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 should I talk to my doctor about?

  • If you take LIVALO, tell your doctor right away if you experience any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by fever or a general feeling of discomfort. This could be a sign of a rare but serious side effect.
  • Your doctor should do blood tests to monitor your liver function before starting LIVALO, and then at 12 weeks following the start of LIVALO, after any increase in dose, and periodically (e.g., every 6 months) thereafter.

How LIVALO® Works

LIVALO belongs to a class of drugs that are commonly known as “statins.” LIVALO works by blocking a certain protein known as an “enzyme” from being made in your body. This protein controls how much cholesterol your body makes.

Since this protein is no longer made, your liver can also collect more LDL “bad” cholesterol from your blood and remove it. Because of this, your LDL “bad” cholesterol may be reduced, while your HDL “good” cholesterol may 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 (CYP).

LIVALO is mainly metabolized apart from a common metabolic pathway.

  • LIVALO is not dependent on this common metabolic pathway in order to be processed. Depending on the medications you are taking, this may mean there is potential for fewer drug interactions with LIVALO.

Illustrated metabolism of LIVALO

Could LIVALO Be Right for Me?

Important Safety Information for LIVALO® (pitavastatin) Tablets

Who should NOT take LIVALO?

LIVALO is not right for everyone, including:
  • Those who have had an allergic reaction to LIVALO
  • Anyone with active liver disease
  • Women who are nursing, pregnant, or who may become pregnant
  • Anyone currently taking cyclosporine

What should I talk to my doctor about?

  • If you take LIVALO, tell your doctor right away if you experience any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by fever or a general feeling of discomfort. This could be a sign of a rare but serious side effect.
  • Your doctor should do blood tests to monitor your liver function before starting LIVALO, and then at 12 weeks following the start of LIVALO, after any increase in dose, and periodically (e.g., every 6 months) thereafter.
  • Please talk to your doctor about your alcohol use.
  • Tell your doctor about all the medications you take including nonprescription medicines, vitamins, or herbal supplements.

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.

Other Important Information about LIVALO

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

Please see Full Prescribing Information.
PS73370 LIV-RA-0032    8/2011

What else should I know about LIVALO?

  • LIVALO can be taken with or without food. It’s even okay to continue drinking grapefruit juice.
  • LIVALO is available in 1-mg, 2-mg, and 4-mg doses.

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