IMPORTANT SAFETY INFORMATION for ZYPITAMAG (pitavastatin) tablets

What is ZYPITAMAG?

ZYPITAMAG is a cholesterol-lowering medication called a "statin" that, along with a heart-healthy diet, helps to lower "bad" cholesterol (LDL-C) in adults with elevated cholesterol levels.

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.
• 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, or if breastfeeding.

What are the most common side effects of ZYPITAMAG?

The most common side effects of pitavastatin in clinical studies were:

• Muscle pain
• Constipation
• Diarrhea
• Back pain
• Pain in arms or legs

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, protected from light, and keep 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 is available by prescription only.
• ZYPITAMAG is not approved for use in patients under 18 years of age.

For additional information, refer to full Prescribing Information.

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.