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
- 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.
What else should I know about LIVALO?
- You may be able to continue drinking grapefruit juice while taking LIVALO.
- LIVALO is available in 1-mg, 2-mg, and 4-mg tablets.