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.

Glossary

Artery
One of the many elastic-walled vessels that carry blood away from your heart to other areas of your body.
Calorie
The unit of measurement that records the amount of energy released by the food that you eat.
Drug Interaction
The result of a medication combining with something else, including disease, another medication, food, or supplements, which may influence the medication’s action or cause side effects.
Fat
An organic compound made up of glycerides and fatty acids found in the tissue of animals and in certain plants.
High blood pressure
A medical condition in which blood pumps at a higher-than-average force through your arteries.
HDL “good” cholesterol/HDL-C
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.
LDL “bad” cholesterol/LDL-C
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.
Metabolism
The sum of the processes by which a particular substance is handled in the living body.
Saturated fat
A type of fat, most often from animals, that is solid at room temperature. Saturated fats may raise the level of cholesterol in your blood.
Soluble fiber
A type of fiber that attracts water and slows your digestion, making you feel full longer. Soluble fiber is found in certain foods, such as peas, beans, and apples.
Statin
A type of drug that lowers your bad cholesterol and triglycerides, and raises your good cholesterol.
Triglycerides
An energy source forming much of the fat that is stored by your body. Triglycerides should be kept at low levels for good health.

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.