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.

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.

Healthier Eating Choices

Consider the following

  • Eat more foods with soluble fiber such as peas, beans, apples, broccoli, and oatmeal.
  • Lower your fat intake to about 30% of the total calories that you eat in a day.
  • Reduce the saturated fats in your diet.

Some facts about fat

  • All fats give your body energy, but there are some big differences.
  • Trans and saturated fats raise your LDL “bad” cholesterol. Foods that contain these types of fats include pastries, fried foods, fatty meat, and butter.
  • Monounsaturated and polyunsaturated fat can lower your LDL "bad" cholesterol. Foods that contain monounsaturated and polyunsaturated fats include vegetable oil, olive oil, fatty fish like salmon, and nuts.
  • All fats are equally high in calories. They contain nine calories per gram, which is more than twice the calories of carbohydrates and proteins. While your body needs some fat, it’s best to choose foods with monounsaturated and polyunsaturated fat, while keeping your intake of foods with high saturated fat to a minimum.

Choosing leaner meats

  • Instead of frying, try broiling, grilling, roasting, or poaching.
  • Before serving, be sure to drain off any fat that appears after cooking.
  • Try to avoid breading your meat. Besides adding calories, breaded meat can soak up more fat when frying.

Understanding empty calories

  • Foods with empty calories are loaded with sugar and/or fat and contain few essential vitamins and minerals.
  • Foods that contain empty calories include cakes, cookies, soda, hot dogs, and whole-fat dairy products such as some cheeses and ice cream.

Heart-healthy diet tips and recipes

Regular Exercise Routine

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 may be able to continue drinking grapefruit juice while taking LIVALO.
  • LIVALO is available in 1-mg, 2-mg, and 4-mg tablets.