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.

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.

The LIVALO® (pitavastatin) Promise Program

A Money-Back Offer for Up to the First 90 Days

If your doctor is concerned about lowering your LDL “bad” cholesterol and triglycerides and raising your HDL “good” cholesterol, you may be prescribed LIVALO. Along with diet, LIVALO can help you reach healthier cholesterol levels.

We welcome you to try LIVALO. Through our Promise Program, if you are not satisfied, you may be reimbursed up to 100% of your out-of-pocket prescription costs, with a maximum reimbursement of $75, for up to the first 90 days.*

*Maximum reimbursement of $75. You are not required to use LIVALO for the full 90 days in order to be eligible for reimbursement. Please see full Terms and Conditions, including eligibility requirements, below.

The LIVALO Promise Program is not a guarantee of efficacy. It provides a trial period that may help doctors and patients to assess the efficacy, safety, and tolerability of LIVALO.

Terms and Conditions

Reimbursement offered for up to the first 90 days on out-of-pocket prescription costs for LIVALO therapy to a maximum of $75. No reimbursement will be made if the reimbursement form is submitted after 8 months from the date of the first paid prescription. Prescriptions for more than one tablet per day are not eligible for reimbursement. Limit one reimbursement per person.

Offer void where prohibited by law. Valid only in the United States and Puerto Rico for residents of the US and PR. This offer is unavailable for patients whose prescription claims for LIVALO are reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap or any other federal or state program, such as Champus, DOD, the VA, TRICARE, or any State Patient or Pharmaceutical Assistance Program. By accepting this offer, you agree to notify your insurance carrier of reimbursement if required to do so by law or under the terms of coverage.

Additional exclusions may apply and this offer may be terminated, rescinded, revoked, or amended by Kowa Pharmaceuticals America, Inc. and Lilly USA, LLC at any time without notice.

To be eligible for reimbursement, the entire reimbursement form must be complete. A copy of pharmacy receipt(s) must be submitted with the reimbursement form, clearly identifying LIVALO as the product purchased and indicating your name, the number of capsules dispensed, and the out-of-pocket amount paid. If any portion of your prescription costs are paid or reimbursed by a third-party payer (i.e., insurance company), a copy of your prescription coverage card, clearly identifying your name and group number, must be submitted with your reimbursement form. To be eligible for reimbursement, receipts must be submitted within eight months of the transaction date. Please allow 6-8 weeks to receive reimbursement.

If you have questions about the LIVALO Promise Program, please call toll-free, 1-866-923-1953.

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.