar levels have been reported with statins, including LIVALO.
  • Tell your doctor about your alcohol use.

What are the most common side effects of LIVALO?

The most common side effects of LIVALO in clinical studies were:
  • Back pain
  • Constipation
  • Diarrhea
  • Muscle pain
  • Pain in the legs or arms

This is not a complete list of side effects. Talk to your healthcare provider for more information.

You are encouraged to report negative side effects of all drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

How should I store and take LIVALO?

  • Store LIVALO tablets at room temperature, in a dry place, and out of the reach of children.
  • LIVALO can be taken at any time of day, with or without food.
  • Swallow the tablet whole. Do not split, crush, dissolve, or chew.

Other important information I should know about LIVALO.

  • LIVALO has not been studied to evaluate its effect on reducing heart-related disease or death.
  • LIVALO is available by prescription only.

For additional information please see the full Prescribing Information.
LIV-RA-0052 PS81389 10/2012

What else should I know about LIVALO?

  • You can continue to drink grapefruit juice while taking LIVALO.
  • LIVALO is available in 1-mg, 2-mg, and 4-mg tablets.