Important Safety Information for Zypitamag® (pitavastatin) tablets

Who should NOT take ZYPITAMAG?

ZYPITAMAG is not right for everyone. Do not take ZYPITAMAG if:

• You have a known allergy to ZYPITAMAG 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 ZYPITAMAG.
• Serious liver problems have been reported rarely in patients taking statins, including pitavastatin. Your doctor should do liver tests before you start, and if you have symptoms of liver problems while you are taking ZYPITAMAG. 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 pitavastatin.
• Tell your doctor about your alcohol use.
• Tell your healthcare provider of a known or suspected pregnancy.

What are the most common side effects of ZYPITAMAG?

The most common side effects of ZYPITAMAG 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 ZYPITAMAG?

• Store ZYPITAMAG tablets at room temperature, in a dry place, and out of the reach of children.
• Take ZYPITAMAG orally once daily with or without food at the same time each day.
• Swallow the tablet whole. Do not split, crush, dissolve, or chew.
• The maximum recommended dosage is ZYPITAMAG 4 mg once daily.
• If you take too much ZYPITAMAG or you or someone else takes an overdose, call your doctor and/or local Poison Control Center.

Other important information I should know about ZYPITAMAG.

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

For additional information, please see the full Prescribing Information.