Select Safety Information about your liver and LIVALO.

Anyone with active liver disease should not take LIVALO. 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.

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.

You might be aware that cholesterol is made in the liver. But did you know approximately 75% of all drugs processed in the body share a common metabolic pathway in the liver? When drugs that share this pathway are taken together or with other drugs that affect this pathway, a drug interaction may occur.

LIVALO reduces your cholesterol, but it’s not dependent on this pathway in order to be processed. Why is this important? Because knowing how drugs are processed in the body may help avoid certain interactions.

To learn more about potential drug interactions that may occur with LIVALO or other medications, talk to your doctor and ask whether LIVALO may be right for you.

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.

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.