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.

How LIVALO® (pitavastatin) Is Processed in the Body

LIVALO belongs to a class of drugs that are commonly known as “statins.” LIVALO works by blocking a certain protein known as an "enzyme" that controls how much cholesterol your body makes. Because of this, your LDL "bad" cholesterol can be reduced, while your HDL "good" cholesterol can be increased.

Metabolism of LIVALO

  • The more drugs that are metabolized by a shared pathway, the greater the chance for drug interaction. You might not be aware that approximately 75% of all drugs processed in the body share the common metabolic pathway known as cytochrome P450 (CYP450).

LIVALO is mainly metabolized apart from this common metabolic pathway.

  • LIVALO is minimally dependent on this common metabolic pathway in order to be processed and may be less likely to interact with drugs that depend on this pathway.

Illustrated metabolism of LIVALO

Drug Interactions with LIVALO

  • If you are taking cyclosporine, do not take LIVALO.
  • Avoid use with gemfibrozil.
  • Caution should be taken when using LIVALO in combination with other cholesterol drugs like niacin and fibrates, as this may increase your risk of serious muscle problems.
  • Some drugs, like erythromycin and rifampin, may lead to drug interactions requiring a lower maximum daily dose of LIVALO, when used in combination.
Things to Know About LIVALO

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.